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As such, you will provide scientific input into design & implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product ( clinical input to NDA/BLA.
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Lead the review of safety data and monitor the safety of patients on allocated clinical trials. The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting.
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The incumbent will apply advanced data analysis skills and machine learning in collaboration with a group of computational and biological scientists to perform translational oncology research around multimodal translational data sets for programs in clinical development.
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Responsibilities: Responsibilities will include, but not limited to, the following:· To conduct statistical analysis from real-world observational or clinico-genomic data from Tempus and publicly available databases (e.g., TCGA, clinical trials, etc.
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To work collaboratively on multi-functional projects and interact with biomarker scientists and scientists from other functions including clinical pharmacology, biology, bioinformatics, clinical research, and clinical data science on a regular basis.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.
$237,660 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with healthcare data domain in at least one of: electronic medical records (EHR/EMR), clinical imaging, clinical workflows; Electronic Data captures (EDC), and/or clinical research/trials.
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Work with the ArsenalBio Finance, Clinical Operations, and Clinical Data management teams to support financial reporting activities including reconciliation of clinical site/vendor invoices and payments.
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Bachelor’s degree, preferably in biological sciences, health care management, or life sciences research; BSN/RN or experience with management of clinical trials. Typically requires a minimum of 3 years of experience and/or a combination of experience and education/training (e.g., Clinical Trials Design and Management Certificate.
$105,000 - $120,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the CMO. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Clinical Research Manager of Blood & Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator Associate will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to to manage data, enroll and follow patients on trial, and assist with regulatory and financial requirements of the trials.
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As a Business Intelligence Manager, you will own the delivery of actionable insights to inform data-driven decisions on sales & marketing strategy, and increase efficiency of our go-to-market operations.
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Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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License, Certification, Registration Licensed Clinical Social Worker (California) OR Licensed Marriage and Family Therapist (California) OR Licensed Professional Clinical Counselor (California) AND Licensed Professional Clinical Counselor Couples and Families Endorsement (California) within 24 months of hire National Provider Identifier required at hire Additional Requirements:Must be familiar with DSM-V as a means of diagnosis.
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clinical trials data jobs Title: operations in San Mateo, CA
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