• Insmed Incorporated (Bridgewater, NJ)
    …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.Assists… more
    HireLifeScience (02/16/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
    HireLifeScience (03/28/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
    HireLifeScience (03/22/24)
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  • 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
    HireLifeScience (03/27/24)
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  • 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 ... Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (Rahway, NJ)
    …activities across CSO workstreams to support the business.Collaborating closely with Global Clinical Trial Operations (GCTO) and Regulatory teams to ensure ... Job DescriptionThe Associate Director, Clinical Supply Operations (CSO)... clinical supply packaging and distribution operationsExperience with clinical trial operationsFamiliarity with SAP Operations Management… more
    HireLifeScience (03/15/24)
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  • Merck & Co. (North Wales, PA)
    …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.Required-Experience and Skills:Expertise in SAS for system… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …or related field plus 9-12 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life ... be a key collaborator with modelers, statisticians and other project stakeholders and is expected to execute project...7 or more years SAS programming experience in a clinical trial environment Department Required Skills and… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …is preferred Requires a minimum of 10 years of progressively responsible clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...setting. Prior supervisory, project management, or leadership experience preferred A minimum of… more
    HireLifeScience (03/28/24)
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  • Merck & Co. (North Wales, PA)
    …subject matter expertise for informed consent process improvements, and work with Global Clinical Trial and Operations to maintain GCD standards, processes, and ... Job DescriptionOur Biomarker Operations team is seeking an Associate Principal Scientist in Genomics Policy to help...the protocol and informed consent processes and templates for clinical trial biomarker and future researchProviding country… more
    HireLifeScience (02/21/24)
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  • Merck & Co. (North Wales, PA)
    …or related field plus 9-12 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and… more
    HireLifeScience (02/27/24)
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  • Merck & Co. (North Wales, PA)
    …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
    HireLifeScience (02/24/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle. Qualifications: Successful candidates will be able ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
    HireLifeScience (03/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence...other vendor performance against project goals and milestones to monitor and ensure compliance… more
    HireLifeScience (03/09/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    … Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the protocol ... understanding of advanced statistical concepts and techniques applicable to Clinical ResearchExcellent project management, interpersonal and communication… more
    HireLifeScience (03/12/24)
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  • Associate Director - Clinical

    Lilly (Indianapolis, IN)
    …determined to make life better for people around the world. The purpose of the Associate Director **-** Clinical Trial Design Capabilities- Budgets & Costing ... Finance, and Project Management, we aim to drive excellence in clinical trial design, enabling more efficient planning and execution to speed medicines to… more
    Lilly (03/26/24)
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  • Sr. AD, Clinical Trial Diversity…

    Boehringer Ingelheim (Ridgefield, CT)
    **Description** The Senior Associate Director, Clinical Trial Diversity supports the Clinical Development & Operations (CD&O) strategy for Diversity & ... requirements. + Supports the development and execution of Diversity & Inclusion in clinical trial strategies, core processes and best practices. + Partners with… more
    Boehringer Ingelheim (03/23/24)
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