Overview

In this role, you drive end-to-end study start-up for clinical trials at designated sites, ensuring compliant launch and ongoing execution. You will liaise with cross-functional teams to secure EC/CA approvals, prepare key study documents, and act as the primary start-up expert for site personnel. You’ll foster inclusive, cross-regional collaboration while converting regulatory requirements into actionable, timely study activities. This position shapes efficient, compliant trial initiation within Roche’s mission to improve global health.

Responsabilidades

- Lead end-to-end study start-up activities, including site identification, selection, and activation
- Manage Ethics Committee (EC) and Competent Authority (CA) submissions to meet regulatory timelines
- Serve as primary contact for start-up activities for assigned study site personnel
- Develop essential study documents (informed consent, patient guidance)




- Collaborate with global/local/virtual teams to deliver clinical diagnostic solutions
- Foster inclusive team environments across regions and time zones

Requisitos principales

- Degree in a scientific discipline or related field (or equivalent experience)
- Proven track record in clinical operations or clinical trial coordination
- Hands-on experience with EC and CA regulatory submissions
- Strong understanding of IVD/MDR frameworks and general standards (ICH-GCP)
- Exceptional verbal and written communication (English) and ability to influence cross-functional partners

- proactive
- collaborative
- highly organized
- EC/CA submissions for diagnostic trials
- IVD/MDR knowledge
- ICH-GCP familiarity

📌 Clinical site manager (study start up for npc - german speaking) (Barcelona)
🏢 Roche
📍 Barcelona