Manager Clinical Quality Assurance
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol.
Since 2012, we have marketed Korlym for the treatment of patients suffering from Cushing's syndrome, a life-threatening orphan disorder caused by excess cortisol activity.
In 2022, we generated revenue of $402 million and net income of $101 million.
We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.
Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing's syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (ALS).
We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (NASH) by the end of this year.
Every year, we advance new molecules to the clinic.
Over the next few years, we expect to submit several new drug applications.
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.
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 Preferred Education & Experience 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 Some travel required for this role Corcept has a dynamic and authentic culture where we remain true to our principles while embracing continued growth.
Our work is marked by innovation, integrity, collaboration, and honest communication.
We all have unique contributions to make, and our success is the sum of those contributions.
Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol.
Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases.
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.
If you are based in California, we encourage you to read this important information for California residents linked here.
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:
https:
//www.
corcept.
com/ Corcept is an Equal Opportunity Employer Recommended Skills Auditing Business Process Improvement Clinical Quality Management Clinical Research Clinical Study Reports Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
Since 2012, we have marketed Korlym for the treatment of patients suffering from Cushing's syndrome, a life-threatening orphan disorder caused by excess cortisol activity.
In 2022, we generated revenue of $402 million and net income of $101 million.
We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.
Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing's syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (ALS).
We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (NASH) by the end of this year.
Every year, we advance new molecules to the clinic.
Over the next few years, we expect to submit several new drug applications.
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.
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 Preferred Education & Experience 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 Some travel required for this role Corcept has a dynamic and authentic culture where we remain true to our principles while embracing continued growth.
Our work is marked by innovation, integrity, collaboration, and honest communication.
We all have unique contributions to make, and our success is the sum of those contributions.
Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol.
Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases.
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.
If you are based in California, we encourage you to read this important information for California residents linked here.
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:
https:
//www.
corcept.
com/ Corcept is an Equal Opportunity Employer Recommended Skills Auditing Business Process Improvement Clinical Quality Management Clinical Research Clinical Study Reports Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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