In this role you lead end-to-end study start-up and site activation for clinical trials, ensuring regulatory compliance and timely delivery. You will oversee EC/CA submissions, monitor CRO performance, and serve as the clinical trial expert for site personnel. Collaborating with global and local teams, you create key study documents and ensure quality and audit readiness. This position offers impact through shaping study launches and upholding Roche’s commitment to accessible healthcare.Lead end-to-end study start-up activities, including site selection, activation, and qualification assessmentsManage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring regulatory complianceProvide CRO oversight and monitor external partner deliverables and milestonesAct as primary contact for assigned study sites, training site personnel and providing technical assistanceDevelop critical study documentation (informed consent, patient guides,



EC/CA submissions)Collaborate cross-functionally with global, local, and virtual teams to achieve business goals and operational excellenceAdhere to regulations, SOPs, and maintain audit/inspection readinessValidate product performance claims and provide data for regulatory submissionsWork in local and general study teams while exhibiting diversity and cultural awarenessBuild and maintain strong cross-functional relationshipsTypically 3–5 years of experienceBachelor in scientific discipline or related field (or equivalent experience)Awareness of Roche organization and processes related to own disciplineProvides informal guidance to new team membersStrong problem-solving using analysis and judgmentAbility to explain complex information clearlycross-functional collaborationcommunicationIVDRStudy Start-UpEC/CA submissions
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📌 Clinical Site Manager - Roche (Barcelona)
🏢 Roche
📍 Barcelona