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

539

Not specified
Bachelor's degree in healthcare area
6-8 years clinical research experience
Deep knowledge of ich-gcp and local regulations
The position of (Associate/Senior) Manager, Country Clinical Quality Management involves ensuring patient safety and data quality in company-sponsored clinical trials. The role requires expertise in clinical research regulations and processes, with responsibilities including quality control, training, audits, and continuous improvement initiatives

Job Summary

  • The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all company-sponsored clinical trials.
  • The incumbent serves as the primary local point of contact for R&D Quality Assurance and Regulatory Agencies during audits and inspections.
  • This position requires leading continuous quality improvement activities and managing Corrective and Preventive Actions (CAPAs) at the country level.

Matching Summary

Match Score: 85

The position of (Associate/Senior) Manager, Country Clinical Quality Management involves ensuring patient safety and data quality in company-sponsored clinical trials. The role requires expertise in clinical research regulations and processes, with responsibilities including quality control, training, audits, and continuous improvement initiatives.

Skills & Requirements

Must-have

  • Bachelor's Degree in healthcare area
  • 6-8 years clinical research experience
  • Deep knowledge of ICH-GCP and local regulations
  • Experience managing audits and inspections
  • CAPA management and root cause analysis skills

Nice-to-have

  • Experience in Country Operations preferred
  • Project management and cross-functional leadership
  • Experience coordinating training sessions
  • Strong communication in international environment

Key Requirements

  • Minimum 6-8 years relevant clinical research experience
  • Bachelor's Degree or equivalent in health care
  • Demonstrated record of accomplishments in clinical trials
  • No VISA Sponsorship available

Work Rights

Not specified

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