Clinical Compliance Manager
Core
Strategic quality leader ensuring clinical research operations meet GxP regulations and global standards through audits, risk management, and continuous improvement.
Role type
Senior Clinical Compliance Manager
Builds
Clinical research programs and quality management systems for global clients
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulations expertise, Quality Management Systems (QMS) management, audit leadership, root cause analysis, risk assessment, stakeholder collaboration, project management, data reporting
Preferred skills
Mentorship of junior auditors, travel flexibility, proficiency with quality management software
Technologies
Microsoft Office, Quality Management Systems
Responsibilities
Develop and execute quality/compliance strategies, conduct internal and external audits, investigate non-conformances and implement corrective actions, maintain QMS documentation, create compliance dashboards and reports, mentor quality professionals, support regulatory inspections
Seniority
Senior, hands-on IC with strategic oversight