Eg-100 Tmf Study Lead

Bristol Myers Squibb

Hybrid (50% onsite)
Tmf processes and inspection readiness
Ich/gcp guidelines adherence
Etmf system experience
Bristol Myers Squibb is seeking a TMF Study Lead with expertise in Trial Master File processes to ensure compliance and accuracy throughout clinical trials. The role requires collaboration with study teams and a strong understanding of regulatory guidelines, with a focus on inspection readiness

Job Summary

  • Work at Bristol Myers Squibb is anything but usual, offering uniquely interesting work that transforms the lives of patients and the careers of those who do it.
  • The role involves monitoring TMF adherence to guidelines, initiating TMF plans, conducting reviews, and proactively working with contributors to ensure timely document uploading.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility, offering competitive benefits and programs to support employees' goals both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a TMF Study Lead with expertise in Trial Master File processes to ensure compliance and accuracy throughout clinical trials. The role requires collaboration with study teams and a strong understanding of regulatory guidelines, with a focus on inspection readiness.

Skills & Requirements

Must-have

  • TMF processes and inspection readiness
  • ICH/GCP Guidelines adherence
  • eTMF system experience
  • Clinical trial regulatory requirements
  • Risk-based TMF reviews
  • TMF oversight with CROs

Nice-to-have

  • Interpersonal and influencing skills
  • Change management
  • Collaborative relationships
  • Knowledge sharing
  • Adaptability in changing environment

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter