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Director Trial Master File Specialist Jobs (NOW HIRING)

Medpace, Inc.

Trial Master File Specialist

Cincinnati, OH · On-site

$32.25 - $44/hr

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

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 ...

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Director Trial Master File Specialist information

What does a director trial master file specialist do?

A Director Trial Master File (TMF) Specialist oversees the management and quality of the Trial Master File, which is a collection of essential documents for clinical trials. They ensure that all regulatory, legal, and compliance requirements are met and that the TMF is inspection-ready at all times. This role involves developing TMF strategies, leading teams, training staff, and collaborating with cross-functional departments to maintain accurate and timely documentation throughout the clinical trial lifecycle.

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

To thrive as a Director Trial Master File Specialist, you need deep knowledge of clinical trial processes, regulatory requirements (such as GCP and ICH guidelines), and significant experience managing TMF systems, often supported by a degree in life sciences or a related field. Expertise with electronic Trial Master File (eTMF) platforms, document management systems, and relevant certifications like RAC or DIA TMF Certificate is highly valuable. Excellent organizational skills, attention to detail, and leadership abilities set outstanding candidates apart. These skills ensure the integrity, compliance, and efficiency of clinical trial documentation, which is critical for regulatory submissions and successful trial outcomes.

What are some common challenges faced by a director trial master file specialist, and how can they be navigated?

A Director Trial Master File (TMF) Specialist often encounters challenges such as ensuring ongoing regulatory compliance, maintaining TMF completeness and accuracy, and managing large, distributed teams across multiple studies. Navigating these obstacles typically involves implementing robust quality control processes, leveraging advanced electronic TMF systems, and fostering clear communication between clinical, regulatory, and data management teams. Proactive training and regular audits also help preempt issues, ensuring the TMF remains inspection-ready and supports successful clinical trial outcomes.

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

AspectDirector Trial Master File SpecialistTrial Master File Coordinator
CertificationsRegulatory and document management certifications, experience in clinical trialsSimilar certifications, often entry to mid-level experience
Work EnvironmentLeads TMF management teams, oversees compliance, strategic planningSupports TMF processes, manages document uploads, maintains files
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for senior TMF rolesCommonly found in clinical trial sites and CROs for operational support

The Director Trial Master File Specialist typically holds a senior role with strategic oversight, managing teams and ensuring compliance across clinical trials. In contrast, the Trial Master File Coordinator focuses on day-to-day document management and supporting TMF processes. Both roles require relevant certifications and industry experience, but the director position involves higher-level responsibilities and leadership within the TMF function.

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Infographic showing various Director Trial Master File Specialist job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 4% Part Time, 1% Temporary, and 4% Contract. Highlights an 98% In-person, 1% Hybrid, and 1% Remote job distribution.

Trial Master File Specialist

Medpace, Inc.

Cincinnati, OH • On-site

$32.25 - $44/hr

Other

Medical, Retirement, PTO

Re-posted 22 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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