Hybrid Study Start-Up Director – Clinical Trials

AstraZeneca; Barcelona; Hybrid; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

AstraZeneca is seeking a Study Start-Up Associate Director in Barcelona to lead regulatory and Ethics Committee start-up activities for national clinical trials. You will manage the SSU team, ensure alignment with timelines and AstraZeneca procedures, and drive continuous improvements in start-up processes.

The role requires strong leadership, regulatory expertise, and the ability to coordinate cross-functional teams across local and regional levels.

Qualifikationen

• Leadership and management of cross-functional teams.
• Knowledge of ICH-GCP and local regulations.
• Experience in regulatory start-up activities and submissions.
• Strong project management and risk assessment abilities.

Aufgaben

• Lead and manage the SSU team to deliver study start-up activities on time.
• Oversee regulatory submissions and Ethics Committee approvals.
• Coordinate with Local Study Teams and LSADs for start-up readiness.
• Drive continuous process improvements to enhance quality and efficiency.

Kenntnisse

Leadership

Regulatory know‑how

GCP compliance

Project management

Stakeholder management

Communication

Ausbildung

Bachelor’s degree in Life Sciences

Jobbeschreibung

AstraZeneca is seeking a Study Start-Up Associate Director in Barcelona to lead regulatory and Ethics Committee start-up activities for national clinical trials. You will manage the SSU team, ensure alignment with timelines and AstraZeneca procedures, and drive continuous improvements in start-up processes.

The role requires strong leadership, regulatory expertise, and the ability to coordinate cross-functional teams across local and regional levels.