Clinical Data Lead (Data Manager)

Sanofi•Morristown, NJ

2d•Onsite

About The Position

In the scope of clinical development of our products, the incumbent's mission is to adapt and coordinate the data management strategy during development and conduct of clinical studies/projects. He/she ensures integrity of data and appropriate level of quality for each assigned clinical study to deliver a cleaned and accurate clinical database, allowing its statistical analysis and submission. He/she acts as Clinical Data Management (CDM) referent within the clinical team and with other departments or external partners. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com ! About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Requirements

Bachelor's degree in Health/Life Sciences, Technical Sciences, or a related scientific field.
A minimum of 3+ years of experience in data management within the clinical or medical field.
Proficiency in data management software including Rave, EDC systems, and eCOA platforms, as well as SAS and data visualization tools.
Solid understanding of clinical/medical field standards and regulations, along with project management capabilities and experience in outsourcing oversight.
Full professional proficiency in English

Nice To Haves

French is considered an asset.

Responsibilities

Plan and coordinate the data management activities in line with Standards and Regulations
Ensure the oversight of external vendors/partners as applicable
Represent CDM with Clinical Team and other departments (Digital, Pharmacovigilance, Labs) or external parties
Perform and/or ensure oversight of the processes allowing to reach required level of quality of database in respect of timelines, documentation and readiness for audit and inspection
Contribute to improvement of global data management processes by providing business expertise and project management skills
Cooperate transversally within Sanofi with various partners