Study Start Up Manager

Do you have expertise in clinical study start-up, and a passion for Cell Therapy? Are you ready to play a pivotal role in the site activation process 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!

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.

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 to support our clinical trials as we work towards the next generation of cell therapies.  

What you’ll do 

As a Study Start Up Manager based in either Sydney or Melbourne, you will join a supportive and nimble SMM team with access to robust training, modern systems and global expertise.  You will lead and coordinate end-to-end site start-up for Cell Therapy trials, ensuring regulatory compliance, cross-functional alignment, robust documentation and systems management, proactive risk control, and continuous improvement to enable timely site activation.

Key responsibilities: 

• Lead site start-up end-to-end for assigned studies, ensuring compliance with ICH-GCP, AZ Procedural Documents and local regulations.

• Own essential documents and TMF: obtain, QC and maintain regulatory docs; ensure timely TMF (Veeva) filing and study master file completeness.

• Coordinate cross-functionally with Contracts, Feasibility, Study Support Services, Monitors and the Local Study Delivery Team to unblock timelines and align on site readiness.

• Regulatory readiness and QA: primary review of site ICFs; prepare for audits/inspections; support submissions to Regulatory Authorities.

• Systems, tracking and risk: update Veeva Clinical Vault and other tools; share activation metrics; proactively identify delays and implement mitigation.

• Supplies, binders and improvement: ensure regulatory binders/study supplies for start-up; contribute to process improvements and best-practice sharing. 

Essential for the role 

• Bachelor’s degree (or equivalent experience) in a relevant discipline

• Study start-up/Study Management experience within pharmaceutical, biotech or clinical research

• Strong working knowledge of ICH-GCP, local regulations and clinical development processes

• Proficiency with TMF and clinical systems (e.g., Veeva, VCV) and document control

• Collaborative communicator able to drive cross-functional alignment and timelines

Desirable for the role 

• Cell Therapy exposure or experience in related therapeutic areas (haematology/multiple myeloma, transplant, or autoimmune disease areas such as MS, scleroderma, myositis, rheumatoid arthritis. 

• Advanced degree and/or professional certification (e.g., PMI, SOCRA, ACRP)

• Experience preparing for audits/inspections and leading start-up across multiple sites

• Broader understanding of Study Management disciplines and vendor/contract coordination

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 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

Closing Date

AstraZeneca 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.