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The Clinical Laboratory Scientist, Data Review will review chromatographic data and calculated results obtained from a variety of standardized urinalysis tests in a toxicology laboratory for the detection of prescription and illicit drugs using advanced LC-MS-MS technology and EIA; applies toxicological and chromatographic rule sets to determine acceptability of results; requests additional testing as necessary; approves reports and patient results to ordering physicians.
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Conducts chart review and data abstraction in support of quality measurement, analysis, and improvement across the organization, as needed. Knowledge of data abstraction, data analysis principles and chart review is preferred.
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Performs certifying review of analytical data from immunoassay screens, headspace GC and mass spectral confirmatory techniques (LCMS/MS and GCMS) for Regulated, Non-Regulated, and Forensic casework.
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Certifying & Laboratory Support Performs certifying review of analytical data from immunoassay screens, headspace GC and mass spectral confirmatory techniques (LCMS/MS and GCMS) for Regulated, Non-Regulated, and Forensic casework.
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Data includes but is not limited to Certificates of analysis or performance, Verification and approval documentation, Monthly review documentation etc. Participate in quality control activities throughout the laboratory to assure that accurate results are reported by reviewing final reports and collecting all data necessary for routine quality control functions and tests.
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Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia, etc. May assist in conducting investigations associated with laboratory data review.
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The objective of this position is to provide therapeutic area medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes oversight of signal detection activities at the single case level, single case medical review.
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Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred.
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Publication Subcommittee (PSC) Membership: Collaborate with Clinical Development and Clinical Affairs global colleagues on key governance committee to support development of a strategic global and regional publication plans, participate in data analysis efforts, and lead or participate in manuscript, abstract, and poster development.
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The SS&C team conducts descriptive research, medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed Research Network (DRN) tools, Observational Medical Outcomes Partnership (OMOP) CDM, Patient-Centered Outcomes Research Initiative (PCORI) CDM, and Aetna's Enterprise Data Warehouse (EDW.
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With national remote training and campuses in 20+ cities and counting, Per Scholas offers no-cost training programs in the most sought-after tech skills, spanning Cloud, Cybersecurity, Data Engineering, IT Support, Software Engineering, and more.
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Review curriculum materials and assessments weekly and report to instructor and curriculum development team any proofreading or subject-matter errors. You are data-driven, result-oriented and a forward-looking catalyst for social change.
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Coordinate matters and work closely with the IP, Compliance, Regulatory, and Data Privacy counsel. Review, draft, and negotiate complex commercial contracts - Sales, Procurement, Distribution, Collaboration, Services, Consulting, Confidentiality, and other types of agreements, such as complex distributor, sales, Software as a Service (SaaS) contracts, RFP, public tenders, supply, licensing, and joint development agreements - to meet the contractual requirements established by the Company.
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CAA Brand Consulting is a strategy-led, full-service marketing agency with expertise in Cultural and Consumer Insights, Data and Analytics, Talent/Influencer and Property Partnership Advisory, Experiential, Social Impact, Creative Services, and Content and Digital Strategy.
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Overseeing the coordination of HEDIS data ingestion activities and driving strategy to optimize HEDIS data ingestion, EHR/HIE interoperability, supplemental data, and record review for the Medicaid line of business.
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