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Partners with colleagues in BEST, Digital Quantitative Sciences, Clinical Data Sciences, Data Acquisition, Biostatistics, Development Operations and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered studies.
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The Quality Systems Lead is responsible for the quality operations and quality and regulatory compliance for MEDIPOST’s cell therapies from research through the clinic to commercialization, including the build-out of a phase-appropriate quality roadmap.
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Proclinical is collaborating with a Global pharmaceutical company who are seeking a Senior Research Associate to join our team in Cambridge, MA. They will collaborate closely with computational experts to develop data analysis pipelines and investigate the application of NGS in diverse areas to expedite workflows and enhance pipeline programs.
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Keywords: Clinical Pharmacology, Pharmacokinetics, Drug Metabolism, Clinical, PK/PD, Pharmaceuticals, Research and Development, Boston, Cambridge, New Jersey. KEMIO are working with a global pharmaceutical company buiilding on their capabilities in Pharmacokinetics, Dynamics, and Metabolism.
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Knowledge of biotechnology/pharmaceutical product development process including technical transfer, manufacturing, process development and characterization, analytical/assay development, regulatory filings, and clinical/commercial operations.
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This position will report to the Senior Vice President, General Counsel Commercial and and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders, including with colleagues in across the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.
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SUPERVISORY RESPONSIBILITY (if applicable): A Clinical Research Coordinator I does not have any supervisory responsibility. A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Partner with CMO/CRO teams to bolster lab research and experiment quality.
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The Clinical/Research Nurse specialist works in a strategic role in the Maternal/Child HIV Program and as a Research Coordinator within the Section of Pediatric Infectious Diseases.
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Our client is a leading pharmaceutical company seeking a Director, Insights and Analytics. Drive insights agenda: Scope, lead, and deliver cross-functional projects across core insights functions, including market research, forecasting support, competitive intelligence, brand analytics, and field analytics.
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Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trials, Data Entry, Drug Discovery, Due Diligence, Electronic Components, Gene Therapy, Lifesciences, Medical Research, Microsoft Office, Modeling And Simulation, Patient Care, Physics, Translational Medicine, Waterfall Project Management.
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As part of a defined training plan, this position is reporting the Laboratory Director and includes participation in multi-disciplinary research in collaboration with clinical teams, lead quality improvement initiatives, contribute to process improvements, develop, and validate new procedures, and train lab staff, medical students, residents, and fellows.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs.
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Under the direct supervision of the Metabolism & Nutrition Research Director/Manager and within hospital and departmental guidelines, the Research Diet Technician (RDT) performs a broad range of responsibilities to support research studies on the Translational & Clinical Research Centers (TCRC) on White 12/13 (MGH main campus.
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Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
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clinical research pharmaceutical company regulatory compliance jobs Company: Wirb Copernicus Group in Cambridge, MA
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