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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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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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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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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 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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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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Johnson & Johnson is recruiting for an Analyst II, Trial Supply Planner to be located in Titusville, NJ; Horsham, PA or Beerse, Belgium. Use business tools to set and actively manage inventory targets at depots and sites and provide guidance to Trial Supply Leaders (TSL) to ensure timely delivery with minimal overage of clinical supplies.
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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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Our Staff Counsel legal team is seeking a dynamic, collaborative and experienced Senior Trial Attorney to join us. Senior Trial Attorney- Insurance Defense. Experience in handling the defense of auto and premises liability personal injury cases, including jury trial experience, in NJ is required.
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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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Innova Solutions is immediately hiring for a Health Economics & Outcomes Research (HEOR) Consultant. a Health Economics & Outcomes Research (HEOR) Consultant, 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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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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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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trial file jobs Title: trial in Lawrence, NJ
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