- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryAssist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo's quality measures. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.Support ... diseases and immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to… more
- Merck & Co. (Rahway, NJ)
- …function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and ... responsible for the conduct of Good Clinical Practice (GCP) studies , and occasionally Good Laboratory Practice (GLP) studies.... The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data ... delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external… more
- Merck & Co. (Boston, MA)
- …will manage the entire cycle of late-stage clinical development and studies , including development strategy, study design, initiation, execution, monitoring, ... or marketed Atherosclerosis drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... will manage the entire cycle of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and… more
- Merck & Co. (Upper Gwynedd, PA)
- …and programs.In collaboration with internal teams and external partners, designs studies ; authors study protocols; and develops measurement questionnaires, case ... technology assessment (HTA)/reimbursement agencies and health systems globally.Types of studies executed include prospective and retrospective observational studies… more
- Merck & Co. (Upper Gwynedd, PA)
- …Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- ... Director may be responsible for: -Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Merck & Co. (MA)
- …determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and ... clinical trials for investigational drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as… more
- Merck & Co. (North Wales, PA)
- …with the Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports affiliates to understand ... and gain input on research design and implementation of retrospective database studies , assessment of patient reported outcomes, epidemiological studies and… more
- Merck & Co. (Rahway, NJ)
- …plans for all activities associated with clinical supplies for their assigned studies , which could vary in complexity. This individual serves as the primary ... Responsible and accountable for establishing the timelines for clinical-supply-needs-per study and providing-the signal for sourcing, manufacturing, packaging, and… more
- Merck & Co. (Rahway, NJ)
- …Is involved in late clinical development planning (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and ... data and interprets results from experiments to meet objectives of the study protocol.- Independently applies and implements basic and complex techniques to these… more
- Aequor (Athens, GA)
- …this individual assists with scientific procedures in accordance with study protocols, completes and maintains appropriate documentation associated with all ... and maintains records of animal care, preventive medicine, USDA-required, and study protocol-driven documents. Provides animal husbandry and care including provision… more
- Insmed Incorporated (NJ)
- …Role:The Manager, Programming will provide statistical programming and analytic support clinical studies . As a team member of the Programming function, the Manager, ... well as external vendors.What You'll Do: Represents programming function in Study Team meetings and interacts with functional colleagues from other departments.Stay… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …role in guiding toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific ... cell and gene therapy.Design, implement, and interpret nonclinical safety studies , including IND-enabling toxicology, biodistribution, and pharmacokinetics.Provide scientific and… more
- Formation Bio (New York, NY)
- …the Clinical Development Strategy and Plans, including protocol development, for clinical studies . As part of this responsibility you will provide strategic input to ... and monitor the execution of clinical studies as a project physician.Your ability to understand and navigate the complexities of healthcare data and clinical trials… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction for respective interventional/non-interventional programs such as post marketing studies or post approval commitments, medical access programs.Partner with ... execution of Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies .Provide comprehensive quality oversight for Medical Affairs activities, including… more
- AUROBINDO (Durham, NC)
- …Dispensed. (We are#27 in 2010)Job OverviewCapable of performing characterization studies for inhalation products, particularly for metered dose inhalers (MDIs). ... and ICH guidelines and should follow cGMP guidelines.ResponsibilitiesAssists in the development of study designs and plans for study types ranging from reverse… more
- Genmab (NJ)
- …Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, perform sponsor oversight of relevant ... consistency across programs and systems. Responsibilities Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific… more
- Eisai, Inc (Pittsburgh, PA)
- …Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data.Demonstrate full knowledge of ... Research Support Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary contact… more
