TMF Specialist

Piper Companies is currently looking for an TMF Specialist based in the Montgomery County, Maryland area to work a hybrid role. The TMF Specialist will join a mission-driven organization focused on delivering research, technical, and operational solutions that help advance healthcare innovation.

• Manage and maintain Trial Master File (TMF) documentation, ensuring completeness, accuracy, quality, and inspection readiness in compliance with ICH/GCP guidelines, regulatory requirements, and company SOPs.
• Oversee TMF quality control activities, including document review, filing, reconciliation, tracking, reporting, and resolution of missing or incomplete records.
• Serve as a primary point of contact for internal teams and external clients, coordinating document collection, retrieval requests, record transfers, and ongoing TMF-related support.
• Contribute to process improvement initiatives through the development and maintenance of SOPs, training materials, best practices, and staff training while providing subject matter expertise on TMF processes.
• Support audit and inspection readiness efforts, monitor project timelines and deliverables, and assist with resource planning, project oversight, and records management operations.

• Prior experience working within eTMF platforms, with Veeva Vault and/or Trial Interactive
• Working knowledge of clinical research processes, study documentation, and trial operations.
• Strong understanding of ICH-GCP guidelines and regulatory requirements governing clinical document management.
• Familiarity with ICH, GCP, and other applicable regulatory standards related to clinical trial documentation.
• Capable of providing guidance and support to project teams on TMF-related processes and best practices.
• Experience training, mentoring, and supporting the development of team members.
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.

• Hourly rate: $/hr
  • Based heavily on experience
• Comprehensive Benefits:
  Medical, Dental, Vision, 401K, and Sick Leave as required by law

Trial Master File (TMF), eTMF management, Veeva Vault, Trial Interactive, clinical trial documentation, clinical research, document management, records management, TMF quality control, TMF quality assurance, inspection readiness, audit readiness, ICH-GCP compliance, regulatory compliance, clinical operations, regulatory documentation, document reconciliation, essential documents, study startup documentation, electronic filing systems, document lifecycle management, SOP development, process improvement, training and mentoring, quality review, cross-functional collaboration, project coordination, stakeholder communication, tracking and reporting, database management, risk mitigation, analytical problem-solving, attention to detail, Microsoft Office Suite, site documentation, investigator files, sponsor and CRO experience, clinical trial support, and regulatory affairs support.

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