TMF Coordinator
Core
Maintain the quality, completeness, and compliance of Trial Master File (TMF) documentation to ensure inspection readiness and support clinical trial execution.
Role type
TMF Coordinator (Clinical Operations)
Builds
Inspection-ready TMF documentation for clinical trials
Domain
Clinical Trials / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
TMF structure knowledge, ICH-GCP/FDA/EMA regulations, ALCOA+ principles, eTMF systems (Veeva Vault, Phlexglobal, Trial Interactive), document classification and indexing, version control, QC checks, gap resolution, root cause analysis
Preferred skills
Bachelor's degree in Life Sciences, 1-3 years clinical trial TMF experience
Technologies
Veeva Vault, Phlexglobal, Trial Interactive, Microsoft Excel, Microsoft Word, SharePoint
Responsibilities
Maintain TMF structures (paper and electronic), ensure compliance with global regulatory requirements, file and index documents accurately, perform QC checks on TMF documents and metadata, investigate and resolve TMF gaps and discrepancies, collaborate with study teams to follow up on outstanding documentation
Seniority
Mid-level, hands-on IC