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

Position

Clinical Site Manager - IVDR & Study Start Up, Roche Diagnostics Solutions (RDS), location: Burgess Hill, United Kingdom

Responsibilities

• 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 is available and that approvals meet stringent regulatory requirements.
• Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalating any issues.
• Act as the primary contact and clinical trial expert for assigned study site personnel, including training, coordinating certification and providing technical assistance as needed.
• Develop critical study documentation, such as informed consent documents, patient instruction guides, and key documents for EC/CA submissions.
• Collaborate cross functionally with global, local, and virtual teams, fostering strong, collaborative relationships with internal stakeholders and external partners to achieve business goals and operational excellence.

Qualifications

• Education & Experience: A degree in a scientific discipline or related field (or equivalent combination of education and experience) with a proven track record in clinical operations or clinical trial coordination.
• Study Start Up & Submission Expertise: Hands on experience navigating the early phases of clinical trials, specifically managing EC and 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: Understanding of In Vitro Diagnostic Regulation (IVDR) frameworks 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.
• Nice to have: German speaking skills.

Equal Opportunity Statement

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. We are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.