Tmf Study Lead Archival

Bristol Myers Squibb

50% onsite
Tmf archival procedures
Ich/gcp guidelines adherence
Etmf system management
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

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

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.

Skills & Requirements

Must-have

  • TMF archival procedures
  • ICH/GCP Guidelines adherence
  • eTMF system management
  • document integrity and retention
  • risk-based quality reviews

Nice-to-have

  • interpersonal and influencing skills
  • change management
  • collaborative relationships
  • project management skills
  • time management skills

Key Requirements

  • Years of experience in TMF management
  • Experience with TMF archival procedures
  • Familiarity with regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter