Clinical Data Manager

Role: Clinical Data Manager responsible for overseeing data management activities for clinical trials, ensuring compliance with industry standards, regulations, and SOPs. Responsibilities: manage CRO Data Management teams, develop high-quality study documentation including Data Management Plans, oversee data collection, handling, and quality control; facilitate filing in TMF; design and maintain CRFs and data entry systems (EDC, IRT, ePRO); develop data review strategies, coordinate data transfers, monitor data review processes, and support timely database lock. Collaborate with Clinical Operations, Safety, and Biostatistics teams, as well as external vendors; identify and escalate risks; ensure adherence to GxP, ICH, CDISC, FDA guidelines. Requirements: minimum 2 years of Clinical Data Management experience (preferably >3 years in the role), Bachelor's degree in a scientific or medical field, proficiency in clinical data systems, strong analytical, communication, and multitasking skills. Preferred: experience in Phase 3 trials. HighValue: clinical trial data management, GxP, CDISC, electronic data capture, cross-functional collaboration, regulatory compliance. WorkSetup: not specified; likely office-based or hybrid based on typical industry standards.