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May

Clinical Study Manager (Pt)

Total Presence Management - Camperdown, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Expert staffing agency, Total Presence Management, is actively seeking a Clinical Study Manager, to join a World-Class Medical Manufacturing Company at their facility in Sydney, Australia.

Job Description:

  • Coordinate with local EC (Ethics Committee) to make corrections to site-specific regulatory study items. Including but not limited to:
  • Meeting with site monitor during monitoring visits.
  • keep site contact information and site staff (PI, Coordinator, Ancillary Staff) up-to-date with EC.
  • Submitting continuing / partial reviews within specific deadlines.
  • SAE submission as needed.
  • Protocol and/or GCP deviation submission as needed.
  • EC acknowledgement/approval retrieval, and other misc. EC communications.
  • Coordinate with Sponsor to provide EC submission and acknowledgement/approvals for study files.
  • File EC submission and acknowledgement/approvals in site files. Communicate with site PI and Coordinator to provide updates and maintain team alignment on project status.

Requirements:

  • Clinical Research training/experience required.

Camperdown, NSW

Health, Medical & Pharmaceutical




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