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The 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 general regulatory guidelines.

Key Accountabilities
- 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.

Responsibilities
- Adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
- Vali

📌 Clinical Site Manager (Madrid)
🏢 F. Hoffmann-La Roche
📍 Madrid