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Cell therapy, t cell, GMP, batch record, batch record review, biologics, tcr, validation, manufacturing technician, Lab Technician, Laboratory Technician, cell biology, flow cytometry. Performs batch record review, procedure revisions, and work order generation.
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To manage model risk effectively, the Bank needs to monitor, review, and validate the RTC bank-wide inventory of models, including models that significantly impact: credit decisions, credit loss estimates, risk forecasting and stress testing, operations, asset/liability management, liquidity and market risk management, and transaction monitoring for anti-fraud and anti-money laundering compliance.
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Specialist review of safeguards compliance documentation for humanitarian assistance, post-conflict, and food-security and other development projects. Review, develop, and/or revise guidance documents to inform environmental and social management processes for humanitarian assistance and/or post-conflict transition programming.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. S/he will work with a Beam's Analytical Development team to enable the rapid advancement of cell and gene therapy candidates from clinical development through commercialization.
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Performs routine analytical chemistry data review and reporting of data generated through the laboratory tests including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc.
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Review estimates with Division Manager, Project Manager, Chief Estimators and Executives in a timely manner. Review subcontractor and vendor quotations, negotiate favorable prices, compare alike quotes and recommend best value to include within estimates.
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Oversee and direct the design and implementation of the CDM process with vendors, including clinical systems design, build and testing, data integration, data review, dictionary coding, data quality checking, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems.
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Strong experience with review of MEP & fire alarm systems installation in accordance with design documents. A minimum of 15 years of experience as a Building Engineer or equivalent experience and responsibilities including working knowledge of commercial office building plumbing, electrical, fire, and various HVAC systems, as well as pneumatic, DDC and building automation control systems.
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock.
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The dispatcher for Public Safety operates, including planned synchronization, all video surveillance, audio messaging and response throughout the division with acute focus on current deployment and emergency response, and information intake for review and analysis by supervisory management.
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Chart Review with aim to promote evidence based medical practice and adherence toDispatchHealth clinical pathways - Work as part of a clinical care team with a DHMT (Medical Technician) and individually, as appropriate for the service line to deliver care in the patient's home through our innovative in-home care service lines (i.e., Acute Care, Bridge Care, Advanced Care, Tele-presentation and others.
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In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plans to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
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Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
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Under the guidance of the individual's manager in the Therapeutic Area department, the individual collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed.
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Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools. Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL.
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review job in Needham Heights, MA
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