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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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Proven knowledge of or experience with clinical trial development process and use of clinical technologies. As a Digital Biomarker Lead, you will oversee all aspects of digital biomarkers-related research, from benchtop experiments, data analysis to validation and deployment of digital health technologies (DHT) in large-scale clinical trials.
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Provide analytical and statistical support on HEOR research performed within claims data, EMR data, clinical trial data, and registry data. Comprehensive understanding of clinical development strategies and trial designs.
$88 an hourExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Forensic Psychology & Neuropsychology Services, P.C. and Neuropsychology & Rehabilitation Associates, P.C., with offices in Morristown and Pennington, NJ, is pleased to announce two openings in our two-year postdoctoral fellowship in clinical neuropsychology with a strong emphasis in forensic psychology and forensic neuropsychology.
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Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Understanding of the digital health field and clinical drug development. Create business cases, develop hypotheses, plan pilot and concept testing, and execute surveys to progress innovative digital health solutions on a trial, program, or corporate level.
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Apply SCL Charge Master, Compliance and regulatory guidelines to identify and appropriately charge for all procedures and supply charges. Partner with physicians, clinical departments, and others to clarify documentation questions as needed utilizing SCL standardized logging and communication process.
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Perform concept level design and analyze hydrologic and hydraulic models and computations for storm water and watershed master planning, ecosystem restoration, and water quality studies. Working knowledge of Stormwater Management, Drainage, Erosion and Sediment Control, Hydrology & Hydraulics Design, Watershed Studies, Floodplain Delineation, etc.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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2-5 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material.
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Support the creation of the clinical trial master file folders and system elements. lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc.
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Experience with SAP ERP system, master data management system, or product lifecycle management system. firstPRO is looking for a Master Data Steward for a 6+ month consulting opportunity.
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Required Qualifications: Bachelor’s degree in Engineering, Chemistry, Biology, or related Science 2-5 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material Ability to work independently.
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In MDM we collaborate with many departments of the business, and you’ll become familiar with dsm-firmenich MDM processes (+60 processes) of Material Introductions, Maintenance, Commercial, Packaging, Customer and Vendor master.
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clinical trial master file jobs Title: master in West Windsor, NJ
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