Trial Master File Manager

at  Sanofi

• Job title: Trial Master File (TMF) Manager- Vaccines
• Location: Budapest
• Flexible working: 60% home, 40% office
• Job type: Permanent, Full-time

TECHNICAL SKILLS:

• Good knowledge of MS Office Suite (Word, Excel, PowerPoint)
• Good technical orientation, eager to learn new technical aspects of a tool
• Veeva eTMF or RIM experience is a plus

Education:

• BS/BA degree required

Languages:

• Fluent written and verbal communication skills in English

For studies assigned you will be responsible for:

• Set up and lock Clinical TMFs
• Monitor the completeness and quality of the TMF and provide support to TMF Contributors on TMF management processes and the eTMF/EDMS system. Propose and coordinate remediation plans in case of compliance issues
• Provide support and direction to the Associate TMF managers, Clinical Documentation Administrators in the processing of TMF documents, and be the main point of contact for TMF Contributors
• Write the TMF Plan and perform TMF Review checks during the life of the study
• Coordinate and participate in the preparation and conduct of TMF audits and GCP inspections for the TMF Management platform
• Report study TMF progress or any issue to the Clinical Team and the Global TMF Management Head
• Participate in continuous improvement and digital/process initiatives and train newcomers on the TMF tools and processes
• Manage approximately 5 to 10 trials concomitantly and can manage Ph3 trials