(asso./sr.) Manager, Country Clincial Quality Management
29
Bachelor's degree in healthcare area
6-8 years clinical research experience
Deep knowledge of ich-gcp and local regulations
The role is critical for ensuring patient safety, high-quality data, and compliance with company requirements and regulations across all country-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 country-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 coordinating local training needs in close collaboration with country operations management.
Matching 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.
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
Root cause analysis and CAPA management
Nice-to-have
Experience in Country Operations preferred
Cross-functional team leadership skills
Project management certification or practice
Training coordination and delivery experience
Supplier qualification management experience
Key Requirements
Minimum 6-8 years relevant clinical research experience
Direct field monitoring experience or management oversight
Demonstrated record of accomplishments in clinical trials
Solid track record of initiating and delivering projects