Manager, Clinical Study Lead

Role: Clinical Study Lead responsible for the global execution of smaller or less complex clinical trials, from design through close-out, ensuring adherence to timelines, budgets, and regulatory standards. Responsibilities include leading cross-functional study teams, vendor management, overseeing study documentation, site evaluation and selection, and risk mitigation. The role involves supervising Clinical Trial Management staff, managing study systems, and contributing to process improvements. Requirements: Bachelor's degree with at least six years of industry experience, proven budget and vendor management expertise, strong proficiency in trial management systems (e.g., CTMS, EDC, IVRS), and solid knowledge of ICH/GCP and regulatory guidelines. High-value specifics: global trial operations, experience with protocol development, and managing studies that may include unmasked components; on-site work at Armonk, NY, or Warren, NJ, with 25% travel. The role emphasizes leadership, operational strategic alignment, and cross-functional collaboration within a biopharma setting.