Tmf Study Lead, Archival

Bristol Myers Squibb

Hybrid (50% onsite)
Ich/gcp guidelines adherence
Tmf completeness and accuracy
Etmf system navigation
Bristol Myers Squibb is seeking a TMF Study Lead, Archival, to ensure compliance and accuracy in the trial master file (TMF) processes for clinical studies. The ideal candidate will have extensive experience in TMF management and a strong understanding of clinical trial documentation, regulatory requirements, and project management

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.
  • Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies.
  • Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a TMF Study Lead, Archival, to ensure compliance and accuracy in the trial master file (TMF) processes for clinical studies. The ideal candidate will have extensive experience in TMF management and a strong understanding of clinical trial documentation, regulatory requirements, and project management.

Skills & Requirements

Must-have

  • ICH/GCP Guidelines adherence
  • TMF completeness and accuracy
  • eTMF system navigation
  • ALCOA+ standards
  • Good Clinical Practice
  • Good Documentation Practices
  • International Council for Harmonization guidelines

Nice-to-have

  • Interpersonal and influencing skills
  • Collaborative relationships
  • Critical thinker
  • Proactive and prospective work

Key Requirements

  • 3-5 years of TMF experience
  • Veeva Vault eTMF experience
  • Experience in study start-up, maintenance, closeout and archival
  • Performing quality and completeness reviews
  • Relevant experience in clinical trials related roles
  • Independently managing projects
  • Handling concurrent tasks

Work Rights

Not specified

Tailored Resume

Cover Letter