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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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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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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 integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system. 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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Strong familiarity Medidata RAVE, Veeva EDC or Medrio. Monitor quality of data deliverables from external vendor sources used for the clinical database for all assigned studies with focus on assessing and producing metrics on overall database trends, including but not limited to EDC, eTMF, etc.
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Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform. Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred.
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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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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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Experience working with an Electronic Data Capture system (EDC) (e.g. Medidata Rave) and with other databases (e.g. Central Imaging, IVRS/IWRS) The Sr. Clinical Data Manager will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.
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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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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 experience of EDC systems, especially Medidata Rave. Strong experience of EDC systems, especially Medidata Rave. Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.
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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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Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system. 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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