TMF Management Specialist

Job Summary

A company is looking for a Manager, TMF Management & Oversight.

Key Responsibilities

• Manage TMF activities throughout the study lifecycle, ensuring quality and compliance
• Lead TMF quality control and reconciliation, maintaining inspection readiness
• Oversee CRO/vendor TMF deliverables and drive continuous process improvement

Required Qualifications

• 5-8+ years of hands-on TMF/eTMF experience in clinical research
• Expertise in TMF quality management and inspection readiness
• Strong knowledge of ICH-GCP and global regulatory requirements
• Experience with eTMF systems and document management practices
• Bachelor's degree in Life Sciences, Health Sciences, or related field required; advanced degree preferred