AI-Enabled Global Study Data Leader

Job Title: AI-Enabled Global Study Data Leader

Location: Morristown, NJ Cambridge, MA

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.

We are seeking a highly motivated and experienced AI-Enabled Global Study Data Leader to support the end-to-end data management digital transformation in our clinical studies. This role will be pivotal in driving innovation and efficiency throughout the entire value chain of our clinical development organization. The ideal candidate will possess a deep understanding of current digital data technologies and innovations as well as direct experience implementing these related roadmaps, including experience in methodology to assess business case, go-no go stage gates, and return of investment (ROI). The incumbent must have strong leadership and change management skills, and a passion for delivering transformative approaches for our patients.

The AI-Enabled Global Study Data Leader:

• Influences and leads critical elements of the clinical data management digital transformation of clinical operations.
• This person will serve as a catalyst for digital change within the organization and offer expert perspectives on potential solutions and changes for the ways of working.
• Develop a transformation plan to solve common challenges or develop / propose digital solutions for data management.
• Contribute to Sanofi's commitment to accelerate the development of new drugs and medical devices for all patients through our clinical trials.

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:

• Identify new data management digital AI opportunities, in close collaboration with digital.
• Be the Data Management leader in the cross-functional study team and oversee study processes at a global level, including but not limited to preparing protocols, data collection methods, risk-based data management processes and timelines.
• Explore new ways of data collection (eSource access, patient devices, etc.)
• Works with cross-functional teams, including medical leads, global study lead, statisticians, clinical supply managers, regulatory affairs specialists, etc.
• Ensures compliance with relevant regulations, such as Good Clinical Practice (Google Cloud Platform), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), internal SOPs. Propose update and improvements to the processes as relevant.
• Pilot and implement any available digital / AI solutions to improve study efficiency and quality of the data collection.
• Maintains current awareness of industry trends and progress, assesses opportunities for innovative transformative digital solutions, preparing business cases and proposals to drive value for the business.
• Drives the implementation of innovative data management methodologies and technologies.
• Helps foster a culture of continuous improvement and learning.
• Displays strong leadership and influence skills in overseeing the efforts in setting, conducting and closing clinical studies, ensuring everything runs smoothly and efficiently.
• Defines and monitors the progress of the studies and innovative solutions, including identifying risks and issues, conducting corrective measures and oversight timelines,
• Implement new and innovative methods of communications and updates.
• Lead the selection, implementation, and oversight of new vendors to support AI solutions.

About You

Education:

• Bachelor's degree required, Master preferred. Preferably in a life sciences or health information management field. Clinical Data Management in the pharmaceutical/healthcare industry a significant plus.

Experience:

• 6+ years' experience within clinical data management and/or clinical data science with proven background in directly assessing and implementing digital technologies as they relate to clinical development.
• Deep knowledge in clinical data science, digital tools, Artificial Intelligence and Generative AI tools applicable to Data Management.
• Ability to manage cross-functional projects using intermediate project, risk, and vendor management skills to deliver results aligned with compliance and quality standards.

Why Choose us:

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can