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

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

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.

 

The Opportunity

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.

• Leadership & Coaching: You will dedicate time to coaching colleagues, helping others develop their skills, and acting as a resource for less-experienced team members.

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: Direct experience in Clinical Operations, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions.

• Vendor Management: Demonstrated experience in CRO oversight, with the ability to effectively monitor external partner deliverables and keep study timelines on track.

• IVDR & Regulatory Knowledge: 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.

• 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.

 

 

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.

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.