- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types. Advises Study Data Manager on complex vendor ... other research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery… more
- BioAgilytix (Durham, NC)
- …including GLP, GMP, and 21 CFR Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead ... The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... of systems. Identifies and drives continuous improvement in process. Utilizes data to make decisions on process improvements, measure process performance, etc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main… more
- Aequor (Parsippany, NJ)
- …summary data on all claim submissions to ensure rebate eligibility and data consistency. 20% Perform Claim Level Detail validation . Review suspect claim ... summary data on all claim submissions to ensure rebate eligibility and data consistency 5% Perform Claim Level Detail validation . Review suspect claim… more
- Genmab (Plainsboro, NJ)
- … transfers from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- BioAgilytix (San Diego, CA)
- …as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans and reports ... to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and submit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data . Work closely ... protocol development, CRF review, SAP development, analysis files development, data surveillance review, statistical analysis accuracy validation , results… more
- Genmab (Plainsboro, NJ)
- …integral part of the product roadmaps and planning and embed code validation services in POD processes.Security Awareness: Actively promotes information security and ... minimum eight years of demonstrable work experience in security officer or manager function with strategic / tactical responsibilitiesFive or more years of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... approves validation documentation Reviews and assesses deviations; includes tracking, follow-up...Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors. KEY Excellent written… more