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Implement, review, and maintain master data in SCLT systems to facilitate the enrollment and scheduling of clinical and commercial Cell Therapy patients. This individual will be instrumental in managing patient scheduling master data for a rapidly growing Cell Therapy portfolio, enabling a best-in-class customer experience for our patient treatment centers around the world.
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The Senior Specialist, Sr. Manufacturing Systems Engineer, MS&T MSEO is responsible for supporting the solution intake and design, delivery, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the production of personalized cell therapy products for both global clinical trials and commercial supply.
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Is responsible for supporting the solution intake and design, delivery, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the production of personalized cell therapy products for both global clinical trials and commercial supply.
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4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, including development and review of imaging section of the protocol, imaging charter, site manuals, and communication plan •Deep knowledge of implementation of oncology tumor assessment performed by (1) investigator/site and (2) BICR for both solid tumors and hematological malignancy.
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Unless expressly allowed by state or federal law, or regulation, must be located in a state or territory of the United States when conducting utilization review or an appeals consideration and cannot be located on a US military base, vessel or any embassy located in or outside of the US.Minimum of 10 years of clinical experience; or any combination of education and experience, which would provide an equivalent background.
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Utilization review activities and optimizing of revenue, including tracking Medicare residents, reviewing pre-admission intake information, performing concurrent MDS review and participating in the interdisciplinary team process.
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Requests guidance from RCP II, RCP III, Clinical Director and other resources when appropriate. Graduate of a Joint Review Committee for Respiratory Therapy Education approved program of Respiratory Care.
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The Sr Clinical Investigator, CRS oversees the clinical research of consumer products involving healthy paid volunteers. Interfaces with the Sponsor, staff, contractors, professional societies, Institutional / Investigational Review Board (IRB), subjects, government agents / agencies and other business units.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
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RWJBarnabas Health and Cooperman Barnabas Medical Center in partnership with Rutgers Cancer Institute of New Jersey - the state's only NCI-designated Comprehensive Cancer Center - brings a world-class team of researchers and specialists to fight alongside you, providing close-to-home access to the latest treatment and clinical trials.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Review and contribute to safety sections within clinical documents such as Investigator’s Brochure, Study Protocol, and Informed Consent Forms. Knowledge of drug development process, safety monitoring and risk/benefit analysis in clinical trials.
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Responsible for championing the designated care manager concept throughout the neighborhood, assisting in the recruiting, hiring, and training of team members, completing staffing, scheduling and timekeeping review, team member recognition, engagement, and performance management.
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This role will also work closely with global and regional (Osaka, Japan [SHQ]; Florham Park, New Jersey [SI]; and London, England [SEU/SBV]) cross-functional team members including Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, Commercial teams and external collaborators/vendors to lead and conceptualize research questions, propose study designs, identify appropriate databases, write and review protocols, oversee data analyses, reports, presentations, and publications.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
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Responsibilities include: (1) review available translational and clinical results, both from internal as well as external research, (2) determine the implications for cross-project strategy, and (3) coordinate pre-clinical/clinical research plans to progress the strategy with keen attention to the potential for impact on the clinical development of each project, the portfolio of related projects and next generation therapies.
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review clinical jobs in Summit, NJ
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