Clinical Study Manager

2 days ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $86,880 - $124,210

Clinical Research Specialist

Project managers and site managers collaborate on clinical study management from site selection to initiation until monitoring and close-out of assigned studies. Management of project timelines, budgets, and resources is ensured in accordance with Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), and other applicable regulations.

The position ensures that all data generated by the assigned sites is accurate, timely, and within budget.

Responsibilities:

  • Site Selection and Initiation:
  • Pre-study visits ensure eligible sites are selected according to sponsor criteria, including adequate resources and experience.
  • Study start-up visits provide training for relevant site staff to proceed with study conduct in compliance with protocol and regulations.
  • Principal Investigator/study staff compliance with safety reporting requirements is ensured as defined in protocol, SOP, ICH-GCP, and GCP.
  • Study recruitment targets are achieved through tracking and coordination with sites.
  • Monitoring visits are conducted according to SDV plans and SOPs; issues with sites are addressed, and monitoring visit reports are completed in a timely manner.
  • Study materials (drug, non-drug, equipment, CRFs) are coordinated with sites for start-up and throughout the study.

Training and Documentation:

  • Ongoing training is provided to site staff regarding ICH-GCP, GCP, study protocol, and requirements.
  • Site initiation visits ensure sites have a thorough understanding of the study protocol and requirements.

Drug Safety and Finance:

  • Safety information dissemination to all sites is ensured in accordance with SOPs and applicable regulations.
  • SAE reporting within the timeline is ensured in compliance with SOPs and regulations.

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