(asso./sr.) Manager, Country Clincial Quality Management
Merck & Co., Inc.
6-8 years clinical research experience
Deep knowledge of ich-gcp and local regulations
Experience managing audits and inspections
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 have a demonstrated record of initiating projects and leading cross-functional teams to implement global processes and drive continuous improvement.
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
Deep knowledge of ICH-GCP and local regulations
Experience managing audits and inspections
Root cause analysis and CAPA management
Leading cross-functional teams in quality
Nice-to-have
Experience in country operations preferred
Project management practices knowledge
Conflict resolution expertise
International environment communication skills
Clinical Quality Management background
Key Requirements
Bachelor's Degree in relevant health care area
Minimum 6-8 years relevant clinical research experience
No VISA Sponsorship available
Direct field monitoring or oversight experience required