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Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar.
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In MDM we collaborate with many departments of the business, and you’ll become familiar with dsm-firmenich MDM processes (+60 processes) of Material Introductions, Maintenance, Commercial, Packaging, Customer and Vendor master.
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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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Assist with the review of monthly GP utilization files (GP rebate claims), 340B | PHS program, GTN accrual summary file, and GTN reporting package. Key Responsibilities Manage GP models, review, parallel calcs, and analyze reporting of programs requiring price reporting, per legislative requirements, including Average Manufacturers Price (AMP), PHS Price, Best Price (BP), VA/FSS (Federal Supply Schedule), Average Sales Price (ASP), non-Federal Average Manufacturer Price (nFAMP), Federal Ceiling Price (FCP), Industrial Funding Fee (IFF) and Unit Rebate Amounts (URA.
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With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. SpecialtiesProcess Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
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Familiarity with clinical data standards, including CDISC, SDTM, and ADaM , and experience with clinical trial data management systems (e.g., EDC, CTMS). Ensure that the platform enables data visualization and reporting that provides actionable insights into clinical trial performance (e.g., timelines, patient recruitment, data quality.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed) Subspecialty training in relevant therapeutic area preferred (Sickle Cell/Hemoglobinopathies) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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High school graduate or equivalent (Preferred) Fully vaccinated Experience in oral advocacy activities such as Speech and Debate, Mock Trial, Model United Nations, or similar (Required) Experience working at a summer camp: 1 year (Preferred) Competitive Public speaking: 2 years (Required) Compensation is set and will be discussed during interview.
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In-depth knowledge of claims, litigation, arbitration, and trial processes as well as excellent analytical, investigative, and negotiating skills. Managing costs, including use of coverage counsel and litigation costs as well as collaborating and working with the Litigation Management and Vendor Management teams ensuring cost management and the development and enhancement of the.
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The Mr. Appliance Academy is designed to take you from Apprentice to Master Technician quickly. If you enjoy taking care of the customer, are awesome at troubleshooting, and love working with your hands and technology, a career at Mr. Appliance as an Appliance Repair Technician could be your future.
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The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. Develops trial designs that address study objectives that will support regulatory approval and market access.
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Our openings include receptionist, data entry, customer service, collections, office managers, call center, administrative assistant, accounts payable clerk, accounts receivable clerk, file clerk, warehouse, assembly, production, pickers, packers, forklift, machine operators, and maintenance mechanics.
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They will execute research contracts including own 3-5 HCE Master agreement execution from start to finish: For this they will collaborate closely with business strategy and operations BSO, Contracting, Procurement, Legal and HCC stakeholders.
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This does not include intra-oral occlusal adjustment;Trial size (pre-select) orthodontic bands, wires, stainless steel crowns and temporary crowns intra-orally or on diagnostic models;Place and remove arch wires and ligature wiresRemaining items that are within the scope of Registered Dental assistant.
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trial master file jobs Title: master in Princeton, NJ
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