TMF Specialist

Piper Companies; Bethesda (MD); Hybrid; USD 40,000 - 75,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Piper Companies is seeking a TMF Specialist to join a clinical research organization. This hybrid role allows 3 remote days per week from Bethesda, MD, with responsibilities for TMF setup, quality management, and reporting to clients.

The role requires TMF experience, knowledge of FDA/ICH/EMA TMF requirements, and experience with Veeva Vault and Trial Interactive. A B.A./B.S. in science or healthcare is required.

Qualifications

• 1+ year TMF (trial master file) experience.
• Experience with TMF review and knowledge of FDA, ICH, EMA TMF requirements.
• TMF monitoring experience; generation of TMF Plans and Indexes.

Responsibilities

• TMF set-up, quality management, reports and metrics, and TMF quality control/QA.
• Maintain overall TMF document quality and filing, cross-functional coordination, and TMF tracking/reporting to clients.
• Ensure documentation aligns with eTMF specs, ICH/GCP, regulatory reqs, and SOPs.
• Ensure new/updated record information is entered and maintained per TMF SOPs for inspection readiness.

Skills

TMF experience

Veeva Vault

Trial Interactive

Documentation coordination

Education

B.A. or B.S. in science/healthcare

Tools

Veeva Vault

Trial Interactive

Job description

Piper Companies is looking for a TMF Specialist to join a clinical research organization (CRO). This is a hybrid position with 3 remote days out of Bethesda, MD.

Essential Duties of the TMF Specialist:

• Responsible for TMF set-up, quality management, reports and metrics, and TMF quality control/quality assurance.
• Accountable for overall TMF document quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, and TMF tracking and reporting to internal and external clients.
• Ensures clinical trial documentation is consistent with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and applicable SOPs.
• Ensures that all new and updated record information is accurately entered and is maintained in accordance with TMF storage SOP’s, processes and data structure for inspection readiness

Qualifications of the TMF Specialist:

• 1+ year of TMF (trial master file) experience
• Experience with TMF review and with knowledge of FDA, ICH, and EMA TMF requirements
• TMF monitoring experience, generation of TMF Plans and Indexes.
• Experience with Veeva Vault and Trial Interactive
• Minimum B.A. or B.S. in science or healthcare field

Compensation for the TMF Specialist:

• $40,000 - $75,000 (based on experience)
• 3 remote days per week
• Comprehensive benefit package; Cigna Medical, Cigna Dental, Vision, 401k w/ ADP, PTO, paid holidays, Sick Leave as required by law, paid holidays

This job opens for applications on 9/25/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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