- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study conduct, close out and reporting.Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against trial ... be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence...identification activities in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical monitor activities for Phase 2 studies ; Regional sponsor medical monitor for Phase 3 study .Medical Surveillance (MD only): For large Phase 2 or ... KOLs and PIs to plan study and monitor completion. Study Outputs: For Phase 2 Studies : Drafts responses to IRBs and HA, Collaborates with TMCP to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as well as external investigators is ... of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study conduct, close out and reporting.Proactively assess potential risks to the study and propose mitigation plans. Monitor study budget against trial ... and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the internal and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical Monitoring activities are conducted in-house:-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the ... execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies ; Coordinate sponsor medical monitors across regions; Direct CRO medical monitor activities for a large study and/or across a programMedical ... and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational studies ; Develop prospective contingency plans for management of key risks in a large … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as ... Medical Monitor . Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... by managing Program / Therapeutic level external data collection process, study requirements as well as the overall process.Accountable for the maintenance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF document trackers generated by the… more
- Insmed Incorporated (Bridgewater, NJ)
- …certification preferred.Minimum of 10 years of experience as a regulatory toxicologist ( study director/ monitor and/or project lead) in the pharmaceutical or ... certification preferred.Minimum of 10 years of experience as a regulatory toxicologist ( study director/ monitor and/or project lead) in the pharmaceutical or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Insmed Incorporated (Bridgewater, NJ)
- …of biological samples. The successful candidate is expected to establish, monitor validated bioanalytical methods and sample analyses of regulated bioanalytical ... assays for clinical, nonclinical and biomarkers studies . This translational role resides within the Clinical Development organization, works closely with colleagues… more
- American Honda Motor Co Inc (Marysville, OH)
- …and expense for the department, and lead countermeasure activity on gaps.*Performing studies and investigations on Dept & Plant short and long term ... recover when Expense Budget is not to plan.Lead Cost Studies for the department and work with each team...the HIP Program to Department, Division, and Plant Leadership.Coordinate, monitor , and report on training for the departmentWho we… more
- Catalent (Philadelphia, PA)
- …configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and ... automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data acquisition, processing, and reporting of external data across programs. Monitor vendor performance by collection and review of metrics and key performance ... such as successful achievement of target timelines and meeting critical study milestones. Participates in Contract/SOW reviews and MSA discussions of external… more
- Catalent (Philadelphia, PA)
- …configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and ... and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and...include reading of written documents and use of computer monitor screen frequently. Why you should join Catalent: Defined… more
- Merck & Co. (Rahway, NJ)
- …with scientists who are manufacturing drug substance to enable early clinical studies , scaling up new chemistries, and exploring new technologies. - Primary ... to supply material for both development work and clinical studies in our kg scale (Prep Lab) and pilot...that can interface directly with the process stream to monitor and control the process. As time permits, the… more
- American Honda Motor Co Inc (Marysville, OH)
- …and meaning, elevate business processes and improve on/create new reporting insights/features. Monitor and track performance based on KPIs and ensure consistent ... Computer Science, Statistics, Data Science, or other related field of study or equivalent knowledge and experience5+ years of relevant experience (developing… more
- American Honda Motor Co Inc (Marysville, OH)
- …meaning, elevate business processes and improve on/create new reporting insights/features. Monitor and track performance based on KPIs and ensure consistent delivery ... Analytics, Computer Science, Statistics, Data Science, or other related field of study or equivalent knowledge and experience 5+ years of relevant experience… more
