Clinical Site Manager (San Cugat del Vallés)

Clinical Site Manager (San Cugat del Vallés)

12 ago
|
Roche
|
San Cugat del Vallés

12 ago

Roche

San Cugat del Vallés

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.

Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.
Position Overview
As a Clinical Site Manager for Continuous Glucose Monitoring studies in our Study Delivery Near Patient Care CVMD team, you are responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at the clinical study sites. You ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.

Responsibilities

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- Act as the primary contact and clinical trial expert for assigned study site personnel, coordinating training, certification,



and providing technical assistance to ensure successful study execution.
- Perform site assessments and qualification visits to support the site selection decision process and site activation activities, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements.
- Develop and manage key study site documentation such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts.
- Oversee CROs for the delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise.
- Execute site management activities for sponsored studies

📌 Clinical Site Manager (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés

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