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 PositionThe position 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.Key AccountabilitiesThe key accountabilities for this position include, but are not limited to: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 submissionsCollaborate cross-functionally with integral, local, and virtual teams, demons

📌 Clinical Site Manager (España)
🏢 Roche
📍 España