Corcept Therapeutics · 2 months ago
Manager, Regional Clinical Operations
United States
Full-time
Remote
Senior Level, Lead/Staff
$152K/yr - $198K/yr
8+ years expCorcept Therapeutics is a leader in the research and development of cortisol modulators aimed at treating serious diseases. The Manager, Regional Clinical Operations, will coordinate and oversee site management activities for clinical studies, providing leadership to Regional CRAs and ensuring compliance with ICH-GCP guidelines.
BiotechnologyMedicalPharmaceutical
No H1B
Responsibilities
Lead and manage Regional CRAs assigned to the project, ensuring adherence to productivity and quality metrics outlined in the Clinical Monitoring Plan
Oversee site management activities, including protocol deviation and safety reporting, action item resolution, GCP compliance and site allocation
Monitor study progress, identify risks and trends, and escalate issues promptly to the Study Management Team (SMT)
Participate in SMT meetings, providing updates on site metrics and study status
Contribute to the development and review of study-specific documents, including Clinical Monitoring Plans, site logs, and monitoring tools (e.g., SQV/SIV slides, MV agendas, checklists)
Review and approve monitoring trip reports and follow-up letters
Conduct periodic co-monitoring visits to assess site performance and CRA effectiveness
Support resource planning, site assignments, and performance throughout the study lifecycle
Ensure proper maintenance and quality of site eTMF, including periodic audits
Mentor and evaluate Regional CRAs, contributing to performance assessments and professional development
Promote solution-oriented thinking and effective issue resolution across studies
Qualification
Required
Lead and manage Regional CRAs assigned to the project, ensuring adherence to productivity and quality metrics outlined in the Clinical Monitoring Plan
Oversee site management activities, including protocol deviation and safety reporting, action item resolution, GCP compliance and site allocation
Monitor study progress, identify risks and trends, and escalate issues promptly to the Study Management Team (SMT)
Participate in SMT meetings, providing updates on site metrics and study status
Contribute to the development and review of study-specific documents, including Clinical Monitoring Plans, site logs, and monitoring tools (e.g., SQV/SIV slides, MV agendas, checklists)
Review and approve monitoring trip reports and follow-up letters
Conduct periodic co-monitoring visits to assess site performance and CRA effectiveness
Support resource planning, site assignments, and performance throughout the study lifecycle
Ensure proper maintenance and quality of site eTMF, including periodic audits
Mentor and evaluate Regional CRAs, contributing to performance assessments and professional development
Promote solution-oriented thinking and effective issue resolution across studies
Willingness to travel 25% regionally and on occasion, cross-country
Proven leadership and mentoring skills with a collaborative, problem-solving approach
Excellent interpersonal, oral, and written communication skills
BS/BA in a science or healthcare field, or nursing degree
8+ years of experience that includes 5+ years CRA experience along with at least 2 years of leadership
Strong knowledge of ICH-GCP guidelines, eTMF requirements, and site start-up processes
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
Recent News
2026-01-24
2026-01-24
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2026-01-23
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