Global Study Data Leader - VIE Contract

Global Study Data Leader - VIE Contract

• Location: United States of America, Morristown

• Target start date: 01/07/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address. 

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Research & Development team as Global Study Data Leader VIE and you’ll work with different team members cross-functionally, being involved in variety of activities.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Being responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct, and close-out, complying with GCP and applicable regulatory guidance.
• Provide comprehensive data management expertise and support to team members.
• Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial. Ensure activities are completed according to agreed standards and timelines and serves as the Data Management representative in the study team.

About you

Experience:

• Minimum 1 year full time work experience in Clinical Data Management in the pharmaceutical industry (or equivalent) is required. 
• Clinical Data Management System experience (CDMS) and understanding of database/programming concepts is mandatory.
• Experience using Data Visualization tools, e.g. Spotfire, J-Review, Cluepoints preferred.

Education:

• Master’s Degree, preferably in a life science or health related field.

Technical and soft skills:

• Understanding of industry standards, terminologies, (e.g., CDISC SDTM, MedDRA, etc.) current regulatory guidelines, and GCP practices regarding Data Management.
• Solid knowledge of the clinical trial development process and understanding of relevant and current regulatory guidelines, Good Clinical Practice (GCP), industry standards, and practices regarding Data Management.
• Solid Clinical Data Management System experience (CDMS & EDC) and understanding of database development/programming concepts.
• Vendor management.
• Solid knowledge of the clinical trial development process, strong Data Management expertise i.e., understanding of Data Management scope and objectives.
• Strong collaboration and interpersonal behaviors (manage activities effectively with study team and other functions, demonstrate flexibility through effective negotiations etc.).
• Strong communication skills (ensure clear, concise, consistent, and timely communication including risks identification, and escalation).
• Knowledge of digital tools, Artificial Intelligence and Generative AI tools applicable to Data Management is an added value.

Languages:

• Communication Language: English.

Why choose us?

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. 

#LI-EUR