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The Associate Director ensures compliance with all regulatory policies and guidelines including federal, state, local, as well as the policies and procedures outlined by DFCI and the Dana-Farber Harvard Cancer Center (DF/HCC) consortium.
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Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
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Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or observational or social behavioral and/or public health research. Provide consultations in the form of direct, one-on-one and small group education on regulatory aspects to the conduct of research throughout the life of the study, including: investigator and sponsor responsibilities, study conduct, adverse event reporting, documentation, consenting, protocol planning, IRB submissions, questions on study implementation, assistance with FDA IND/IDE submissions, consent development and writing, HIPAA issues, DSMP development, planning and submitting.
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Our projects include but are not limited to clinical trials in addiction, infectious disease, neurology, cardiovascular critical care, novel point-of-care test devices, behavioral health emergencies, advanced care planning, and state-of-the-art digital health innovations such as digital pills, emergency ultrasound, and other novel medical technology.
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Keywords: clinical pharmacokinetics, clinical pharmacology, clinical trials, clinical drug development, scientific leadership, associate director, drug discovery, pharmacodynamics, bioanalysis. Strong knowledge of pharmacokinetics and pharmacodynamics , with experience in drug development processes and regulatory interactions.
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A PI of the New England Consortium Node of the NIDA Clinical Trials Network (CTN), we are currently leading a major multi-site CTN trial focused on treatment of opioid use disorder. Conducts library searches Performs administrative support duties as required Verifies accuracy of study forms Updates study forms per protocol Prepares data for analysis and data entry Assists with formal audits of data Documents patient visits and procedures Assists with regulatory binders and QA/QC procedures.
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The research nurse is responsible for knowledge of Code of Federal Regulations and Good Clinical Practice, policies and procedures of the Tufts Medical Center/Tufts University Health Sciences Institutional Review Board and all other guidance documents for the conduct of human clinical trials and human research participant protection.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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Collaborate/work with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other line functions/departments on clinical trials.
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The Associate Director, Biomarker Operational Quality will provide biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. This leader will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence.
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Sanofi is recruiting a new Global medical Director to support post- regulatory authorization clinical trial program for dupilumab in the Global respiratory Franchise for the respiratory indications including asthma and Chronic Obstructive Pulmonary Disease (COPD) for dupilumab and itep.
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Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
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Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH). Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures.
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Collect, review and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study. The NCRI employs physician clinical researchers, research nurse, project managers, data managers, SAS programmers, systems analysts, grants managers and administrative assistants dedicated to planning and implementing clinical trials.
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The role is responsible for overseeing trials in clinical development and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs.
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trials regulatory jobs in Waltham, MA
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