Clinical Site Lead — IVDR & Study Start-Up

Roche; Wien; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Roche in Sant Cugat del Vallès seeks a Clinical Site Manager specialising in IVDR and Study Start-Up to design, plan, coordinate, and conduct initiation, monitoring, and completion activities for clinical studies at assigned sites.

You will lead regulatory submissions, ensure compliance with SOPs and global guidelines, and collaborate with cross-functional teams to enable efficient trial startups and site activation.

Qualifikationen

• Minimum 3–5 years of experience in a clinical setting or clinical trial coordination.
• Experience with regulatory submissions and ICH/GCP guidelines is desirable.
• Ability to work across global/local teams and adapt to diverse environments.

Aufgaben

• Lead end-to-end study start-up activities, including site selection and activation.
• Manage Ethics Committee and Competent Authority submissions to meet regulatory requirements.
• Provide CRO oversight and coordinate external partner deliverables and milestones.
• Collaborate with cross-functional teams and train site personnel as needed.

Kenntnisse

Clinical trial coordination

Regulatory awareness

Cross-functional collaboration

Ausbildung

Bachelor's degree in science

Jobbeschreibung

Roche in Sant Cugat del Vallès seeks a Clinical Site Manager specialising in IVDR and Study Start-Up to design, plan, coordinate, and conduct initiation, monitoring, and completion activities for clinical studies at assigned sites.

You will lead regulatory submissions, ensure compliance with SOPs and global guidelines, and collaborate with cross-functional teams to enable efficient trial startups and site activation.