Clinical Site Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The Opportunity 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. Who You Are 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 & Experience: A degree in a scientific discipline or related field (or equivalent combination of education and experience) combined with a proven track record in clinical operations or clinical trial coordination. Study Start-Up & Submission Expertise: Hands-on experience navigating diagnostic and medical device trials, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions. IVD/MDR Knowledge: Strong understanding of In Vitro Diagnostic Medical Device frameworks and Medical Device Regulations alongside global standards such as ICH-GCP guidelines. Stakeholder Engagement: Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross-functional partners. At Roche, you’ll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together. Let’s create a healthier, brighter future for all. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.