TMF Operations Lead
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Job Description
TMF Operations Lead ensuring clinical trial documentation accuracy for Praxis Precision Medicines. Key responsibilities include overseeing eTMF setup and guiding trial teams towards compliance.
Responsibilities:
- Be the 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, escalating 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.
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO and paid holidays.
- Company-wide shutdowns.
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