Clinical Trials Manager, Oncology or I & I

Role: Lead clinical trial management for oncology and I&I programs, overseeing planning, execution, and vendor oversight from First-in-Human to Phase III. Responsibilities: develop operational strategies, manage budgets and timelines, ensure quality and regulatory compliance (ICH/GCP), lead cross-functional collaboration, oversee CRO/vendor activities, contribute to clinical document development, and mentor team members. Requirements: Bachelor's in health sciences; 8-10 years in global clinical trial operations, with 4+ years managing trials end-to-end across phases; experience in oncology or I&I; proficiency in FDA, ICH/GCP regulations; strong project management, communication, and negotiation skills. HighValue: oncology and I&I indications, Phase I-III, global scope, CRO/vendor oversight, regulatory compliance, clinical trial strategy. WorkSetup: hybrid with Boston office; 70% onsite presence; travel approximately 30-40% for site visits, co-monitoring, and international activities.