Clinical Site Manager (Study Start Up / IVDR)

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 Clinical Site Manager specialising in IVDR and 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 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 is available, local contracts, Ethics Committee and Competent Authority approvals meet stringent regulatory requirements.
• Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalation of any issues.
• Act as the primary contact and clinical trial expert for assigned study site personnel, for execution of the study - including training and coordinating certification of study site personnel, and provide technical assistance, as necessary.
• Develop critical study documentation, including informed consent documents, patient instruction guides, and key documents for EC/CA submissions.
• Collaborate cross‑functionally with global, local, and virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross‑functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence.

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.
• Hands‑on experience navigating the early phases of clinical trials, 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.
• Understanding of In Vitro Diagnostic Regulation (IVDR) frameworks alongside global standards such as ICH‑GCP guidelines.
• Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross‑functional partners.
• German‑speaking skills (nice to have).

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.