Tmf Operations Manager

Definiumtherapeutics

Remote
$122,205.00 - $144,400.00 py
Remote
Trial master file (tmf) documentation
Etmf build to archival
Tmf quality review activities
Definium Therapeutics is seeking a TMF Operations Manager to oversee Trial Master File documentation for global clinical studies. The ideal candidate will have significant experience in clinical operations, with a strong focus on regulatory compliance and document management

Job Summary

  • The TMF Operations Manager is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies.
  • This hands-on role requires leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams.
  • The Company provides competitive benefits to employees including: 100% paid health benefits including Medical, Dental and Vision for you and your dependents, 401(k) program with company match, Flexible time off, and Generous parental leave.

Matching Summary

Match Score: 85

Definium Therapeutics is seeking a TMF Operations Manager to oversee Trial Master File documentation for global clinical studies. The ideal candidate will have significant experience in clinical operations, with a strong focus on regulatory compliance and document management.

Salary

$122,205.00 - $144,400.00

Skills & Requirements

Must-have

  • Trial Master File (TMF) documentation
  • eTMF build to archival
  • TMF quality review activities
  • CRO TMF team liaison
  • regulatory compliance
  • inspection readiness

Nice-to-have

  • patient-centric, intelligent individuals
  • process improvement initiatives
  • data visualizations and summaries

Key Requirements

  • Bachelor's degree or equivalent
  • Minimum 5 years clinical operations experience
  • Global trial experience
  • Knowledge of CDISC TMF Reference Model
  • Experience with eTMF systems

Work Rights

Not specified

Tailored Resume

Cover Letter