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Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Learn More

About The Role

Job Title : Clinical Support Specialist - West

The Clinical Support Specialist is responsible for all aspects of the initial training and support for the customer team, including physicians, nurses, radiographers, MRI Technologists, and other relevant personnel in the use of Hyperfine’s Swoop Portable MRI System. This role will assist in optimizing customer experience by acting as a true consultant with regards to integrating the Swoop System within a customer’s workflow and procedures. The person in this role will partner effectively to relay customer feedback to internal Hyperfine teams and will function as the clinical specialist during the product sales cycle in close collaboration with the Sales, Marketing, Clinical Science, and R&D groups. They will also support clinical adoption, utilization, customer engagement, and related account activities for our customers.

RESPONSIBILITIES:

• Train hospital staff on the safe and effective use and operation of Hyperfine products within the clinical areas including amending workflow and optimize product value and utilization
• Provide customized training and support for new operators of the Swoop System and maintain strategic relationships and support post-installation
• Develop and maintain relationships in accounts with key personnel within the hospital and consult on best practices and use cases
• Provide R&D with clinical input and feedback for new projects
• Support the sales team byidentifyingcustomer needs and relaying potential opportunities within the existing installed base
• Support new product evaluation and clinical studies
• Support the centers in optimizing their standard procedures and workflows
• Support adoption and utilization activities and escalate retention or expansion opportunities
• Collaborate with the sales team by providing technical support in various sales cycles to win new business, including accompanying site visits as neededfor demonstrations
• Work with the sales team to support Swoop utilization activities
• Support assigned opportunities to enhance client relationships and increase adoption within a facility or network.
• Partner with internal stakeholders (ex. sales, product, marketing, clinical sciences,clinical applications) to share feedback, identify trends, and make introductions thatresult in increased value for the customer and Hyperfine
• Identify potential attrition risks and product gaps and escalate them with recommended follow-up actions.
• Work closely with teammates and/or RN counterparts to provide customer success to install base customers and future potential customers
• Represent Hyperfine and demonstrate products at trade shows and society meetings
• Support MRI peer champion and Key Opinion Leader (KOL) development activities.
• MRI safety and screening knowledge and analyzing contraindications regarding portable low field vs. high field MR
• MRI sequence and protocol understanding workflow optimization
• Support scanner software and firmware upgrades for customers
• Perform scanner implementations at customer sites
• Perform virtual and on site training of scanners to customers
• Participate in image review with customer physicians and Hyperfine medical officers
• Backup / support for image demonstrations
• Case review with healthcare staff
• Trade show image support and case reviews

KNOWLEDGE AND SKILL:

• In-depth knowledge reading of the critical care setting to make consultative clinical recommendations to optimize procedures
• Experience working with a variety of stakeholders including physicians, business administration, clinical, etc.
• Ability to build effective relationships with customer stakeholders and support adoption of clinical workflows
• Strong problem solver with sound judgment
• Hands on, strong team player, and fully accountable for delivering agreed-upon tactical performance metrics
• Excellent written and verbal communication skills
• Highly organized and able to multitask
• Articulate, analytical, technically savvy, and professional
• Strong computer skills
• Self-driven and self sufficient
• Positive attitude and team player-oriented individual
• Excellent time management, including managing daily schedule, travel plans, and expenses

EDUCATION/EXPERIENCE REQUIRED:

• Associate’s degree in Radiology Sciences or related field
• Registered Technologist with the ARRT (American Registry of Radiologic Technologists) and current credentialing in MR (Magnetic Resonance) or equivalent
• 3+ years’ experience in clinical MR imaging or similarexperiencesuch as 3+ yearsX-ray + 2 years in MRI in a hospital setting
• 2+ years’ experience operating in clinical applications or clinical training experience

PHYSICAL DEMANDS:

• Reside in assigned territory and ability to work from home-based office
• Able to travel up to 75% of the time within and outside of territory, including occasional weekend travel
• Ability to work long hours and execute under pressure with short turnaround times
• Live near a major airport
• Have an automobile for ground-based transportation

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa.

The annual base salary for this position is between $100,000 - $120,000. This position is also eligible for to participate in Hyperfine’s corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set, relevant experience, qualifications, location, position level, and other job-related reasons.

