Clinical Trial Manager (Oncology)

Role: Clinical Trial Manager overseeing the UTUC clinical trial from start-up to close-out, focusing on study execution, vendor oversight, and regulatory compliance. Responsibilities: manage CROs, study vendors, and sites; support protocol development, regulatory submissions, and study documentation; coordinate study activities, ensure audit readiness, and contribute to process improvements; track metrics and support budget management. Requirements: Bachelor's in life sciences; 6-8 years of clinical trial support experience, including early phase and global trials; 1-2 years in a CTM role preferred; extensive knowledge of ICH/GCP and FDA regulations; proficiency with eTMF, CTMS, EDC; strong project management and communication skills; minimal travel (~5-10%). HighValue: experience with early phase/registrational trials, CRO/vendor management, regulatory compliance, and electronic trial systems. WorkSetup: remote with periodic in-person collaboration.