Global Study Associate, Oncology R&D, Early Oncology Clinical

Responsabilities

• 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.

• 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 orientated.
• Ability to coordinate and prioritise multiple tasks and deliverables.
• Proactive approach.
• High degree of flexibility.
• Demonstrated verbal and written communication skills.

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!