Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Remote Clinical Trials Manager
Richmond, VA · Remote
$64.23/hr
Support Trial Master File (TMF) management by ensuring accurate, complete, and inspection-ready documentation. * Coordinate study start-up activities, including ethics committee submissions ...
Quick apply
Remote Clinical Trials Manager
Richmond, VA · Remote
$64.23/hr
Support Trial Master File (TMF) management by ensuring accurate, complete, and inspection-ready documentation. * Coordinate study start-up activities, including ethics committee submissions ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
New
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
New
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution * Oversees engagement, contracting and management of ...
$115K - $145K/yr
Assists in TMF management and manages TMF reviews as needed. * Prepares for and participates in third-party audits and FDA inspections. * Complies with and ensures team compliance with ICH GCP ...
New
$115K - $145K/yr
Assists in TMF management and manages TMF reviews as needed. * Prepares for and participates in third-party audits and FDA inspections. * Complies with and ensures team compliance with ICH GCP ...
New
Clinical Trial Associate
Boston, MA · On-site
$86K - $100K/yr
Manages trial related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users. * Uploads and reviews ...
Clinical Trial Associate
Boston, MA · On-site
$86K - $100K/yr
Manages trial related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users. * Uploads and reviews ...
Clinical Operations Associate (Pool)
CA · Remote
$70K - $80K/yr
TMF Management * Perform QC review of TMF documents. * File documents per TMF Reference Model. * Identify gaps, inconsistencies, and missing documentation. * Support audit and inspection readiness.
Clinical Operations Associate (Pool)
CA · Remote
$70K - $80K/yr
TMF Management * Perform QC review of TMF documents. * File documents per TMF Reference Model. * Identify gaps, inconsistencies, and missing documentation. * Support audit and inspection readiness.
Clinical Study Manager
Cleveland, OH · On-site
$90K - $120K/yr
Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site ... Oversee TMF, CTMS, and database for assigned projects. Participate in development of protocols ...
Clinical Study Manager
Cleveland, OH · On-site
$90K - $120K/yr
Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site ... Oversee TMF, CTMS, and database for assigned projects. Participate in development of protocols ...
Clinical Study Manager
Cleveland, OH · On-site
$90K - $120K/yr
Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site ... Oversee TMF, CTMS, and database for assigned projects. Participate in development of protocols ...
Clinical Study Manager
Cleveland, OH · On-site
$90K - $120K/yr
Manage end-to-end lifecycle of assigned IVD clinical research projects, including startup, site ... Oversee TMF, CTMS, and database for assigned projects. Participate in development of protocols ...
Clinical Document Management Specialist IV
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% * Supports CDM initiatives to enhance efficiencies in document management practices * Supports Managers in ...
Clinical Document Management Specialist IV
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% * Supports CDM initiatives to enhance efficiencies in document management practices * Supports Managers in ...
Manager, Clinical Research
Paramus, NJ · On-site
$110K - $135K/yr
TMF oversight review during study conduct and TMF management during study closeout. * Support creating and maintaining clinical SOPs as part of global QMS. * Perform administrative tasks (e.g ...
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Manager, Clinical Research
Paramus, NJ · On-site
$110K - $135K/yr
TMF oversight review during study conduct and TMF management during study closeout. * Support creating and maintaining clinical SOPs as part of global QMS. * Perform administrative tasks (e.g ...
Associate Director, Trial Master File
South San Francisco, CA · On-site
$40.25 - $55/hr
Drive risk-based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps * Partner cross-functionally with Clinical Operations, Quality, Regulatory Affairs ...
Associate Director, Trial Master File
South San Francisco, CA · On-site
$40.25 - $55/hr
Drive risk-based TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps * Partner cross-functionally with Clinical Operations, Quality, Regulatory Affairs ...
Sr. Clinical Trial Associate
South San Francisco, CA · On-site
$100K - $120K/yr
Support TMF audits and health checks Additional Responsibilities * Support Clinical Trial Manager (CTM), Study lead and Study Management Team (SMT) in study start up and executional activities * Site ...
