Eg-100 - Tmf Study Lead, Archival

Bristol Myers Squibb

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Tmf adherence to ich/gcp
Etmf system navigation
Clinical trial document integrity
** Bristol Myers Squibb is seeking a TMF Study Lead for archival responsibilities, focusing on ensuring compliance with regulatory requirements and maintaining the accuracy of the Trial Master File (TMF). The ideal candidate will have extensive TMF experience, particularly with eTMF systems, and possess strong project management and communication skills. **

Job Summary

  • Monitor adherence to ICH/GCP Guidelines and BMS policies for TMF completeness and accuracy, ensuring inspection readiness.
  • 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 support change management.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a TMF Study Lead for archival responsibilities, focusing on ensuring compliance with regulatory requirements and maintaining the accuracy of the Trial Master File (TMF). The ideal candidate will have extensive TMF experience, particularly with eTMF systems, and possess strong project management and communication skills. **

Skills & Requirements

Must-have

  • TMF adherence to ICH/GCP
  • eTMF system navigation
  • Clinical trial document integrity
  • Study completion archival
  • Risk-based TMF quality reviews

Nice-to-have

  • Proactive collaboration with study teams
  • Independent problem-solving
  • Change management participation
  • Building collaborative relationships

Key Requirements

  • 3-5 years TMF experience
  • Veeva Vault eTMF proficiency
  • Clinical trial operations experience
  • Project management experience
  • ALCOA+ standards knowledge
  • GCP and ICH guidelines knowledge

Work Rights

Not specified

Tailored Resume

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