As a Clinical Site Manager specialising in Study Start-Up, you will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at assigned sites. You will work independently to ensure studies are delivered, recorded, and reported in accordance with protocols, standard operating procedures, and global regulatory guidelines. In this role, you will: Lead end-to-end study start-up activities, driving site identification, selection, and activation to ensure clinical trials launch efficiently and are compliance-ready. Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation, local contracts, and institutional approvals meet stringent regulatory timelines. Act as the primary contact and clinical trial expert for start-up activities for assigned study site personnel, and coordinate necessary certifications. Develop critical study documentation, including informed consent documents, patient instruction guides, etc Collaborate cross-functionally with global, local, and virtual teams to help deliver top-tier clinical diagnostic solutions. Foster a culture of belonging by partnering across diverse regions, cultures, and time zones to build inclusive team environments. You are a proactive, collaborative, and highly organised clinical research professional who thrives in a fast-paced, matrixed environment. You possess strong problem-solving skills, make sound independent decisions, and excel at managing external vendor relationships. To be successful in this role, you bring: Education
Clinical Site Manager employer: Roche
At Roche, we pride ourselves on fostering a culture that values individuality and encourages personal growth. As a Field Service Engineer in the North Region, you will not only contribute to life-saving healthcare solutions but also benefit from a supportive work environment that promotes open dialogue and collaboration. With opportunities for continuous development and a commitment to diversity, Roche is an exceptional employer dedicated to creating a healthier future for all.
