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Builds a robust medical writing team of internal employees and external contract medical writers for a fast-growing cell therapy company with multiple products in clinical trials. The role works hands-on, directly with teams and management to produce high quality clinical program documents to support regulatory submissions and scientific communications while simultaneously building up the team.
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We also offer revolutionary CAR T-cell therapy, access to innovative clinical trials as well as social, emotional, nutritional and physical therapies and support. · Participates in Sarah Cannon Blood Cancer Network Quality Initiatives and workgroups/committees in collaboration with the Sarah Cannon Network Director of Quality.
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Scientific background and interest – particularly clinical trials, medicine, or public health. Department BSD PED - Hematology, Oncology, and Stem Cell Transplantation - Pediatric Cancer Data Commons: OperationsAbout the Department The Biological Sciences Division’s ‘Data for the Common Good’ (D4CG), is a rapidly-growing team of experts in medicine, clinical research, public health, data standards, data infrastructure and programming, data governance and international data sharing.
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Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
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Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.
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Working under the COE Bronx Oncology Living Daily (BOLD) Program, a Psychosocial Oncology Initiative, and with Montefiore’s clinical and community programs and partners, the Project Manager will help manage multiple community outreach and inreach efforts towards increasing community partnership, patient engagement, and Bronx resident participation in cancer screening, psychosocial care, clinical trials, and cancer center events/committees, as relevant.
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The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials.
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Under the direction of the study PI and supervised by the Director of Clinical Research within the UC Davis Alzheimer’s Disease Research Center, this position serves as a Recruitment and Retention specialist for the Alzheimer’s Disease Research center longitudinal cohort and the associated projects.
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The Clinical Research Nurse is a licensed clinical professional working with and under the direction of the Principal Investigator, Assistant Director, Lead Research Nurse, and in close conjunction with the Clinical Project Manager on early or late phases of clinical trials related to the treatment of diabetes.
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Under the general direction of the Associate Director of the Clinical Trials Office (CTO), the Senior Contracting Specialist works with investigators, clinical trial coordinators and industrial sponsors and contract research organizations to negotiate clinical research agreements in accordance with BIDMC' institutional policies.
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Reporting to the Head of Clinical Development, this individual will have oversight of and accountability for clinical trials from study start-up to BLA approval. Collaborate with Clinical Operations to expedite execution of clinical trials.
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May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office.
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Leads small and large collaborations with academia and industry partners to identify biobanks, clinical trials and existing databases to collate multi-parameter genomic and clinical datasets to mine for novel biomarkers of unmet need patients in conjunction with computational biologists, data scientists and statistician.
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The Clinical Research Program Manager- Monitor, under the supervision of the Assistant Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Comprehensive Cancer Center Clinical Trials Office.
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The Rater is responsible for the organization, administration, management, and efficient execution of clinical ratings associated with clinical trials. Manage aspects of the study related to ratings with the rater training representative, study sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
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