The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and

quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with General Study Director (GSD) or Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model, AZ

Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ

values and behaviours.

Typical Accountabilities
- In partnership with AZ team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery.




- Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
- Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
- Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
- Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
- Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
- Ensures that all study documents in scope of G

📌 Global Study Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona