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Trial Master File Specialist Jobs (NOW HIRING)

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

  • Medical

  • Retirement

  • PTO

The Trial Master File (TMF) is a collection of documents that stores all data and research ... In this position, you will be working with a highly experienced team of administrators, specialists ...

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site +1

$32.25 - $44/hr

  • Medical

  • Retirement

  • PTO

The Trial Master File (TMF) is a collection of documents that stores all data and research ... In this position, you will be working with a highly experienced team of administrators, specialists ...

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 ...

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Trial Master File Specialist information

What is a trial master file specialist?

A Trial Master File (TMF) Specialist is responsible for managing and maintaining the Trial Master File, a collection of essential documents required for clinical trials. They ensure compliance with regulatory guidelines, organize and track documents, and support audit readiness. TMF Specialists work closely with clinical teams, sponsors, and regulatory authorities to facilitate efficient document management. Their role is critical in ensuring the integrity, accuracy, and completeness of clinical trial documentation.

What skills and qualifications are needed to thrive as a trial master file specialist?

To thrive as a Trial Master File Specialist, you need strong organizational skills, attention to detail, a solid understanding of clinical research regulations (such as GCP/ICH), and often a bachelor's degree in a life science field. Experience with electronic Trial Master File (eTMF) systems and knowledge of regulatory compliance tools or certifications like DIA TMF Reference Model are highly valued. Effective communication, problem-solving abilities, and the capacity to collaborate with cross-functional teams are key soft skills for success. These qualifications ensure the integrity, completeness, and audit-readiness of clinical trial documentation, which is critical for regulatory compliance and successful trial outcomes.

What are common challenges a trial master file specialist faces in their daily work?

Trial Master File Specialists often encounter challenges such as managing large volumes of documentation from multiple sources, ensuring that files remain current and audit-ready, and keeping up with evolving regulatory requirements. Coordinating with various stakeholders—including clinical operations, site staff, and quality assurance—to obtain missing or incomplete documents can require strong communication and follow-up skills. The role demands meticulous attention to deadlines and detail to avoid compliance gaps, and specialists must be comfortable working with specialized eTMF systems. Successfully navigating these challenges is crucial for maintaining high standards of data integrity and ensuring clinical trial readiness for inspections.

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Infographic showing various Trial Master File Specialist job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, and 14% Contract. Highlights an 86% In-person, and 14% Remote job distribution.

Trial Master File Specialist

Medpace, Inc.

Cincinnati, OH • On-site

$32.25 - $44/hr

Other

Medical, Retirement, PTO

Re-posted 23 days ago

Medpace rating

8.6

Company rating: 8.6 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

13th of 73 rated research

Job description

Job Summary
We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. 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 receiving approval by the FDA. In this position, you will be working with a highly experienced team of administrators, specialists, and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is office-based in Cincinnati, OH.
Responsibilities
  • Provide guidance and support to study team members and sponsors regarding TMF management;
  • Initiate and manage TMF Specifications based on scope of work, protocol, and other core documents working with functional area leads and sponsor contacts;
  • Set up and maintain study specific TMF folder structure;
  • Support CTMs with review of TMF Plans as required;
  • Support study team(s) during periodic TMF QCs by assisting with report development and metric reporting;
  • Report on TMF Health to Sponsors and CTMs;
  • Contribute to audit/inspection readiness activities by reviewing the TMF, TMF Specifications, and TMF Plans for accuracy, consistency, and completeness;
  • Train and mentor other TMF staff; and
  • help with other project and responsibilities, as assigned.

Qualifications
  • Bachelor's degree, life science field preferred
  • Proficient knowledge of Microsoft® Office and Adobe Acrobat®
  • Computer literacy (i.e., ability to file, scan, create folders, and organize files using various
  • software);
  • Ability to accurately and carefully follow procedures for completing work tasks; and
  • Ability to perform repetitive work without losing effectiveness/accuracy.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
    • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture
    • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
    • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development
    • Office based environment with on-site mentors
    • Defined career paths with clear advancement opportunities
    • Industry renowned onboarding and training programs designed to accelerate professional development
    • Ongoing training and continuous learning opportunities throughout your career
    • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits
    • Competitive compensation programs that recognize and reward performance
    • Comprehensive health, wellness, retirement, and PTO benefits
    • Office based culture with occasional WFH that provides flexibility for eligible positions after training
    • Company-sponsored social events and intramural sports

Cincinnati Headquarters Experience
    • A modern corporate campus designed to support collaboration and productivity
    • Multiple on-site dining options in the heart of Madison Square
    • Free on-site parking
    • Convenient access to on-site 24-7 fitness and wellness facilities

What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992

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