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Trial Master File Manager Jobs in Washington, DC

MacroGenics

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

Summary of Position This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities ...

IQVIA

MedTech Site Manager 1

Washington, DC · On-site

$74K - $124K/yr

Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...

IQVIA

MedTech Site Manager 1

Washington, DC · On-site

$74K - $124K/yr

Responsible for management of investigator site and Clinical Research Associate (CRA) activities ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...

Emmes

Sr. In-House CRA

Rockville, MD · On-site +1

Under the high level supervision of the project site management staff oversight lead (i.e ... Performs upload of essential documents into the trial master file. * Independently communicates and ...

IQVIA

CRA 1, IQVIA Biotech

Rockville, MD · On-site

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Rockville, MD · On-site

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA · On-site

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

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Trial Master File Manager information

See Washington, DC salary details

$50.4K

$85.6K

$129.1K

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

As of Aug 26, 2026, the average yearly pay for trial master file manager in Washington, DC is $85,574.00, according to ZipRecruiter salary data. Most workers in this role earn between $62,800.00 and $105,900.00 per year, depending on experience, location, and employer.

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.

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

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 are the most commonly searched types of Trial Master File jobs in Washington, DC?

The most popular types of Trial Master File jobs in Washington, DC are:

What are popular job titles related to Trial Master File Manager jobs in Washington, DC?

For Trial Master File Manager jobs in Washington, DC, the most frequently searched job titles are:

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Trial Master File Manager jobs near you

In-House Clinical Research Associate

TRI Challenge Convention

Bethesda, MD • Hybrid

Full-time

Re-posted 29 days ago

Job description

The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to: Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor/Client. Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.

Track essential regulatory documents in a centralized web-based system and/or other database. Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems. Coordinate or assist in distribution of trial-related materials to study sites.

May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation. NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.Understanding of medical and clinical trials terminology

Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution. Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity.

Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum). Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation.

Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right. Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.

Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Understanding of medical and clinical trials terminology. Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution

Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity. Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).

Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation. Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.

Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus. Experience with using a Trial Master File, a plus.

This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

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