- Merck & Co. (Rahway, NJ)
- …on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager. Your Fellowship ProjectYou ... be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the multiple late development ... (Oncology) Clinical Science resources are deployed to clinical studies from end to end in...clinical data), database lock, creating Clinical Study Report, and submission to the Health … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global (Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead and manage a group of ... CS lead may also be responsible for study level clinical sciences responsibilities, as well...clinical data), database lock, creating Clinical Study Report, and submission to the Health … more
- Merck & Co. (Rahway, NJ)
- …planning and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...project assignments under the direction of Lead Clinical Scientist and Lead Study … more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead , you will collaborate with ... cross- functional team-members including clinical directors and study managers to lead /support clinical ...COVID-19 vaccinations for positions, such as in Global Employee Health , where the Company determines in its discretion that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans 4) people manage in future. Responsible for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate ... awareness of the evolving global requirements for diversity in clinical trials -Continually evaluate industry landscape and lead...for diversity and patient voice plans.Partner with the asset lead , GPTs, and study teams to establish… more
- Merck & Co. (Rahway, NJ)
- …to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries ... be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of...study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SVO to develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and ... and/or contractor-based) are available to support current and future clinical programs and studies .Drive a feedback-oriented cultureQualifications: Successful… 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 ... organization. From health -care-provider interactions and developing and implementing regulatory strategies with...Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is… more
- Merck & Co. (Rahway, NJ)
- …in-house, 400+ outsourced or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning, ... sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to...be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... collaboration with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external stakeholdersProvides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)- Clinical Surveillance: Documents ... clinical studies . Provides senior level clinical representation at meetings with health authorities;...or arrange requisite support to lead large study teams, coordinate complex studies , lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... collaboration with Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external stakeholders- Provides… more
- Merck & Co. (North Wales, PA)
- …medical drugs and vaccines for the benefit of patients and global human health . Responsibilities :Serves as a statistical lead in project teams.Develops, ... teams for the strategic planning and execution for product development-Is involved in clinical development planning to ensure that study designs are consistent… more
- Amplifybio, LLC (New Albany, OH)
- …stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an ... product quality.Production Planning:Develop and execute production schedules to meet clinical trial and commercial supply requirements, while optimizing resource… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the US, real-world data sources and analytical methods, including registry-based studies , electronic health records, and claims data analysis Proven ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with… more
