The Global Study Associate (GSA) is a vital member of the extended global study team, supporting the delivery of clinical studies within Haematology Clinical Operations. From the development of the Clinical Study Protocol (CSP) through study set-up, maintenance, close-out, and the creation of the Clinical Study Report (CSR) to study archiving, the GSA ensures that clinical studies are delivered on time, within budget, and to the highest quality standards. The GSA provides essential administrative and system support, aiding the Global Study Director (GSD), Global Study Associate Director (GSAD), and Global Study Managers (GSMs) in various aspects of clinical study execution. This role adheres to the Study team Operating Model for Internal Delivery (SOLID) or SOLIS, AZ Project Management Framework, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies, and best practices.

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 with International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
• Collaborate with Site Management & Monitoring, extended study team, and external vendors in the collection of regulatory and other essential documents.
• Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
• 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.
• Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.g., VCV/VQV, SharePoint, BOX if used, MS Teams, and study team shared mailbox) 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 fulfill AstraZeneca compliance and meet regulatory authority needs.
• Support the GSD/GSAD with tracking, reconciliation, and follow-up of the study budget/payments in relevant systems (e.g., COUPA).
• Contribute to application, coordination, supply, and tracking of study materials and equipment. Contribute to the 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.
• Prepare, contribute to, 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
• 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
• Understanding of drug development and clinical study lifecycle
  
  
  

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 follow the science to pioneer new frontiers. Our dedication to Oncology drives us to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we continuously push forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Empowered by investment, we aim to deliver six new molecular entities by 2025. Our collaborative research environment unites some of the world's foremost medical centers, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career as part of a team committed to improving millions of lives.

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