Do you have expertise in clinical trial monitoring, and a passion for Cell Therapy? Are you ready to play a pivotal role driving study quality and speed for clinical studies in this fast-moving and innovative area in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
Within Oncology R&D, AstraZeneca, we are investing in our internal capabilities to help us realise our ambition to become leaders in the delivery of next-generation cellular therapies. Leveraging historical expertise in biologics engineering, gene editing and immunology across solid and haematological malignancies, we are uniquely positioned to develop cutting-edge technologies to advance cell therapies in cancer treatment.
We are recruiting for new Site Monitoring and Management (SMM) team members based in Australia (Sydney or Melbourne) to support our clinical trials as we work towards the next generation of cell therapies.
As a Clinical Research Associate (CRA) or Senior CRA, you will join a collaborative team that values ethics, quality and continuous improvement, with the scale and support to grow your career. With access to robust training, modern systems and global expertise, you will support start-up, monitoring and close-out of Australian study sites to deliver high-quality, inspection-ready data at speed.
Investigator engagement: Contribute to site/investigator selection and drive site activation and performance
Start-up and regulatory: Coordinate submissions to EC/IRB and authorities; maintain approvals and essential documents
Training and oversight: Train and support site teams on ICH-GCP and RbQM; ensure ongoing compliance and inspection readiness
Monitoring excellence: Conduct remote/onsite visits, Source Data Review/Source Data Verification/Case Report Form review, manage data queries, and adjust intensity based on risk
Safety and quality: Ensure timely Serious Adverse Event reporting; identify, escalate and resolve quality issues in line with AZ SOPs
Data and systems: Maintain CTMS/eTMF, manage study/drug supplies and accountability, and produce timely monitoring reports and follow-up
Bachelor’s degree (life sciences preferred) or equivalent
Strong knowledge of ICH-GCP; basic GMP/GDP; solid understanding of Australian clinical regulations
Proven experience in site start-up, monitoring, drug handling, data management and SAE process
Meticulous attention to detail with robust documentation and inspection readiness
Clear written/verbal skills, effective collaboration and negotiation with site teams
Ability to travel to site locations; valid driver’s licence
Haematology (e.g., multiple myeloma, transplant comparators) and/or autoimmune trial experience (e.g., MS, scleroderma, myositis, RA)
Risk-based monitoring: Familiarity with RbQM and remote monitoring approaches
Flexibility and comfort in a build environment; proactive process improvement and problem solving
Digital fluency, with eTMF/CTMS proficiency and the ability to leverage technology for efficiency
Ability to be successful in distributed teams; cultural awareness; ability to manage competing deadlines
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.
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.
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 Gold 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 via this Form
Date Posted
25-Nov-2025Closing Date
14-Dec-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.