TMF Specialist

Job Summary: Piper Companies is seeking a TMF Specialist to support a leading clinical research and healthcare organization. This position is Hybrid in Bethesda, MD . Responsibilities for the TMF Specialist include: Manage TMF setup, quality management activities, reporting, metrics, and ongoing quality control/quality assurance processes. Ensure clinical trial documentation is complete, accurately filed, and maintained in accordance with eTMF standards, ICH-GCP guidelines, regulatory requirements, and company SOPs. Coordinate document collection, filing, tracking, and reporting activities across internal teams, sponsors, and external stakeholders. Conduct quality control reviews and approve documents to ensure inspection readiness and TMF compliance. Serve as a subject matter expert (SME) on TMF processes, providing guidance, training, and support to project teams and junior staff. Support audit and inspection readiness activities, including document retrieval, reconciliation, and records transfers. Monitor project timelines and deliverables to ensure commitments, deadlines, and quality standards are consistently achieved. Required Qualifications for the TMF Specialist include: Bachelor's degree in a science, healthcare, or related field. Experience working with eTMF systems; experience with Veeva Vault and/or Trial Interactive preferred. Strong understanding of clinical research processes and clinical document management requirements. Knowledge of FDA, ICH-GCP, EMA, and other applicable regulatory requirements governing TMF management. Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment. Strong written and verbal communication skills with demonstrated ability to collaborate effectively across functional teams and external partners. Proficiency with Microsoft Office Suite. Compensation for the TMF Specialist includes: Salary Range: Competitive based on experience Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset Experience Requirements: Level I 0-2 years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements. Level II 2-4 years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements. Level III 5+ years of experience with TMF review and knowledge of FDA, ICH, and EMA TMF requirements. 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. Keywords: TMF Specialist, Trial Master File, eTMF, Veeva Vault, Trial Interactive, Clinical Operations, Clinical Research, Clinical Documentation, TMF Management, ICH-GCP, FDA Regulations, EMA Regulations, Regulatory Compliance, Inspection Readiness, Audit Readiness, Records Management, Clinical Trials, Quality Assurance, Quality Control, Document Review, TMF Oversight, Healthcare, Biotechnology, CRO, Life Sciences, Microsoft Offic24 #J-18808-Ljbffr