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Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. The Lead Clinical Research Associate (LCRA) is responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for clinical studies with guidance from the Clinical Trial Manager.
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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This position is to work with our world renowned Pediatric Stem Cell Transplant team as an Advanced Practice Provider on our in-patient unit at LPCH. Our team offers unique treatments not available elsewhere, including clinical trials testing gene therapy for blood diseases like sickle cell disease and pyruvate kinase deficiency, and a first-in-the-world treatment that combines kidney and stem cell transplantation to give patients a new kidney that will last without long-term immune suppression.
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Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs.
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Weve developed a proprietary AI-guided antibody discovery platform as a solid foundation for innovative biologics with diverse formats (e.g. mAb, bispecific antibody and fusion proteins), and other diverse modalities such as ADC, mRNA, and CART. Well-funded and supported by our unique research, development, and clinical validation ecosystem under our corporate umbrella, the team encompasses industry veterans with proven track records of bringing novel biologics to global clinical trials.
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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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Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
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By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.
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Provide support in production or validation of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
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Two years of work experience as a clinical dietitian AND a specialty certification (Certified Nutrition Support Specialist (CNSC), Certified Diabetes Educator (CDE), Certified Specialist in Oncology (CSO), etc.
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This position is integral to our investment decision-making process, requiring the intern to gather and analyze data related to various aspects of drug discovery and development, including but not limited to diseases, fundamental science, clinical development, and regulation.
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Behavioral Health, Mental Health, Licensed Clinical Social Worker, Licensed Marriage and Family Therapist, Licensed Professional Clinical Counselor, Clinical Leadership, Team Leader.
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The Senior Research Scientist II, Purification Process Development (Pre-Pivotal) will be responsible for leading purification development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II.
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What Additional Experience Makes A Strong Candidate: 4+ years of production experience with Scala 4+ years of production experience with Micro Services / Streaming Services Experience addressing ML problems, particularly in domains such as Time Series, Computer Vision (CV), Natural Language Processing (NLP), and data mining Proficiency with popular ML frameworks (Xgboost, TensorFlow, PyTorch, etc.
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clinical trials data jobs Title: operations Company: Boston Pharmaceuticals in Belmont, CA
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