Clinical Trial Manager

Job description

Position Overview and Key Responsibilities

The Early Development Operations (EDO) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of early development phase clinical trials (FIH to POC) clinical trials in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines. The CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (e.g. Study Team (ST)) to guarantee release of homogeneous high quality clinical data in close collaboration with the EDO Data Manager (DM) and Study Medical Manager  (SMM).  Early development phase clinical trials will be conducted at either the Clinical Site Service Provider (CSSP), academic sites, or CROs (Contract Research Organization).

The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The CTM may also participate in intra or inter-department Working Groups.

Formal Education And Experience Required
· 
Bachelor's Degree

· 
8+ yrs. Laboratory/medical experience or 5+ years in clinical research

· 
Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations.

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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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.