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Praxis

Focused patient recruitment.

TMF Operations Lead

OperationsOperationsFull TimeRemoteSeniorTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

37 days ago

Salary

$95K - $118K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

TMF Operations Lead

Praxis

• 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.

Job 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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