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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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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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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.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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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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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.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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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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. 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.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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Job DescriptionTakeda 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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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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Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Conduct data management training as well as study specific training for the CDM and study teams. Oversee and participate in the process of data review and query generation procedures. Keep supervisor updated on study progress and staff management through routine meetings.
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PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
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edc rave jobs in Waltham, MA
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