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Under the direction of the Executive Director, Clinical Operations, this role will support and manage several aspects of one or more AAV gene therapy clinical trials, including engagement and direct oversight of the clinical centers, investigators, study coordinators, and clinical CROs. The role is responsible for actively contributing to the development and implementation of the strategies and timelines needed to achieve targets and goals, as well as managing the clinical budget.
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Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions with FDA, PMDA, and other global agencies.
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A Strategy and Value Management (SVM) Initiative, set up to drive these efforts, requires a Data and Visualization Analyst to support the overall SVM Lead and Project Managers, focusing on data gathering, transformation, analysis, and visualization of financial and operational data for executive and field decision making.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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There is opportunity to serve as both first- and second-chair on a variety of matters at different stages of litigation, including pre-filing investigation and client intake, drafting of complaints, law and motion, written discovery, taking and defending depositions, working with experts, trial preparation, bench and jury trials, and appeals.
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Clinical Operations plays a key role in ensuring all Client clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Client products.
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Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Understands drug development phases and the nature of associated clinical trials across phases.
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Our client has an approved drug with multiple Phase II and Phase III trials across metabolism/endocrinology, oncology, and neurology. You will interact with cross-functional leaders to acquire relevant information for assigned documents (Clin Ops, Clin Dev, Regulatory Affairs, PM, CMC, Drug Safety.
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Innova Solutions is immediately hiring Manager Vendor OutsourcingPosition type: Fulltime – Contract Duration: 12 MonthsLocation: REMOTE As Manager Vendor Outsourcing, you will: Job Description: The R&D Sourcing and Contracting Associate will be responsible for assistance in the pre-clinical / research, clinical sourcing in support of Client’s global Phase I-IV clinical trials, and other ad hoc projects in the Vendor Outsourcing department.
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Provide counsel on clinical trials, product approvals, and post-market compliance. Advise on corporate governance, SEC reporting, and the Sarbanes-Oxley Act. Provide counsel on clinical trials, product approvals, and post-market compliance.
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A Senior Clinical Research Associate will work closely with clinical operations and the cross-functional study execution team to implement all aspects of clinical trials to support multiple clinical programs.
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With its foundations in engineering disciplines, the company's platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
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Manage and execute clinical trials pertaining to MRI. Manage and execute clinical trials pertaining to MRI. Masters degree in science field. 10+ years of clinical research experience. Must have MRI experience.
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This may include, and is not limited to, eDiary, eCOA, patient engagement dashboard, patient recruitment, telemedicine, decentralized clinical trials, CTMS, and clinical operations dashboards. The Executive Director of Digital Clinical Operations is a member of the GCO Leadership Team, responsible for leading a team, setting and implementing the GCO technology strategy with the goal to increase Global Clinical Operations productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies.
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As a member of the Clinical Trials leadership team, the Director will contribute to the strategic direction and operational excellence of the company’s clinical research initiatives supporting the Clinical Trial department mission.
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trials job Company: Eteam in Foster City, CA
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