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Kaplan Hecker’s highly experienced lawyers serve clients across a wide range of matters, including commercial litigation, white-collar criminal defense, and complex regulatory and securities cases.
$80,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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He/she works closely with Director, Clinical Pharmacy, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for all clinical trials.
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Assists with and attends trials/hearings, matters in alternative dispute resolution forums, and those before governmental entities, including assembling/tracking exhibits, exhibit lists, deposition designations, reference and witness lists/materials, and key documents; tracks admitted exhibits and ensures delivery of draft/final transcripts.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
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Experience in clinical trials and other areas of pharmaceutical medicine (i.e. medical affairs, regulatory, pharmacovigilance, etc.) The Medical Officer has functional responsibility for medical monitoring of clinical trials, medical review activities and for broad spectrum of internal and external medical consulting, including, but not limited to protocol development study feasibility, medical training and engagement with external clinical experts and key opinion leaders.
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Ensure the smooth running of the clinical research program team including that colleagues are updated on all relevant issues, develops systems to track multiple projects including all regulatory files, investigator and IRB information, patient recruitment activity and financial management as well as ensuring high data quality across all clinical trials.
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Expertise in FDA regulatory requirements related to conduct of clinical treatment trials in oncology preferred. Provide scientific and regulatory expertise in drug development for symptom management clinical trials.
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1+ year Life Sciences / Clinical Trials / Pharma / EDC experience; familiarity with the roles of a sponsor, CRA and Investigator; an EDC system; and ICH-GCP preferred but not required. About CRIO: CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture.
$75,000 - $90,000 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide expert guidance on CTEP regulatory guidelines for clinical trials. Expertise in clinical trial design and conduct, especially with respect to biomarker-driven, precision medicine oncology treatment trials.
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Provide SAS statistical programming support for multiple clinical research projects or regulatory submissions. Produce and/or validate SDTM/ADaM datasets, analyses, tabulations, graphics and listings of clinical trials data.
$100,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. Solid knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
$240,000 - $325,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Senior Director in Biostatistics is a core member of the Evidence Generation Team (EGT), support design, analysis, interpretation and reporting of clinical studies, regulatory submissions, Health Technology Assessments (HTA) and payer submissions, and dissemination of clinical data insights.
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Located at the George Washington University School of Medicine and Health Sciences, the Research Assistant will assist the Principal Investigator (PI) with the clinical trials at GW and in Barranquilla, Colombia.
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Minimum 10 years in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
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IQVIA is a leading provider of scientific services spanning clinical trials, real world evidence, consulting, and technology. Advise clients on good practice in generating patient experience data, and how it addresses needs for evidence generation and dissemination, regulatory and market access strategy.
$167,400 - $286,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
trials regulatory jobs in Bethesda, MD
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