Clinical Project Lead

Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally. The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool. Main responsibilities: The Clinical Project Leader (CPL) is responsible and accountable for start-up and follow up on Registries in close collaboration with Registry Team and Medical Affairs staff in the countries or locally. The CPL has responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures (SOP), and local regulatory guidelines. Feasibility Activities: Involvement in the country and site selection process together with the Registries Team, Local Medical Affairs. Study Start-up Activities: Arrange supply of necessary Registry materials e.g., Protocols, Case Report Form (CRFs), Protocol Agreement Forms (PAFs) etc. for ethical and regulatory submissions (where applicable) Ensure a financial contract is executed for each site and assist with the contracting process itself. Project Management: Responsible for all the Registries in the assigned countries. Maintain oversight of the Registries and provide country status to Global Registries Team. Coordinate and collaborate with the Clinical Research Associates. Registries Oversight in a matrix environment. Review and approve site visit reports (Site Selection, Site Initiation, Routine Monitoring and Close Out Visits), follow-up letters (as needed), etc. Monitor contract related issues and arranges payments in accordance with agreed upon payment milestones for each individual site, following the status with the Finance team. Monitor data quality (including contact with data management) and prepare project tracking and reporting systems. Coordinate international data collection projects. Give input to align activities with Clinical Project Leads of other Regions within the scope of the Global Registries Program. Liaise with Medical Affairs Teams in the countries for any applicable topic. Implement and perform miscellaneous projects or administrative tasks. Liaise with vendor for different activities (startup, onsite monitoring). Safety & Quality: Assure adequate safety reporting process according to country regulations and SOPs. Quality control of study conduction at country level - with "audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. Study administration: Responsible for training or arrange training for new CRAs. Responsible for Training (train the trainer) additional resources hired on a temporary basis in the countries. To maintain tables, trackers, and databases to follow the study progress locally and globally. To know and use all the tools needed. Support the improvement of internal processes by providing feedback on e.g., CAPA, and (re)writing Quality Management System (QMS) and/or project specific documents. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in filing country documents as required. Study Meetings: To participate with the rest of the study team in local and international investigators meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

Sanofi is a global biopharmaceutical company focused on human health. We prevent illness and protect life, from Paris to Beijing, from Waterford to Los Angeles. With our team of over 100,000 dedicated employees in more than 100 countries, we are committed to transforming scientific innovations into healthcare solutions that matter. From vaccines to rare disease treatments, we have a diverse portfolio aimed at serving patient needs worldwide. Together, we are Empowering Life.