- 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 ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the ... Center for Data Governance (CFDG) execution of the change management efforts...operating framework, goals and practices as well as expressing Data Governance value from an organization, domain, function and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, ...data at Daiichi Sankyo including: the stewardship organization, data quality, metadata management, lineage capabilities and the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and ... position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge… 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 ... internal statistical programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the… 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 .- Drug Development ... Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Merck & Co. (Rahway, NJ)
- …security role management across various SAP and non-SAP systems.Configure and schedule Data Manager packages through BPC for Office.Perform detailed system and ... Analyzer and Analysis for Office reporting tools.Experience in configuring and scheduling Data Manager packages through BPC for Office.Ability to analyze systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed ... of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based...team based in Raritan, NJ. Role Overview The QC Data Reviewer is an exempt level position responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …targets and create variances report. Maintaining vendor contracts, contractor data , and critical database information.Responsibilities- Project Management- Plan and ... to enhance efficiency and effectiveness.- Research and analyze information or data for trends, and variances to ensure acceptable business practices, procedures… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...Gen AI security and governance policies to ensure that data is collected, managed, and used in a responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored Studies (CSS) ... Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with Functional and Regional Operational managers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... and Alliance Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development ... required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics preferred.Demonstrated ability driving or participating in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate ... content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with the Lead Global QA Strategy and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... and validating statistical analysis; independently reviewing CSRs and performing data interpretation; and supporting preparation of inputs for regulatory documents,… more
- Lundbeck (New York, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... Leadership - Ability to use digital tools and apply customer and data -based insights to build opportunities, develop strategy & tactics and prioritize resources… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Manager , Commercial Analytics, Respiratory will be a key member of the ... for generating, analyzing, and supporting Directors of Commercial Analytics with transforming data into an actionable perspective of the business. The incumbent will… more
