Clinical Trial Manager II

Role: Clinical Trial Manager 2 overseeing global Phase 3 oncology studies, including NSCLC and colorectal cancer, managing trial start-up through closeout. Responsibilities: site selection, feasibility, activation, enrollment, monitoring, issue escalation, CRO oversight, review of essential documents, data and quality management, ensuring regulatory compliance and inspection readiness. Mentors team members and manages operational risks. Requirements: Bachelor's in life sciences or related field; 6+ years in clinical trial management within biotech/pharma, with 5+ years managing Phase II/III oncology trials; strong understanding of GCP/ICH guidelines, data assessment, and regulatory standards. Preferred: Global oncology experience, ability to travel up to 20%. HighValue: experience with international Phase 3 oncology trials, oversight of site operations, CRO management, and data review. WorkSetup: role involves international travel; based in or willing to work at Summit's locations.