Sr. Manager, Tmf Process Lead

Bristol Myers Squibb

50% onsite
Tmf governance structure
Etmf system expertise
Ich guidelines understanding
Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams

Job Summary

  • Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams.
  • Develops training materials, templates, job aids, plans, etc… for TMF and archival processes.
  • Communicates and coordinates with internal and external stakeholders to ensure TMF compliance and inspection readiness.

Matching Summary

Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams.

Skills & Requirements

Must-have

  • TMF governance structure
  • eTMF system expertise
  • ICH guidelines understanding
  • CRO TMF transfers oversight
  • Vault eTMF system knowledge

Nice-to-have

  • continuous improvement initiatives
  • matrixed organization collaboration
  • innovation and automation implementation

Key Requirements

  • Minimum of 5 years of experience
  • Bachelor's degree in a related field
  • Thorough understanding of ALCOA+ standards
  • Strong working knowledge of TMF
  • Comprehensive knowledge of regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter