- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an ... This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards .This position has a working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the required functions, in regions and countries for all GOMA clinical activities. Process/Policies/Compliance Provide input to process standards and tools ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs ... in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW.Promotes Daiichi Sankyo values...optimal approaches to support the collection of diverse external data types.Advises Study Data Manager … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that enable positive business outcomes.- Support the creation and us of policies, processes, data standards , data quality and enabling IT and digital ... research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a...program, data stewardship program or similar intent data management program focused on setting standards ,… 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 ... of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards , data quality rules and data governance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … review listings and reports to support Data Management and clinical teams.Develop, implement and maintain SAS programming standards and performs quality ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of...clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …architects and digital technology teams to support data stewardship and governance processes, data cataloging data standards , data quality, and ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …( Clinical Operations, Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, data standards and data cleaning needs ... to external data acquisition, and establishes external data standards , reinforces adherence to existing ...meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...including experience in one or more key functions (eg, clinical research, clinical operations, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… 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 the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical aggregate spend solutions and data associated with promotional and clinical data , preferred. Ability to manage multiple projects to completion ... team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is… more
- Merck & Co. (Rahway, NJ)
- …DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Clinical Data Standards (GCDS) Sr. Director of Operations...Clinical Data Standards (GCDS) Sr. Director of Operations and Reference ... Management & Standards (GDMS) organization, the Manager Global Data Standards -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all vendor managed business setups with the objective of achieving the highest data quality standards , full adherence to patient's rights and well-being and ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... leaders to ensure CRAs are updating appropriate systems.Ability to analyzes data /metrics/key performance indicators to support vendor/CRO oversight of CRAs in … more