Sr. Clinical Trial Associate
South San Francisco, CA · On-site
$100K - $120K/yr
Support TMF audits and health checks Additional Responsibilities * Support Clinical Trial Manager (CTM), Study lead and Study Management Team (SMT) in study start up and executional activities * Site ...
Associate Director, Trial Master File
$40.25 - $55/hr
Drive riskbased TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps * Partner crossfunctionally with Clinical Operations, Quality, Regulatory Affairs, and ...
Associate Director, Trial Master File
$40.25 - $55/hr
Drive riskbased TMF oversight, issue management, and CAPA development related to TMF quality or compliance gaps * Partner crossfunctionally with Clinical Operations, Quality, Regulatory Affairs, and ...
Provide leadership for Clinical Records strategy, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans ...
Provide leadership for Clinical Records strategy, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans ...
Clinical Document Management Specialist
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% Supports CDM initiatives to enhance efficiencies in document management practices Qualifications Education and ...
Clinical Document Management Specialist
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% Supports CDM initiatives to enhance efficiencies in document management practices Qualifications Education and ...
This role coordinates site outreach, study and site start-up activities, IRB submissions, and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing ...
This role coordinates site outreach, study and site start-up activities, IRB submissions, and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing ...
Clinical Document Management Specialist
Lexington, MA · On-site
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% Supports CDM initiatives to enhance efficiencies in document management practices Supports Managers in ...
Clinical Document Management Specialist
Lexington, MA · On-site
$39 - $52.50/hr
Supports assigned TMF corrective action plans under direction of Senior CDM/Manager. 10% Supports CDM initiatives to enhance efficiencies in document management practices Supports Managers in ...
Tmf Manager information
See salary details
$28.85 - $34.97
4% of jobs
$34.97 - $41.08
6% of jobs
$41.08 - $47.20
7% of jobs
$51.79 is the 25th percentile. Wages below this are outliers.
$47.20 - $53.32
9% of jobs
$53.32 - $59.44
15% of jobs
The median wage is $62.14 / hr.
$59.44 - $65.56
18% of jobs
$69.92 is the 75th percentile. Wages above this are outliers.
$65.56 - $71.68
21% of jobs
$71.68 - $77.80
7% of jobs
$77.80 - $83.92
6% of jobs
$83.92 - $90.03
3% of jobs
$90.03 - $96.15
2% of jobs
$28
$62
$96
How much do tmf manager jobs pay per hour?
What are some typical challenges a TMF Manager might face in their role?
TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.
What are the key skills and qualifications needed to thrive in the Tmf Manager position, and why are they important?
To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.
What is a TMF Manager job?
A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 14 days ago
Regeneron rating
8.7
Based on 42 frontline employees who took The Breakroom Quiz
12th of 74 rated pharmaceutical
Job description
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial management team. In this role, you will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, applying to both internally sourced studies and studies out-sourced to CROs, while collaborating with the study team internally and externally with vendors such as CROs.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: Armonk, NY, Warren, NJ
- Hybrid: 4 days per week onsite
- Travel percentage: May require 25% travel
Discover your role:
- May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study
- Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
- Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials
- Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
- Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation
- Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies
- Monitors recruitment and retention, and monitors progress for site activation and monitoring visits
- Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites, and escalates data flow and data quality issues to Clinical Study Lead
- Oversees the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes
- Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required
- Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact)
This role requires:
- Bachelor's Degree and 4+ years of relevant industry experience
- Excellent communication and interpersonal skills; ability to build relationships internally and externally
- A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities
- Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Budget awareness with the ability to participate in various aspects of budget management
- Familiarity with medical terms, and vendor management experience
- Experience in clinical trial operations including experience developing key study documents
- Knowledge of ICH/GCP and regulatory guidelines/directives
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$109,900.00 - $179,300.00
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About Regeneron
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
5,001 - 10,000 Employees
Headquarters location
Tarrytown, NY, US
Year founded
1988