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When required, review and provide input to clinical data management deliverables including, but not limited to, the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (Plan; and the ongoing data review TLFs in accordance with the Plan), and Data Management Plan (DMP.
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Bachelor's degree required plus a minimum of ten (10) years' experience in clinical research with a minimum of six (6) years in the regulated Pharmaceutical industry; Master's or Advanced degree such as JD preferred.
$167,000 - $289,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD.
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Coordinate, review, analyze, and report on clinical practice professional and hospital billed statistics, including wRVUs∯*∯ Use of reporting and data mining applications in Excel, UR Financial Workday, Axiom, eRecord/EPIC, and McKesson for tracking and reporting purposes.
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Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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You will have experience in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully.
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This role will encompass Team leadership of RWA scientists deployed to support Respiratory/Immunology Research Unit (RIRU - currently the most complex RU at GSK), in close partnership with Real World Data Management and Programming (RWDMP – Bangalore based programming team) and Real World Data Strategy and Partnership (RWDS) functions.
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Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Deal sheet with demonstrated record of leading negotiations to successful completion, including deals for regional rights (Asia, Europe, LATAM, MENA) and for late-clinical stage/commercial programs Preferably with an established network of contacts in the area of specialty cardiology.
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Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update.
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Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; global clinical research experience and experience working with clinical trial sites preferred.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately.
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Support study teamProvides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team.
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Engage in planning, methodology, and analysis for Phase 1-3 clinical studies, not limited to protocol development, sample size calculation, authoring of statistical analysis plans, data review, analysis implementation and interpretation.
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Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Director/Senior Medical Director-Clinical Research-Prostate.
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The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trials and their delivery, clinical data review, interpretation of results, and activities required for worldwide registration of the product.
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clinical research data review jobs Title: director
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