AstraZeneca

Study Start Up Manager

AstraZeneca  •  Commonwealth of Australia (Hybrid)  •  3 hours ago
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Job Description

Do you haveexpertiseincomplexclinical 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 contractsexpertisein 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 leadend-to-end start-upof oncology study sites,with responsibility forethicsandregulatorysubmissionsas well assite-levelcontractand budget negotiations to enabletimely, compliant activation.

You’llwork cross-functionally internally and directly with sites, and reportto theOncology Study StartUpAssociateDirectorThisfull time12 monthcontractrole is based in Sydney with hybrid working (in the office 3 days/week).

Key Responsibilities:

  • Drive site start-up activities,includingethics,governanceand regulatory submissions,contractand budgetnegotiationsand site activation across assigned clinical trials
  • Prepare, review, and coordinate submission of ethics (HREC), research governance (RGO)and regulatory(TGA)documentation, ensuring high-qualityandcompliantsubmission packages tofacilitatetimelyapprovals
  • Lead contract and budget negotiations with clinical sites,ensuring alignment withfair market value(FMV),optimisingcost efficiency and supportingstudy timelines - processing contract amendmentsas needed.
  • Drive site activation readiness, including coordination of essential document collection and vendor set-up activities to supporttimelystudy initiation.
  • Ensuring alignment with agreed timelines and KPIs, proactivelyidentifyingrisks and delays, and delivering in line withproject milestones
  • Ensure study start-up activities are conductedin accordance withICH-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
  • Maintainaccurateand up-to-date documentation and tracking systems for all start-up activities, ensuringtimelyand compliant Trial Master File (TMF) filingin accordance withregulatory and organisational requirements.

Essential:

  • Experience inclinical study start-up within Australia, covering HREC, RGO and TGA submissions, and site activation.
  • Familiarity with clinical trial budgets, FMV principlesand contract negotiations, ordemonstratednegotiation skills.
  • Strong knowledge of ICH-GCP,NHMRC guidelinesand local regulatory frameworks, withtheabilitytoapplycompanySOPs and proceduralrequirements effectively
  • Ability to work independently within a small, dynamic team, proactively managing timelines,risksand stakeholder communications.
  • Strong problem-solving skills, with the ability to proactivelyidentifyrisks and implement mitigation strategies during study start-up.
  • Excellent communicationand organisationalskills,with the abilityto effectively manageprioritiesand meet deadlines.
  • Proficiencywith clinical systems (e.g., Veeva Clinical Vault) and document/file management, includingstart-uptrackingandTMFmaintenance

Desirable:

  • Experience working inoncology clinical trials
  • Hands-on contract and budget negotiation experience with clinical trial sites, includingalignment with global and local templates and requirements,andadherenceto FMV principles
  • Bachelor’s degree inlifesciences or arelatedfield(or equivalentwork 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 andshowcaseyour knowledge,skillsand abilitiesReview our guide to help you do this: https://careers.astrazeneca.com/aiguidance

Where can I find out more?

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

05-June-2026

Closing Date

03-July-2026

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.

AstraZeneca

About AstraZeneca

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.

Community Guidelines: bit.ly/2MgAcio

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Cambridge, GB
Year Founded
Unknown
Website
astrazeneca.com
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