This role will be responsible to oversee and monitor the quality and completeness of the local study files (paper and/or electronic) within the North American Clinical Studies Unit (NA CSU) to ensure audit and inspection readiness.
The NACSU Records Management will be responsible for the development of process/document controls and the implementation of these controls. He/she will collaborate with the CSU Quality Leads in the development and maintenance of Local Quality Document(s) pertaining to the local study files, and will be responsible for ensuring the implementation of local templates (i.e., supporting documents) and study team/stakeholder training on applicable systems and tools.
This role will act as the subject matter expert locally and collaborate with the Global Record Management Team. The scope of the filing activities spans from study start-up to final archiving. This role will oversee and facilitate the collaboration of all CSU file contributors within each study program (e.g., monitoring team, IMP manager, Clinical Safety officer, etc.) to ensure that all procedures, systems, and timelines are being maintained.
This role will provide functional management to Local Study File staff/room (located in Bridgewater), indexing staff and additional assigned personnel as applicable to ensure that all Trial Master Files (TMF) are maintained up to date and systematically throughout the life cycle of the clinical trials.
This role will act as the key operational interface with internal and external stakeholders to develop, implement, maintain and improve operational TMF processes for CSU Americas. This position supports the CSU Study Teams in the conduct and management of the Trial Master File (TMF) for clinical trials and will be a key contributor/SME to the CTP-to-Veeva implementation.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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