Praxis

TMF Operations Lead

Praxis

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $105,000 - $117,000 per year

Job Level

Senior

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
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