Local expert for ICH-GCP and local regulations
Manage the local network of owners / Subject Matter Experts (SMEs) for global/local processes
Identify process gaps / opportunities for process improvement
Lead continuous improvements activities at the country level
Local training point of contact and liaison between local country operations and the internal Institute
Coordinates and oversees all Quality Control activities
Manage and support activities during audits or inspections
Communicates/escalates quality/compliance issues to management
Evaluates trends on Clinical Supply GCP Inquiries
Leads local vendor qualifications of locally selected vendors

Bachelor's Degree or equivalent in relevant health care area
A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals
Deep knowledge and understanding of Clinical Trial processes
Demonstrated experience leading cross-functional teams of business professionals
Solid track record of initiating, planning and delivery of projects
Ideally, experience in managing audits and inspections
Ideally, experience in coordinating and delivering training sessions

Clinical Quality Manager

Key skills