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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Act as an internal expert in PET/SPECT and Molecular Imaging with focus on clinical trials. Ensure quality and timely execution of imaging trials to deliver critical drug development decisions; be agile and responsive to clinical teams during the course of design, execution and interpretation of imaging trials.
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Overview The CTO PI-Initiated Research Project Manager (CTO RPM) for Waldenstrom’s Macoglobulinemia Think Tank Network (WM-NET) is responsible for assigned day-to-day coordination and overall management of WM-NET activities for assigned clinical trials and program; primarily multi-center, PI-initiated trials.
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PRINCIPAL DUTIES AND RESPONSIBILITIES: Study Start-Up·Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
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Education: Requires MD or MD/PhD, Immunology, Inflammation and Neurology specialty required , but other specialists with experience in GI, Rheumatology, Allergy and Hematology clinical trials will be considered.
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Provides CMC regulatory support and review for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, clinical protocols, investigator brochures, labels, and other study-related materials) and for cGMP activities as they relate to regulatory affairs (e.g., inspections.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams.
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Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across relevant methods (e.g. qPCR, digital drop PCR, Western blotting), to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates.
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The laboratory of Dr. Pradeep Natarajan at the Massachusetts General Hospital Cardiovascular Research Center (CVRC) and Center for Genomic Medicine (CGM) and Broad Institute of Harvard & MIT has a unique post-doctoral fellow position open for a highly qualified applicant interested in investigating the genetics and biology of cardiovascular diseases using human genetics across diverse epidemiological cohorts, hospital-based biobanks, and within clinical trials.
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Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.
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Work with MGB Research Management, Clinical Trials Office (CTO) and Innovation offices to manage lifecycle of research grants and contracts. Maintain working knowledge of federal Human Subjects System (HSS) and Clinical Trials.gov to assist with entry and troubleshooting of clinical trials and human subjects data.
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The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials are in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.
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The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. Minimum of 1 year of clinical experience in Echocardiographic lab in a hospital or outpatient set up.
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The Institute for Lung Health at Beth Israel Deaconess Medical Center, Harvard Medical School invites applications for a Clinical Research Coordinator to coordinate research activities, including clinical trials evaluating the impact of interventions on respiratory health and to support the research faculty and staff of the Institute.
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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. This role is based in our Waltham, MA headquarters.
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clinical trials jobs Company: Thermofisher Scientific in Boston, MA
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