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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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Utilize your extensive master data expertise to demonstrate a profound understanding of SAP MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection, Costing among others.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education.
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Collaboration with clinical science, data management, and clinical trial sub-team members based in other regions or companies (and other team members) to develop protocols that reflect good clinical practice, evolving landscape, regulatory and reimbursement requirements and meet the strategic program objectives.
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Assist in the preparation of domestic patent applications, and file same at the USPTO. Prepare and file PCT international applications. This Senior Patent Paralegal position reports to the Chief IP Counsel and provides patent paralegal support to Church & Dwight's R&D function in Princeton, New Jersey and to its Water Pik business in Fort Collins, Colorado.
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The Candidate: Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience Master of Science in Analytical Chemistry/Pharmaceutics preferred or more years of applicable industry experience in support of pharmaceutical product development Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The DTS Business Process Owner will promote a manufacturing process excellence culture by identifying, developing and implementing program initiatives focused on manufacturing process improvement solutions within the highly integrated platform of SAP S4/HANA, SAP-ME, & LIMS. The individual will lead and direct the activities of Process Experts, Super Users, Specialists and Trainers (where they exist) and directly manage DTS process experts and master data stewards.
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Minimum 4 years of relevant work experience in Pharmaceutical Manufacturing System Processes (GxP) Systems environment and related Master Data Management. Develop and implement robust site Governance around E2E ERP Master Data, including defining and authoring local standardizations, SOPs, and work instructions.
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Join us as an Outsourcing Manager/BioMarker Operations Manager and play a crucial part in advancing our clinical biomarker and bioanalytical activities. If you meet these qualifications and are eager to contribute to a dynamic team, apply now and help us advance our clinical biomarker and bioanalytical initiatives.
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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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This position will involve internal CAP/CLIA lab support, assay development responsibilities and clinical trials support. The candidate should have a strong interest in providing pathology support for biomarker development programs across oncology and hematology as well as an interest in clinical trials support/enablement.
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Overall responsible for the Trial Master File, including review of the TMF plan, related metrics, and ongoing quality review of the TMF. Oversee TMF related CRO and internal team activities to ensure inspection readiness of trial documentation.
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Understanding of data science concepts, as well as MDM (Master Data Management), CDP (Customer Data Platform), BI (Business Intelligence), DWH (Data Warehouse) design and implementation techniques.
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Professional Counselor License or NJ Licensed Clinical Social Worker or Marriage and Family Therapy,Professional Counselor. providing direct clinical services to youth and young adults with co-occurring behavioral health and substance use treatment needs.
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clinical trial master file jobs Title: trial master file in Belle Mead, NJ
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