- 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
- Merck & Co. (Rahway, NJ)
- …quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director) / Director, Clinical Research, the individual is ... responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by providing… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… 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)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , 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)
- …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
- Eisai, Inc (Nutley, NJ)
- …reports, cumulative reports, or international regulatory reports and requests. 20%Set standards for data collection and distribution processes; coordinates with ... meet respective goals and regulatory responsibilities. 20% Requirements Application of clinical medicine to patient careMedical terminology and standards of… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… 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
- Eisai, Inc (Nutley, NJ)
- …strengthen compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards . Your responsibilities span security operations, risk ... optimization. Essential Functions: Partnerships and Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial,… more
