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Market Intelligence: Stay ahead of the curve by keeping abreast of market trends, competitor activity, and the latest developments in the additive manufacturing industry. With an aim to help companies accelerate innovation and rethink manufacturing, BigRep's German-engineered 3D printers enable engineers, designers, and manufacturers from start-ups to Fortune 100 companies to go from prototyping to production faster, getÝng their products to market faster.
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The Clinical Data Analyst partners cross functionally to identify risk to data integrity throughout the data flow to drive quality collection for non-EDC data sources (fluid & tissue labs, digital, imaging, wearables) in Dyne's clinical studies.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Working with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies.
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4 plus years of experience required to be considered for Senior Principal Scientist level including 2 plus years of experience in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development.
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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MelroseWakefield Hospital and Lawrence Memorial Hospital are distinguished by the range of high-quality clinical care and services. Acts as a resource for all staff in regards to education, planning, relocating and development of evidence-based, best practice clinical programs pertaining to the specialty or primary care patient population.
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The scope of the Head of Digital Health encompasses leading digital strategies for healthcare solutions, focusing on pricing, market access, and evidence generation using digital technologies. Create comprehensive strategies for digital health that align with Takeda’s innovation goals and market access requirements, emphasizing the utilization of digital tools for evidence generation.
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Alerts the Clinical Dietitian to any actual or potential nutritional problems of patients. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Qualifications: Education/Training: Masters degree Social Work or Mental Health CounselingCurrent MA licensure as an Licensed Mental Health Counselor (LMHC), Licensed Clinical Social Worker (LCSW), or Licensed Independent Clinical Social Worker(LICSW) Work Experience: Minimum of clinical internship training or job experience in clinical human service work with population specific to service site.
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Pearson VUE is a business of Pearson, the world's leading learning company with global-reach and market-leading businesses. Pearson VUE offers a great environment to start or grow your career, we are now hiring for a part time Test Administrator to join our team in Lexington, MA (24 Hartwell.
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Role OverviewThe Human Research Compliance Specialist (compliance auditor) provides education and support to researchers and is responsible for performing audits of IRB-approved clinical research protocols across our institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice (GCP) guidelines, as well as with our organization's clinical research policies.
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Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS) A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing.
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