Eg-100 - Tmf Study Lead, Archival

Bristol Myers Squibb

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Ich/gcp guidelines adherence
Tmf completeness and accuracy
Etmf system navigation
** Bristol Myers Squibb is seeking a TMF Study Lead, Archival, to ensure compliance with ICH/GCP guidelines, manage document integrity for clinical trials, and oversee the archiving process. The ideal candidate will have extensive TMF experience, particularly with Veeva Vault eTMF, and will work collaboratively across multidisciplinary teams to maintain high-quality standards in documentation. **

Job Summary

  • Monitor adherence to ICH/GCP Guidelines, regulatory requirements, and BMS policies for TMF completeness and accuracy.
  • Coordinate long-term storage archival of original documents, maintain document integrity per retention policies, and ensure controlled access to archive systems.
  • Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams and assist in change management.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a TMF Study Lead, Archival, to ensure compliance with ICH/GCP guidelines, manage document integrity for clinical trials, and oversee the archiving process. The ideal candidate will have extensive TMF experience, particularly with Veeva Vault eTMF, and will work collaboratively across multidisciplinary teams to maintain high-quality standards in documentation. **

Skills & Requirements

Must-have

  • ICH/GCP Guidelines adherence
  • TMF completeness and accuracy
  • eTMF system navigation
  • ALCOA+ standards
  • Good Clinical Practice
  • Good Documentation Practices
  • ICH guidelines (E6(R2))

Nice-to-have

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

Key Requirements

  • 3-5 years TMF experience
  • Veeva Vault eTMF experience
  • Study start-up, maintenance, closeout, archival experience
  • Quality and completeness review experience
  • Clinical trials related roles experience
  • Project management experience
  • Handling concurrent tasks experience

Work Rights

Not specified

Tailored Resume

Cover Letter