- 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
- Insmed Incorporated (NJ)
- …limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of ... study budgets, monitoring oversight of site-level activities related to...and/or orphan indications is preferred.Experience managing large and/or complex studies and project teams is preferred. Experience in rare… more
- Merck & Co. (South San Francisco, CA)
- … studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug ... into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in… more
- Insmed Incorporated (NJ)
- …effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents Clinical Operations ... and successful execution of operational aspects of regional and global studies as appropriate, including timelines, budget, data delivery and reporting, vendor… 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)
- …I studies ; close collaboration with internal and external clinical study support staff and scientistsProvide clinical pharmacology support for programs through ... into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in… 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
- Insmed Incorporated (San Diego, CA)
- …and expression in tissue samples from both preclinical models and clinical studies .The successful candidate will work at the interface of research and ... accession, and verify tissue specimens from preclinical and/or clinical studies .Perform tissue fixation, processing, embedding, and sectioning (paraffin and frozen… 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
- Insmed Incorporated (NJ)
- …collaborate across functions to support downstream analyses from in vivo studies .What You'll Do: Lead cell-based assay development, perform efficacy assessment ... sorting of rare populations.Support downstream analyses from in vivo studies , including sample collection, processing, and ex vivo measurements.Maintain accurate,… 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
