Senior Research Study Manager

7 days ago

Sydney, New South Wales, Australia beBeeResearch Full time $90,000 - $120,000
Job Title

A Clinical Research Associate will oversee clinical studies, ensuring compliance with regulations and sponsor SOPs. Key responsibilities include site management, drug safety, finance, and administration.

Key Responsibilities:
  • Manage study sites from selection to close-out in accordance with ICH-GCP and GCP standards.
  • Perform pre-study visits to select eligible sites and ensure adequate resources and experience.
  • Prepare and conduct Site Initiation Visits (SIV) to train site staff on study protocols and requirements.
  • Ensure Principal Investigator/study staff complies with safety reporting requirements and track study recruitment.
  • Conduct monitoring visits and address issues with sites, coordinating timely completion of monitoring visit reports.
  • Coordinate study materials delivery and assemble site-specific EC submission dossiers for submission.
  • Provide ongoing training to site staff on ICH-GCP, GCP, and study protocol requirements.
Requirements:
  • Bachelor's degree or above in Medical, Pharmacology, or Biology related field.
  • At least 3 years' experience as a CRA, with a good understanding of Good Clinical Practice and clinical trial operations.
  • Excellent knowledge of Microsoft Office Suite, including Word, Excel, PPT, and Outlook.
Benefits:
  • Mid-senior level position with opportunities for growth and development.
  • Full-time employment with a reputable organization.
  • Healthcare provider and research role within the pharmaceutical manufacturing industry.

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