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Trial Master File Manager Jobs (NOW HIRING)

Pathos

Clinical Trial Assistant

New York, NY · On-site

$75K - $85K/yr

This means maintaining our Trial Master File, coordinating with CROs and sites, managing documentation across multiple programs, and ensuring every submission to FDA is inspection-ready. What makes ...

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 ...

NWRPros

Clinical Trial Manager

Bellevue, WA · On-site

Ensuring completeness and accuracy of Trial Master File * Managing investigational product release packages and investigational product accountability * Performing clinical data review of data ...

NWRPros

Clinical Trial Manager

Bellevue, WA

Ensuring completeness and accuracy of Trial Master File * Managing investigational product release packages and investigational product accountability * Performing clinical data review of data ...

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$44.5K

$75.6K

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

As of May 31, 2026, the average yearly pay for trial master file manager in the United States is $75,583.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,500.00 and $93,500.00 per year, depending on experience, location, and employer.

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

To thrive as a Trial Master File Manager, you typically need a strong background in clinical research, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, GCP guidelines, and relevant industry certifications like DIA's TMF Professional Certification is important. Attention to detail, organizational skills, and effective communication help ensure TMF integrity and coordination across cross-functional teams. These skills are crucial for maintaining regulatory compliance, audit readiness, and efficient clinical trial operations.

What are some common challenges faced by Trial Master File Managers, and how can they be addressed?

Trial Master File Managers often encounter challenges such as ensuring TMF completeness, maintaining regulatory compliance, and coordinating document submissions across multiple stakeholders. Keeping documents up-to-date and audit-ready requires strong attention to detail and effective communication with clinical teams, vendors, and sponsors. Leveraging electronic TMF systems, implementing standardized processes, and promoting regular training can help address these challenges and ensure the integrity of the TMF throughout a study.

What is a Trial Master File Manager?

A Trial Master File Manager is a professional responsible for overseeing the creation, maintenance, and quality control of the Trial Master File (TMF) in clinical research. The TMF is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. The manager ensures that all documents are complete, accurate, and compliant with regulatory requirements throughout the trial's lifecycle. They work closely with clinical teams, auditors, and regulatory authorities to guarantee readiness for inspections and audits. Their role is crucial for maintaining transparency and credibility in clinical research processes.
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Trial Master File Manager jobs near you
Infographic showing various Trial Master File Manager job openings in the United States as of May 2026, with employment types broken down into 94% Full Time, and 6% Contract. Highlights an 83% In-person, 11% Hybrid, and 6% Remote job distribution, with an average salary of $75,583 per year, or $36.3 per hour.
Associate Director (Trial Master File)

Associate Director (Trial Master File)

Integrated Resources INC

Cambridge, MA

$36.50 - $50/hr

Other

Posted 5 days ago

Job description

Company Description

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

DIRECT CLIENT NEED - Immediate interview!!! 

Position: Associate Director (Trial Master File Operations and Systems Management)

Location: Cambridge MA

Duration: 6+ Months

 

Responsibilities:

  

Manage overall TMF operations and third party vendors, and act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor. 

Manage and provide direction to external TMF Document Specialists and ensure that all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards. 

Manage and provided direction for internal and external systems used for TMF records. Work with stakeholders to identify issues and remediation activities with vendors. 

Review document quality audit outputs to identify trends across the portfolio to ensure quality documentation. 

Identify root cause of performance issues, determine the appropriate remediation, and escalate issues with performance when required. 

Prepare and deliver effective presentations for external and internal audiences. 

Represent company to external vendors

Additional Functions:


Contribute to organizational effectiveness. 

Effectively serve as a role model within regulatory and cross-functionally. 

Positively impact industry and agency organizations.

Experience Required:


9 years pharmaceutical/biotechnology industry experience. Relevant clinical, regulatory and TMF systems experience preferred. 

Solid knowledge of applicable regulations. 

Experience in interpretation of regulations, guidelines, policy statements, etc. 

Foster effective, positive interactions with other functions, vendors, and partners.

Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. 

Ability to represent the department in project teams, committees and external meetings. 

Demonstrate strong organizational and project management skills, including the ability to prioritize personal workload. 

Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical and scientific staff. 

Education: 

Bachelor's degree required, Masters or PhD in Biology / Chemistry, Life Sciences, or Drug Development preferred.



Qualifications

Bachelor's degree required, Masters or PhD in Biology / Chemistry, Life Sciences, or Drug Development preferred.



Additional Information

Nikki Sharma

Technical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # : 732-429-1928

BOARD # : 732-549-2030 - Ext - 314

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)


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About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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