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The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design.
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This includes working with scientists in Research, Translational Science, Clinical Development, in addition to colleagues in QCP. QSP Scientists have the opportunity to work within the QSP Model Development Team (MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology.
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Solid understanding of additional revenue cycle functions such as patient scheduling, care delivery and care coordination, patient flow/throughput, charge capture, revenue integrity, clinical documentation, and clinical/operational analytics coupled with proficiency with advanced consulting skills such as analytical, written, and verbal communication; possess appropriate client presence, facilitation and presentation skills.
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Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred. - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred.
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DescriptionThe Protocol Management Office (PMO) at Clinical Center of Excellence (CCoE) ensures scientific rigor and quality of clinical documents within Global Drug Development (GDD). Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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Lead successful execution and on time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to company standards and quality principles.
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Ensure commercial direction for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This should be proactive and facilitate the timely resolution of business-critical issues.
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Prior experience working with pharmacovigilance databases (e.g. ARGUS, ArisG) and EDC clinical trial systems (e.g. Medidata Rave, ClinTrak, Veeva Vault). Profound knowledge of scientific, medical, and clinical research terminology such as MedDRA coding.
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The Associate Director will work closely with HEOR team members and others across the company including market access, marketing, medical affairs, and clinical development to support Insmed's business needs.
$140,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Associate Director/Director, a member of Shionogi's Global Epidemiology and Real-World Evidence (GEE) team, is responsible for strategizing and generating real-world evidence using fit-for-purpose data to support global products at each stage of the product lifecycle.
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The Inside Sales Associate will be responsible for prospecting new business opportunities for our non-clinical vertical and setting up first meetings for the sales team. The Inside Sales Associate reports to the Area Director of Sales, Operations & Centralized Services.
$20 - $23 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.
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To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
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A New Jersey State license to practice as a Psychologist (Psy. D/Ph. D), Licensed Professional Counselor (LPC), Licensed Clinical Social Worker (LCSW), Licensed Associate Counselor (LAC), or Licensed Social Worker (LSW.
$65 - $95 an hourFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Reports to Associate Director, Manufacturing Science & Technology (MSAT), Cell Therapy. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ Building S12.
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clinical associate jobs in Bernards, NJ
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