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

Merck & Co., Inc.

Argentina
Not specified
Ich-gcp and local regulations expertise
6-8 years clinical research experience
Direct field monitoring or oversight experience
Merck & Co., Inc. is seeking an experienced (Associate/Senior) Manager for Country Clinical Quality Management in Argentina, responsible for ensuring patient safety, quality data, and compliance in clinical trials. This role requires expertise in clinical research regulations, quality improvement, and training coordination

Job Summary

  • The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all country-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 along with a minimum of 6-8 years of relevant experience in clinical research.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an experienced (Associate/Senior) Manager for Country Clinical Quality Management in Argentina, responsible for ensuring patient safety, quality data, and compliance in clinical trials. This role requires expertise in clinical research regulations, quality improvement, and training coordination.

Skills & Requirements

Must-have

  • ICH-GCP and local regulations expertise
  • 6-8 years clinical research experience
  • Direct field monitoring or oversight experience
  • CAPA management and root cause analysis
  • Audit and inspection management
  • Local SOP and WI implementation

Nice-to-have

  • Experience in continuous quality improvement
  • Cross-functional team leadership skills
  • Project management and delivery track record
  • Training coordination and delivery experience
  • Supplier qualification and re-qualification experience

Key Requirements

  • Bachelor's Degree in healthcare area
  • 6-8 years clinical research experience
  • Deep knowledge of GCP and clinical regulations
  • Demonstrated project management skills
  • Experience leading cross-functional teams

Work Rights

Not specified

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