Clinical Study Administrator

Are you ready to make a difference in the world of oncology clinical trials? As a Clinical Study Administrator, you'll provide technical expertise and support for the administrative aspects of these trials, ensuring each study meets its objectives with adequate resources while adhering to methodology standards. You'll collaborate with various departments on both local and global levels to ensure each study is set up correctly, providing solutions to a variety of issues related to the conduct of studies with moderate scope and complexity.

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas - Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease.

At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life-changing medicines.

**_ What you’ll do _**
- Assist in the coordination and administration of study activities from start-up to execution and close-out within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives.
- Interface with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serve as the local administrative main contact and work closely with CRAs and/or the LSAD for the duration of the study.
- Maintain operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
- Ensure essential documents under your responsibility are uploaded in a timely manner to maintain eTMF “Inspection Readiness.”
- Coordinate administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
- Lead practical arrangements and contribute to the preparation of internal and external meetings, e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaise with internal and external participants and/or vendors in line with international and local codes.
- Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.

This is an initial 12 month maximum term contract role based in Sydney.

**Essential for the role**
- Bachelor’s Degree preferred
- Knowledge of any relevant legislation and new developments in the area of clinical development

**Desirable for the role**
- Working towards a professional qualification
- Experience within the pharmaceutical industry
- Experience in supporting clinical trials and study development

**Why AstraZeneca?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

**So, what’s next**
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available and we hope it’s yours.

**Where can I find out more?**

We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know.