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Tmf Manager Jobs (NOW HIRING)

TMF Group

Business Development Director

Houston, TX · On-site +1

The commercial focus of the role is to bring in new business for TMF Group's portfolio of services, including HR & Payroll; Global Entity Management; Accounting & Tax; and Trust and Corporate ...

Ipsen

Clinical Trial Administrator

Cambridge, MA

Prepare and customize the TMF Management plan, & TMF master index, according to the clinical study specificities, with the CPM and the Document Owners. * Inform the eTMF Support Team of any ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH

$32.25 - $44/hr

It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device ...

TMF Center

Maintenance Tech STE

Williamsport, IN · On-site

Inform the Purchasing Manager when replacement parts or materials are needed. * Provide general ... Follow instructions from all TMF Center and equipment documentation, including Shop Traveler ...

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How much do tmf manager jobs pay per hour?

As of Jul 21, 2026, the average hourly pay for tmf manager in the United States is $62.52, according to ZipRecruiter salary data. Most workers in this role earn between $50.72 and $70.43 per hour, depending on experience, location, and employer.

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.

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Tmf Manager jobs near you
Infographic showing various Tmf Manager job openings in the United States as of July 2026, with employment types broken down into 72% Full Time, 17% Part Time, and 11% Contract. Highlights an 83% In-person, and 17% Remote job distribution, with an average salary of $130,034 per year, or $62.5 per hour.
Associate Director, Trial Master File Lead

Associate Director, Trial Master File Lead

Dyne Therapeutics

Waltham, MA

$36.25 - $49.25/hr

Other

Re-posted 13 days ago

Job description

Role Summary:

The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end to end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high quality clinical execution, and operate efficiently at scale. This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance 
Primary Responsibilities Include: 

TMF Strategy & Leadership: 

  • Define and own the company's TMF strategy, including innovation opportunities and continuous improvement initiatives 
  • Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals 
  • Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends 
  • Represent TMF leadership in cross functional forums, governance committees, and senior level operational discussions 

Governance & Process Ownership: 

  • Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards 
  • Oversee TMF lifecycle management-from planning and setup through closeout and archival 
  • Define TMF roles, responsibilities, and RACI structures across internal teams and vendors 
  • Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues 
  • Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners  

TMF Oversight & Compliance: 

  • Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs) 
  • Ensure TMFs across the portfolio remain inspection ready  
  • Lead TMF related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate  
  • Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities to implement proactively 

Vendor & Technology Management: 

  • Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements 
  • Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations 
  • Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF 
  • Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices  

Cross Functional Partnership & Support: 

  • Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations 
  • Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements 
  • Advise leadership on TMF health and organizational readiness for key regulatory events 

Education and Skills Requirements: 

  • Bachelor's degree in life sciences or related field; advanced degree preferred 
  • 8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise 
  • Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations 
  • Proven experience developing TMF strategy, governance frameworks, or enterprise level processes 
  • Ability to lead cross-functionally without authority Demonstrated leadership in managing TMF operations or oversight at a portfolio level 
  • Experience working with eTMF systems and CRO/vendor oversight 
  • Excellent communication, influencing, and stakeholder management skills 

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