Study Start Up Manager

AstraZeneca

Sydney, Australia
Hybrid
Oncology clinical study start-up
Hrec, rgo, tga submissions
Site activation
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

Job Summary

  • 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.
  • 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.

Matching Summary

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.

Skills & Requirements

Must-have

  • Oncology clinical study start-up
  • HREC, RGO, TGA submissions
  • Site activation
  • Contract and budget negotiation
  • ICH-GCP, NHMRC, local regulations
  • Veeva Clinical Vault proficiency

Nice-to-have

  • Cross-functional collaboration
  • Risk and timeline management
  • Process improvement contribution
  • Life-changing medicines impact

Key Requirements

  • Proven experience in clinical study start-up in Australia
  • Hands-on contract and budget negotiation experience
  • Oncology clinical trial experience
  • Strong knowledge of ICH-GCP and local regulatory frameworks
  • Ability to work independently
  • Proficiency with clinical systems and document management

Work Rights

Not specified

Tailored Resume

Cover Letter