Senior eTMF Specialist

New

Skills

Clinical Study Operations DIA TMF Reference Model Essential Document Lists (EDLs) eTMF Management Good Clinical Practice (GCP) Key Performance Indicators (KPIs) Quality Control (QC) Regulatory Compliance Training Development Veeva Vault

The Senior eTMF Specialist will serve as the primary contact for electronic Trial Master File (eTMF) management in clinical studies. This role involves ensuring compliance with Good Clinical Practice (GCP) and regulatory standards while collaborating closely with CROs and study teams to facilitate efficient TMF operations.

Key Responsibilities
  • Act as the primary eTMF contact for studies, addressing inquiries promptly.
  • Manage quality control and completion of TMF documents in accordance with GCP and regulatory rules.
  • Collaborate with CROs and partners on TMF activities and monitor Key Performance Indicators (KPIs) and Essential Document Lists (EDLs).
  • Provide TMF guidance to study teams per established processes.
  • Support TMF training initiatives and contribute to the development of Work Instructions (WIs), Standard Operating Procedures (SOPs), and tools.
  • Assist with TMF elements of regulatory inspections by providing relevant documentation.
Required Skills & Qualifications
  • BSc in biomedical, life science, or related field.
  • 4+ years of experience in TMF operations for clinical studies.
  • Proficiency in TMF, GCP, and eTMF systems, particularly Veeva Vault.
  • Experience with TMF processes in a sponsor company, not a CRO.
  • Knowledge of the DIA TMF reference model and cross-functional processes.
  • Experience with Veeva eTMF, including uploading, reviewing, quality control, and approvals.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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