Job Description

Introduction to role
Are you ready to make a significant impact in the world of clinical research? As a Global Study Associate (GSA), you'll be an integral part of the extended global study team, driving the delivery of clinical studies within Late Development Oncology. From the development of Clinical Study Protocols to study archiving, you'll support the Global Study Director and Managers in executing clinical studies with precision and efficiency. Your role will involve navigating AstraZeneca's Project Management Framework, adhering to clinical trial regulations, and embodying our values and behaviors. Are you up for the challenge?
Accountabilities

• Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) 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 Harmonization 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 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.
• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools.
• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.
• Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/payments in relevant systems.
• Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.
• Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.
• Prepares, contribute and distribute presentation material for meetings, newsletters and websites.
• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Essential Skills/Experience

• Education in medical or biological sciences or discipline associated with clinical research preferred
• Proven organizational and analytical skills
• Previous administrative training/experience
• Computer proficiency in 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 presentation materials
• 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 Skills/Experience

• Bachelor level education (or higher)
• Proven study admin/assistant or relevant experience on a study level
• Experience in clinical study lifecycle

Great People want to Work with us! Find out why:

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• Top 100 Employers Award
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• Learn more about working with us in Canada
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
Date Posted 19-Nov-2025
Closing Date 20-Nov-2025
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.

Skills Required