Agency Resumes: We do not accept resumes from recruitment agencies without a prior agreement in place. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.

Who We Are

Evergreen Nephrology partners with nephrologists to transform kidney care through a value-based, person-centered, holistic, and comprehensive approach to kidney care. We believe patients living with kidney disease deserve the best care. We are committed to improving patient outcomes and improving quality of life by delaying disease progression, shifting care to the home, and accelerating kidney transplants.

We help nephrologists focus on the right patients at the right time across the full care spectrum. We do this by providing them with the best-in-class interdisciplinary clinical resources, analytical insight and tools, and services to patients. We listen to the needs of our patients, our employees, and our client partners, continually working to push beyond the status quo in which the care system manages patients today.

Who You Are

You are devoted, compassionate, and enjoy being on the front lines of healthcare, changing the lives of patients by supporting them and the team by focusing on customers. You’re excited about being part of a team that is building a healthcare delivery model that ensures the highest possible quality of life and best outcomes for those in our care. You believe people living with kidney disease deserve the best person-centered, holistic, comprehensive care and want to influence the healthcare system to drive towards that. You thrive in innovative and evolving environments with high rates of change.

Your Role

As a Telephonic Pharmacy Care Coordinator with Evergreen, you play a critical patient-facing and operational role in our pharmacy program. This is a 6-month contract with the opportunity to convert to full-time employment. This program connects patients with a specialized mail-order pharmacy that provides pre-sorted, multi-dose medication packaging (pill packs) along with proactive refill management and periodic care team check-ins, helping ensure patients stay on track with complex medication schedules. Working fully remotely by phone, you are often the first voice patients hear from the pharmacy care team — helping establish trust, explain the value of the pharmacy service, and guide patients through enrollment.

You work with patients from our partner practices to engage them, capture consent, and set up timely access to medications and pharmacist-led clinical services. You’ll explain how the service works — multi-dose pill packs organized by date/time, home delivery and automatic refill coordination so patients never run out, and scheduled check-in calls to review adherence and address new prescriptions or dose changes. When a patient agrees to participate, you act directly in the electronic health record — updating the patient’s preferred pharmacy, triggering electronic prescriptions, and documenting consent or decline based on the patient’s decision. Your primary focus is high-volume outbound outreach to patients who do not have an office visit, or who cannot be supported onsite, along with inbound support as needed.

This role is focused on telephonic patient engagement, consent and enrollment, EHR documentation, and care coordination for patients living with chronic kidney disease and other complex chronic conditions. Success depends on your ability to connect with patients quickly over the phone, communicate value clearly, and remove the barriers that keep patients from staying consistent with their medications.

Role Responsibilities

Some responsibilities may vary based on specific patient programs, but this role’s primary duties include the following:

• Conduct high-volume outbound telephone outreach to patients to introduce Evergreen’s pharmacy service, establish rapport and trust, and guide patients through enrollment.

• Deliver clear, standardized messaging over the phone — using approved scripts and talking points to drive consistent, informed enrollment decisions and manage patient questions and objections.

• Obtain and document patient consent by phone, and capture the information needed to enroll the patient.

• Make the necessary changes in the EHR based on the patient’s decisions — updating the patient’s preferred pharmacy, triggering electronic prescriptions (eRxs) to the pharmacy partner, and accurately documenting consent or decline in the patient’s chart.

• Manage outreach queues and follow-up cadences, completing multiple contact attempts per patient and prioritizing outreach based on urgency and targets.

• Accurately document all call activity, outreach attempts, accepts/declines, and coordination activities in Evergreen’s clinical and operational systems, supporting accurate enrollment and success-rate tracking.

• Meet call center performance expectations, including call quality, productivity, average speed of answer, and enrollment/conversion targets.

• Uphold patient privacy and confidentiality standards in accordance with HIPAA and organizational policies.

• Other duties consistent with this role, as assigned.

Location

• While this position is fully remote, you must be able to work 8:30am – 5pm in the eastern time zone.

Required Qualifications

• Current Medical Assistant certification (CMA/RMA).

• Experience in a telephonic, call-center, or high-volume outbound patient/customer outreach environment.

