Clinical Trial Manager

Role: Clinical Trial Manager (CTM) responsible for operational execution of global clinical trials in cell therapy, ensuring compliance with ICH-GCP and regulatory standards. Responsibilities: manage study activities across all phases, oversee site and vendor qualification, monitor trial progress, review data for quality, maintain trial documentation, and collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams. Ensure trial timelines, budgets, and inspection readiness are met while managing risk and quality standards. Requirements: BS in life sciences with 6+ years or MS with 4+ years in Clinical Operations; 3+ years sponsor trial management experience; proven support for complex global Phase III trials, preferably in cell therapy or oncology; strong knowledge of GxP, regulatory requirements (FDA, EMA); proficiency in Microsoft 365; excellent communication skills; ability to travel up to 20%. Nice-to-haves: experience in a fast-paced biotech startup environment. High-value: cell therapy, oncology, Phase III, global trials, regulatory compliance, GxP, cross-functional collaboration, trial oversight, inspection readiness, remote/hybrid work option.