• Novo Nordisk Inc. (Plainsboro, NJ)
    … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. Relationships Reports to… more
    HireLifeScience (03/26/24)
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  • 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 ... review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.Assists with… 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 ... trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with… 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 ... trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with… 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, ... project 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 ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (North Wales, PA)
    …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
    HireLifeScience (03/22/24)
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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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  • 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...years prior training experience preferred Advanced knowledge of Good Clinical Practice (GCP), ICH Guidelines, federal and local regulations,… more
    HireLifeScience (03/28/24)
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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 ... plus 7 or more years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Excellent interpersonal skills and… more
    HireLifeScience (03/12/24)
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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 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)
    …Management and Clinical Development. Responsibilities Creates and oversees process for clinical trial sample testing activities and data capture to support ... regulatory submission or associated drug regulatory submissions.Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
    HireLifeScience (03/02/24)
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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 ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
    HireLifeScience (02/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …build payer evidence, economic models, and Global Value Dossiers- Oversee analysis of clinical trial data for cost effectiveness models and market specific ... areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Oncology HEOR & RWE will work...reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act… more
    HireLifeScience (03/01/24)
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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)
    …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)
    …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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