- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... data anomalies, inconsistencies, and errors through effective data profiling and analysis - Support the creation of automated, scalable approaches for … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Master Data Management (ie Customer, Patient, Geography, Patient) and Data Analysis a plus, preferably in Pharmaceutical/ Health Industry Professional and ... for Personal Promotion. The role will also serve as backup to the Manager for Data Stewards of Patient, Customer and Product masters. Role will also be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample ... Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on Statistical Analysis … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of serious and non-serious adverse events and associated technical complaints and analysis results related to marketed NNI products into the local intake tool,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Commercial Insights & Analytics, provides insights and analytics expertise, primarily through the analysis of complex data , to help guide Novo Nordisk on ... with the development and design of key lines of investigation via custom analysis and assessments utilizing relevant and appropriate data sources and business… more
- BioAgilytix (Durham, NC)
- …including administrative and sample reconciliation activities.Coordinate with Central Lab and/or Data Analytic group for Data Transfer Agreement setup and ... activities, database systems, and resource planningSupport Validation and Sample Analysis ProjectsEnsure great customer experienceSupport Operational Excellence MetricsMinimum Preferred… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... to development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... supply forecasts through evaluation of the clinical development plan and protocol analysis . Reviewing and providing input for draft medical protocols to develop… more
- Tris Pharma (Monmouth Junction, NJ)
- …laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mentors' colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's ... required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics preferred.Demonstrated ability driving or participating in… more
- Merck & Co. (Rahway, NJ)
- …-the Financial Sharing Area, -and the SAP BW and BPC systems.Assist Finance with data analysis and reconciliation between the various SAP & Non-SAP systems ... security role management across various SAP and non-SAP systems.Configure and schedule Data Manager packages through BPC for Office.Perform detailed system and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …parameters and provide technical leadership for deviation investigations Analyze data to provide recommendations for improvements in the manufacturing process ... 11 in a manufacturing settingDemonstrated application of FMEA, Risk Analysis , Validation principles, guidelines, and industry best practiceDemonstrated history of… more
- Merck & Co. (Rahway, NJ)
- …solutions and carries them out.Contributes to individual protocols and develops data analysis plans and independently determines appropriate statistical ... mixed models, variance component analysis , DOE, nonlinear regression, Bayesian analysis .Working knowledge of statistical and data processing software eg,… more
- Eisai, Inc (Nutley, NJ)
- …compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards. Your responsibilities span security operations, risk assessment, ... US's compliance with GDPR, HIPAA, CSL, and other relevant Security and Data Privacy standards through continual risk and security assessment.Collaborates with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …gathering, design, build/testing and deployment), process automation and/or technology implementation Data analysis skills and experience working with large ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …short- & long-term targets. Provides the organization with information & business analysis to support decision processes & follow up. Assists with improvement ... projects with business impact analysis & continuously improves business information processes. Acts as the implementation partner for Line of Business (LoB) when… more
