The Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept.

Responsibilities:

• Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
• Serve as a QA representative and support clinical study teams to provide compliance advice
• Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
• Manage study-specific Study Audit Plans compliance for the assigned program by using a risk-based approach for Corcept clinical studies
• Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time
• Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence
• Manage and support inspection readiness activities for GCP
• Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspections
• Support GMP, GLP, and PV inspections
• Lead clinical non-compliance event investigations and CAPA implementation
• Perform quality metric analysis for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
• Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs. Maintain the GCP regulatory surveillance program
• Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor
• Some travel required

Preferred Skills, Qualifications and Technical Proficiencies:

• Understanding of Quality Systems that support GCP quality activities
• Experience developing GCP processes for the best industry practices and training
• Strong proficiency in Microsoft Office

Preferred Education and Experience:

• BS / BA (science or related field) or equivalent experience
• 6 or more years clinical research experience

The pay range that the Company reasonably expects to pay for this position is $144,800 - $170,300; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered.

Applicants must be currently authorized to work in the United States on a full-time basis.

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