Senior Trial Master File Manager

Start free →

Or apply yourself on the official page →

About the role

• Location: Budapest • Job type: Permanent, Full-time • Hybrid working About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our global Clinical Sciences and Operations (CSO)'s Record Management team and take on a leadership role at the heart of Clinical Documentation. This is a position for an experienced TMF Manager who has demonstrated proficiency in leveraging eTMF processes and tools in a fast-paced environment for complex, high-visibility studies such as phase 3 trials. In this role you will act as a subject matter expert for specific areas of Record Management and will support strategic initiatives while maintaining operational excellence. As a senior member of the team, you will provide mentoring and supervision of junior colleagues and serve as a primary point of contact during regulatory inspections, including Pre-Approval Inspections (PAI).   We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities: Operations   Assignments to the Senior TMF Manager are at study- and product-level. More specifically, the Senior TMF Manager takes charge of: • Managing a portfolio of complex clinical trials for defined projects, ensuring TMF completeness and quality whether assigned or, delegated to other TMF Managers • Leading inspection and audit preparation activities for high-priority trials, including gap assessments, remediation coordination, and serving as a TMF subject matter resource throughout the preparation process • Fulfilling Inspector-facing responsibilities, which can include: presenting and demonstrating the eTMF platform during onsite inspections; responding to Inspector questions in real-time; reporting on follow-up requested, within the required timeframe Supervision and Mentoring The Senior TMF Manager will provide support and back-up to the Line Manager according to business needs, supervising team members across a variety of situations: • Guide and mentor TMF Managers on complex TMF issues, inspection preparation, best practices • Act as a first escalation point for local TMF-related challenges, coordinating cross-functional resolution efforts when needed • Co-manage local assignment strategies as the field evolves technologically • Oversee selected activities of TMF managers engaged in process improvements at Task or Procedural level • Contribute to growth and development discussions based on factual observations from daily operations, identified gaps, and needed skills   Process improvement and digitalization   As the ecosystem evolves to AI-enabled processes with high automation, the Senior TMF Manager will:  • Identify opportunities for process optimization and participate in the harmonization of standards and processes with ClinDoc and other teams, sharing best practices and lessons learned • Lead or participate in function or department projects related to TMF process improvement, digital transformation, and innovation initiatives • Collaborate with TMF contributor departments to implement TMF strategies and standards whether as continuous improvement, or major roll-outs • Represent Sanofi in external industry working groups related to TMF and clinical documentation best practices About you Education & experience • BS/BA degree required • 3 to 5 + years of experience in managing TMFs and/or managing

View the official posting →