• Strong interpersonal and communication skills, with the ability to build trust and engage patients over the phone.

• Experience in healthcare, pharmacy, care coordination, or other patient support roles.

• Comfort and proficiency working within an electronic health record (EHR/EMR) — documenting encounters, reviewing medication lists, and making authorized updates.

• Strong organizational skills and attention to detail, with the ability to manage multiple patients, tasks, and follow-ups across an outreach queue.

• Working knowledge of HIPAA and a demonstrated commitment to protecting patient privacy and PHI.

• Intermediate skills with MS Office Suite of products including Outlook and Teams

• Able to work effectively in a primarily remote environment:

  • Home internet must support a minimum download speed of 25 Mbps and upload speed of 10 Mbps. Cable, Fiber, or DSL connections hardwired to the internet device are recommended
  • Evergreen will provide remote employees with telephony applications and equipment to meet the business requirements for their role
  • Employees must work from a dedicated space lacking ongoing interruptions to protect member PHI / HIPAA information

Preferred Qualifications

• Prior experience in a healthcare call center or telephonic patient outreach/enrollment role.

• Bilingual (English/Spanish)

• Experience with phone-based consent capture or enrollment workflows.

• Background in care navigation, including connecting patients to community resources and addressing social determinants of health.

• Familiarity with common chronic disease medications and prescription coverage terminology.

Compensation

The pay range for this role is $19-$23 per hour. Exact pay is determined based on experience, education, demand for the role, and other role-specific factors.

Benefits

Evergreen Nephrology’s total rewards program is designed to support you in and outside of work. You can expect:

• Paid time off starting at 4 weeks for full-time employees

• 12 paid holidays per year

• Medical, dental, vision and life insurance, including an HSA with employer match

• Reimbursement for continuing medical education for eligible roles

• A 401(k) program where Evergreen matches up to 4% of contributions after six months of tenure

• Paid parental leave

• A robust training and development program that starts with onboarding and continues throughout your career with Evergreen Nephrology

Evergreen Nephrology is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition or any other protected category under local, state or federal laws.

If you are an applicant with a disability who requires reasonable accommodation for any part of the hiring process, please contact us for assistance at recruiting@evergreennephrology.com.

Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.

We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.

Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

About The Role

The Clinical Lab Supervisor is a leader in Natera’s lab operations whose role is to oversee employees’ performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines.

What You Will Do

• Responsible for day-to-day staffing/scheduling/setting up sample run schedules.
• Ensures production work is consistently completed according to department goals.
• Ensures all case samples are processed and accounted for.
• Monitors team members to ensure adherence to SOPs and safety procedures.
• Oversees training for new hires: works in conjunction with lead to train new hires.
• Document nonconformance reports and all corrective actions taken when test systems deviate from the established performance specifications as needed. Escalates protocol deviation to lead/supervisor.
• Handles employee issues. Collaborates with Manager and/or Human Resources to resolve issues.
• Assists manager in initiating and completing CAPAs.
• Ensures alignment with team for reasoning behind instructions/processes and changes.
• Meets regularly with individual team members to discuss goals and progress.
• Responsible for staff performance reviews.
• Plans and leads shift meetings.
• Maintains team morale and professionalism of team members, including by acting as role model. Adheres to Departmental Expectations.
• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action. Go-to person when manager is not present.
• May assist lab team in day to day tasks.
• Keeps team morale up and maintains professionalism of team members, including by acting as role model.
• Assists the team in day to day lab work if necessary.
• Approves timecards and PTO requests.
• Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.
• Understands the entire lab process and can identify and troubleshoot issues when they arise. Understands when and how to escalate issues appropriately.
• Makes sure the goals set by manager for the team are being met in the lab.
• Performs and completes side projects assigned by the manager.
• Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.
• Receives assignments in the form of objectives with goals and the process by which to meet goals.
• Provides direction to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees.
• Recommends changes to unit or sub-unit policies.
• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors.
• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• Employee must pass post offer criminal background check.
• Performs other duties as assigned.

