Study Start Up Manager

Do you have expertise in complex clinical study start-up, and passion for accelerating site activations to bring life-changing medicines to patients? Would you like to apply your end-to-end start-up and contracts expertise in a company that follows the science and turns ideas into 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.

What you’ll do

You will lead end-to-end start-up of oncology study sites, with responsibility for ethics and regulatory submissions as well as site-level contract and budget negotiations to enable timely, compliant activation.  

You’ll work cross-functionally internally and directly with sites, and report 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:

• Drive site start-up activities, including ethics, governance and regulatory submissions, contract and budget negotiations and site activation across assigned clinical trials 

• Prepare, review, and coordinate submission of ethics (HREC), research governance (RGO) and regulatory (TGA) documentation, ensuring high-quality and compliant submission packages to facilitate timely approvals. 

• Lead contract and budget negotiations with clinical sites, ensuring alignment with fair market value (FMV), optimising cost efficiency and supporting study timelines - processing contract amendments as needed. 

• Drive site activation readiness, including coordination of essential document collection and vendor set-up activities to support timely study initiation. 

• Ensuring alignment with agreed timelines and KPIs, proactively identifying risks and delays, and delivering in line with project milestones  

• Ensure study start-up activities are conducted in accordance with ICH-GCP, NHMRC, local regulatory requirements, and organisational policies 

• Support development and implementation of best practice, tools, and process improvements to enhance start-up efficiency and cycle times 

• Maintain accurate and up-to-date documentation and tracking systems for all start-up activities, ensuring timely and compliant Trial Master File (TMF) filing in accordance with regulatory and organisational requirements. 

Essential:

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

• Familiarity with clinical trial budgets, FMV principles and contract negotiations, or demonstrated negotiation skills.

• Strong knowledge of ICH-GCP, NHMRC guidelines and local regulatory frameworks, with the ability to apply company SOPs and procedural requirements effectively. 

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

• Strong problem-solving skills, with the ability to proactively identify risks and implement mitigation strategies during study start-up. 

• Excellent communication and organisational skills, with the ability to effectively manage priorities and meet deadlines.

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

Desirable:

• Experience working in oncology clinical trials 

• Hands-on contract and budget negotiation experience with clinical trial sites, including alignment with global and local templates and requirements, and adherence to FMV principles. 

• Bachelor’s degree in life sciences or a related field (or equivalent work experience); 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 - apply now!

Guidance on AI use:

We support you using AI tools responsibly in the recruitment process to help you be at your best and showcase your knowledge, skills and abilities.   Review our guide to help you do this: https://careers.astrazeneca.com/aiguidance

Where can I find out more?

• Visit our Global Website- https://www.astrazeneca.com/

• Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

• Follow us on Instagram – https://www.instragram.com/astrazeneca/

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.