TMF Operations Lead

Praxis

TMF Operations Lead ensuring clinical trial documentation accuracy for Praxis Precision Medicines. Key responsibilities include overseeing eTMF setup and guiding trial teams towards compliance.

Posted 4/25/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $95,000 - $118,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

TMF managementeTMF systemsTMF structureTMF contentTMF processesSOPsquality reviewsmetrics analysiscompliance monitoringproblem solving

Soft Skills

critical thinkingorganizationdetail orientationcommunicationteam collaboration

Certifications

bachelor's degree