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Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinical trials.
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Thorough knowledge of the clinical drug development process and experience in all aspects of global drug safety reporting from Clinical trials to Post Marketing. We are seeking a self-motivated and talented person who will be responsible for Pharmacovigilance (PV) activities involving the companys investigational products and clinical trials.
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Conduct data review, analyses, and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics. They will lead, plan, and execute study-level activities for 1 or more trials, and interact with Translational Scientists, Project Leadership, Safety, Regulatory, Data Management, Biostats, and Clinical Operations to drive Clinical Development strategy, design, execution, and interpretation of clinical trial data.
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Reporting to the Senior Director, Clinical Trials Office, the Associate Director, Clinical Trials Operations is responsible for the overall management and oversight of the assigned Clinical Research Disease group managers.
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Desired: Clinical trials, case-control and cohort studies, statistical genetics, protocol monitoring, hierarchical, longitudinal, survival, categorical, nonlinear, and epidemiology. This position involves project management for the statistical analyses and programming of clinical trials from small investigator initiated studies to large scale international clinical trials.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The Clinical Research Coordinator work within the Neuro Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
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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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Strong scientific background and experience with assay development and validation across technology platforms in genomics, especially those that are employed in clinical trials (e.g., NGS, WES, WGS, RNASeq, PCR, ddPCR and Nanostring.
$143,500 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Co-Op will contribute to teams responsible for advancing vaccine candidates from discovery to clinical trials. Perform molecular biological assays to support clinical & preclinical vaccine research programs.
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Approximately 1,200 clinical trials are taking place at Mass General at any given time. Reviews patient history and other supporting clinical data to facilitate optimum diagnostic results.
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The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer.
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We are seeking a highly skilled and motivated Scientist to come join our CMC, Process Development team and help drive our clinical trials to market. Contribute to the scale-down and scale-up of downstream processes for clinical and commercial production.
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The Research Project Manager (RPM) will have the opportunity to oversee cutting-edge industry and investigator-initiated clinical trials while interfacing with pharmaceutical / biotech experts, research organizations and physician investigators in a multidisciplinary fashion.
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The Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Partners HealthCare Institutional Review Board (IRB.
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clinical trials jobs in Cambridge, MA
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