The Senior 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 by Corcept.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:- Develop/manage study audit plans ensuring compliance oversight for assigned studies by using a risk-based approach
- Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site, Trial Master File (TMF), and applicable study documents, including Clinical Study Reports (CSRs)
- 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 and provide compliance support and oversight throughout the study lifecycle
- Support clinical study teams in risk management activities including the identification of critical to quality (CtQ) factors for each clinical study, implementing risk proportionate study activities in accordance with CtQs and the monitoring of identified risks to the CtQs
- Review clinical study documents and plans and provide CQA compliance review and approval of clinical development SOPs
- Manage and support GCP inspection readiness activities for assigned studies in alignment with study milestones
- Support clinical inspections conducted by regulatory agencies, including sponsor, clinical investigator site, and service provider inspections
- Lead critical investigations, to ensure regulatory reporting compliance
- Support, review and approve clinical non-compliance records (deviations and CAPA)
- Maintain a contemporary knowledge of agency and industry trends, standards, regulations and methodologies related to GCP
- Provide cross-training development opportunities to CQA team, and mentor/coach junior QA team members
- Some travel required
Preferred Skills, Qualifications and Technical Proficiencies:- 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
Preferred Education and Experience:- BS/BA (science or related field) or equivalent experience
- 8+ years clinical research experience, 2+ years CQA experience preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 - $204,030; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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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.
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