TMF Specialist

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.

• 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

• 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

• $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.