Compliance Manager, Clinical Quality Assurance Oversight
Core
Provide Clinical Quality oversight and support for clinical study teams, acting as a dedicated single point of contact for clients.
Role type
Senior Compliance Manager (Clinical Quality Assurance)
Builds
Clinical trial study portfolios and quality governance frameworks
Domain
Clinical Research / Pharma / CRO
Required skills
Clinical Quality Assurance, Good Clinical Practices (GCP), FDA and EU regulations, ICH Guidelines, Clinical Development processes, Quality Risk Management, Audit and Inspection management, Stakeholder relationship building
Preferred skills
CRO/Pharma industry experience, Team motivation and education, Operational lessons learned integration
Technologies
Office equipment and standard technology
Responsibilities
Provide Clinical Quality oversight and support for clinical study teams; Prepare and analyze QA-related Key Quality Indicators for emerging trends; Co-chair Joint Quality Councils and present quality metrics/trends to stakeholders; Escalate issues appropriately to minimize client impact; Promote compliance of client-specific requirements related to quality events and audit responses.
Seniority
Senior, hands-on IC