Clinical Trial Manager, Clinical Operations

Role: Clinical Trial Manager responsible for independently leading operational execution of global Phase I–IV clinical trials within a biopharma focused on metabolic liver disease (MASH). Objectives include ensuring study timelines, budgets, quality, and compliance across multiple trials, supporting regulatory inspections, and optimizing operational efficiency. Responsibilities: oversee trial start-up, maintenance, and close-out; develop and review key study documents; manage CRO/vendor performance; coordinate investigator/site activities; monitor enrollment, data quality, and study metrics; and mentor junior staff. Requirements: Bachelor's in Life Sciences or related field; 5–7 years of clinical operations experience in biotech/pharma, with proven management of multiple global studies. Skills include strong knowledge of ICH-GCP, FDA regulations, CRO/vendor oversight, project management, and proficiency with clinical systems (CTMS, eTMF, EDC). Desired: experience supporting early-phase or global studies, especially in metabolic, hepatology, or cardiovascular areas. High-value: leadership of complex, global trials in a fast-growing biotech, with an emphasis on operational excellence, inspection readiness, and cross-functional collaboration. Work setup is not specified but involves partnership with CROs, vendors, and clinical sites, with a focus on ensuring operational success in a regulated environment.