Clinical TMF Operations Administrator

Job Summary

To support the execution of the Phase 3 clinical development program for EFX, the full-time remote Clinical TMF Operations Administrator will manage TMF activities across trial phases, oversee eTMF health, and ensure compliance and inspection readiness while collaborating with Clinical Trial Teams and CRO partners.

Key responsibilities

• Lead TMF activities for assigned trials, ensuring effective communication with Clinical Trial Teams and CRO partners
• Manage eTMF health by overseeing Quality Issue workflows and monitoring compliance with TMF processes
• Support TMF document processing and participate in trial-specific meetings, providing TMF expertise and status updates

Required qualifications

• Bachelor's degree in a related discipline and 4+ years of relevant clinical research experience
• 2-3+ years of experience in eTMF document management
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Experience leading TMF operations and collaborating with Clinical Trial Teams and CROs
• Proven ability to generate and interpret TMF health metrics to inform decision-making