TMF Specialist Job at Piper Companies (Bethesda)

Job Description

Piper Companies is looking for a TMF Specialist to join a clinical research organization located in Bethesda, MD.

Job Responsibility

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

Requirements

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

What we offer

Cigna Medical/Dental/Vision
401K
Sick Leave as Required by Law

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