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Experience using Medidata EDC and data visualization programs (e.g., R-Shiny, SAS, SpotFire, Tableu, Excel Pivot Tables, etc.) Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer.
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In-depth knowledge of clinical trial process, EDC systems (i.e., Medidata Rave, InForm, etc.) This includes personals, CDM service models and EDC systems to support the expanding clinical programs.
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Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical coding dictionaries, controlled terminologies, as well as in industry standards for electronic submission of data to FDA.
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Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRS/EDC, STDM, statistical programming for TLFs, and data reporting.
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Proficiency with Medidata Rave EDC, Clinical Data Repositories and Visualization software. The Clinical Data Manager will be responsible for daily data management tasks for all phases of clinical trials including CRO/vendor oversight and support other functional areas such as clinical operations, statistical programming, and biostatistics.
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Conduct Clinical Research Coordinator activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system.
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Clinical Systems Analyst , working in. Installs and develops company data management systems including EDC and FTP. Improving lives globally with 20+ years experience in clinical research and strategic resourcing.
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Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment. Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.
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Are you ready to be part of a close-knit clinical trial team that is passionate about saving and improving the lives of patients every single day? and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.
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Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology. Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms.
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Prior experience with electronic data capture (EDC) systems and clinical data management software. Collaborate cross-functionally with clinical operations, biostatistics, and other departments to ensure data quality and integrity.
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Work with statisticians/biometrics to develop the required tables/listings/figures and contribute to the interpretation of efficacy and safety data from clinical trials. in science is required, and 1+ years of experience in clinical research and/or drug development within the pharmaceutical industry.
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Oversee all EDC,and IRT vendor contracts for assigned clinical trials. Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
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Oversee programmers (vendors and internal) who produce CDISC-compliant derived datasets, (SDTM and ADaM) and produce validated tables, listings, and figures (TLFs) to support clinical study reports, safety update reports, publications and internal decision making.
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Response Technology (IRT) vendors for assigned clinical trials. Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive.
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edc clinical jobs in South San Francisco, CA
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