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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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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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Oversee, prepare, and/or review aggregate safety review documents (e.g., Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (e.g., clinical trial applications [CTA], marketing authorization applications [MAA.
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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.
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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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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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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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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.
$91,000 a yearExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Assists in weight management policies and weight certification programs, including assisting the Clinical Sports Dietitian with direct collaboration between UHS and Athletics staff, for all weight class sports (lightweight rowing and wrestling.
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This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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clinical trial master file jobs Title: trial in Princeton, NJ
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