TMF Specialist

Piper Companies; Bethesda (MD); On-site; USD 40,000 - 50,000; Full time

Benefits offered by this job

Cigna Medical

Cigna Dental

Vision

401k with ADP

PTO

Paid holidays

Sick Leave

Job summary

A clinical research organization is seeking a TMF Specialist in Bethesda, MD, for a hybrid role with three remote days weekly. The successful candidate will manage TMF set-up, document quality, and regulatory compliance. Applicants should have at least one year of TMF experience, knowledge of FDA and ICH requirements, and a degree in a science or healthcare field. Benefits include a competitive salary between $40,000 and $50,000 based on experience, along with a comprehensive package covering medical, dental, 401k, and paid time off.

Qualifications

• 1+ year of TMF experience is a must.
• Experience with TMF review and monitoring expected.
• Knowledge of regulatory TMF requirements essential.

Responsibilities

• Manage TMF set-up and quality management.
• Ensure TMF document quality and completion.
• Maintain accurate record information for inspection readiness.

Skills

TMF experience

FDA, ICH, and EMA TMF requirements knowledge

TMF monitoring

Experience with Veeva Vault

Education

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

Tools

Veeva Vault

Trial Interactive

Job description

Overview

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.

Responsibilities

• Responsible for TMF set-up, quality management, reports and metrics, and TMF QC/QA.
• Accountable for overall TMF document quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, and TMF tracking.
• 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

• 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

• $40,000 - $50,000 (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 1/21/2026. Applications for this job will be accepted for at least 30 days from the posting date.