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TMF Manager
Il y a 2 mois
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
Missions :
Represent the TMF Management team in the Clinical Team
Responsible for the following activities for the assigned trials:
- TMF set-up and closure
- TMF management activities oversight
- TMF plans writing and updating to always have an up-to-date document
- TMF completion and quality monitoring:
- Participate in clinical team meetings and provide metrics and TMF progress reports to the clinical -team
- Provide support and expertise to the Clinical Trial TMF Contributors on TMF management processes and on the eTMF/EDMS system
- Act as the main point of contact and provide support for the Contributors for TMF management for the assigned trials
- Perform TMF Review Checks per the TMF Plan. Propose and lead any corrective action plan
- Report any study progress or challenges and any TMF Process issues to Sanofi Vaccines Point of Contact
- Coordinates the preparation and the conduct of TMF audits for the TMF Management platform
- Complete/create all documents requested in the TMF related to TMF Management team activities : i.e., SOP list, who’s who list, trial summary, List of computerized system
