Director Data Management
As a leader in developing and commercializing innovative therapies for central nervous system disorders we are committed to improving the lives of patients.
Over 23 years of industry experience in trial management, developmental management, and data management. Trial management consists of leading multiple studies simultaneously, coordinating study personnel, training study personnel, contract and invoice review for external service provider activities, creating and maintaining open communication with study monitors and study sites, and Data Management (DM) liaison with regulatory agencies. Developmental management includes performance reviews, personnel advancement planning, and training of new personnel. Data management consisting of creating/updating standard operating procedures, protocol review, case report form (CRF) design, data review, construction of computerized edit check specifications, design of database for data capture, query generation, query response integration, and preparation of clinical data for final FDA review. Areas of experience include tissue repair, gastrointestinal, cardiovascular, viral infection, oncology, and autoimmune disease studies.
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