Clinical Site Manager - Roche

Roche; Barcelona; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Roche is seeking an experienced professional to lead end-to-end study start-up activities, including site activation and qualification assessments. You will manage EC/CA submissions and oversee CRO performance while serving as the clinical trial expert for site personnel.

You’ll collaborate with global and local teams to ensure regulatory compliance, quality, and audit readiness, shaping study launches and upholding Roche’s commitment to accessible healthcare.

Formación

• 3–5 years of experience in study start-up/clinical operations
• Bachelor in scientific discipline (or equivalent)
• Awareness of Roche processes and organization related to own discipline
• Ability to guide new team members informally
• Strong analytical judgment and problem-solving abilities

Responsabilidades

• Lead end-to-end study start-up activities including site activation and qualification assessments
• Manage Ethics Committee (EC) and Competent Authority (CA) submissions for regulatory compliance
• Provide CRO oversight and monitor external partner milestones
• Act as primary contact for assigned study sites, train site personnel and provide technical assistance
• Develop critical study documentation (informed consent, patient guides, EC/CA submissions)
• Collaborate cross-functionally with global/local teams to achieve business goals
• Maintain audit/inspection readiness and ensure compliance with SOPs and regulations
• Validate product performance claims and support regulatory submissions
• Work with local and global study teams while embracing diversity and cultural awareness
• Build and maintain strong cross-functional relationships

Conocimientos

Cross-functional collaboration

Communication

Problem solving

Regulatory awareness

Site training

Educación

Bachelor in scientific discipline

Descripción del empleo

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.

• 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 global, 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
• 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
• IVDR
• Study Start-Up
• EC/CA submissions