- 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
- Option Care Health (Columbus, OH)
- …over 6,000 team members including 2,900 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 ... states. Through our clinical leadership, expertise and national scale, Option Care Health...and materials that reflect the analysis of prior marketing data to build on the success or failure of… 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
- 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)
- …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)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... for assigned protocols and sites in a-country.-Under the oversight of the CRA manager or CRD, the person ensures compliance of study-conduct with ICH/GCP and country… 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
- Option Care Health (Columbus, OH)
- …over 6,000 team members including 2,900 clinicians, we work compassionately to elevate standards of care for patients with acute and chronic conditions in all 50 ... states. Through our clinical leadership, expertise and national scale, Option Care Health...48 hours of receipt of payment. Notifies the Reimbursement Manager if there are overpayments and/or duplicate payments for… 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
- 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
