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In this vital role the Observational Research Senior Manager will be a member of the Bone team within CfOR and will be responsible for gathering insights and building collaborations and capabilities to advance the generation, use, and dissemination of real-world evidence (RWE) related to disease state epidemiology, treatment patterns, and medication safety and effectiveness to inform regulatory decision making and enhance access and use of Amgens medicines.
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Identify potential data gaps, contribute on data-generation activities including real-world evidence, supporting local needs for the clinical research unit (CSU), regulatory affairs, and market access functions.
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Ensure the timely completion of assigned HEOR projects that include appropriate outcome assessments, analysis plans and final reports with expectations for peer-reviewed publicationsrelevant to HEOR evidence generation strategies.
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The MEL conducts critical activities that support advancing science, educating on evolving clinical practices, transforming science into patient care, and facilitating the development of new research collaborations (including Investigator Initiated Trials and Real-World Evidence.
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Overview - Associate Principal – Patient Centered Solutions, CNS PracticeIQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle.
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The position is a unique opportunity to gain experience in a variety of computational approaches and work with industry leaders in broadening your skillsets in cancer biology, genetics and omics approaches, RWE (Real World Evidence), and computational biology methods including AI. It is also an opportunity to grow yourself in a team environment of feedforward (vs feedback), continuous improvement, and team empowerment.
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Identifies data collection opportunities and recognizes opportunities to gather Real World Evidence within the territory and informs internal stakeholders using appropriate channels.
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Quality Oversight for study types conducted in the real world evidence generation platform including Non-Interventional, Low Interventional and Collaborative Research. The RWE Platform QCLs will provide quality oversight of the conduct of global epidemiological studies, collaborative research and low intervention studies (LIS) types 1&2 to support the Integrated Evidence Plans (IEP) and strategic goals of all regions including IDM and EM. All study types are within remit including PMCs, PMS, PAES and voluntary & committed PASS and epidemiological studies across the asset life cycle from POC onwards.
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Proactively leads BMS major evidence readouts to investigators partnering with GDD. Reactively discuss major evidence readouts with other thought-leaders. Responsible for conducting evidence read-outs with the most prominent institutions, e.g., Phase 3 top-line data.
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Experience collecting real world evidence. In this role, you will have the opportunity to:Design and lead early phase clinical research focused on neurodegenerative disease clinical evidence planning and portfolio development.
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Exhibit a high degree of scientific and clinical knowledge in the therapeutic field to help identify and critically assess research opportunities and to play a supportive role in the execution of evidence generation plans to enhance the value of our products in a real-world setting.
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This will include participation in oversight and execution of phase IV studies, Health Economics and Outcomes Research and Real World Evidence generation. The incumbent will drive the delivery of high quality scientific, medical and strategic communications and evidence generation strategies for the product globally.
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Lead the design and execution of the medical plan and tactics including Real-World Evidence generation plans, working in close collaboration with other functional colleagues, including regulatory, commercial, and clinical development.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
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