Etmf Specialist

IQVIA

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Global etmf operations oversight
Etmf procedure creation and revision
Inspection readiness at all times
** IQVIA is seeking an eTMF Specialist for Chiesi Farmaceutici to oversee global electronic Trial Master File operations in a dynamic environment. The role requires managing eTMF processes, ensuring compliance with regulations, and maintaining inspection readiness across study teams. **

Job Summary

  • This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management.
  • Responsible for creation and revision of all eTMF associated procedures, ensuring they are up to date and compliant with the applicable regulations.
  • This position will assume the leadership role for global eTMF operation to ensure the quality KPIs are met and eTMFs are inspection ready at all times.

Matching Summary

Match Score: 75

** IQVIA is seeking an eTMF Specialist for Chiesi Farmaceutici to oversee global electronic Trial Master File operations in a dynamic environment. The role requires managing eTMF processes, ensuring compliance with regulations, and maintaining inspection readiness across study teams. **

Skills & Requirements

Must-have

  • Global eTMF operations oversight
  • eTMF procedure creation and revision
  • Inspection readiness at all times
  • Process excellence and consistency
  • TMF Reference Model knowledge
  • ICH GCP and applicable regulations

Nice-to-have

  • Dynamic working environment
  • Intelligent connections
  • Zero tolerance for fraud

Key Requirements

  • Minimum 5 years experience
  • BS/BA in Life Sciences or similar
  • Experience managing eTMF systems
  • Experience with paper TMF preferred
  • Previous audit/inspection experience

Work Rights

Not specified

Tailored Resume

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