(asso./sr.) Manager, Country Clincial Quality Management
39med
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 incumbent acts 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 at the country level while supporting global initiatives.
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
Training coordination and delivery skills
Supplier qualification leadership
Continuous improvement initiative support
Key Requirements
Bachelor's Degree in relevant health care area
Minimum 6-8 years relevant clinical research experience
Direct field monitoring or management oversight experience