Experteer Overview
In this role you lead the start-up phase of clinical studies at assigned sites, ensuring timely, compliant initiation and ongoing study delivery. You work with cross-functional teams to manage regulatory submissions, site activation, and essential study documentation, enabling efficient trial launches. You collaborate across regions to foster inclusive, high-performing teams and uphold Roche’s mission of improving patient access to healthcare. This is an opportunity to shape how studies are started and monitored in a global, fast-paced environment.

Compensaciones / Beneficios
• 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 start-up expert for assigned sites and coordinate necessary certifications
• Develop critical study documents (e.g., informed consent forms,



patient instruction guides)
• Collaborate with general, local, and virtual teams to deliver clinical diagnostic solutions
• Foster an inclusive team environment across diverse regions and time zones

Responsabilidades
• Degree in a scientific discipline or related field with proven clinical operations or trial coordination experience
• Hands-on EC/CA regulatory submissions experience for diagnostic or medical device trials
• Strong knowledge of In Vitro Diagnostic Medical Device frameworks and MDR, plus ICH-GCP standards
• Excellent verbal and written communication skills in English; German is a plus
• Ability to manage external vendor relationships and work in a fast-paced, matrix environment

Requisitos principales
• flexible working

📌 Clinical Site Manager (Study Start Up for NPC - German Speaking) (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés