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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne's clinical studies.
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The Clinical Laboratory Technologist will be responsible for performing high-complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Working with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations. Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
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The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs. Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization.
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The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors.
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Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies. Extensive knowledge and experience in clinical data management. Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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The Human-centered AI team in Digital Health Oncology R&D is looking for an Associate Director of Data Science to specialize in the development of novel digital endpoints using data science, statistical learning, and innovative machine learning methods on multi-modal datasets including clinical data, real world evidence, imaging, wearables, and other biomedical data sources to address patient burden.
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Knowledge of cardiovascular, neuroscience, or rare disease clinical trials desirable. The Clinical Scientist is a Director/Senior Director who will help design and execute the clinical development plan for Affinia’s cardiac and neurology gene therapy pipeline.
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Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, PowerPoint, Veeva CRM) for data collection, analysis and reporting.
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Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
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To achieve this vision, we need to establish a common data continuum ecosystem across diverse teams, including Research & Biomarkers (R&B), Process Development & Industrialization, Analytical Sciences, Clinical, Manufacturing, and various internal/external sites.
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Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
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Title: clinical Company: Sanofi Group in Waltham, Troy, New York
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