Senior Study Start-Up Director, Clinical Trials

AstraZeneca plc; Barcelona; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca plc in Barcelona, Spain is seeking an Study Start-Up Associate Director to lead regulatory and Ethics Committee start-up activities for country-level trials within SMM. You will oversee the SSU team, ensure alignment with ICH-GCP, AZ procedures, and local regulations, and drive continuous process improvement.

The role requires strategic oversight, resource planning, coaching, and collaboration with LSADs and study teams.

Qualifications

• Bachelor’s degree in related discipline, preferably life science, or equivalent.
• Experience in the pharmaceutical industry, preferably in Clinical Operations.
• Understanding of drug development, GxP, ICH-GCP, and local regulations.

Responsibilities

• Lead and manage SSU team and ensure timely start-up activities.
• Oversee regulatory and Ethics Committee submissions and timelines.
• Ensure compliance with AstraZeneca procedures and local regulations.
• Provide performance management and coaching to LSADs and SSU team.
• Drive continuous process improvement in start-up activities.

Skills

Leadership

Regulatory acumen

ICH-GCP knowledge

Stakeholder engagement

Team coaching

Project management

Communication

Strategic thinking

Education

Bachelor's degree in life sciences

Experience in pharma Clinical Operations

Job description

AstraZeneca plc in Barcelona, Spain is seeking an Study Start-Up Associate Director to lead regulatory and Ethics Committee start-up activities for country-level trials within SMM. You will oversee the SSU team, ensure alignment with ICH-GCP, AZ procedures, and local regulations, and drive continuous process improvement.

The role requires strategic oversight, resource planning, coaching, and collaboration with LSADs and study teams.