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Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.
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Experience with Medidata Rave (EDC) and Metadata Repository (MDR) preferred. Reporting to the Senior Director of Clinical Operations, the individual in this role will offer guidance and leadership across all stages of clinical studies, from EDC study design to study closeout.
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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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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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Responsibilities: Senior Rave Programmer Responsible for designing the eCRF in leading EDC systems in Rave Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
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Two to three years developing Inform, iDatafax/DFdiscover, Clinical One and/or Medidata Rave (or similar) clinical databases. Participate in EDC vendor’s technical learning and exchange meetings, as well as other internal and external training meetings.
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Experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and other clinical trial data management tools. Experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and other clinical trial data management tools.
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Experience configuring Rave EDC to CTMS is a big plus. An ideal candidate would be experienced with python and can own the management of custom EDC to CTMS solution - Including CI/CD in Azure DevOps, understanding of SDLC principles in regulated industry.
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Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems. Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems.
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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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Knowledge of industry standard clinical technologies including CTMS, EDC (RAVE, InForm) Knowledge of CDISC data standards. Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of visualization tools.
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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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Job Description Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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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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