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Clinical Excellence: Oversee the development of digital solutions for clinical trials, patient monitoring, and healthcare analytics, ensuring adherence to regulatory standards and best practices.
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At least 5 years of on-going clinical trials experience in the pharmaceutical or device industry. Ability to interpret articles published in medical and scientific journals relative to projects and activities in Clinical Programs.
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The research portfolio of the Dermatology Service includes optical engineering, artificial intelligence, basic science, translational science, epidemiology and clinical trials with over $5 million of annual funding from NIH, Foundations, Industry, and philanthropic sources.
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Responsible for the evaluation and support of investigator-sponsored trials, clinical research collaboration trials, and real world evidence studies. Experience in the conduct of clinical trials in hematology/oncology.
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Minimum of 5 years of experience in developing statistical programming deliverables for clinical trials using the SAS system. Good understanding of clinical standards as well as clinical data sets from major EDC systems (e.g., Medidata Rave, INFORM), safety systems (Argus), and CTMS systems.
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Oversee all EDC,and IRT vendor contracts for assigned clinical trials. Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
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Experience designing Fund Accounting, Clinical Trials, Labor Costing, Effort Certification, and Pre-Award business processes within an Enterprise Resource Planning platform. Other leading Cloud based SaaS financial application implementation experience: (Oracle E-Business Suite, NetSuite, Infor, Unit 4, PeopleSoft, Oracle Cloud ERP, SAP, Lawson, etc.
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Reporting to the R Shiny Programming Lead, within the Analytics and Reporting Tools (ART) team, you will contribute to multiple projects aimed at improving the success, efficiency, and quality of our trials from design to statistical reporting, data exploration, and visualization.
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Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE.
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Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred. - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred.
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Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.
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PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
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This CRS will focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials. Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL.
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We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. Participate in training opportunities to advance knowledge of drug development and Good Clinical Practice Guidelines Support company's visibility and position with the CRO industry through publications and presentations Develop new and enhances existing client/investigator relationships whenever possible Participate in process improvement activities for company.
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clinical trials jobs in Basking Ridge, NJ
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