- 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
- 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
- BS / BA (science or related field) or equivalent experience
- 6 or more years clinical research experience
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Manager, Clinical Quality Assurance - Menlo Park, United States - Corcept Therapeutics
Description
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 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 advance 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 (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:
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at:
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
