The Global Study Associate is a member of the global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality.
The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and 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 execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours
Accountabilities:
Support GS(A)D and GSMs 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 external stakeholders in collection of regulatory and other essential documents.
Contribute to electronic applications/submissions in regulatory information management system 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, maintain and/or support the creation 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 GS(A)D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems, including the creation 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, if required, at the study close-out.
Coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.
Lead the 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.
Prepare, 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.
Other duties as assigned and within scope of role.
Essential Requirements:
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
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by our commitment to deliver accelerated growth and make people's lives better. Our Operations team thrives on personal dedication and out-of-the-box thinking. With a focus on Lean processes, cutting-edge science, digitalization, and sustainable practices, we are evolving how we work. We offer an inclusive environment where anyone can step up and lead. With global opportunities for career growth and development, AstraZeneca is a place where your passion can make a meaningful impact on society.
Ready to take the next step? Apply now to join our team and be part of something extraordinary!
Date Posted
17-mar-2026Closing Date
06-abr-2026AstraZeneca 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.