Senior Trial Master File Manager

Job description

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 youEducation & experience BS/BA degree required 3 to 5 + years of experience in managing TMFs and/or managing sets of complex clinical documents Strong knowledge of regulations surrounding TMF, ICH-GCP guidelines, and clinical development processes is required Leading teams, managing resources, enhancing processes including experience in or exposure to implementation of tools Soft skills Project management experience in a complex, regulated environment, including familiarity with metrics monitoring and analysis Demonstrated ability to lead or supervise others whether in hierarchical or matrix environment Collaborative team player with orientation towards building and maintaining effective relationships, with cross-cultural awareness and customer focus Capacity to analyze situations and needs, reconcile diverse opinions from various internal stakeholders, and subsequently develop and implement appropriate action plans Capacity to create and encourage innovative approaches and problem-solving, when necessary, without compromising professional integrity Able to work under pressure; resourceful, confident, and self-directed Demonstrated work ethics, integrity, and professional conduct Technical skills AI Literacy: training on AI tools and techniques; prompting knowledge; ability to discuss and leverage AI, available and emerging in the framework of TMF or similar processes Veeva eTMF, RIM or similar platform experience is required Good knowledge of MS Office Suite (Word, Excel, PowerPoint) Language(s): Fluent written and verbal communication skills in English Why choose us?Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment Work from an "Office of the Year 2025" award winner with flexible home office policy Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs) Office of the Year 2025 – Evolution Award Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability. Marketing Diamond Award 2026 – Employer Branding One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding. BSC Investor of the Year 2025 Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector. PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers Ranked 3rd among the most attractive employers in Hungary. Hungarian Employer Branding Awards 2025 – Gold & Silver Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver). Pursue Progress. Discover Extraordinary. Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying. #Sanofi #SanofiCareers #joinSanofi #jobopportunities #careeropportunities #sscjob #Sanofi_Budapest_Hub #Budapest #clinicalsciences #clinicaldocumentation #recordmanagement #TMF #trialmasterfile #eTMF #LI-EUR #LI-hybrid Pursue progress, discover extraordinar