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Director Trial Master File Jobs (NOW HIRING)

Celerion

Trial Master Files Representative

$25 - $28/hr

... a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based ... You will be responsible for maintenance of the TMF, creating a file structure and indexing contents.

Cellectis

Clinical Trial Associate

Manhattan, NY · On-site

$36.75 - $50.25/hr

This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...

Cellectis

Clinical Trial Associate

Manhattan, NY

$36.75 - $50.25/hr

This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance ...

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Director Trial Master File information

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$45K

$128.4K

$232.5K

How much do director trial master file jobs pay per year?

As of Sep 15, 2026, the average yearly pay for director trial master file in the United States is $128,367.00, according to ZipRecruiter salary data. Most workers in this role earn between $58,000.00 and $188,500.00 per year, depending on experience, location, and employer.

What are the roles and responsibilities of a director trial master file?

A Director of Trial Master File (TMF) oversees the management and quality of TMF systems, which are essential for documenting the conduct of clinical trials. They ensure that all trial documentation is complete, accurate, and compliant with regulatory requirements. This role involves developing TMF strategies, leading teams, implementing best practices, and collaborating with clinical, regulatory, and quality assurance departments to support clinical trial audits and inspections. The director also manages TMF vendors, monitors key performance indicators, and drives process improvements.

What are the key skills and qualifications needed to thrive as a director trial master file?

To thrive as a Director Trial Master File, you need deep knowledge of clinical trial processes, regulatory guidelines (such as GCP and ICH), and extensive experience in TMF management, often supported by a relevant degree and prior leadership in clinical operations. Expertise with electronic Trial Master File (eTMF) systems, document management platforms, and familiarity with industry certifications like DIA TMF Practitioner are highly valued. Strong leadership, attention to detail, and excellent communication skills distinguish top performers in this role. These capabilities ensure regulatory compliance, audit readiness, and effective oversight of clinical trial documentation, which are critical for successful drug development.

What are some common challenges a director trial master file faces when ensuring TMF completeness and inspection readiness?

A Director of Trial Master File often encounters challenges related to maintaining TMF completeness across multiple studies and vendors, ensuring timely document submission, and preparing for regulatory inspections. Coordinating efforts among cross-functional teams—including clinical operations, regulatory affairs, and external partners—can be complex, especially when aligning on documentation standards and resolving discrepancies. Proactive communication, robust quality control processes, and familiarity with evolving regulatory requirements are key to overcoming these challenges and ensuring inspection readiness.

What is the difference between Director Trial Master File vs Clinical Trial Coordinator?

AspectDirector Trial Master FileClinical Trial Coordinator
CredentialsAdvanced degrees (e.g., Life Sciences, Healthcare), experience in clinical trial documentationBachelor's degree, certification in clinical research preferred
Work EnvironmentSenior management, overseeing TMF processes across projectsOperational role, supporting trial activities at site or sponsor level
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for document oversightCommonly employed in clinical sites and research organizations

The Director Trial Master File focuses on strategic oversight and management of trial documentation, ensuring compliance and quality. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, including document collection and site coordination. Both roles are essential but differ in scope, responsibilities, and seniority within the clinical research process.

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Director Trial Master File jobs near you
Infographic showing various Director Trial Master File job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 88% Full Time, 8% Part Time, and 2% Contract. Highlights an 72% Physical, 2% Hybrid, and 26% Remote job distribution, with an average salary of $128,367 per year, or $61.7 per hour.

Associate Director, Trial Operations & Budget

Boston, MA • On-site

AdvanCell
See more jobs at AdvanCellexternal

Other

Re-posted 10 days ago

Job description

The Associate Director, Trial Operations & Budget is responsible for supporting the oversight, planning, and execution of clinical trial activities, with a strong emphasis on financial management and operational excellence. This role ensures that clinical operations deliverables related to CROs, vendors, and clinical sites management and oversight, including budgeting, contracting, invoicing, and Trial Master File (TMF) quality and completeness verification—are conducted in alignment with corporate financial and clinical operations SOPs, study protocols, ICH/GCP guidelines, regulatory requirements, and established budget and timelines. Reporting to the VP, Clinical Development and Operations, this position plays a critical role in vendor management, financial stewardship, and the delivery of high-quality, efficient clinical trials.

Key Responsibilities and Duties

Responsibilities will include, but not limited to:

  • Develop, manage, and track site and study budgets in collaboration with CROs and internal Finance partners.
  • Review, reconcile, and approve vendor and CRO invoices against contracts, milestones, and deliverables.
  • Support clinical operations contracting processes, including review of scopes of work, vendor agreements, and amendments.
  • Manage and review change orders, ensuring alignment with scope, timelines, and budget.
  • Generate andmaintainpurchase orders (POs)in accordance withcompany processes and study budgets.
  • Support vendor selection, onboarding, and ongoing performance management to ensure adherence to KPIs and contractual commitments.
  • Support oversight of CROs to ensure clinical trials are executed according to timelines, quality standards, and contractual obligations.
  • Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and continuous inspection readiness. Monitor TMF completion metrics to ensure timely and comprehensive document completeness.
  • Collaborate closely with cross-functional teams including Finance, Legal, CMC, Pre-clinical to ensure seamless execution of clinical programs.
  • Proactively identify risks in study execution and financial management, and implement mitigation strategies.
  • Support onboarding procedure and training on internal processes for new team members.
Other Responsibilities
  • Adhere to the Company’s quality management system processes and policies.
  • Comply with applicable regulatory requirements, policies, and procedures related to financial reporting transparency, Good Clinical Practice (GCP), and Good Documentation Practice (GDP).
  • Other tasks as requested by the VP Clinical Development and Operations.
Essential Skills, Qualifications, Industry and Educational Requirements
  • Strong knowledge of clinical trial conduct, ICH-GCP guidelines, regulatory requirements, and the Sunshine Act.
  • Meticulous attention to detail to ensure accuracy in documentation and financial tracking.
  • Demonstrated ability to manage budgets, forecasting, and financial reconciliation.
  • Flexibility to collaborate across different time zones
  • Experience with TMF processes andinspectionreadiness standards.
  • Ability to worktotimelines and perform effectively in high-pressure environments.
  • Strong organizational, analytical, and problem-solving skills.
Desirable Skills, Qualifications, Industry and Educational Requirements
  • Proventrack recordin clinical operations delivery within a sponsor or CRO environment.
  • Demonstratedexpertisein vendor management, CRO oversight, and contract management.
  • Experience with budgeting tools, CTMS, and eTMF systems.
  • Strong communicationand collaboration skills across cross-functional teams.
  • Minimum 6–10 years’ experience in clinical operations (depending on level).
  • Bachelor’s degree in life sciences required; advanced degree (MSc or higher) preferred.
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