What You Will Bring

• 6+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment.
• BS/BA degree (or equivalent) in Medical Technology, Biological Sciences, or a related field.
• Current MT/MLS/CLS certification preferable from ASCP, AMT, or AAB.
• Proven leadership experience.
• Able to take on projects with little supervision.
• Excellent interpersonal, communication, computer, troubleshooting, and pipetting skills.
• Experience in Molecular Biology.
• Excellent oral and written communication skills.
• Word processing and data management skills.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in BSL-1 to 2 laboratories with potentially hazardous material Standing or sitting for long periods of time may be necessary
• Duties may require working weekends and overtime
• Must be able to lift boxes or supplies up to 35lbs
• Duties require wearing safety goggles, gloves, and laboratory coat.
• Duties may require exposure to cold air due to frequent accessing of refrigeration and/or freezer units.

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range

$91,100.00 - $100,000.00

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Italian and English.
• Attention to detail.
• Able to perform well as a team member.

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Experience with contract negotiation.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Bulgarian and English.
• Attention to detail.
• Able to perform well as a team member.

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

Build the pharmacy business that powers the next generation of Medicare Advantage. Clover is building more than a dispensing operation. We are building a strategic healthcare business that can improve...

When our values align, there's no limit to what we can achieve.

This telework opportunity allows you to customize your schedule and caseload within the week while maintaining client-mandated turnaround times.

Du interessierst dich für ADHS im Erwachsenenalter und möchtest dich in diesem Bereich fachlich weiterentwickeln?

Telehealth Mental Health Therapist – Remote. Both FT and PT opportunities.

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Eurofins BPT-Columbia is seeking a Deviations & Investigations Scientist to join our Chemistry team in Columbia, Missouri. This partially remote position is responsible for supporting laboratory investigations, deviation management, stability studies, and batch release activities within a GMP-regulated environment.

The Deviations & Investigations Scientist serves as a key contributor to quality and compliance initiatives by leading and documenting investigations associated with laboratory deviations, out-of-specification (OOS) results, out-of-trend (OOT) findings, atypical results, and other quality events. This role partners closely with laboratory operations, Quality Assurance, and technical teams to identify root causes, assess impact, implement corrective and preventive actions (CAPAs), and maintain compliance with regulatory expectations.

This intermediate-level position combines scientific expertise with technical writing, data analysis, and quality systems knowledge. The successful candidate will independently manage investigations, review analytical data, support stability and batch release programs, and contribute to continuous improvement efforts while ensuring data integrity and adherence to GMP requirements.

Key Responsibilities

• Lead and author laboratory investigations related to deviations, OOS, OOT, atypical results, and quality events.
• Perform root cause analyses and support development and implementation of CAPAs.
• Review analytical data and laboratory documentation to support investigation conclusions.
• Support stability testing and batch release activities through data review and quality assessments.
• Collaborate with laboratory, quality, and operational teams to resolve technical and compliance issues.
• Ensure investigations are completed accurately, thoroughly, and within established timelines.
• Maintain compliance with GMP, GLP, regulatory, client, and internal quality requirements.
• Utilize LIMS and quality systems to manage documentation and maintain records.
• Prepare technical reports, investigation summaries, and supporting quality documentation.
• Identify quality trends and contribute to process improvements and operational excellence initiatives.

Qualifications

The ideal candidate would possess:

• Experience with GLP and/or GMP and hands-on experience with HPLC and/or GC desirable.
• Experience with LIMS system desirable.
• Familiarity and/or experience in a laboratory setting is required.
• Good organizational skills; ability to follow direction and good communication skills are required.
• Ability to work on multiple on-going projects.

Minimum Qualifications:

• Bachelor’s degree in relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas.
• 1-3 years of experience working in a cGMP compliant lab
• Authorization to work in the US indefinitely without restriction or sponsorship

Additional Information

Position is full-time position, Monday - Friday 8:00am - 4:30pm. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply.

Excellent full time benefits including

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

The Senior Utilization Management Audit & Compliance Analyst serves as the subject matter expert for external customer audits, regulatory inquiries, and utilization management oversight activities. This position is responsible for reviewing audit requests, performing detailed analyses of utilization management data, researching findings within the UM system, Essette, and related systems, and preparing professional, evidence-based responses for health plans, clients, regulators, accreditation organizations, and other external stakeholders.

