Clinical Site Manager (Study Start Up for NPC - German Speaking)

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.* German speaking is a plus. 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.Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Burgess Hill. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. #J-18808-Ljbffr