(asso./sr.) Manager, Country Clincial Quality Management
med-in.at
6-8 years clinical research experience
Ich-gcp and local regulatory expertise
Capa management and root cause analysis
The role is critical for ensuring patient safety, high-quality data, and compliance with regulations across all company-sponsored clinical trials
Job Summary
The role is critical for ensuring patient safety, high-quality data, and compliance with regulations across all company-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.
This position requires leading continuous quality improvement activities and managing corrective and preventive actions (CAPAs) at the country level.
Matching Summary
The role is critical for ensuring patient safety, high-quality data, and compliance with regulations across all company-sponsored clinical trials.
Skills & Requirements
Must-have
6-8 years clinical research experience
ICH-GCP and local regulatory expertise
CAPA management and root cause analysis
Audit and inspection management
Quality control activities coordination
Nice-to-have
Experience in country operations
Leading cross-functional teams
Project management practices
Training session delivery experience
Supplier qualification leadership
Key Requirements
Bachelor's Degree in health care area
Minimum 6-8 years relevant clinical research experience
Direct field monitoring or oversight experience
Deep knowledge of GCP and clinical trial regulations