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In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials.
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In 2009 and 2013 our practice received the ASCO clinical trials participation award. We have been members of the Jefferson Cancer Network since its inception and received JCN clinical trials awards.
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5+ years of work experience in technology enablement for clinical trials, scientific leader engagement and/or real world evidence generation. Be the chief advocate and evangelist within the widerorganization for Clinical & Real-World Evidence Generation products to drive adoption, fantastic user experience, and value realization.
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Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
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The Chief Medical Affairs Office's Evidence Generation (EvGen) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products.
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From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. Our projects range from phase II safety and efficacy trials to large scale outcomes mega-trials.
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In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials.
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Experience with statistical applications and clinical data management procedures in the conduct of clinical trials. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
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The Process Engineering Team within the Upper Providence Pilot Plant delivers technical and engineering expertise to support the manufacture of active pharmaceutical ingredient (API) used for development and clinical trials.
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ROLE SUMMARYAs part of our purpose to achieve “breakthroughs that change patients’ lives”, Pfizer is creating a new Pragmatic Clinical Trials Center of Excellence (PCT-CoE) within the Worldwide Medical & Safety (WMS) organization.
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Statistical analyst will assist asset/study statisticians to fulfill the analytical requests using multiple data sources to answer questions related to clinical trials and epidemiological research on vaccine development in pharmaceutical setting.
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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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Review protocols, case report forms (CRF) and statistical analysis plans (SAP) for clinical trials and provide feedback to functional teams in order to fast track pre-study processes. Analyze clinical data complying with CDISC standards and by implementing various statistical procedures.
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clinical trials jobs in Collegeville, PA
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