Clinical Project Lead

Roles & Responsibilities
• Involvement in the country and site selection process with the Registries Team and Local Medical Affairs.
• Arrange the supply of necessary Registry materials (e.g., Protocols, Case Report Forms, Protocol Agreement Forms) for ethical and regulatory submissions.
• Ensure financial contracts are executed for each site and assist with the contracting process.
• Maintain oversight of Registries in assigned countries and provide country status to the Global Registries Team.
• Coordinate and collaborate with Clinical Research Associates.
• Review and approve site visit reports, follow-up letters, etc.
• Monitor data quality and prepare project tracking and reporting systems.
• Ensure adequate safety reporting process in compliance with country regulations and SOPs.
• Implement Corrective and Preventive Actions (CAPA) when necessary.
• Train new CRAs and temporary resources.
• Maintain tables, trackers, and databases to follow the study progress locally and globally.
• Support the improvement of internal processes and ensure TMF compliance.
• Align with internal and external stakeholders to prioritize Registry study activities.

Qualification
• Degree in Pharma/Scientific Discipline or related Life Science degree.
• Project management certification preferred.

Experience
• 5+ years of experience in Clinical Research & Development, including at least 2 years in clinical trial project management.

Vacancies
• 1 Clinical Project Lead position available.

Skills
• Strong project management, leadership, and negotiation skills.
• Excellent communication skills (written and oral).
• Proficiency in ICH-GCP principles, CTMS, EDC systems, and FDA regulations.
• Experience in clinical trial project management and drug development.
• Ability to work across global projects and in an international matrix environment.
• Strong analytical, quantitative, and problem-solving skills.
• Cross-functional collaboration skills.

About the Company
Sanofi S.A. is a global healthcare company that focuses on advancing science and providing innovative solutions for patient care. With a strong commitment to improving global healthcare access, Sanofi operates across several therapeutic areas and is known for its contributions to clinical research and development. The company fosters a collaborative work environment where employees are encouraged to innovate and grow professionally.