Global Study Associate

Are you ready to make a difference in the world of clinical studies? As a Global Study Associate, you will play a crucial role in supporting the delivery of clinical studies by providing essential administrative and system support. You will work across several studies, requiring a high degree of flexibility and adaptability. Join us in our mission to pioneer new frontiers in Oncology research and development.

Accountabilities

• Collect, review, and track relevant study documents.
• Support set-up, maintenance, closeout, and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
• Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
• Set-up, populate, and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
• Manage and contribute to the coordination and tracking of study materials and equipment.
• Assist in the tracking and reconciliation of invoices.
• Support study team and provide study metrics/reports during the study, audits, and regulatory inspections.
• Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, investigator meetings, and advisory boards.
• Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
• Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters, and websites.

Essential Skills/Experience

• University degree / Bachelor’s degree, or equivalent experience
• Good understanding of drug development
• Minimum of 1-2 years’ experience of administrative/operational support of clinical studies
• Knowledge of ICH-GCP principles
• Team oriented
• Ability to coordinate and prioritize multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills

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 push boundaries and achieve breakthroughs. Our commitment to Oncology research is unwavering as we aim to eliminate cancer as a cause of death. With significant investment in research and development, we are dedicated to delivering new molecular entities that transform patient outcomes. Our collaborative approach unites academia and industry, fostering an environment where bold decisions are made, curiosity is encouraged, and smart risks are taken.

Ready to join our team? Apply now to be part of our journey in transforming the future of medicine!