Tmf Study Lead

Bristol Myers Squibb

**
Tmf processes and inspection readiness
Ich/gcp guidelines and regulatory requirements
Etmf system management
** Bristol Myers Squibb is seeking a TMF Study Lead to oversee the Trial Master File (TMF) processes, ensuring compliance with regulations and internal policies while collaborating with study teams. The role emphasizes proactive management of essential documents and inspection readiness, requiring at least 3-5 years of relevant experience. **

Job Summary

  • Monitor adherence to ICH/GCP Guidelines and regulatory requirements for TMF completeness and accuracy, ensuring inspection readiness.
  • Proactively work with TMF Contributors to ensure timely uploading of Essential Documents and perform risk-based reviews to assess TMF health.
  • Leverage interpersonal 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 to oversee the Trial Master File (TMF) processes, ensuring compliance with regulations and internal policies while collaborating with study teams. The role emphasizes proactive management of essential documents and inspection readiness, requiring at least 3-5 years of relevant experience. **

Skills & Requirements

Must-have

  • TMF processes and inspection readiness
  • ICH/GCP Guidelines and regulatory requirements
  • eTMF system management
  • Risk-based TMF reviews
  • TMF document completeness and accuracy monitoring
  • CRO TMF oversight

Nice-to-have

  • Interpersonal and influencing skills
  • Change management and collaboration
  • Proactive communication with study teams
  • Knowledge sharing and peer collaboration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter