Are you ready to make a difference in the world of oncology clinical trials? As a Clinical Study Administrator, you’ll provide technical expertise and support for the administrative aspects of these trials, ensuring each study meets its objectives with adequate resources while adhering to methodology standards. You’ll collaborate with various departments on both local and global levels to ensure each study is set up correctly, providing solutions to a variety of issues related to the conduct of studies with moderate scope and complexity.

WHAT YOU’LL DO

• 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.
• Interface with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serve as the local administrative main contact and work closely with CRAs and/or the LSAD for the duration of the study.
• 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.
• Ensure essential documents under your responsibility are uploaded in a timely manner to maintain eTMF “Inspection Readiness.”
• Coordinate administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
• Lead practical arrangements and contribute to the preparation of internal and external meetings, e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaise with internal and external participants and/or vendors in line with international and local codes.
• Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.
  This is an initial 12 month maximum term contract role based in Sydney.

ESSENTIAL FOR THE ROLE

• Bachelor’s Degree preferred
• Knowledge of any relevant legislation and new developments in the area of clinical development

DESIRABLE FOR THE ROLE

• Working towards a professional qualification
• Experience within the pharmaceutical industry
• Experience in supporting clinical trials and study development