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Experience and/or knowledge of the healthcare data domain in at least one of: electronic medical records (EHR/EMR), clinical imaging, clinical workflows; Electronic Data captures (EDC), and/or clinical research/trials.
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Familiarity with common software and technologies used in clinical data science (e.g., SAS, R, Python, Rave, Veeva). Integrate expertise in EDC, RWE and external data to optimize data collection and standardization.
$224,000 - $233,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical coding dictionaries, controlled terminologies, as well as in industry standards for electronic submission of data to FDA.
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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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Custom reporting using Business Objects, SAS, Python, Crystal Reports, and understanding of Medidata Rave Study Build is required. Custom reporting using Business Objects, SAS, Python, Crystal Reports, and understanding of Medidata Rave Study Build is required.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Experience with web-based EDC (IBM Clinical preferred), clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug. background in programming is preferred. Responsibilities: Develop requirements for EDC including CRF and system design; performs and organizes all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT.
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Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
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G., Medidata Rave, InForm, etc.) G., Medidata Rave, InForm, etc.) Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the CMO. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience with EDC and IXRS set up and development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines). Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and liases with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
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Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Perform and manage all data cleaning activities, including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution.
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Responsible for all new patient triage for Outpatient Psychiatry Clinic, EDC Admission and Consultation Services. The Peds Psych Intake Coordinator Lead is responsible for coordinating all aspects of the patient intake process by overseeing insurance verification, pre- certifications, authorizations, referrals, intake screenings and patient scheduling.
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Oversees and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock. Acts as primary liaison with CROs, third party data vendors, EDC vendors. Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.
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