Manager, Regional Clinical Operations

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

Lead and manage Regional CRAs, ensuring adherence to productivity and quality metrics. Oversee site management activities, including protocol deviation and safety reporting, GCP compliance. Monitor study progress, identify risks, and escalate issues promptly. Participate in SMT meetings, providing updates on site metrics and study status. Contribute to the development and review of study-specific documents. Review and approve monitoring trip reports and follow-up letters. Conduct periodic co-monitoring visits to assess site performance. Support resource planning and site assignments. Ensure proper maintenance and quality of site eTMF. Mentor and evaluate Regional CRAs. Promote solution-oriented thinking and effective issue resolution.