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The Associate Director of Quantitative Science is a self-sufficient and high-impact position that focuses on supporting the statistical and data science needs in the risk-based monitoring (RBM) of clinical trials, serving in roles such as CSM lead (CSM: Centralized Statistical Monitoring), while also support other activities such as preclinical studies, biomarkers, application of AI/ML and development of analysis applications.
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Desired: Clinical trials, case-control and cohort studies, statistical genetics, protocol monitoring, hierarchical, longitudinal, survival, categorical, nonlinear, and epidemiology.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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Lead large BioPharma accounts to successfully integrate Predicine’s liquid biopsy solutions into the oncology clinical trials pipeline. In-depth knowledge of oncology liquid biopsy solutions and applications in clinical trials.
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Manage administration of multiple complex grants including center grants, training grants, industry projects clinical trials, etc., to include, but not limited to T32, U01, P01, multiple NIH, DOD, and NSF grants, as well as foundation awards.
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Responsible for reviewing and/or approving clinical study documents, such as project timelines, pharmacy manuals, laboratory / PK manuals, informed consent, study start-up plans, monitoring plans, CRFs, data monitoring plan, edit checks, safety plans, DMC charter, close-out plans, and CSRs.
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The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Chicago, Illinois (IL.
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We offer unique opportunities for our patients not available at many GI practices, including enrollment in clinical research trials, infusion services, and participation in remote monitoring and management of IBD (SonarMD.
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Our research approach supports important National Cancer Institute goals including ensuring every cancer patient has access to the newest and most innovative clinical trials in the nation, clinicians and researchers work together to initiate new research protocols based on the clinician’s interaction with the patient, and each cancer patient receives personalized treatment through the interaction of the multidisciplinary team of clinicians and allied health professionals.
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Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
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Authors, reviews and finalizes the medical and scientific portions of protocol synopsis and clinical study protocols and amendments; Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions.
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Works closely with CROs to set up study systems, such as Safety management, data management, clinical monitoring, TMF, etc. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.
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The QC Microbiology Data Reviewer is an exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
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Interface with representatives from key functional groups (Monitoring, Data Management, Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups.
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The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.
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clinical trials monitoring jobs
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