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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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Skilled in the use of data management software application, Medidata RAVE. Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
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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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Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint Working knowledge of Electronic Data Capture(EDC) and Electronic Medical Record(EMR) Systems i.e. EPIC, Medidata RAVE, Medio.
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Experience with any of the following Clinical technologies highly desirable: eTMF, CTMS, Medidata/RAVE, IRT/IVRS, Clinical Data repository, Clinical trial Supply management, sample management, Oracle/SQL, SAS, Clinical Data exploration tools like Spotfire, Power BI, MicroStrategy, QlikView, JMP and-or J-review etc.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Lead data management for clinical trials from launch to closeout. Proficiency in Medidata Rave or similar tools. Manage data collection, review, and reporting. Coordinate with vendors and senior management.
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Syndicated Data experience: Experience with IRI, Nielsen, and other relevant platforms preferred. The Company is one of North America’s leading sales and marketing agencies specializing in outsourced sales, merchandising, category management and marketing services to manufacturers, suppliers and producers of food products and consumer packaged goods.
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Lead the following data management activities for multiple clinical development programs: Database transfer, CRF development, Database specifications, User acceptance testing, Query resolution, Data review, Database lock.
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Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical). Lead discussions and interacts with members of the Data Management and Clinical Affairs teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities.
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Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools. Develop or lead the review of all DM documents, including Data Management Plans (DMP), eCRF Completion Guidelines (CCGs), Data Transfer Agreements, etc.
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We are seeking a dedicated Category Manager whose role requires the ability to understand our retailer's processes, understand what data is available, understand our client's objectives and marry the three together with compelling, data-driven "storytelling.
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Perform targeted source data verification in Medidata RAVE, review select source documentation remotely for compliance with protocol guidelines, issue/resolve queries where indicated. A minimum of five (5) years of experience in clinical research and/or in oncology data management.
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EDC design, build, UAT (CRFs and Edit Checks)Data collection, reconciliation, processing, coding, reporting, validationReview and approve data management documentation and specifications (data management plans, external data transfer agreements, validation plans etc.
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Contribute to RAVE process, focusing efforts on measurable value creation with customers and clients. The Category Manager role requires the ability to understand our retailer’s processes, understand what data is available, understand our client’s objectives and marry the three together with compelling, data driven “story telling.
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