Manager, Clinical Quality Assurance

Corcept Therapeutics•Redwood City, CA

66d•Hybrid

About The Position

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Manager of Clinical Quality Assurance position is an exciting opportunity to build upon solid clinical research experience to become a key member of the Clinical Quality Assurance team. This role will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept. This is a hybrid role typically requiring on-site presence 3 days per week.

Requirements

BA/BS degree in a relevant field, or equivalent experience
6+ years' clinical research experience
Understanding of Quality Systems that support GCP quality activities
Experience with advanced Microsoft Office applications (Word, Excel, PowerPoint)
Experience developing GCP processes for the best industry practices and training

Responsibilities

Lead/manage Good Clinical Practice (GCP) audits, including clinical investigative 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 Clinical Study Audit Plans (CSAP) 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 investigative 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 clinical QA 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 as 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