Requirements: English
Company: Sanofi EU
Region: Budapest , Budapest
- Job title: Trial Master File Manager
- Location: Budapest, Hungary
- 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.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were 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?
Join our global Clinical Sciences and Operation (CSO)s Record Management team as a Trial Master File (TMF) Manager and youll be the part of supporting global activities related to the TMF, ensure inspection readiness, provide clinical documents for submissions and participate in continuous improvement initiatives. As part of the study Clinical team you will ensure TMFs are Inspection ready at any time.
Main responsibilities:
For Vaccine 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
About you
Experience:
- Good knowledge of the TMF regulations, ICH, GCP and clinical development process is a plus
Soft Skills:
- Excellent verbal, written, organizational and interpersonal skills with a sharp attention to detail and the ability to handle multiple tasks simultaneously
- Collaborative team player with orientation towards building and maintaining effective relationships with cross-cultural awareness and customer focus
- Ability to organize and conduct meetings, assign tasks, develop project/activity plans, and follow a project/activity through to completion
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:
- Proven, extensive, relevant experience in coordination or TMF management activities (eTMF Veeva Vault Clinical)
Language(s):
- Strong English skills (verbal and written), ability to exchange fluently in a global environment
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 2023" 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)
Pursue Progress . Discover Extraordinary .
Progress doesnt 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. Lets pursue progress. And lets discover extraordinary together.