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Clinical Operations Manager

3 weeks ago

Adelaide, South Australia beBee Careers Full time

**Clinical Operations Manager**

A dynamic Clinical Operations Lead is required to oversee the clinical operations of a project within a defined regional/global level. This role involves providing oversight of project deliverables, assigned Clinical Research Associates (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.

The successful candidate will act as a primary liaison between the CRAs and the clinical project team, providing operational support and guidance throughout the project. Additional responsibilities include:

  • Project Oversight:
    • Overall oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
    • Monitoring support visits (Co-monitoring) per project requirements to aid the site/CRA in satisfactory performance and compliance with standards.
    • Support clinical project teams by providing oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations).
    • Oversight of regional startup and feasibility activities.
    • Assistance with vendor management activities as required per project.
  • Project Liaison:
    • Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls.
    • Attend meetings with Study Sponsors to provide status updates on country and site progress.
    • Provide operational support and guidance to the monitoring team throughout the project.
    • Provide project training/mentoring to regional CRAs on study procedures, clinical plans, and guidelines, and timelines for the study.
    • First point of contact for regional CRAs for study-specific questions and issues.
  • Study Documents and Plans:
    • Develop training materials and study tools for sites and CRAs, including monitoring plans.
    • Develop and implement enrollment and recruitment strategies together with the clinical project team.
    • Prepare presentation materials for Sponsor Kickoff meetings, Investigator meetings, and Sponsor Calls (as needed).