Clinical Study Start-Up Lead: Site Activation & Compliance

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

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.