At Roche you can show up as yourself, embraced for the unique qualities you bring. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. 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 general regulatory guidelines. 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. Collaborate cross-functionally with global, local, and virtual teams to help deliver top-tier clinical diagnostic solutions.

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. 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.

Hands-on experience navigating diagnostic and medical device trials, specifically managing Ethics Committee (EC) and Competent Authority (CA)



regulatory submissions. 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.

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 integral impact.

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.

📌 Clinical Site Manager (Cataluña)
🏢 Roche
📍 Cataluña