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Proficiency with the Waters Empower Chromatography Data System (CDS) for data acquisition, processing, and management is essential, as is experience working with biologics like antibodies and peptides.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Coach junior Data Analysts & Data Scientists on project execution and management. Experiences in healthcare datasets (e.g., Komodo, IQVIA, Symphony, Truven, Optum, Flatiron, Charge Master, Lab, Provider and Payer data.
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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You act as the key scientific and technical Artificial Intelligence expert for Clinical Data Sciences; defines and drives the data monitoring and management strategy and standards in the AI space, utilizing techniques such as RPA, Natural Language Processing, Machine Learning, genAI, etc., across all areas of Clinical Data Sciences (CDS) (including data management, Risk-Based Monitoring, Data Surveillance and standards.
$318,800 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Data storage, database infrastructure, and data engineering) to maintain efficient and secure management of data assets as well as application hosting. Develop and enforce best practices for IT infrastructure management, including disaster recovery, data storage, network design, and cloud services.
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PK Science is an enterprise organization, working across both Biomedical Research (BR) and the Global Drug Development (D) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology from discovery through approval and life-cycle management.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Humana is seeking a Senior Economist to lead the development and management of advanced econometric models to forecast and understand drug utilization trends and costs. Preferred Qualifications Experience with Pharmacy Benefit Manager, Pharmacy, or Healthcare data, in particular drug utilization, claims, costs and forecasting.
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Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead or support projects on bispecific antibody development targeting key inflammatory and fibrotic pathways, integrating data to elucidate mechanisms of action. Develop and optimize ex vivo and in vitro functional assays using immune cell lines, primary immune cells, fibroblasts, and whole blood to assess drug efficacy, immune modulation, and fibrosis reduction.
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Support drug discovery, development, and personalized medicine through data-driven research and analysis. Lead the establishment and execution of data management practices to support research and development, clinical trials, and business operations.
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Responsibilities Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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Report and discuss bioanalytical and biomarker results with integrative knowledge of how the data contributes to the drug development process. Work effectively with global project team members to support non-clinical drug development projects.
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data management drug development jobs Title: president in Cambridge, MA
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