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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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Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post marketing safety data management) and at least one EDC system Experience performing Medidata Rave dictionary upgrades, impact analysis and developing and maintaining coding processes and conventions.
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Minimum of 1 year of experience in building case report forms (CRFs) using the Medidata Rave electronic data capture (EDC) system. The Medidata Rave Study Builder will be responsible for creating Rave studies for therapeutic oncology trials.
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Working knowledge of EDC systems – preferably Medidata RAVE. Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
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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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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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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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Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Masters degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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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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Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S. Prior experience must include: Develop and maintain study-specific data management documentation such as CRF Specifications, Edit check specifications, Data Management Plan, and Data Cleaning Plan documentation, etc.
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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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Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. This includes all global validated applications across the Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance business units.
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Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S.Apply on-line at www. LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time.
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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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