Manager, Regional Clinical Operations

Role Summary

The Manager, Regional Clinical Operations coordinates and oversees site management activities for clinical studies conducted by Corcept Therapeutics. This role provides leadership to Regional CRAs and ensures compliance with ICH-GCP guidelines, contributing to the successful execution of monitoring activities. The position requires proactive communication, strategic planning, risk management, and strong organizational skills to support Corcept’s Clinical Operations objectives.

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

Qualifications

• Preferred: Willingness to travel 25% regionally and on occasion, cross-country
• Preferred: Proven leadership and mentoring skills with a collaborative, problem-solving approach
• Preferred: Excellent interpersonal, oral, and written communication skills
• Preferred: BS/BA in a science or healthcare field, or nursing degree
• Preferred: 8+ years of experience that includes 5+ years CRA experience along with at least 2 years of leadership
• Preferred: Strong knowledge of ICH-GCP guidelines, eTMF requirements, and site start-up processes

Education

• BS/BA in a science or healthcare field, or nursing degree

Additional Requirements

• Willingness to travel 25% regionally and on occasion, cross-country
• Applicants must be currently authorized to work in the United States on a full-time basis