Tmf Study Lead

Bristol Myers Squibb

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Tmf processes and inspection readiness
Ich/gcp guidelines and regulatory requirements
Etmf system experience
** Bristol Myers Squibb is seeking a TMF Study Lead who will oversee the Trial Master File (TMF) processes to ensure compliance with regulatory standards and maintain inspection readiness. The ideal candidate should have significant experience in TMF management, particularly with eTMF systems, and possess strong project management skills. **

Job Summary

  • Monitor adherence to ICH/GCP Guidelines and regulatory requirements for TMF completeness and accuracy, ensuring inspection readiness at all times.
  • Work proactively with TMF Contributors to ensure timely uploading of Essential Documents and perform risk-based reviews to assess TMF health.
  • Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams and provide TMF training as required.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a TMF Study Lead who will oversee the Trial Master File (TMF) processes to ensure compliance with regulatory standards and maintain inspection readiness. The ideal candidate should have significant experience in TMF management, particularly with eTMF systems, and possess strong project management skills. **

Skills & Requirements

Must-have

  • TMF processes and inspection readiness
  • ICH/GCP Guidelines and regulatory requirements
  • eTMF system experience
  • Risk-based TMF reviews
  • TMF trend monitoring and escalation

Nice-to-have

  • Interpersonal and influencing skills
  • Change management and collaboration
  • Proactive communication with study teams
  • Ability to make decisions and deliver commitments

Key Requirements

  • 3-5 years of TMF experience
  • Experience with eTMF systems (preferably Veeva Vault)
  • Relevant experience in clinical trials roles
  • Expertise with GCP, ICH guidelines, and FDA/EMA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter