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Director Trial Master File Jobs (NOW HIRING)

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TMF Lead

Blue Bell, PA · On-site

$32 - $43.75/hr

As a Trial Master File (TMF) Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compliance with regulatory requirements and best practices ...

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 ...

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 ...

Actalent

Sn Clinical Trial Associate

Santa Cruz, CA

$38.75 - $52.75/hr

Support management of CEC and DSMB if applicable. • Manage trial master file, maintain study documentation, and clinical trial management systems. • Track and process site payments, develop ...

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All JobsDirector Trial Master File Jobs

Director Trial Master File information

See salary details

$45K

$128.4K

$232.5K

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

As of Jun 23, 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 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.

What are the key skills and qualifications needed to thrive as a Director Trial Master File, and why are they important?

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 of 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 are Director Trial Master File roles and responsibilities?

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.
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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 June 2026, with employment types broken down into 100% Full Time. Highlights an 78% In-person, and 22% Remote job distribution, with an average salary of $128,367 per year, or $61.7 per hour.
Clinical Trial Assistant

Clinical Trial Assistant

Rigel Pharmaceuticals Inc.

South San Francisco, CA • On-site

$78K - $95K/yr

Full-time

Posted 13 days ago

Job description

POSITION SUMMARY:
This opportunity will support the Clinical Operations team in a fast paced, busy hematology/oncology pharmaceutical development department. As a Clinical Trial Assistant (CTA), you will assist the clinical research teams in clinical trial conduct, oversight, and logistics by providing administration and project tracking support.
Salary Range: Premium (NY/CA) $78,000 to $95,000
ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Provide administrative support to the Clinical Operations Department.
  • Assist Clinical Operations in minute generation and finalization of study related meetings. .
  • Support the Clinical Operations teams with archived, ongoing, and future clinical conduct of studies.
  • Be familiar with ICH, GCP, appropriate regulations, Rigel SOPs and internal systems.
  • Assist internal and external project teams with documentation and guidelines as appropriate.
  • Maintains and manages the study trial master files using Veeva Vault and other platforms.
  • Organize study documentation, including archiving, reviewing, and standardizing local study files for department consistency.
  • Accurately uploading and filing study documents to the Veeva Vault electronic Trial Master File.
  • Ensures study documents filed into the Veeva Vault electronic Trial Master File comply with filing guidelines and acceptability criteria. This includes, but is not limited to, reviewing documents for accuracy, quality and legibility, pagination, layout orientation, filing location, and compliance with GCP guidelines.
  • Provides additional support in quality reviews of study the trial master file plans and indexes.
  • Route and manage correspondence for the clinical trial teams.
  • Provides administrative support with department project planning, execution, and follow up.
  • Assist with team member tracking and distribution of study related information.
  • Tracking of screening, enrollment, and subject status reports from CRO and sites.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Bachelor's degree in science related field required. 1-2 years' experience in clinical research type role preferred.

WORKING CONDITIONS:
  • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
  • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

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