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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?

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.

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.

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Role Title: Bilingual Japanese Psychiatrist Role Type: ContractorLocation: Remotemicro1 is engaging Bilingual Japanese Psychiatrists to contribute to a customer-focused project.

Role Title: Bilingual Indonesian Psychologist (PhD) Role Type: Contractor Location: Remote micro1 is engaging Bilingual Indonesian Psychologist (PhD)s to contribute expertise to an innovative customer project.

Role Title: Bilingual Indonesian Psychiatrist Role Type: Contractor Location: Remote micro1 is engaging Bilingual Indonesian Psychiatrists to contribute to a customer-focused project.

Role Title: Bilingual Gujarati Psychologist (PhD) Role Type: Contractor Location: Remote micro1 is engaging Bilingual Gujarati Psychologist (PhD)s to contribute expertise to an innovative customer project.

Why Choose Two Chairs?

• Compensation: Hourly rate of $62–$96/hr (determined by experience, qualifications, and place of residence).

  • 90-day ramp period: 100% full rate while you build your caseload.
  • Post-ramp: 80% guaranteed base rate + productivity incentive

• AI-Assisted Documentation: Spend less time on administrative notes and more time on client care with our optional built-in AI documentation tools.

• True Work-Life Balance: Set your own schedule up to 8 hours/week (with the potential to increase) within M-F, 8am-8pm. No late nights, no weekends, no on-call obligations.

• Paid Non-Clinical Time: Get paid for administrative tasks, clinical team consultations, required training, and client no-shows.

• Safety & Coverage: Enjoy 24⁄7 crisis line support for client risk assessments and seamless coverage support when you take time off.

• Additional W-2 advantages you won’t find with 1099 contract work:

  • No tax headaches – We handle withholdings and filings, so you don’t have to
  • Earn paid sick time – Accrue up to 80 hours per year
  • Merit-based raises – Be recognized and rewarded for your contributions
  • Retirement benefits – Access an employer-sponsored 401(k) plan
  • Malpractice insurance provided – Full coverage at no cost to you
  • Access to state-mandated benefits  –  Like unemployment, disability, and paid leave where available

About You

• A board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC) licensed to practice in Illinois.
• Willing and committed to becoming licensed in other states. We’ll cover the entire cost.
• 2+ years of experience providing mental health services as a PMHNP, including remote, outpatient telepsychiatry with adults.
• Passionate about high-quality, measurement-based, collaborative care.
• Eager to collaborate with a dedicated psychiatric team to build upon and refine our care delivery systems.
• Preferred: additional PMHNP licensure in Texas, Georgia, New Jersey, Pennsylvania, or Arizona
• Preferred: Able to start November 2026

About the Role

• Conduct remote 55-minute psychiatry assessments and 25-minute follow-up sessions designed for combined medication management and brief psychotherapeutic support.
• Prescribe and manage psychiatric medications in accordance with state and federal regulations.
• Integrate brief psychotherapy when clinically appropriate to support your clients in reaching their goals efficiently and sustainably.
• Partner closely with therapists in a true integrated care model, through our shared EHR system and consultation spaces.
• Collaborate with physicians and clinical leadership, sharing direct feedback that shapes how our clinical care is delivered.
• Use data-informed tools and measurement-based care to tailor treatment plans and improve outcomes.

About Two Chairs

Two Chairs is setting a new standard in mental health care with seamlessly integrated therapy and psychiatry delivered by highly trained clinicians, powered by smart technology, and measured for real impact. By combining timely access, personalized care, and proven outcomes — we’re creating a system that works — for patients, providers, health plans, and clinicians alike. With that, we’re excited and honored to have been recognized as a 2025 Great Place to Work and 2025 Fortune’s Best Workplaces in Healthcare .

One of our company values is “Embrace Differences,” and diversity, equity, inclusion, and belonging are the principles guiding how we build our business and teams. We encourage interested candidates from all backgrounds to apply, even if they don’t think they meet some expectations of the role.

