The Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the study including startup, conduct and reporting phases. The Clinical Data Manager is also responsible for the development, maintenance and training of peers in the applicable processes. This role is critical to the successful collection, reporting and analysis of clinical trial data as well as the mentorship of junior team members. Responsibilities include assisting in translation of clinical study requirements into trial Casebook, developing and maintaining Data Management Plans (DMPs) for clinical trials, developing edit check specifications for the automated cleaning of data management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues, conducting user acceptance testing of clinical study databases, reports, study notifications and database customizations, developing study specific data listings and ensuring data accuracy and integrity, identifying and resolving data discrepancies and inconsistencies, identifying opportunities for improvement and proposed solutions, developing procedures and training to new processes, and mentoring junior team members in the roles and responsibilities of the Clinical Data Management Analyst. Required qualifications include a B.S. in Computer Science, Life Sciences or Technical Field and a minimum of 5 years in clinical or medical or research setting. Preferred qualifications include expertise in data collection best practices for clinical trials, expert knowledge of global clinical operations, experience utilizing electronic data capture systems (EDC) and eTMF systems, knowledge of industry-standard data analysis and reporting software such as SAS and SQL, intermediate to advanced therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device, intermediate to advanced medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route), excellent attention to detail with problem-solving and analytical skills, and Certified Clinical Data Manager (CCDM) or equivalent.
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