The ideal candidate possesses extensive Utilization Management experience across Medicare, Medicaid, Commercial, and Dual Eligible populations and maintains a strong understanding of applicable UM regulations, accreditation standards, and delegation requirements. This role requires exceptional analytical, writing, and communication skills, along with advanced Excel proficiency to analyze large data sets, identify trends, validate findings, and support audit responses.

JOB QUALIFICATIONS: KNOWLEDGE/SKILLS/ABILITIES

The Senior Utilization Management Audit & Compliance Analyst’s responsibilities include but are not limited to:

Audit Management & Customer Response

• Serve as the primary business lead for external customer audits and oversight reviews,
• Review audit findings, inquiries, corrective action requests, and data validation requests from health plans, clients, and regulatory agencies.
• Conduct comprehensive investigations to validate audit findings and determine root causes.
• Gather supporting documentation and evidence from UM systems, reporting tools, and operational teams.
• Draft clear, accurate, and professional written responses to customer audit findings.
• Develop corrective action plans and supporting documentation when appropriate.
• Ensure audit responses are completed accurately and within required timelines.
• Assist in customer meetings related to audit findings and performance reviews.
• Track recurring issues and recommend process improvements.
• Support implementation and monitoring of corrective action plans

UM System Review & Investigation

• Conduct detailed reviews of authorization records, cases, determinations, timelines, and workflow activities within Essette.
• Validate regulatory time frames, determination accuracy, and documentation requirements.
• Research audit findings and customer concerns using system data and supporting records.
• Collaborate with operational teams to resolve discrepancies and provide supporting documentation.
• Ensure audit findings are supported by accurate data and complete case reviews.

Data Analysis & Reporting

• Analyze utilization management data to support audits, customer inquiries, and business reviews.
• Utilize advanced Excel functions including: Pivot Tables, Pivot Charts, Advanced Filtering, VLOOKUP/XLOOKUP, Conditional Formatting, Data Validation, Trend Analysis and Reconciliation of large datasets
• Develop data summaries, reports, and audit exhibits.
• Identify trends, anomalies, and opportunities for operational improvement.
• Validate the accuracy and completeness of reported UM performance metrics.

Utilization Management Compliance

• Interpret and apply Utilization Management requirements across Medicare, Medicaid, Commercial, and Dual Eligible populations.
• Monitor compliance with CMS, NCQA , state regulatory, and client-specific requirements.
• Review UM processes for regulatory adherence and operational effectiveness.
• Identify potential compliance risks and recommend corrective actions.
• Partner with operational leaders to improve audit readiness and compliance performance.

Process Improvement & Audit Readiness

• Develop audit preparation tools, templates, and standard responses.
• Establish audit tracking and documentation processes.
• Identify opportunities to improve data accuracy, reporting consistency, and operational compliance.
• Participate in mock audits and readiness reviews.
• Assist in developing policies, procedures, and training materials related to UM compliance and audit activities.

EDUCATION:

• Bachelor’s degree in healthcare administration, public health, or related field preferred

EXPERIENCE:

• 5-10 years of experience in healthcare operations, UM, and/or audit support.
• Strong organizational skills with the ability to manage multiple operational processes and competing deadlines.
• Experience preparing reports and analyzing data.
• Excellent written and verbal communication skills, with attention to detail and accuracy.
• Ability to build strong cross-functional relationships across Operations, IT, and external clients.

SALARY: $90,000/Annually

Benefits Offered

• Competitive compensation and annual bonus program
• 401(k) retirement program with company match
• Company-paid life insurance
• Company-paid short term disability coverage (location restrictions may apply)
• Medical, Vision, and Dental benefits
• Paid Time Off (PTO)
• Paid Parental Leave
• Sick Time
• Paid company holidays and floating holidays
• Quarterly company-sponsored events
• Health and wellness programs
• Career development opportunities

Remote Opportunities

We are actively seeking new colleagues in: Arizona, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Michigan, North Carolina, Nevada, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington.

