Tmf Study Lead, Archival

Bristol Myers Squibb

**
Ich/gcp guidelines adherence
Tmf completeness and accuracy
Etmf system navigation
** Bristol Myers Squibb is seeking a TMF Study Lead for Archival to ensure the accuracy and completeness of the Trial Master File (TMF) in compliance with regulatory requirements. The role involves overseeing document management, quality reviews, and collaboration within multidisciplinary teams, while promoting a supportive work culture that values innovation and accountability. **

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.
  • Generate, organize, and deliver on TMF performance metrics at the site, study, country and compound levels.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a TMF Study Lead for Archival to ensure the accuracy and completeness of the Trial Master File (TMF) in compliance with regulatory requirements. The role involves overseeing document management, quality reviews, and collaboration within multidisciplinary teams, while promoting a supportive work culture that values innovation and accountability. **

Skills & Requirements

Must-have

  • ICH/GCP Guidelines adherence
  • TMF completeness and accuracy
  • eTMF system navigation
  • ALCOA+ standards
  • ICH E6(R2) guidelines
  • Clinical trial documentation expertise

Nice-to-have

  • Proactive collaboration
  • Independent problem-solving
  • Interpersonal and influencing skills
  • Change management participation
  • Building collaborative relationships

Key Requirements

  • 3-5 years TMF experience
  • Veeva Vault eTMF experience
  • Clinical trials related roles experience
  • Project management experience
  • Handling concurrent tasks
  • Advance proficiency with Window Office tools

Work Rights

Not specified

Tailored Resume

Cover Letter