TMF Specialist - Bethesda - ZP Group

    ZP Group
    ZP Group Bethesda

    1 week ago

    Description

    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

    Qualifications for the TMF Specialist include:

    • 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

    Compensation for TMF Specialist includes:

    * Rate Range: $20-25/hr* Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

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

    Keywords: eTMF Management, Trial Master File, TMF Reference Model, Veeva Vault, Trial Interactive, ICH‐GCP Compliance, FDA Regulations, EMA Requirements, Regulatory Inspection Readiness, TMF Quality Control, TMF Quality Assurance, Clinical Document Management, TMF Indexing, TMF Plans, Audit Readiness, Inspection Support, Metadata Management, Records Management, SOP Compliance, Clinical Operations, TMF Monitoring, Document Lifecycle Management, TMF Reconciliation, Quality Metrics Reporting, Electronic Records Management, TMF Archiving, Cross‐Functional Coordination, Risk‐Based TMF Management, Data Integrity, Vendor Oversight

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