- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development ... at different levels are also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter expert in clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and ... execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study… more
- 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 ... centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for...data collection practices required- 4 or more years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset ... dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming… more
- Merck & Co. (Rahway, NJ)
- …database set up) Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical ... on the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study… more
- Merck & Co. (Rahway, NJ)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi… 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 ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing ... study requirements Participate in the development and testing of clinical systems (eg, data capture, IxRS) Ensure...pharmaceutical industry Minimum 2 years of experience as a Clinical Trial/Project Manager Experience with global … 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 ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ancillary and printing supplies Ensures financial transparency between R&D Finance and clinical operations while maintaining data consistency and accuracy across ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects and ... collaborate with our Research & Development Division colleagues from Global Clinical Development, the Center for Observational and Real-World Evidence, Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Synthesis and Strategy (HEOR-ESS) sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits within the CMR ... by the RWE and modeling teams within CDSE. The Manager , HEOR Evidence Strategy and Synthesis is responsible to...Director of HEOR Evidence Strategy and Synthesis within the Clinical Data Science and Evidence HEOR-ESS team;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the...and report on the effectiveness of implemented tactics, making data -driven recommendations for continuous improvement Data -Driven Insights… more
- Eisai, Inc (Nutley, NJ)
- …code to create summary Tables, Graphs, and Listings (TLGs) to summarize the data according the Statistical Analysis Plan. 15%Develop code to verify the accuracy of ... with a minimum of 6 years proven pharma industry experience in clinical development statistical programming methods & processes is required.In depth experience as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the...and report on the effectiveness of implemented tactics, making data -driven recommendations for continuous improvement Data -Driven Insights… more
- Genmab (Plainsboro, NJ)
- …You will report to the Director, Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions ... purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the Statistical Programming team and Development Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... roles Strong understanding of pharmaceutical product development processes, including clinical development, regulatory pathways, and commercialization strategies, especially within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key ... the information from SAP, the technical documentation and other data systems. With this information, the Asset / Reliability...of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can… more