Eg-100 Tmf Study Lead

Bristol Myers Squibb

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Trial master file (tmf) processes
Ich/gcp guidelines
Etmf system
** Bristol Myers Squibb is seeking a TMF Study Lead to ensure compliance with ICH/GCP guidelines and oversee the Trial Master File (TMF) processes at the study level. The ideal candidate should have 3-5 years of TMF experience, particularly with eTMF systems, and will play a crucial role in document management and inspection readiness. **

Job Summary

  • Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMS policies as it relates to the completeness and accuracy of the TMF at the study level.
  • Work proactively and prospectively with TMF Contributors at Study, Country and Site level to ensure timely uploading of all Essential Documents in the TMF.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a TMF Study Lead to ensure compliance with ICH/GCP guidelines and oversee the Trial Master File (TMF) processes at the study level. The ideal candidate should have 3-5 years of TMF experience, particularly with eTMF systems, and will play a crucial role in document management and inspection readiness. **

Skills & Requirements

Must-have

  • Trial Master File (TMF) processes
  • ICH/GCP Guidelines
  • eTMF system
  • risk-based reviews
  • TMF oversight
  • inspection readiness

Nice-to-have

  • interpersonal and influencing skills
  • change management
  • collaborative relationships
  • supportive culture
  • adaptability

Key Requirements

  • 3-5 years of TMF experience
  • Experience with eTMF systems
  • Relevant experience in clinical trials related roles

Work Rights

Not specified

Tailored Resume

Cover Letter