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Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.) experience as a Study Management Associate/CRA/Trial Manager in a. The Sr. Clinical Trial Manager/Clinical Trial Manager, Clinical Operations (Sr. CTM/CTM) will report to the Associate Director, Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution.
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Skills:Litigation skills, including courtroom experience and trial advocacy. Job Overview:The Attorney will manage their own caseload, overseeing all aspects of claims and cases, from client intake through pre-litigation, litigation, and trial.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Director, Biostatistics is a member of a cross-functional product development team and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
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Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. 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.
Full-timeRemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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In-depth knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission, and adverse event reporting. Clinical Trial Professional certification from a professional society within one year in the position.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
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Strong understanding of the Trial Master File structure (TMF) Review study plans, including; Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
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Oversee assigned studies through review of monitoring visit reports and Trial Master File QC reports. The Clinical Trial Manager is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives.
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Job Summary: Looking to hire an individual with a nursing or clinical research background to act as the Clinical Research Coordinator for a research site in San Francisco, CA on an HIV clinical trial.
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The Litigation Paralegal will handle discovery, medical record review and analysis, subpoenas, and trial preparation. The Litigation Paralegal will handle discovery, medical record review and analysis, subpoenas, and trial preparation.
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Conducts ABA specific therapeutic services at the directionof a BCBA (e.g. Pivotal Response Training, Verbal Behavior Training, EarlyStart Denver Model, Assessment Services, Discrete Trial Training, etc.
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You’re familiar with antitrust litigation including managing the collection, review, and production of documents, preparing witnesses for depositions and/or trial testimony; and complying with third party subpoenas.
$239,400 - $350,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
trial job in San Francisco, CA
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