The Global Study Associate (GSA) is a member of the extended Global Study Team, supporting the delivery of clinical studies within Late Development Oncology (LDO) to time, cost, and quality standards.

The GSA supports clinical studies throughout their lifecycle, from Clinical Study Protocol (CSP) development and study set-up through maintenance, close-out, Clinical Study Report (CSR) development, and study archiving.
Working closely with the Integral Study Director (GSD), Global Study Associate Director (GSAD), and Global Study Managers (GSMs), the GSA provides support across delegated aspects of clinical study execution, ensuring alignment with the AZ Project Management Framework, current clinical trial regulations such as ICH/GCP, AstraZeneca Standard Operating Procedures (SOPs), internal policies, guidelines, best practices, and AZ values and behaviours.

Key Responsibilities:

• Support the GSD, GSAD, and GSMs by completing delegated activities related to clinical study execution.
• Initiate and lead the set-up of the electronic Trial Master File (eTMF),



as well as maintain and close the eTMF, ensuring compliance with ICH/GCP requirements and AZ SOPs.
• Collaborate with Site Management & Monitoring teams, other internal stakeholders, and external vendors to collect regulatory and other essential study documentation.
• Contribute to electronic applications and submissions by creating and managing clinical and regulatory documents according to required technical standards, supporting effective publishing and delivery to regulatory authorities.
• Proactively plan and coordinate the administrative appendices required for the Clinical Study Report (CSR).
• Initiate and maintain study documentation, ensuring appropriate template and version compliance according to study-specific requirements.
• Set up, populate, and accurately maintain information within AstraZeneca tracking and communication tools, while supporting study team members in their use.
• Support the set-up

📌 Global Study Associate, Late Development Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona