Lead Clinical Site Manager (Study Start Up / In Vitro Diagnostic Regulation) in Burgess Hill

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.

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption, and reimbursement globally so we can save lives and improve patient quality of life.

As a Lead Clinical Site Manager specialising in IVDR and Study Start-Up, you will be responsible for designing, planning, coordinating, and independently conducting all activities involved in initiating, monitoring, and completing clinical research studies. You will play a vital role in ensuring 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 selection, activation, and qualification assessments 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.
• Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and ensuring vendor performance aligns with Roche quality standards.
• Act as the primary contact and clinical trial expert for assigned study site personnel, providing training, technical assistance, and coordinating necessary certifications.
• Develop critical study documentation, including Study Monitoring Plans, informed consent documents, patient instruction guides, and case report forms tailored to diagnostic protocols.
• Deliver comprehensive site monitoring and data validation activities, executing site visits throughout all study phases from early start-up to final close-out.
• Collaborate cross-functionally with global, local, and virtual teams, across Research & Development, Study Management, and Biometrics to deliver top-tier clinical diagnostic solutions.
• Dedicate time to coaching colleagues, helping others develop their skills, and acting as a resource for less-experienced team members.

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:

• 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.
• Direct experience in Clinical Operations, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions.
• Demonstrated experience in CRO oversight, with the ability to effectively monitor external partner deliverables and keep study timelines on track.
• Strong understanding of In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) frameworks alongside global standards such as ICH-GCP guidelines and FDA regulations.
• 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.