- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and Data Management ... trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems , and fulfillment of data change requests. ResponsibilitiesChange ... change.Take part in impact analysis of changes to IPOS Systems identifying the risks, benefits and assisting with assessing...and ReportsDevelop complex ad hoc safety database searches and report output.For all data requests, perform self-QC… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …needs, collaborating closely with IT teams and external partners to enhance system performance and data quality Operational Enhancements & Technology ... Integration: Support efforts to adapt and optimize systems to improve data entry and reduce...enhancing user experience and operational efficiency within HCP engagement systems by identifying system gaps and driving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and FDA requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding tools), ... Safety information, including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … report on the effectiveness of implemented strategies, making data -driven recommendations for continuous improvement Continued Improvement: Cultivate a strong ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...affairs and market access teams to inform a health systems strategy to ensure system level acceptance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in-depth analytics in partnership with data strategy teams, utilizing various data sets and systems within the organization to deliver actionable insights. ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and ... Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic Data Capture (EDC)… more
- Merck & Co. (North Wales, PA)
- …and validate as required, study design, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.Works with ... Evidence studies to meet the value evidence needs of public health agencies, health systems , and clinicians. -This role will focus on development of research that is… more
- Insmed Incorporated (San Diego, CA)
- …in the review and development of Data Management activities including data cleaning, eCRFs, edit checks, report development, and database lock ... minimum 5 years of drug development experienceExperience with EDC systems (ie, RAVE) and data analysis tools...experienceExperience with EDC systems (ie, RAVE) and data analysis tools (ie, J-Review) requiredStrong medical writing and… more
- Merck & Co. (Rahway, NJ)
- …( data , analyses, tables, graphics, listings); working with SAS systems and statistical databases; designing and developing complex programming algorithms; ... Job DescriptionResponsibilities:Utilize big data to analyze the safety and efficacy claims of potential medical breakthroughs.Support statistical programming… more
- Genmab (Plainsboro, NJ)
- …our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead. S/he ... of our therapies. Ensure the effective dissemination of the data generated through publications, presentations, and other communications.Provide strategic input… more
- Genmab (Plainsboro, NJ)
- …for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab ... of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and Intelligence. The position will be… 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 ... The Position Senior, Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database ... through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sponsor Oversight Visit process. Provide oversight of the DS Trip Report Review process.Responsible for ensuring oversight of Central Monitoring activities according ... for CRAs to execute against. Metrics and Analytics:Ability to analyze data /metrics/key performance indicators to support vendor/CRO oversight of CRAs in clinical… more
- Merck & Co. (South San Francisco, CA)
- …productivityIdentify, evaluate, and champion new enabling technologies and methodsEnsure high-quality data analysis and timely report generation to project ... liquid handling instruments (Biomek, Bravo, Echo, etc.) and integrated robotic systems for assay operationExperience with automated data processing, curve… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database ... through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and… more
- Genmab (Plainsboro, NJ)
- …and will be onsite 60% of the timeReporting StructureThe Director Information Security will report directly to the VP and Global Head of Information Security and IT ... RequirementsEducationMinimum of a Bachelor's degree in computer science, information systems , engineering or related technical field or equivalent work experience.… more
- Lundbeck (Walford, IA)
- …in an efficient and professional manner Maintenance of the Product Range Management system Support the Business Analyst with the process and models for Demand portal ... forecasting Regular and ad-hoc data reporting Support where required for internal and external...reach our patients efficiently and reliably. You will directly report to the Head of Finance and Business Operations… 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 ... budget, quality standards and in compliance. Proactively track, monitor and report trial risks, progress/performance, timelines, and financial metrics on an ongoing… more
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