Typical Accountabilities:

- Support Global Study Leaders (GSL) and Global Study Associate Manager (GSAM) by completing delegated study work.
- Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
- Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.
- Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR
- Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- Se...