Our Story

Founded in 2005, Integra Partners is a leading national durable medical equipment, prosthetic, and orthotic supplies (DMEPOS) network administrator. Our mission is to improve the quality of life for the communities we serve by reimagining access to in-home healthcare. We connect Payers, Providers, and Members through innovative technology and streamlined workflows affording Members access to top local Providers and culturally competent care. By focusing on transparency, accountability, and adaptability, we help deliver better health outcomes and more efficient management of complex healthcare benefits.

With a location in Michigan plus a remote workforce across the United States, Integra has a culture focused on collaboration, teamwork, and our values: One Team, Drive Results, Push the Boundaries, Value Others, and Build Community. We’re looking for energetic, talented, and dedicated individuals to join our team. See what opportunities we have available; there may be a role for you to engage in a challenging yet rewarding career in healthcare. We look forward to learning more about you.

Integra Partners is an equal opportunity employer. We are committed to providing reasonable accommodations and will work with you to meet your needs. If you are a person with a disability and require assistance during the application process, please don’t hesitate to reach out. We celebrate our inclusive work environment and welcome members of all backgrounds and perspectives.

POSITION SUMMARY:  **This position is located in Stony Brook, NY**

A Phlebotomist serves patients by identifying the best method for retrieving blood; preparing specimens for laboratory testing; and performing screening procedures.  The Phlebotomist will also act as an operations manager for the designated patient service center (PSC) and oversee Natera’s phlebotomy program at the specified location.  Depending upon growth opportunities, this role may also require oversight of other phlebotomists as needed to support patient volume growth. *** IF YOUR STATE REQUIRES A PHLEBOTOMY LICENSE, IT MUST BE SENT IN WITH YOUR RESUME WITH YOUR APPLICATION ***

PRIMARY RESPONSIBILITIES:

• Verifies test requisitions by comparing information with orders and requisition documentation; brings discrepancies to the attention of Natera product management leadership.
• Verifies patient by reading patient identification.
• Obtains blood specimens by performing venipunctures and finger sticks.
• Maintains specimen integrity by using aseptic technique, following Natera[KC1]  procedures; observes isolation procedures.
• Tracks collected specimens by initialing, dating, and noting times of collection; maintaining daily tallies of collections performed[MB2]  in Natera provided system.
• Maintains quality results by following Natera procedures and testing schedule; recording results in the quality-control log; identifying and reporting needed changes reporting KPIs to product management leadership on biweekly basis.
• Maintains safe, secure, and healthy work environment by following standards and procedures; complies with legal regulations.
• Resolves unusual test orders by contacting the physician, pathologist, nursing station, or reference laboratory; referring unresolved orders back to the originator for further clarification; notifying internal Natera team [MB3] of unresolved orders. Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Enhances Natera’s phlebotomy reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic), in order to perform the job.
• Report any SPI or CAPA or NCR issues to internal Natera product management leadership team Assists with managing all phlebotomy equipment associated with the establishment and running of the patient service center[KC4] , may require heavy lifting of up to 50 pounds of supplies.
• May require reimbursable travel for stocking of supplies May include onboarding, training, and retraining of individual phlebotomists, as deemed necessary to support volume increases.
• Assists with managing Patient Service Center vendors.
• Assists with phlebotomy program management: Monitor distribution and claiming of blood draws Monitor customer feedback Manage small escalations as needed
• Manage scheduling issues
• Ensure continued and open communication regarding ongoing draw statuses General phlebotomy knowledge for PSC’s location (per state regulations)
• Must maintain a current status on Natera’s training requirements.

QUALIFICATIONS:

• Minimum of 5 years of phlebotomy experience
• 5+ years high-level customer care experience Managing/supervising phlebotomy operations and teams experience preferred BS/BA degree (preferred)
• High School Diploma (or equivalent) required Phlebotomy Certification (or equivalent) preferred, except where regulatory regulations are mandated depending upon state Previous financial and budgetary experience preferred
• Bilingual language skills preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to serve and protect Natera by adhering to professional standards, hospital policies and procedures, federal, state, and local requirements, and JCAHO standards.
• General understanding of mobile phlebotomy and general phlebotomy services.
• Excellent communication skills.
• Ability to work with cross-functional teams.
• Ability to learn and embrace online tools for effective program management.

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for 0.5 Fte! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this role your key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Experience with contract negotiation.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Spanish and English.
• Attention to detail.
• Able to perform well as a team member.

