Study Start-Up Lead, Clinical Trials

Roche; Sant Cugat del Vallès; Presencial; EUR 70.000 - 105.000; Jornada completa

Descripción de la vacante

Roche seeks a Clinical Site Manager specialised in Study Start-Up to lead end-to-end initiation activities at assigned sites, ensuring regulatory compliance and on-time delivery.

You will manage EC/CA submissions, develop essential study documents, and collaborate with global and local teams to drive high-quality diagnostics trials while supporting an inclusive, cross-cultural work environment.

Formación

• Degree in a scientific discipline with clinical operations experience.
• Experience navigating EC and CA regulatory submissions.
• Knowledge of IVD/MDR and global standards (ICH-GCP).
• Excellent verbal and written English; German is a plus.

Responsabilidades

• Lead end-to-end study start-up activities.
• Manage EC and CA submissions within regulatory timelines.
• Serve as primary contact for start-up activities at the site.
• Develop study documents such as informed consent forms.
• Collaborate across global, local, and virtual teams.
• Foster inclusive, cross-cultural collaboration.

Conocimientos

Study Start-Up

Regulatory submissions

Stakeholder engagement

English communication

Educación

Science degree

Descripción del empleo

Roche seeks a Clinical Site Manager specialised in Study Start-Up to lead end-to-end initiation activities at assigned sites, ensuring regulatory compliance and on-time delivery.

You will manage EC/CA submissions, develop essential study documents, and collaborate with global and local teams to drive high-quality diagnostics trials while supporting an inclusive, cross-cultural work environment.