Senior Study Monitor

2 days ago


Hong Kong, Central and Western District, Hong Kong SAR China KPS Life Full time
Job Summary

We are seeking an experienced Senior Study Monitor to join our team in Hong Kong. As a key member of our clinical operations department, you will be responsible for ensuring the high-quality conduct and execution of clinical studies at sites in Hong Kong.

The primary responsibility of this role is to provide Sponsor oversight of the conduct, monitoring, and management of clinical studies and assigned monitors at clinical study sites. This includes contributing to the development of overall study management plans, site and monitoring plans, and oversight monitoring plans.

  • Key Responsibilities:
  • Contribute to the development of comprehensive study plans and protocols
  • Ensure compliance with quality, regulatory, and governance requirements
  • Conduct regular monitoring visits and report reviews to ensure high-quality data collection
  • Address issues identified with study conduct, monitoring, and site management through effective communication and escalation
  • Support the collection of key study performance information, including start-up metrics, enrollment, and data collection timeliness/quality

Requirements:

  • Minimum 8+ years' relevant clinical research experience
  • 6+ years' experience in monitoring and site management of industry-sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent)
  • Thorough understanding of the drug development and clinical trial process
  • Ability to assess CROs' monitoring performance and provide constructive feedback and remediation as necessary
  • Active management experience of countries and sites in a region


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