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-BL1

As a clinical informaticist on the product management team, you will play a crucial role in ensuring that clinical data sourced from dozens of EHR systems and health information exchanges is accurate, standardized, and actionable.

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations.

Responsibilities:

• Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
• Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits.
• Effectively communicate audit results, both orally and in writing, within target timeframes.
• Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion.
• Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit.
• Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.
• Participate in and support GCP inspections, as required.
• Provide support and consultation to RDQA and business partners with regards to GCP regulations.
• Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.

Qualifications

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
•  3-5 years of experience in the biopharmaceutical industry or with a regulatory authority
• 3-5 years of experience in Quality Assurance and/or Clinical Research Development
• Strong analytical skills and the ability to draw conclusions from presented data
• Ability to work effectively and efficiently in a dynamic environment with minimal supervision
• High level of awareness and understanding of clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
• Flexibility to adapt to changing assignments and ability to effectively prioritize
• Good project management, interpersonal, and communication skills with ability to work independently and as part of a team
• Willingness and ability to perform international travel
• Travel up to 40%

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations.

Responsibilities:

• Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
• Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits.
• Effectively communicate audit results, both orally and in writing, within target timeframes.
• Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion.
• Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit.
• Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.
• Participate in and support GCP inspections, as required.
• Provide support and consultation to RDQA and business partners with regards to GCP regulations.
• Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.

Qualifications

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
•  3-5 years of experience in the biopharmaceutical industry or with a regulatory authority
• 3-5 years of experience in Quality Assurance and/or Clinical Research Development
• Strong analytical skills and the ability to draw conclusions from presented data
• Ability to work effectively and efficiently in a dynamic environment with minimal supervision
• High level of awareness and understanding of clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
• Flexibility to adapt to changing assignments and ability to effectively prioritize
• Good project management, interpersonal, and communication skills with ability to work independently and as part of a team
• Willingness and ability to perform international travel

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About Integrated Specialty Coverages

Integrated Specialty Coverages, LLC (ISC) is a growth stage technology and data-driven commercial MGA and insurance wholesaler leading innovation in the market.

Backed by one of the leading private equity firms, Onex Partners, and led by a forward-thinking management team, ISC is combining the worlds of insurance and technology to create an Insurtech powerhouse. As a leading online distributor of insurance products for a range of industries and “Main Street USA”, we are looking for the right people to help us in our mission of achieving exponential growth. We strive to be the number one place to go for brokers and agents to source insurance. To accomplish this, we’re building a digitally focused team that deeply understands the intersection between user experience, data, and AI/ML to optimize the way we engage with our customers and partners.

Job Summary

The Complex Loss Specialist position at Golden State Claims Services reports to a Claims Supervisor or Claims Manager and will specialize in Allied Health claims. The chief duty of the Complex Loss Specialist for Allied Health claims is to adjust the most time-intensive, complex, and high exposure losses that require a higher level of technical expertise, knowledge, and negotiating ability, for the program(s) to which is assigned. The Complex Loss Specialist will have a high level of ability to provide analysis and presentations to Senior Executives and Program Executives for these complex matters and will be well-versed in leading strategic roundtable discussions to determine optimal resolution strategy.

Position Responsibilities

• Contribute to a collaborative environment by consistently demonstrating teamwork, high motivation, positive behavior, and effort to achieve goals and objectives.
• Building and maintaining productive relationships with internal and external customers, including clients, underwriting and service teams, and agents
• Research applicable coverage for our insureds. Document coverage dates, limits, and restrictions
• Identify and resolve any potential coverage questions. Draft reservation of rights and coverage denials for review and approval by their Supervisor/Manager
• Investigate facts of the loss by securing statements and supporting documentation such as contracts, cost of repair estimates, expert reports, photos, correspondence, etc.
• Document activities in writing within claim files
• Exercise judgment in applying legal liability to assigned claims and will have settlement authority up to their specific authority, which may vary from carrier to carrier.
• Assign defense counsel to answer and defend lawsuits where appropriate. Monitor and direct defense counsel, independent adjusters, and experts.
• Identify claims with potential exposure in excess of authority and advise their Supervisor/Manager
• Evaluate, set, or recommend reserves for each file they are handling.
• Prepare written reports as dictated by company policy and procedures.
• Handle claims within guidelines of the Fair Claims Practices 790.03
• Provide insureds, claimants, underwriters, and carriers with regular updates on status of file handling.
• Discuss unique and complex files with Supervisor/Manager

