TMF Specialist

Piper Companies is looking for a TMF Specialist to join a clinical research organization located in Bethesda, MD Responsibilities of the TMF Specialist include:

• Managing TMF set-up, quality oversight, reporting, metrics, and quality control activities
• Maintaining overall TMF document quality and completeness, including proper filing, coordination, tracking, and reporting
• Ensuring clinical trial documentation complies with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and internal SOPs
• Accurately maintaining all TMF records in accordance with SOPs and data standards to support inspection readiness
• Responding to client requests for TMF retrieval, reproduction, re-filing, and delivery of electronic records
• Supporting the development and maintenance of TMF training materials, SOPs, and guidelines, including training staff as needed
• Assisting with audit and inspection readiness activities and ensuring the TMF remains inspection ready
• Staying current on TMF Reference Model standards, regulatory requirements, and industry best practices
• Serving as a liaison between eTMF records management and internal and external clients
• Monitoring project activities to ensure deadlines and deliverables are met
• Acting as a subject matter expert on TMF-related matters and providing guidance to project staff and subcontractors
• Performing quality control reviews of TMF documents to ensure accuracy
• Coordinating retrieval of requested records and preparing closed studies for transfer within agreed timelines
• Assisting management with records management planning, cost proposals, and resource forecasting
• Performing task management and, depending on experience level, line management responsibilities

• Experience working with eTMF systems;
  Veeva Vault or Trial Interactive preferred
• Strong understanding of clinical research processes and document management requirements
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements related to TMF management
• Excellent organizational skills with strong attention to detail
• Effective written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment
• Strong problem-solving and analytical skills
• Experience advising project teams on TMF-related issues
• Experience training, mentoring, and coaching staff
• Ability to build and maintain positive working relationships across teams and management
• Proficiency in Microsoft Office
• Bachelor's degree in a science or healthcare-related field required

• Rate Range: $20-35/hr
• Comprehensive Benefit Package:
  Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on September 22nd, 2026. Applications will be accepted for at least 30 days from the posting date.

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