Manager, Regional Clinical Operations

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November 13

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Corcept Therapeutics

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Biotechnology • Pharmaceuticals • Science

Corcept Therapeutics is a biopharmaceutical company focused on unlocking the potential of cortisol modulation to revolutionize the treatment of serious diseases. The company is dedicated to understanding and modulating cortisol activity at the glucocorticoid receptor to develop novel treatments for severe disorders. With more than 30 ongoing studies, Corcept is building a scientific foundation to deliver new approaches in fields such as endocrinology, oncology, metabolism, and neurology. The company aims to bring innovative therapies to patients by exploring new possibilities in cortisol modulation science.

201 - 500 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $525.3k Post-IPO Equity on 2012-04

📋 Description

• 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

🎯 Requirements

• 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 • BS/BA in a science or healthcare field, or nursing degree • Willingness to travel 25% regionally and on occasion, cross-country • Excellent interpersonal, oral, and written communication skills.