Clinical Data Manager

Role: Clinical Data Manager responsible for overseeing data management activities for clinical trials in obesity and metabolic disease. Objectives include ensuring high-quality data collection, processing, and documentation, supporting compliance with industry standards, regulations, and GxP practices. Responsibilities encompass managing CRO data management teams, developing and maintaining data systems (EDC, IRT, ePRO), designing CRFs and data review strategies, coordinating data transfer and database lock activities, and ensuring proper documentation in the Trial Master File. Collaboration spans Clinical Operations, Safety, Biostatistics, CROs, and vendors. Requirements: minimum 2 years in clinical data management, Bachelor's in a medical/scientific field, experience with clinical data systems, and knowledge of industry standards (ICH, CDISC, 21 CFR Part 11). Preferred: experience in Phase 3 trials. Skills include strong communication, analytical problem-solving, multitasking, and proficiency with MS Office, online tools, and data review processes. High-value: focus on early to late-stage clinical trials for obesity/metabolic therapies, emphasizing data quality, regulatory compliance, and cross-functional collaboration. Work setup and travel details are not specified.