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Tmf Associate Jobs (NOW HIRING)

TMF

Loan Assistant

Georgetown, TX

$34K - $43K/yr

Demonstrate core values as defined by TMF and Wesleyan Impact Partners when interacting with associates and constituents. * Monitor and handle telephone calls, email, and physical mail. * Respond to ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

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How much do tmf associate jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for tmf associate in the United States is $39.99, according to ZipRecruiter salary data. Most workers in this role earn between $32.21 and $43.99 per hour, depending on experience, location, and employer.

What is the difference between Tmf Associate vs Tmf Analyst?

AspectTmf AssociateTmf Analyst
Required CredentialsBachelor's degree in life sciences, pharmacy, or related fields; basic knowledge of clinical trial processesBachelor's or master's degree; deeper understanding of TMF processes and regulatory requirements
Work EnvironmentClinical research organizations, pharmaceutical companies, or CROs; supporting TMF documentationMore analytical role within similar settings; involved in reviewing and ensuring compliance
Employer & Industry UsageCommonly used in clinical trial documentation teamsUsed in quality assurance and compliance teams within the same industry

The main difference between a Tmf Associate and a Tmf Analyst lies in their experience level and scope of responsibilities. Tmf Associates typically handle documentation support and basic compliance tasks, while Tmf Analysts perform more detailed reviews and analysis to ensure regulatory adherence. Both roles are essential in clinical trial management, with the Analyst position requiring a deeper understanding of TMF processes.

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Tmf Associate jobs near you
Associate Director, Trial Master File Lead

Associate Director, Trial Master File Lead

Dyne Therapeutics

Waltham, MA

$36.25 - $49.25/hr

Other

Posted 27 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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