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Responsible for establishing relationships and engaging in peer-to-peer level scientific discussions around emerging data, treatment guidelines, molecular pathways, mechanism of action Takeda Oncology products including clinical outcomes and research opportunities.
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Ph. D. or an M.D./Ph. D. in Immunology, Molecular Biology, or related field with at least 8 years of applicable biomarker, translational research, program management, clinical trial and/or research experience is required.
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Opinions on GenAI and LLM and their potential impact on medical and clinical research in the future. Knowledge of GenAI and LLM, skillful in using them (e.g., GPT-4) in daily work ranging from clinical practice to medical research.
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ICON Patient Centred Outcomes (PCO) is part of ICON plc, a leading global Clinical Research Organization headquartered in Dublin, Ireland. Direct experience leading a diverse set of bespoke outcomes research studies in collaboration with pharma / biotech / medical device study teams or CRO Clinical Operations divisions.
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Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out. This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate.
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You will work directly with our R&D and Compliance Manager on new product development, herbal formulation,clinical research, claim substantiation, educational content, and DSHEA, FDA, and FTC compliance regulations.
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Master's: Degree in a Mental Health discipline or equivalent education/experience CERTIFICATION & LICENSURE: LCSW-Licensed Clinical Social Worker OR LMFT-Licensed Marriage & Family Therapist OR PSY-Psychologist of California TYPICAL EXPERIENCE: 2 years of recent relevant experience.
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Formal training in health economics and/or outcomes research. Thorough knowledge of clinical medicine, healthcare delivery system structure and function, pharmaco-economics, disease management, quality management, value-based payment, and healthcare delivery policy and trends.
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Coordinates between all internal/external stakeholders (e.g. Clin Ops, Medical, Pre-clinical, MSLs, Regulatory, Research, Drug supply, Market Access, Commercial, HEOR, Medical Affairs, Publications, Corporate Communications, Investor Relations, Launch Excellence, Alliance Partners as well as Investigators, Patient groups) to ensure alignment, operational efficiency and program success.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Develops, maintains, and drives action from analyses to measure the trends, efficiencies, and effectiveness of resource allocation and utilization for JAX Mice and Clinical Research Services.
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Key Responsibilities: Collaborate with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, BMS Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CROs, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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ICON plc is a world-leading healthcare intelligence and clinical research organization. Knowledge in drug development, global clinical operations, and strategic planning is preferred.
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Founded by former Epic managers, we understand the technology landscape in healthcare and provide IT staffing, advisory services, and analytics solutions to create robust data ecosystems that support clinical workflows, automate operational processes, and expedite research.
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Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required. Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Regenerons product ensuring awareness and understanding.
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clinical research jobs in Concord, NH
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