Core Technical Duties

• Healthcare liability claims investigation and evaluation, including medical malpractice, general liability, and professional liability exposures
• Coverage analysis and interpretation of allied health professional liability policies, including review of coverage dates, limits, exclusions, and endorsements
• Medical record review and interpretation across allied health disciplines (physical therapy, home health, diagnostics, behavioral health, etc.)
• Drafting reservation of rights letters and coverage denial communications for supervisor review
• Reserve evaluation, setting, and recommendation based on exposure analysis and claim trajectory
• Litigation management, including assignment and direction of defense counsel, independent medical examiners, and expert witnesses

Investigation & Documentation

• Securing recorded and written statements from insureds, claimants, and witnesses
• Gathering and organizing supporting documentation including incident reports, medical records, licensing records, contracts, and expert reports
• Maintaining accurate, detailed claim file documentation in compliance with carrier and program guidelines
• Preparing written reports and roundtable summaries consistent with company policies and procedures

Minimum Qualifications

• Minimum of 10 years of claims experience, with an emphasis on complex Allied Health claims
• College degree or equivalent claims management experience required.
• Minimum of 10 years litigation management experience preferred.
• Must hold an individual adjusting license for a designated home State and be willing to secure additional required adjusting licenses as needed
• Active adjusters license under your name required
• Proficient computer skills including Microsoft Outlook, Word, and Excel.
• Ability to maintain consistent and clear communication with leadership, the team and all other external points of contact

The starting annual pay scale for this position is listed below. Actual starting pay will be based on factors such as skills, qualifications, training, and experience. In addition, the company offers comprehensive benefits including medical, dental and vision insurance, 401(k) plan with match, paid time off, and other benefits.

ISC’s salary ranges are determined by role and level. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations and could be higher or lower based on a multitude of factors, including job-related skills, experience, and relevant education or training.

National Pay Range

$87,000—$109,000 USD

Benefits of Working at ISC

• Employee Ownership Program - every eligible employee shares in the financial rewards that grow when the company grows
• Professional development opportunities
• Owner Referral Program
• Work from home reimbursement for remote/hybrid roles
• Canary emergency financial assistance program
• Comprehensive medical, dental, vision
• Life/AD&D Insurance
• Confidential, Employee Assistance Program
• Health Savings Account, includes company contribution
• Short-term disability
• Voluntary benefits - supplemental accident, critical illness, hospital insurance
• Employee discounts
• 401(k) Plan with company match contribution
• Addition Wealth Financial Wellness Program
• Various Time Off Programs
• 11 company paid holidays

Applicants may contact the ISC HR department via e-mail or phone to request and arrange for an accommodation that will allow the applicant to successfully complete the application process. Applicants needing assistance may request accommodation at any time. Please contact ISC at HR@ISCMGA.com or 760-599-7242.

ISC believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, we focus on attracting, developing, and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude, and fostering a collaborative and mutually supportive environment.

Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, gender, gender identity, sexual orientation, marital status, medical condition, genetic information, mental or physical disability, military or veteran status, or any other characteristic protected by local, state, or Federal law.

**Must be legally authorized to work in the United States.**

**ISC participates in the Federal E-Verify program**

We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team.   We can consider candidates based in the  Poland, Hungary, Romania, Serbia or Slovakia.

Position Summary:

The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Qualifications:

• Bachelors and/or a combination of related experience
• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
• Set up and Database migrations experience
• Oncology experience preferred
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills
• Ability to undertake occasional travel

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable estimate of the current range for Poland:

190200 PLN gross per annum to 285400 PLN gross per annum

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team.   We can consider candidates based in the  Poland, Hungary, Romania, Serbia or Slovakia.

Position Summary:

The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Qualifications:

• Bachelors and/or a combination of related experience
• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
• Set up and Database migrations experience
• Oncology experience preferred
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills
• Ability to undertake occasional travel

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.