Salary
💰 $105,000 - $117,000 per year
Tech Stack
Google Cloud Platform
About the role
- Ensure clinical trial documentation is accurate, complete, and inspection-ready
- Serve as TMF subject matter expert and trusted partner to study teams
- Oversee eTMF set-up, maintenance, and regular quality reviews
- Monitor TMF health, milestones, and deliver metrics and insights to teams
- Guide and support trial teams to stay compliant with document lists and timelines
- Identify and resolve TMF issues and escalate when needed
- Contribute to SOPs, processes, and industry best practices
- Ensure access and compliance with global TMF standards and regulations
Requirements
- 5+ years of TMF management experience and a bachelor’s degree
- Deep knowledge of ICH/GCP, FDA, and international TMF requirements
- Strong experience with eTMF systems (Veeva preferred)
- Expert understanding of TMF structure, content, and processes
- Critical thinker who can solve problems quickly and effectively
- Organized and detail oriented
- Great communicator and team player
- Comfort with regular use of a computer, devices or other office equipment, clear communication, and occasional movement
- Willingness to travel as needed