Overview 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.

Responsabilidades

Lead end-to-end study start-up activities, including site selection, activation, and qualification assessments

Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring regulatory compliance

Provide CRO oversight and monitor external partner deliverables and milestones

Act as primary contact for assigned study sites, training site personnel and providing technical assistance

Develop critical study documentation (informed consent, patient guides, EC/CA submissions)





Collaborate cross-functionally with general, local, and virtual teams to achieve business goals and operational excellence

Adhere to regulations, SOPs, and maintain audit/inspection readiness

Validate product performance claims and provide data for regulatory submissions

Work in local and global study teams while exhibiting diversity and cultural awareness

Build and maintain strong cross-functional relationships

Requisitos principales Typically 3–5 years of experience

Bachelor in scientific discipline or related field (or equivalent experience)

Awareness of Roche organization and processes related to own discipline

Provides informal guidance to new team members

Strong problem-solving using analysis and judgment

Ability to explain complex information clearly cross-functional collaboration communication cultural awareness

IVDR

Study Start-Up

EC/CA submissions

📌 Clinical Site Manager (Barcelona)
🏢 Roche
📍 Barcelona