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. Objectives include ensuring trial delivery within scope, timeline, and budget, in compliance with SOPs and ICH/GCP standards. Responsibilities encompass leading cross-functional teams, overseeing vendor engagement, managing study documentation, and risk mitigation. The role involves supervising clinical operations staff, supporting protocol development, site selection, and overseeing data review and study close-out activities. Qualifications: Bachelor's degree with at least six years of industry experience, strong expertise in trial management systems, budget management, vendor relations, and global clinical trial operations. Knowledge of ICH/GCP and regulatory guidelines is essential. Skills in project management, team leadership, and cross-functional collaboration are required. High-Value specifics: Focus on early to late-phase clinical trials, with experience in global operations, vendor oversight, and study documentation. The position involves 25% travel, based at Armonk, NY, or Warren, NJ, with some unmasked trial tasks. The salary range is $128,600 - $210,000 annually.