Clinical Trials Manager, Oncology or I&I

Role: Senior Clinical Trial Manager leading oncology and I&I trials from First-in-Human to Phase III, focusing on operational strategy, study execution, and vendor oversight. Responsibilities: develop and implement clinical operations strategies, manage cross-functional team and CRO/vendor relationships, oversee trial budgets, timelines, and quality standards (ICH/GCP), contribute to clinical documentation, and ensure regulatory compliance. Requirements: Bachelor's in health sciences, 8-10+ years in global clinical trial management, extensive experience in Phase I-III oncology or I&I, strong knowledge of FDA, ICH/GCP, and vendor oversight. Preferred: prior experience mentoring staff, proficiency in project management tools, and a track record of successful multi-indication clinical programs. HighValue: oncology and I&I indications, Phase I-III, global scope, CRO/vendor management, regulatory compliance, hybrid work with 70% onsite in Boston, and 30-40% travel for site visits and international activities.