Join our Clinical Study Management Team as a Clinical Study Start-up Specialist (C3S). In this key role, you’ll represent and support the Global Clinical Department at the study level, collaborating with all functions in Clinical to optimize deliverables. The C3S is responsible for managing clinical studies within Sanofi Vaccines R&D. They assist in feasibility and study start-up across all trial regions, ensuring quality deliverables and of information received, adherence to protocols, and compliance with Good Clinical Practice (GCP) and company SOPs. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Partner with Clinical Research Organizations (CROs), Clinical Operations teams, and Feasibility partners to improve overall study startup metrics and implement processes. Coordinates the start-up deliverables of assigned studies in all aspects of start-up (including overall accountability for delivery to time, cost, and quality etc. and communication with relevant stakeholders). Develop and implement global study startup project plans and manage the collection and analysis of all data to influence study startup timelines. Provide accurate projections and timelines based on country’s historical performance with the support of the CRO partner. Monitor start-up activities, identify risks, and manage issues independently, Ensure compliance with local regulatory guidelines and provide support to resolve local issues. Report progress and challenges in trials to the clinical team during team meetings. Oversee collection of investigator and regulatory documents for study submissions. Support negotiations with sites and maintain quality control of study start-up documents. Education: Bachelor's degree or equivalent in a health-related field (Biology, Life science, Pharmacy). Knowledge: Formal training in GCP methods and knowledge of Code of Federal Regulations (US) and other regulatory agency documents. Clinical Trial experience required with proven track record in delivering high quality GCP-compliant Clinical Trials and entry level knowledge of vaccinology. Soft and technical skills: Demonstrated interpersonal skills (ability to work with individuals at different levels), team and negotiation skills, resourcefulness (ability to find solutions to operational problems), strong results orientation, project management and budget management experience. Knowledge of epidemiology and data analysis. Languages: Fluent English communication skills, verbal and written.
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