TMF Specialist

About the Role

Piper Companies is seeking a TMF Specialist to support a leading clinical research and healthcare organization. This position is hybrid, based in Bethesda, MD.

Responsibilities

• 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.

Requirements

• 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.

Experience Levels

• 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.

Benefits

• PTO and paid holidays
• Medical, dental, and vision coverage
• 401K retirement plan
• Tuition reimbursement
• Paid maternity leave
• Military Reserve Pay Offset

Pay

Competitive salary based on experience.