Senior Manager, Clinical Quality Assurance

The role

The Senior Manager of Clinical Quality Assurance performs day-to-day clinical quality operations and compliance activities. This role supports the success of clinical studies sponsored by Corcept.

What you will do

• Develop and manage study audit plans using a risk-based approach
• Lead and manage Good Clinical Practice (GCP) audits
• Support clinical service provider and development internal process audits
• Assess changes to qualified service provider services and their impact to ongoing clinical studies
• Serve as a CQA Lead representative on assigned clinical studies
• Support clinical study teams in risk management activities
• Review clinical study documents and plans and provide CQA compliance review and approval of clinical development SOPs
• Manage and support GCP inspection readiness activities
• Support clinical inspections conducted by regulatory agencies
• Lead critical investigations to ensure regulatory reporting compliance

Required qualifications

• 8+ years clinical research experience
• Applicants must be currently authorized to work in the United States on a full-time basis

Nice to have

• Thorough understanding of Quality Systems that support GCP activities
• Experience developing GCP processes for the best industry practices
• Experience leading complex quality investigations, root cause analysis and corrective and preventative actions
• BS/BA (science or related field) or equivalent experience
• 2+ years CQA experience

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.