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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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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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Assists the Senior Medical Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of promotional materials, maintains KOL relationships and serves as a consultant for Marketing, FMA, SCOE, Market Access, Public Affairs, and Sales.
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3+ years of experience conducting the following activities: Business requirements gathering, fit-gap analysis, functional design process, system testing and solution delivery, UAT customer support, process document creations and review, working with onsite and offshore delivery model.
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In this role, you will be assigned to projects to review, coordinate and summarize the activities of cost control, planning and scheduling, document control, and estimating. 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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Ability to review and interpret contracts, legal documents, and medical records. This adjuster role is responsible for prompt and independent investigations and review of subrogation claims through effective coverage analysis and liability investigation.
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Certified Professional in Healthcare Quality (CPHQ) by the National Association for Healthcare Quality, or be Certified in Healthcare Quality and Management (HCQM) by the American Board of Quality Assurance and Utilization Review Physicians Preferred QualificationsProject management experience preferred.
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This position has the responsibility of working with the brand marketing teams and other key functional areas of the organization in the planning, submission, review and approval, distribution and lifecycle management of promotional marketing materials.
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Work closely with CEO, COO and CFO to develop insightful KPI reports, dashboards, and other operational analyses for review and decision-making. Prepare monthly, quarterly and year-end reporting including detailed general ledger, balance sheet and income statement for CFO and CEO review.
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We're searching for a seasoned Senior Project Manager to enhance our exceptional team's capacity to serve clients facing diverse environmental improvements and land redevelopment issues.
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Health Safety Environment Sr Manager, P&BPrinceton, NJOnsiteAs the Health Safety and Environment Sr Manager, you are responsible to provide HSE leadership, knowledge and guidance across all operational departments and teams of the site.
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Review and ensure, proper accounting of non-routine transaction with the support of GFRT in compliance with IFRS, IND AS and Global accounting policies. Periodic review and update the SOX controls for NAG and coordinate with SOX auditors.
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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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The Senior Manager of Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
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Review of applications will begin July 8, 4 and continue until any available position(s) are filled. Preference will be given to candidates with a background in French as a Foreign Language and/or Linguistics, SLA or Applied Linguistics, although other fields will be considered.
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review job Title: manager project in Skillman, NJ
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