Hello, My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Data Manager for a prominent client of ours. This position is located in South Sanfrancisco, CA Details for the position are as follows: Job Description:Responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.Responsible for the production of non-CRF data collection specification documentationDefines the study specific non-CRF data handling strategyCollaborates with SMT to agree on vendor expectations for the collection and transfer of data Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF dataResponsible for establishing appropriate transfer methodology with external data providerProvides transfer methodology training and documentation on non-CRF data for external vendors.Responsible for configuring the data loading tools based on data collection specificationsReceives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structurePerforms verification and resolves data transmission, file format and loading errors with data providersProactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorizedDelivers data to external recipients and review bodies via established transfer methodologiesRepresent CDM on sub teams and works with the Study Management Team to develop IxRS specifications and implement the systemCoordinates and plans subfunction activities to meet program-level deliverables and timelinesCollaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standardsEffectively communicates ideas, project goals and status of work and can present to senior managementProactively develops solutions to complex problems requiring the regular use of ingenuity and innovationRequires significant experience in one or more Clinical Data Management, Biometrics or relevant clinical development functions. Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite).Clinical data management system experience (EDC Medidata Rave preferred).Ability to apply advanced principles, theories and concepts for CDM as a whole. Understanding of the conceptual basis for data management conventions, standards and processes. Good understanding of the role of data management, biostatistics and statistical programming in the drug development process. If you are interested in hearing more about the position please respond to this posting with your resume attached.
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