- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data ... include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).Responsible for… 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 ... 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)
- …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
- Merck & Co. (Rahway, NJ)
- …data , biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- ... Job DescriptionThe Trial Manager creates and ensures the successful execution of...creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance or feedback to… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …reports, or international regulatory reports and requests. 20%Set standards for data collection and distribution processes; coordinates with others to assure ... timeframes for the processing of adverse event information are met. Reviews data to verify accuracy and completeness of medical information and associated… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 Oversight: Review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in ... of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to… 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)
- …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
- 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
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , IT Project Portfolio Management (IT PPM) is expected to contribute to ... support to the Enterprise Program Management Office (EPMO). This Manager will contribute to three key areas: Integrated IT...the production of executive level reports and visualization of data to help ensure alignment of the project portfolio… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Research and investigate key parameters through quantitative analyses of historical data and assist in designing initiatives and development of analytical ... capabilities and dashboards needed for short- and long-term planning cycle to satisfy growing demands for faster and more complex analysis required to support company's making decisions.- Analytics - Develops and prepare detailed analysis of variances, risks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …/ landscapes, reports and other intelligence deliverables, visualize and customize data , storyboard narratives, and develop clear messaging of intelligence results. ... Must be proficient with communicating results effectively to leadership.- Partner with library team members and related intelligence functions to continually learn and inspire others in the spirit of development and growth, and share and build on Competitive… more
