Senior Clinical Operations Manager

2 weeks ago

Australia beBeeClinical Full time $100,000 - $120,000
Job Overview

This role entails overseeing clinical studies from initiation to completion, ensuring adherence to regulatory requirements and industry standards.

  • Site Management: Identify, launch, and monitor study sites to guarantee high-quality data on time and within budget.
  • Study Training: Provide ongoing education to site staff on ICH-GCP, GCP, and study protocols.
  • Documentation: Ensure timely collection and maintenance of essential documents in investigator files and trial master files.
  • Drug Safety: Distribute safety information and report Serious Adverse Events (SAE) as required by regulations.
  • Finance and Administration: Finalize budgets and obtain signed agreements from sites prior to initiation visits.
Requirements
  • A strong understanding of ICH-GCP, GCP, and clinical research regulations.
  • Excellent communication and interpersonal skills.
  • The ability to work independently and collaboratively as part of a team.

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