- Novo Nordisk Inc. (Plainsboro, NJ)
- …and externally Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data ... difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a...Clinical Program Lead when appropriate Collaborate with the Clinical Program Lead and study team to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and ... of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data...also some of the requirements of this role. The Manager , Clinical Data Standards should be a… more
- Merck & Co. (Rahway, NJ)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... with team members.May interact with internal and external stakeholders (eg,- study -team,-vendors, committees)-in-support-of- clinical -trial-objectives.Core SkillsWorking knowledge of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Merck & Co. (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in the set up and ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...you will collaborate with global, cross-functional team members including clinical directors and study managers to lead/support… more
- Merck & Co. (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...will collaborate with global, cross -functional team members including clinical directors and study managers to lead/support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, ... for performing near real-time biosample tracking for the assigned studies in close collaboration with the QCP, Clinical...QCP, Clinical Biomarker Team, Companion Diagnostics, the Clinical Study Teams, Central Specialty Laboratories, and… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Programs / Studies .- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external data management ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...support the collection of diverse external data types. Advises Study Data Manager on complex vendor management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... Job Summary: Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design, follow… more
- Aequor (New York, NY)
- …over 100&plus markets. The candidate will also serve as the core project manager for the Pneumococcal GASP team. Collaborates with cross-functional team members to ... ensure evidence is on strategy and is considered within key study outcomes. Database analysis, primary market research, literature reviews, decision models, budget… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Eisai, Inc (Nutley, NJ)
- …from you. Job Summary Responsible for SAS programming activities supporting multiple studies for a single, or multiple compounds within related therapeutic areas. ... programmers or by the CRO. 15%Answer questions from the CRO regarding the study analysis. 15%Participate in study team meetings. 15%Represent Biostats and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Genmab (Plainsboro, NJ)
- …Director, Programming.Key responsibilities include:Supports and/or leads programming efforts within a clinical study , depending on background and experience.As a ... purpose.The Role & Department As a Senior Programming Associate or Programming Manager , you will be in the Statistical Programming team and Development Operations… more
- Genmab (Plainsboro, NJ)
- …purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Catalent Pharma Solutions (Somerset, NJ)
- …lean supply chains for individual studies or programs + Create initial study drug projections and supply plan for clinical supply needs throughout life ... **Senior Clinical Supplies Manager ** **Position Summary:** Catalent...and Catalent employee.** **The Role:** + Understand and translate clinical study protocol requirements into demand for… more
- Mount Sinai Health System (New York, NY)
- …per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart and all other databases ... **Job Description** The Clinical Program Manager provides clinical...research program. + Liaison with industry sponsors and CROs. Clinical Research Responsibilities: + Responsible for coordinating study… more
- Novo Nordisk (Plainsboro, NJ)
- …and externally + Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data ... difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a... Program Lead when appropriate + Collaborate with the Clinical Program Lead and study team to… more
