(Asso./Sr.) Manager, Country Clincial Quality Management
Core
Ensure patient safety, high-quality data, and regulatory compliance for company-sponsored clinical trials at the country level.
Role type
Senior IC Country Clinical Quality Manager
Builds
Local implementation of global clinical quality processes, SOPs, and training programs for clinical operations
Domain
Healthcare / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA Management, Clinical Research, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Data Analysis, ICH GCP Guidelines, Investigation Procedures, Quality Management, Root Cause Analysis (RCA)
Preferred skills
Clinical Quality Management, Audit Management, Training Coordination
Technologies
None stated
Responsibilities
Implement and update local Standard Operating Procedures (SOPs) and Work Instructions for global processes; coordinate and oversee all Quality Control activities including site visits; act as primary point of contact for audits and inspections with regulatory agencies; manage Corrective and Preventive Actions (CAPAs) and root-cause analysis for findings; lead local supplier qualifications and quality assessments; coordinate local training needs and delivery; escalate and investigate quality, compliance, and privacy issues.
Seniority
Senior, hands-on IC
