Acts as the system owner for all data management systems and develops and executes strategies to ensure these systems remain state of the art, enable the business, and remain compliant.Provides leadership, direction, and management for the DJO Clinical Affairs team members to ensure accurate, timely, and consistent clinical data collection.Ensures proper development and management of timelines for key clinical data management deliverables (e.g. Case Report Form development, database design specifications, data listing specifications, etc.)Oversees the development of standard data collection forms, reports, and to manage and optimize clinical study performanceActs as the key liaison between system development companies and DJO to ensure on-time/on-budget deployment of data management systemsStrategically leverages external relationships with counterparts at CROs, central laboratories, and other service providers to ensure performance requirements, data quality standards, study objectives, and timelines are met.Ensures data being collected is done so in accordance with DJO SOPs and policies and applicable regulatory standards (e.g., ICH-GCP, ISO 14155, 21 CFR)
Bachelor's degree in a Healthcare-related field and five (5) years of progressively increasing responsibility in the data management field or an equivalent combination of experience, education, and training.Experience using EDC, eTMF, CDMS, IWRS systems (e.g., RAVE, VEEVA, CLINDEX).Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC, SDTM, and CDASH Master's Degree in a Healthcare-related field and ten (10) years of departmental oversight in the data management field or an equivalent combination of experience, education, and training.Experience evaluating and onboarding of clinical trial software (new service agreement initiation): 22-01923 :Philadelphia, PA, United States:
SDL2017
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