Clinical Study Administrator
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?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Visit our website: www.astrazeneca.com.au
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.
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.
Date Posted
24-June-2025Closing Date
23-June-2025AstraZeneca 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.
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