Clinical Data Manager II

divh2Clinical Data Manager II/h2pThis is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial./ppMay be a member of more than one project of low to moderate complexity or member of one project of high complexity./ppThis position makes recommendations and influences decisions for specific trials or assignments./ppThe Senior GDM influences processes, timing, and structure for specific trials or assignments./ppThis position analyzes, provides recommendations, and makes decisions with direction from manager or DML./ppThis position requires in-depth knowledge of the protocol./ppIn-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required./ppThis position needs to understand relevant system/technical knowledge./ppKnowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required./ppSupervision Received:/ppWork is received in broad terms./ppWork is reviewed during major deliverables./ppAmount of instruction is limited./ppWork is reviewed with the Data Manager Leaders as well as with the immediate manager./ppSupervision Given:/ppThere are no direct reports for this position./ppThis position collaborates with Vendors/CROs to achieve successful, cooperative partnerships./ppThis position may delegate tasks and assignments to Global Data Managers./ppThe Senior GDM recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship./ppBS/MS in science related field with relevant experience./ppExperience with CDMS/EDMS system./ppWorking knowledge of contract and budget preparation and negotiations./ppIn-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required./p/div