- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... execution of all operational components of a large-scale global clinical program using strong clinical project...the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also serve as ... experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management required- 1+ years of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...on pediatric regulatory documents and the execution of pediatric clinical trials .Qualifications: Successful candidates will be able… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... if applicable; Defines study strategy across clinical trials within an indication or project ; Attends...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… more
- Merck & Co. (Rahway, NJ)
- …and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- Under the guidance of ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials ...all data management deliverables and services required for a trial .Ensures appropriate use of standards and project -level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish… more
- Merck & Co. (Rahway, NJ)
- …to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Company Management, regulatory ... and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops,...other Company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical… more
- Merck & Co. (Rahway, NJ)
- …to these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, company Management, regulatory ... Management, and other company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … more
- Insmed Incorporated (Bridgewater, NJ)
- …plan, researches and leads the statistical design, analysis, and reporting of clinical trials , and interacts with global regulatory agencies. This role ... understanding of advanced statistical concepts and techniques applicable to Clinical ResearchStrong project management, interpersonal and communication skills… more
- Insmed Incorporated (Bridgewater, NJ)
- …representative responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to ... Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the… more
- Eisai, Inc (Nutley, NJ)
- … deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.Serve as the lead statistician on ... but are not limited to, serving as the statistical lead on project teams. This involves providing...collection, organization, and analysis of diverse data sources (eg, clinical trial data, patient registries, and observational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO...ideally including time in role such as a Global Project Leader at Sr. Director level or… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to 10% overnight travel ... required; Advanced degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines,...strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Eisai, Inc (NJ)
- …Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management; ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and...selection and final contract execution on projects when required.Support project teams in the resolution of performance issues if… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior, cross-functional leader in Daiichi Sankyo's Global R&D… more
