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

Role Overview

Lead Clinical Site Manager specialising in In‑Vitro Diagnostics Regulation (IVDR) and Study Start‑Up within Roche Diagnostics Solutions (RDS). The role is responsible for designing, planning, coordinating and independently conducting all activities involved in initiating, monitoring and completing clinical research studies.

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, 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

• Dedicate time to coaching colleagues, helping others develop their skills and acting as a resource for less‑experienced team members.

Who You Are

• Proactive, collaborative and highly organised clinical research professional who thrives in a fast‑paced, matrixed environment.
• Strong problem‑solving skills, independent decision‑making capability and excellent external vendor relationship management.

Qualifications

• Education: 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.
• English language: Exceptional verbal and written communication skills with a proven ability to build trusted relationships and influence cross‑functional partners.

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 of who we are, what we do and how we do it.

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