Senior Trial Master File Manager
Core
Senior TMF Manager leading record management for complex Phase 3 clinical trials, ensuring TMF completeness and quality while serving as a subject matter expert during regulatory inspections.
Role type
Senior IC Trial Master File Manager (Clinical Operations)
Builds
Production-ready Trial Master Files (TMF) for high-visibility clinical studies
Domain
Healthcare / Clinical Trials / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
TMF management, eTMF platform expertise, regulatory compliance (ICH-GCP), team supervision, inspection preparation, process optimization, AI literacy
Preferred skills
Cross-functional collaboration, strategic initiative support, mentoring
Technologies
Veeva eTMF, RIM, MS Office Suite
Responsibilities
Manage portfolio of complex clinical trials ensuring TMF completeness; lead inspection and audit preparation activities; fulfill Inspector-facing responsibilities including presenting eTMF platform; mentor TMF Managers on complex issues and best practices; oversee process improvements and digital transformation initiatives
Seniority
Senior, hands-on IC with mentoring responsibilities
