Clinical Project Lead

As a Clinical Project Lead at Sanofi Business Operations, your main responsibility will be to lead and manage the start-up and follow-up of Registries in collaboration with the Registry Team and Medical Affairs staff. Your key responsibilities will include: - Feasibility Activities: - Participate in country and site selection process with the Registries Team and Local Medical Affairs. - Study Start-up Activities: - Arrange necessary Registry materials for ethical and regulatory submissions. - Assist in the contracting process for each site. - Project Management: - Maintain oversight of Registries in assigned countries. - Coordinate with Clinical Research Associates and provide country status updates. - Review and approve site visit reports, follow-up letters, etc. - Monitor data quality and prepare project tracking systems. - Safety & Quality: - Ensure safety reporting process according to regulations and SOPs. - Implement Corrective and Preventive Actions as necessary. - Study administration: - Responsible for training new CRAs and additional resources. - Maintain tables, trackers, and databases for study progress. - Support internal process improvement by providing feedback. - People and Performance: - Seek alignment with stakeholders and support team initiatives. - Strategic Planning, Team Leadership, Regulatory Compliance, Problem-Solving, Stakeholder Communication, Monitoring and Evaluation. In terms of qualifications, you should have: - 5+ years of experience in Clinical research & development with 2 years in clinical trial project management. - Project management certification preferred. - Strong quantitative, analytical, and problem-solving skills. - Excellent cross-functional collaboration experience. - Ability to maintain confidentiality and leadership skills. - Proficiency in ICH-GCP principles and local regulatory requirements. - Familiarity with CTMS and EDC systems. - Good understanding of FDA regulations and ICH/GCP guidelines. - Skills in data management and risk assessment. - Competency in Microsoft Office products. - Degree in a Pharma/scientific discipline or related Life science degree. Sanofi Business Operations is committed to diversity, equity, and inclusion, and you will be part of a team that strives for progress and extraordinary outcomes in the field of healthcare.,