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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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Serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM and MMI (Imaging) provide Oversight, guidance, and design of study build activities on Rave URL.
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Serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM and MMI (Imaging)Provide oversight, guidance, and design of study build activities on Arcus Rave URL.
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Direct experience with systems such as Veeva Vault, Documentum, D2, OpenText, SharePoint, FirstDoc, FirstPoint, NextDocs, CARA, MasterControl, TrackWise QMS, BioClinica, IMPACT, Siebel CTMS, Wingspan eTMF, InForm EDC, RAVE, docuBridge, Global Register, goBalto.
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SAS, Programmer, statistics, CDISC, SDTM, ADaM, CRO, clinical research, pharmaceutical, biotechnology, clinical data, data management, EDC, Electronic Data Capture, Medidata, Rave, Oracle, Inform, datasets, TLF, tables, listings, figures, programming, benefits, medical, dental, vision, 401k, Remote.
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Coordinating Skills - Minimum of 2-5 years of research experience Technical Assessment skills Computer skills: EDC experience with RAVE, Oracle, Trial master, IRT, Bracket Demonstrates strong analytical, problem solving skills Strong written and verbal communication skills.
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Develop, program, validate and maintain Medidata Rave EDC clinical trial databases according to company standards; Maintain and contribute to company library of standard Medidata Rave EDC CDASH compliant CRFs.
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BA/BS degree along with at least 5 years of clinical data management experience which includes 3 years in a DM lead role and 1-2 years of experience in developing clinical trials databases in a commercially available EDC system (e.g. RAVE, Medrio, Red Cap, Veeva); Medidata RAVE build certification 5.6.
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Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools. Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools.
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Skilled in the use of data management software application, Medidata RAVE. Ensure proper completion of UAT of EDC system and modules. Review/prepare training materials and user guides for EDC data collection tools, deliver user training.
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E, Rave or SAS preferred). Creates and oversees EDC build and database lock timelines in order to maintain on-time deliverables. May provide project data management training as needed regarding CRF Completion or EDC system usage.
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Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.) Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings.
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Extensive experience with both in-house development and outsourced modelsExtensive experience with DM activities across all stages of clinical trialsExtensive knowledge of Medidata Rave and ability to write the specifications and build a database from scratch, if neededExtensive experience with regulatory requirements, CDISC standards, eTMF, CTMSStrong understanding of datasets/programming tools (e.g., ADaM, SDTM, SAS, etc.
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Prior experience with Medidata Rave is required, URL administration experience a plus. 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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Requirements: BA/BS degree along with at least 5 years of clinical data management experience which includes 3 years in a DM lead role and 1-2 years of experience in developing clinical trials databases in a commercially available EDC system (e.g. RAVE, Medrio, Red Cap, Veeva); Medidata RAVE build certification 5.6.
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