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.
- 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 (GCP), 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.
- 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.
- 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.
- 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.
#LI-SA
#LI-Onsite #vhd 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 be found here.
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