
Posted 9 hours ago
Clinical Operations Study Country Lead (COSCL)
Sanofi
Requirements
Clinical study operation experience, Project management expertise, Knowledge of GCP and ICH guidelines, Digital literacy in AI-powered tools, Data analytics skills, Business-level English, Willingness to travel
Skills
Project ManagementAI
About the role
Responsibilities
- Lead the strategic planning, execution, and oversight of country-level clinical trials to ensure alignment with global strategy, timelines, and budgets.
- Drive digital transformation by identifying and implementing AI-driven solutions to enhance trial efficiency, site performance, and patient engagement.
- Represent the country in global study meetings, escalate risks, and make critical country-level decisions to support study success.
- Oversee study start-up activities, including feasibility, site selection, and recruitment strategies using digital tools and AI analytics.
- Manage local study budgets, monitor financial performance, and ensure data integrity, patient safety, and audit readiness.
- Foster strong communication with internal teams, vendors, and external partners to ensure seamless stakeholder management.
Requirements
- Proven experience in clinical study operations, including project management and clinical trial oversight.
- Strong knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Digital literacy with hands-on experience using AI-powered tools and data analytics.
- Excellent written and verbal communication skills with the ability to manage diverse stakeholders.
- Business-level English proficiency (ability to read/write documents and participate in meetings).
- Ability and willingness to travel both nationally and internationally as required by trial activities.
Preferred Qualifications
- Experience assessing and implementing digital technologies within clinical studies.
- Familiarity with machine learning in healthcare and an understanding of AI ethics and governance.
About the Company
Sanofi is a global healthcare leader where deep immunoscience meets cutting-edge innovation. We work across oncology, rare diseases, neurology, and vaccines to turn breakthrough ideas into real-world impact. At Sanofi, we invest in our people to push scientific boundaries and build smarter solutions that improve lives worldwide.
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Sanofi · Tokyo
