- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study ... The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE ... Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Bring issues with the reconciliation to the attention of the supervisor. Distribute key study documents to the CRO and vendors as appropriate.Upload DS country and ... study level documents to the TMFConfirm Essential Document Listing...career development plan.Assist in planning and execution of clinical studies , under the close supervision of a Manager (or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO study close-out. Liaise with internal Functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock ... The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager, Study Associates, under the guidance of the Associate Director, will supervise a ... group of Study Associates (SAs) or Senior SAs who assist in...assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the Study Data Tabulation Mode (SDTM) ... analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes… more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities May have specific operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical ... & ancillary supplies planning/tracking, lab specimen tracking, status update reports, study closeout activities).May be responsible for tracking study timelines… more
- Merck & Co. (Rahway, NJ)
- …include the following: - May have specific operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ... execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies Proactively ... deliverables are on time and within budget to support drug development processes and global submissions. This position also...identifies and manages risks at the project and/or study level for a smaller number of projects/ studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regarding quality, time, and cost.Establishes medical coding strategy at the project and/or study level for a larger number of projects/ studies with greater ... across programs and organizationProactively identifies and manages risks at the project and/or study level for a larger number of projects/ studies with greater… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, ... study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design, ... report (CSR): Executes statistical activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also ... contribute to the program study strategy, planning, execution and reporting outputs. CS lead...Global (Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external investigators is ... clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is...the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …interpret Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in ... vendors.ResponsibilitiesResponsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as… 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 colleaguesResponsibilities Medical Monitoring: For studies in which Medical Monitoring activities are conducted in-house:Provides… 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)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs ... supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety… more
- Merck & Co. (Rahway, NJ)
- …Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your leadership, ... the following: - Responsible for specific clinical/scientific activities on a single study or across multiple studies (eg, medical monitoring, lab specimen… more
