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As the Manager, Clinical Data Management you will be responsible for data management in clinical trials across all therapeutic areas. Responsible for all clinical data management activities in clinical trials in accordance with Ferring SOPs and current regulatory requirements.
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Experience with data integration tools (e.g., Informatica, Talend, Alteryx, SSIS etc) to carry out an ETL (Extract, Transform & Load) to move data from disparate systems to Master Data Management Hub.
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Knowledge of regulatory requirements such as Health Insurance Portability and Accountability Act (HIPPA), HITECH, Payment Card Industry Data Security Standards (PCI DSS), and FIPS-140. Provide Leadership to the Department: lead and champion organizational change; encourage participation in activities that support relationship development; champion information security and risk management innovation; demonstrate and champion the following characteristics in fulfilling the responsibilities of the job - passion, empowerment, accountability, collaboration and ethics.
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7+ years experience with a combination of Instrumentation and Controls programming/installation, general contractor MEP coordination/project management, commissioning (both mechanical and electrical) of data centers, or other large scale mission critical buildings.
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Provides subject matter expertise for one or more of the following: Risk Adjustment for CMS HCC Medicare Advantage and/or Medicaid (CDPS Rx, Milliman, Mercer), Quality (HEDIS / STARS) measure performance, Population Health including population segmentation, risk stratification models, disease management and case management performance tracking and analytics.
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Designs and implements information assurance and security engineering systems with requirements of business continuity, operations security, cryptography, forensics, regulatory compliance, internal counter-espionage (insider threat detection and mitigation), physical security analysis (including facilities analysis, and security management.
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Support Daiichi Sankyo internal business departments, data steward, and sourcing partners with the following activities: capacity planning, problem management, impact of application issues and overall application (s) stability and associated delays (incident management), operational support for data exchange, integration and data loads, communication on issues and resolutions to DSI.
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The ideal candidate will have in-depth experience in cell therapy, with specialized expertise in CAR-T therapy, solid tumors, leading a data management function, and expertise using Medidata Rave. This role encompasses the management of external Contract Research Organizations (CROs), acting as a Subject Matter Expert (SME) for all data management activities, and ensuring the highest data quality and integrity across the clinical operations organization.
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Demonstrated proficiency in Medidata Rave and familiarity with other clinical data management platforms. A minimum of 10 years of relevant data management experience in the biotech or pharmaceutical sector, with a strong emphasis on cell therapy and CAR-T therapy.
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Call on and secure relationships with senior leadership in Epidemiology, Primary and Secondary Research, Medical Affairs, Value and Evidence, HEOR, Marketing, Brand Management, Product Management, Managed Markets, Market Access, Data Analytics, and other areas within organizations.
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Sr. Analyst, Data Management Operations. Must possess hands-on experience with integration tools (Azure Data Factory, Informatica IICS, or equivalent), enterprise scheduling / orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent.
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Syndicated Data, IRI, Nielsen, Circana, Data Management, Python, R, SQL, Tableau, PowerBI, Strategy, Categories, Analytics, Insights, Statistics, Data Science, Data Analysis, Advanced Analytics, Data Analytics, Consultant, Individual Contributor, CPG, Consumer Product Goods, Consumer Products, Marketing Analyst.
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Disposal Operations: Responsible for the knowledge development and progressive understanding and expertise in all aspects of day-to-day management of a landfill, including, but not limited to, fill sequencing, cover operations, waste placement and compaction operations, equipment and labor deployment, storm water management, and traffic flow.
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Skills required: Azure Data Factory, DataBricks, Data Lake Architecture, Azure DevOps, Python, SQL, solid understanding of Azure fundamentals and security best practices, Release management.
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NET, MS Access, Oracle, SQL Server, Sybase, PL/SQL, SQL, TSQL, SSIS, SSRS, Tableau, TOAD, ERWIN, Data Modeling, Data Quality, Data Governance, Data Visualization, Java, HTML, SAS, R, Python, and other statistical/financial analysis tools and Graphical/presentation design tools, and the Internet in a Windows and UNIX environment.
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data management jobs Company: Smart Data Solutions in Trenton, NJ
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