Study Start Up Manager

Do you have expertise in oncology clinical studies, and you are driven by accelerating site activations to bring life-changing medicines to patients? Would you like to apply your end-to-end start-up and contracts expertise to impact trial delivery in a company that follows the science and turns ideas into medicines?

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

You will lead the end-to-end start-up of oncology study sites, integrating submissions with site-level contracts and budget negotiations to enable timely, compliant activation. Working cross-functionally and directly with sites, you will own deliverables from HREC/RGO/TGA submission through to site activation, driving timelines, quality and risk management.

Reporting to the Oncology Study Start up Associate Director, this full time 12 month contract role is based in Sydney with hybrid working (in the office 3 days/week).

Key Responsibilities:

• Own end-to-end site start-up for assigned oncology studies, managing HREC ethics, RGO and TGA regulatory submissions through to site activation.

• Lead contract and budget negotiations with clinical sites, aligning terms with informed consent forms, AZ templates and Fair Market Value, and processing contract amendments as needed.

• Drive timelines and quality, proactively identifying risks and delays, and delivering regulatory and start-up documents in line with AZ SOPs, ICH-GCP and local requirements.

• Review and produce start-up materials, including site-level ICFs and start-up document templates, ensuring version control and compliance.

• Maintain study systems and files, updating Veeva Clinical Vault and ensuring essential documents are filed in the TMF enterprise system.

• Partner cross-functionally and with sites, sharing progress, supporting audits/inspections, and contributing to process improvements and best practice.

Essential:

• Proven experience in clinical study start-up within Australia, covering HREC ethics, RGO and TGA submissions, and site activation.

• Hands-on contract and budget negotiation experience with clinical trial sites, including alignment to ICFs, AZ templates and fair market value.

• Oncology clinical trial experience; familiarity with multi-arm designs and complex schedules.

• Strong knowledge of ICH-GCP, NHMRC and local regulatory frameworks; adept at applying AZ SOPs and procedural documents.

• Ability to work independently in a small, dynamic team, proactively managing timelines, risks and stakeholder communications.

• Proficiency with clinical systems (e.g., Veeva Clinical Vault) and document/file management for start-up and TMF.

Desirable:

• Experience in a CRO environment managing both submissions and contracts/budgets, or site-based oncology experience with both capabilities.

• Experience negotiating master service agreements, rate cards or partnering templates with major institutions.

• Bachelor’s degree in a relevant discipline; advanced qualifications or professional certifications in clinical research or study management.

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.