Clinical Trials Quality Expert

3 days ago

Jaipur, Rajasthan, India beBeeQualityAssurance Full time ₹ 1,04,000 - ₹ 1,30,878

Job Overview:

The Quality Assurance Specialist plays a pivotal role in ensuring the delivery of high-quality clinical trials. Reporting to the Clinical Research Associate line management, this position is responsible for performing quality oversight activities and collaborating with cross-functional teams to drive operational excellence.

Key Responsibilities:

  • Conduct monitoring evaluation visits (MEVs) and sign-off visits (SOVs) to assess the quality of clinical trials.
  • Analyze data to identify areas for improvement and develop action plans to implement process enhancements.
  • Provide training and support to CRAs to ensure they meet quality and efficiency standards.
  • Collaborate with Clinical Operations to resolve quality concerns and escalate issues as necessary.
  • Act as a consultant to operations teams on quality oversight best practices and tools.
  • Review and revise clinical monitoring SOPs, tools, or templates related to monitoring oversight.

Qualifications:

  • Bachelor's degree in a biological science or healthcare-related field required.
  • A minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech, or pharmaceutical company.
  • Additional experience as a CRA Line Manager, Project Manager, Clinical Team Manager, or Quality Control role preferred.
  • In-depth knowledge of ICH/GCP, local regulations, drug development processes, and clinical operations.
  • Ability to work independently within a matrixed environment across multiple projects and geographies.
  • Strong attention to detail, organizational, documentation, and presentation skills.
  • Excellent interpersonal and communication skills; ability to identify, analyze, and solve problems.
  • Proficiency in written and spoken English; additional languages preferred in regional locations.

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