Clinical Study Administrator

AstraZeneca

Sydney, Australia
Clinical study administration
Etmf and isf maintenance
Ich-gcp compliance
Assist in the coordination and administration of study activities from start-up to execution and close-out within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives

Job Summary

  • Assist in the coordination and administration of study activities from start-up to execution and close-out within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives.
  • Maintain operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
  • Lead practical arrangements and contribute to the preparation of internal and external meetings, e.g., study team meetings, Monitors’ meetings, Investigators’ meetings.

Matching Summary

Assist in the coordination and administration of study activities from start-up to execution and close-out within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives.

Skills & Requirements

Must-have

  • Clinical study administration
  • eTMF and ISF maintenance
  • ICH-GCP compliance
  • Document collection support
  • Meeting preparation and distribution

Nice-to-have

  • Collaborate with local and global departments
  • Push boundaries of science
  • Empowered to unleash entrepreneurial spirit
  • Inclusive culture championing diversity

Key Requirements

  • Bachelor’s Degree preferred
  • Knowledge of relevant legislation
  • Experience supporting clinical trials
  • Experience in pharmaceutical industry

Work Rights

Not specified

Tailored Resume

Cover Letter