Trial Master File Manager

Sanofi

Budapest, Hungary
Hybrid
Trial master file (tmf) management
Etmf/edms system support
Inspection readiness
Sanofi is seeking a Trial Master File (TMF) Manager for their Budapest office, focusing on ensuring the quality and compliance of clinical trial documentation. This hybrid role involves managing TMF activities, supporting global initiatives, and participating in continuous improvement efforts within a collaborative and innovative environment

Job Summary

  • Join the global Clinical Sciences and Operation (CSO)’s Record Management team as a Trial Master File (TMF) Manager to support global activities, ensure inspection readiness, and provide clinical documents for submissions.
  • Responsibilities include setting up and locking Clinical TMFs, monitoring completeness and quality, providing support to TMF Contributors, and coordinating TMF audits and GCP inspections.
  • Sanofi offers a supportive, future-focused international work environment with flexible home office policies, a comprehensive rewards package, and extensive health and well-being benefits.

Matching Summary

Match Score: 85

Sanofi is seeking a Trial Master File (TMF) Manager for their Budapest office, focusing on ensuring the quality and compliance of clinical trial documentation. This hybrid role involves managing TMF activities, supporting global initiatives, and participating in continuous improvement efforts within a collaborative and innovative environment.

Skills & Requirements

Must-have

  • Trial Master File (TMF) management
  • eTMF/EDMS system support
  • Inspection readiness
  • Clinical TMF regulations
  • ICH and GCP knowledge
  • Transversal project management

Nice-to-have

  • Collaborative team player
  • Customer focus
  • Cross-cultural awareness
  • Continuous improvement initiatives

Key Requirements

  • Proven experience in TMF management
  • BS/BA degree required
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter