Clinical Documentation 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. 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. #J-18808-Ljbffr