TMF Specialist

Our client, a Clinical Research Organization, is seeking a TMF Specialist to join their team. As a TMF Specialist, you will be part of the Records Management / Clinical Operations support team, helping ensure trial documentation is organized, accurate, and inspection-ready. The ideal candidate will have strong attention to detail, a customer-focused mindset, and the ability to manage multiple competing priorities with confidence—skills that will align successfully in the organization.

• Own TMF set-up, quality management, reporting, and TMF quality control/quality assurance activities.
• Ensure overall TMF document quality and completion, including accurate document filing and maintenance, cross-functional document coordination, and TMF tracking and reporting to internal and external clients.
• Maintain clinical trial documentation consistency with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and applicable SOPs.
• Verify that new and updated record information is entered accurately and maintained in accordance with TMF storage SOPs, processes, and data structure for inspection readiness.
• Support timely fulfillment of client requests for TMF retrieval, reproduction, re‑filing, and requested records or electronic images (e.g., PDF, JPEG), while assisting with inspection and audit‑ready activities.

• Previous experience working in eTMF system software;
  Veeva Vault and/or Trial Interactive preferred.
• Strong understanding of clinical research concepts and processes, with solid knowledge of ICH‑GCP guidelines and regulatory requirements for clinical document management.
• Excellent organizational skills with outstanding attention to detail and follow-through to support inspection readiness.
• Effective written and verbal communication skills for internal and external customers, including the ability to coordinate cross‑functionally.
• Proactive problem‑solving and analytical skills to identify solutions to technical problems of varying complexity; ability to advise project team members on key TMF issues.

• Play a direct role in ensuring TMF is audit ready and that documentation meets ICH/GCP and regulatory expectations.
• Work with eTMF records management processes and serve as a liaison between eTMF systems and internal/external stakeholders.
• Build confidence by supporting inspection and audit readiness, including QC review and approval of documents for accurate entry.
• Strengthen your expertise as a subject matter expert (SME) for TMF‑related questions and guidance for project staff.
• Contribute to continuous improvement by supporting digital records/TMF training materials, SOPs, and guidelines.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

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