(asso./sr.) Manager, Country Clincial Quality Management

Merck & Co., Inc.

6-8 years clinical research experience
Ich-gcp and local regulations expertise
Capa management and root cause analysis
The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials

Job Summary

  • The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials.
  • The Country Clinical Quality Manager serves as the primary local point of contact for R&D Quality Assurance and Regulatory Agencies during audits and inspections.
  • Candidates must possess a Bachelor's Degree in a relevant healthcare area and demonstrate a solid track record in initiating and delivering complex projects.

Matching Summary

The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all sponsored clinical trials.

Skills & Requirements

Must-have

  • 6-8 years clinical research experience
  • ICH-GCP and local regulations expertise
  • CAPA management and root cause analysis
  • Clinical trial quality control activities
  • Audit and inspection management

Nice-to-have

  • Experience in country operations
  • Leading cross-functional teams
  • Project management practices
  • Supplier qualification leadership
  • Continuous improvement initiatives

Key Requirements

  • Bachelor's Degree in healthcare area
  • Minimum 6-8 years clinical research experience
  • Direct field monitoring or oversight experience
  • Deep knowledge of GCP and clinical regulations

Work Rights

Not specified

Tailored Resume

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