The Global Study Associateis a member oftheglobal study team supporting delivery of clinical studies withinBioPharmaceuticalsClinicalOperations, Study Managementtotime,costand quality
The GSAsupports delivery of global clinical studies from study set-up through maintenance,close-outand study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study executionin accordance withapplicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & bestpracticesand AZ values & behaviours.
Typical Accountabilities
Support GS(A)D andGSMs by completing delegated study work May work across many different studies and delivery models concurrently.
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
Provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes
Interact/collaborate with internal staff and externalstakeholdersin collection of regulatory and other essential documents
Contribute to electronic applications/submissions inregulatoryinformationmanagementsystem bycreating and managing clinicalregulatory 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,maintainand/or support thecreationof study documents, ensuring template and version compliance per study specific requirements
Set-up, populate and accuratelymaintaininformation in AstraZeneca tracking and communication tools and support team members in the usage of these tools
Support the set-up,maintenanceand close-out of Clinical Trial Transparency (CTT) activity inPharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs
Support the GS(A)D with tracking,reconciliationand follow-up of the study budget/payments inrelevant systems,includingthecreation and maintenance of purchase orders, running invoice and payment reports
Contribute to application, coordination, supply and tracking of study materials and equipment.
Contribute to collection of study supplies, ifrequired, at the study close-out
Coordinateand provide oversightofadministrative tasks and logisticalsupportthroughout the conduct of the study,auditsand regulatory inspections, according to company policies and SOPs
Lead thecoordination andcontribute to the preparation of internal and external meetingse.g.,study team meetings, committee meetings,monitormeetings, Investigatormeetingsand virtual meetings. Liaise with internal and external participants and/or vendors
Prepare,contributeand distribute presentation material for meetings,newslettersand websites
Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
Other duties as assigned and within scope of role.
Education, Qualifications,Skillsand Experience
Essential
Education in medical or biological sciences or discipline associated with clinical researchpreferred
Proven organizational and analytical skills
Previousadministrative training/experience
Computerproficiencyin day-to-day tasks
Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.
Excellent verbal and written communication in English
Demonstrate ability to work independently, as well as in a team environment
Ability to prepare presentationmaterials
Demonstrate professionalism and mutual respect
Willingness and ability to train others on study administration procedures
Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
Desirable
Bachelor level education (or higher)
Proven study admin/assistant or relevant experience on a study level
Experience in clinical study lifecycle
Date Posted
03-jul-2026
Closing Date
16-jul-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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