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 8/24/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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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