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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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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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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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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. Proven knowledge of or experience with clinical trial development process and use of clinical technologies.
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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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Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails. Expertise in IBM FileNet suits of products such as IBM Content Manager, IBM Case Manager, IBM Content Navigator, CMIS, IBM Content Collector for file systems and emails.
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Provide general oversight, support and updating for content repositories (Veeva Vault/Portals, SharePoint, Teams Channel) including design, uploads and file organization, and user training. At Client, the Global Field Medical Excellence (GFME) team is positioned within the Scientific Communications and Engagement (SCE) organization.
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Lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc. support the creation of the clinical trial master file folders and system elements.
$91,000 a yearExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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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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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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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We are looking for a Health Economics & Outcomes Research (HEOR) Consultant for our client, a Global Biopharmaceutical Company. PhD/MSc. in Statistics, Mathematics, Epidemiology, or related field with a substantial statistical component.
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TSO/ISPF, SDSF, File-AID, CICS, DB2). Extensive experience in mainframe software development, with hands-on expertise in languages like COBOL, PL/I, Assembler, or JCL.Proven track record of successfully leading and managing software development projects in the mainframe space.
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Strong understanding of data sources, such as clinical trial data, electronic health records, and other healthcare databases. Minimum of 3-5 years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
$67 an hourPart-timeExpandApply NowActive JobUpdated 25 days ago
trial file jobs Title: trial in Skillman, NJ
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