Important Notes:

• If you need a reasonable accommodation, please let your recruiter know so our People Team can assist you.
• Please stay alert for job scams: All communication will come from official Two Chairs email domains (@twochairs.com or @twochairscareers.com). See tips from the FTC to avoid job scams: https://www.consumeraffairs.com/news/ftc-offers-tips-on-avoiding-job-scams-041321.html
• See our AI Usage Policy for Hiring here

#LI-REMOTE #ZR

Why Choose Two Chairs?

• Compensation: Hourly rate of $62–$96/hr (determined by experience, qualifications, and place of residence).

  • 90-day ramp period: 100% full rate while you build your caseload.
  • Post-ramp: 80% guaranteed base rate + productivity incentive

• AI-Assisted Documentation: Spend less time on administrative notes and more time on client care with our optional built-in AI documentation tools.

• True Work-Life Balance: Set your own schedule up to 8 hours/week (with the potential to increase) within M-F, 8am-8pm. No late nights, no weekends, no on-call obligations.

• Paid Non-Clinical Time: Get paid for administrative tasks, clinical team consultations, required training, and client no-shows.

• Safety & Coverage: Enjoy 24⁄7 crisis line support for client risk assessments and seamless coverage support when you take time off.

• Additional W-2 advantages you won’t find with 1099 contract work:

  • No tax headaches – We handle withholdings and filings, so you don’t have to
  • Earn paid sick time – Accrue up to 80 hours per year
  • Merit-based raises – Be recognized and rewarded for your contributions
  • Retirement benefits – Access an employer-sponsored 401(k) plan
  • Malpractice insurance provided – Full coverage at no cost to you
  • Access to state-mandated benefits  –  Like unemployment, disability, and paid leave where available

About You

• A board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC) licensed to practice in Pennsylvania.
• Willing and committed to becoming licensed in other states. We’ll cover the entire cost.
• 2+ years of experience providing mental health services as a PMHNP, including remote, outpatient telepsychiatry with adults.
• Passionate about high-quality, measurement-based, collaborative care.
• Eager to collaborate with a dedicated psychiatric team to build upon and refine our care delivery systems.
• Preferred: additional PMHNP licensure in Texas, Georgia, New Jersey, Illinois, or Arizona
• Preferred: Able to start November 2026

About the Role

• Conduct remote 55-minute psychiatry assessments and 25-minute follow-up sessions designed for combined medication management and brief psychotherapeutic support.
• Prescribe and manage psychiatric medications in accordance with state and federal regulations.
• Integrate brief psychotherapy when clinically appropriate to support your clients in reaching their goals efficiently and sustainably.
• Partner closely with therapists in a true integrated care model, through our shared EHR system and consultation spaces.
• Collaborate with physicians and clinical leadership, sharing direct feedback that shapes how our clinical care is delivered.
• Use data-informed tools and measurement-based care to tailor treatment plans and improve outcomes.

About Two Chairs

Two Chairs is setting a new standard in mental health care with seamlessly integrated therapy and psychiatry delivered by highly trained clinicians, powered by smart technology, and measured for real impact. By combining timely access, personalized care, and proven outcomes — we’re creating a system that works — for patients, providers, health plans, and clinicians alike. With that, we’re excited and honored to have been recognized as a 2025 Great Place to Work and 2025 Fortune’s Best Workplaces in Healthcare .

One of our company values is “Embrace Differences,” and diversity, equity, inclusion, and belonging are the principles guiding how we build our business and teams. We encourage interested candidates from all backgrounds to apply, even if they don’t think they meet some expectations of the role.

Important Notes:

• If you need a reasonable accommodation, please let your recruiter know so our People Team can assist you.
• Please stay alert for job scams: All communication will come from official Two Chairs email domains (@twochairs.com or @twochairscareers.com). See tips from the FTC to avoid job scams: https://www.consumeraffairs.com/news/ftc-offers-tips-on-avoiding-job-scams-041321.html
• See our AI Usage Policy for Hiring here

#LI-REMOTE #ZR

Role Title: Bilingual Japanese Psychologist (PhD) Role Type: ContractorLocation: Remotemicro1 is engaging Bilingual Japanese Psychologist (PhD)s to contribute expertise to an innovative customer project.

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