• Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description: Global Clinical Data Standards Therapeutic Area Lead The Associate Director, Global Clinical Data Standards ... in the area of data standards as it relates to developing clinical data collection tools. The individual may be responsible for coordinating data more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. GDO ... Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries… more
    HireLifeScience (03/08/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    Clinical Science. He/she will be accountable for building and establishing the clinical data review standards across early and late-stage asset trials in ... on-going maintenance of global program.Responsibilities:Accountable for building and establishing the clinical data review standards across early and late phase… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Rahway, NJ)
    … trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review.Conducts clinical data review per Integrated Data Review Plan ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activities.May support addressing eligibility and medical… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (North Wales, PA)
    …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …on the planning, execution and close out of clinical trials within a program.- Clinical trials provide the required data which allows Merck to bring new ... training materials- Prepare clinical narratives- Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity… more
    HireLifeScience (02/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Process, and technology. Accountable for the quality and ... reports, and patient profiles to facilitate in the ongoing review of clinical data during study conduct and study closeout.Build, test, and scale-up programs for… more
    HireLifeScience (01/18/24)
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  • Merck & Co. (North Wales, PA)
    …analysis and reporting deliverables for Research & Development (R&D) projects ( data , analyses, tables, graphics, listings). Clinical Data Interchange ... assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills:Strong… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …reduction of database unlocks. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related ... a focus on quality, lessons learned and inspection readiness. Develop, deliver and maintain clinical data validation standards. Analyze and report on Data more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Sept. They will be accountable for developing (a) a simple SharePoint portal for R&D Data Governance, (b) analyzing clinical data quality using tools such as ... and (c) developing machine learning and NLP-based tools for analyzing clinical data quality, consistency, and privacy. The position requires some familiarity… more
    HireLifeScience (02/29/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …such as Data Science, serving as a key contact point into the Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
    HireLifeScience (02/29/24)
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  • Eisai, Inc (Nutley, NJ)
    …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
    HireLifeScience (03/06/24)
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  • Eisai, Inc (NJ)
    …look at data / continuous stream of publications, collaboration with the Clinical and other teams in data requests, understanding scientific rigor and ... private and public datasets, handling of healthcare relevant datasets and execution of data analysesExperience in post hoc clinical trial data more
    HireLifeScience (02/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …deliver foundational data capabilities like Data Lakes, Master Data Management, NLP Integrations etc. for Clinical , Regulatory & Translational Research. ... experience preferred- 4 or More Years 3 + years of experience with Clinical Trials Data , Genomics, Bio Marker & Regulatory Data preferred- 4 or More… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent ... other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic… more
    HireLifeScience (03/11/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources for the ... as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a product… more
    HireLifeScience (03/01/24)
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  • Taiho Oncology (TX)
    …trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and ... in scientific exchanges and interactions with identified KOLs Present clinical and scientific data on Taiho's products...with identified KOLs Present clinical and scientific data on Taiho's products and relevant therapeutic areas as… more
    HireLifeScience (03/23/24)
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