Clinical Study Start-Up Lead: Site Activation

Roche; Wien; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Roche seeks a Clinical Site Manager specializing in Study Start-Up to design, plan, coordinate and conduct activities at assigned sites, ensuring studies are delivered per protocols and regulatory guidelines.

You will lead end-to-end start-up activities, manage EC/CA submissions, coordinate certifications, and develop essential study documents. Collaborate across global teams and foster inclusive environments; German is a plus.

Qualifikationen

• Degree in a scientific discipline or related field with clinical operations experience.
• Hands-on experience managing EC/CA submissions for diagnostic trials.
• Strong knowledge of IVD/MDR and global GxP standards.
• Excellent English communication; German language a plus.

Aufgaben

• Lead end-to-end study start-up activities at assigned sites.
• Manage EC and CA submissions and regulatory timelines.
• Serve as primary contact for start-up activities and site personnel.
• Develop critical study documentation (informed consent, patient guides).
• Collaborate with global, local, and virtual teams to deliver diagnostics.
• Promote inclusive, diverse team environments.

Ausbildung

Degree in a scientific discipline

Jobbeschreibung

Roche seeks a Clinical Site Manager specializing in Study Start-Up to design, plan, coordinate and conduct activities at assigned sites, ensuring studies are delivered per protocols and regulatory guidelines.

You will lead end-to-end start-up activities, manage EC/CA submissions, coordinate certifications, and develop essential study documents. Collaborate across global teams and foster inclusive environments; German is a plus.