Job Description
The Study Start Up Lead (SSUL) is responsible for overseeing and managing the initiation of clinical studies from planning to activation in South San Francisco, California. In this role, you will coordinate with cross-functional teams to ensure timely site qualification, regulatory document collection, and ethics submissions. Key Responsibilities Include Developing and implementing study start-up plans to meet project timelines and quality standards. Managing site contracts, budgets, and regulatory documentation to facilitate efficient study activation. Monitoring progress and addressing issues related to site preparedness and compliance. Ensuring adherence to all regulatory requirements and internal SOPs throughout the start-up process. Providing leadership and guidance to study start-up team members and external partners. Ideal candidates possess strong project management skills, excellent communication abilities, and a thorough understanding of clinical trial regulations. Benefits include competitive compensation, comprehensive health plans, flexible work arrangements, professional development opportunities, and a collaborative work environment focused on innovation and growth.