Sanofi
Trial Master File Inspection Readiness Support
This job is now closed
Job Description
- Req#: R2692538
- Follow up on eTMF completeness for studies in the eTMF.
- Follow up on TMF Quality Issues (Independent Quality Control).
- Perform customizations of the e-TMF templates.
- Extract reports from eTMF tool to follow-up on TMF compliance, quality and completeness.
- Prepare CRF (Case Report Form) for submissions.
- Copy documents from eTMF to Vault RIM (regulatory tool).
- Experience in Clinical Development and possibly TMF management is an advantage.
- Familiar with Windows-based computer applications (MS Excel, Access and PowerPoint).
- Desired but not mandatory: Knowledge of TMF reference Model, Veeva Tool.
- Understand the clinical development process and GCP's (Good Clinical Practice).
- Consistently meet deadlines according to accepted levels of quality.
- Follow guidelines precisely and follow through on all tasks.
- Provide high quality deliverables.
- Be able to work effectively in a team.
- Bachelor or equivalent.
- English fluent (written and oral).
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary and cafeteria benefits.
- Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
- Work from an "Office of the Year 2020" finalist office.
- Collective life and accident insurance.
- Yearly medical check-up.
- 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.
- Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).
Our position
Job title: Trial Master File Inspection Readiness Support
Location: Budapest, Hungary
Flexible working: 60% home, 40% office
Job type: Permanent, full-time
About the job
Our Team:
The TMF (Trial Master File) is the documentation related to a Clinical Study.
The role of the Record Management team is to support all global activities related to the TMF, ensure inspection readiness at any time and provide clinical documents for submissions. The team interacts with around 4.000 TMF contributors worldwide.
The TMF Inspection Readiness Support is part of the Record Management Team and works in close collaboration with the Record Management Team and TMF contributors to ensure TMF quality and completeness.
Main responsibilities:
About you
Experience:
Technical skills:
Ability to:
Education:
Languages:
When joining our team, you will experience:
Pursue progress. Discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.
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.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
About the company
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
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