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The Associate Director, Clinical Data Analyst, has a critical role in the delivery of high-quality external data across Dyne's development pipeline by proactively identifying, measuring, and mitigating risk prior to acquisition of non-electronic data capture (EDC) data.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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The Human-centered AI team in Digital Health Oncology R&D is looking for an Associate Director of Data Science to specialize in the development of novel digital endpoints using data science, statistical learning, and innovative machine learning methods on multi-modal datasets including clinical data, real world evidence, imaging, wearables, and other biomedical data sources to address patient burden.
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Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization.
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The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions.
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Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations. Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
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The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs. Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors.
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The Associate Director, Clinical Scientist is a key member of the Clinical Development team for the planning, conduct, analysis, and reporting of clinical studies. Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, PowerPoint, Veeva CRM) for data collection, analysis and reporting.
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Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies. Extensive knowledge and experience in clinical data management. Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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The Associate Director Clinical Portfolio Execution is accountable for the development of the operational strategy for the clinical study and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical studies/programs.
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Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist. This role typically manages one or more studies/or products, often the most complex in size and scope with minimal oversight and may take on additional responsibilities as defined by the (Sr) Director Clinical Portfolio Execution.
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The Associate Director (AD), Clinical Data Analytics will be responsible for evaluation of our Miltenyi Biomedicine US (MBM) data management practices to optimize our “hybrid” data management model.
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This position will consider candidates at an Associate Director or Director level dependent on individual qualifications. Director level experience in pharmaceutical/biotechnology industry or related clinical experience.
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Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers.
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Hnliche Stellen (2) Senior Director of Business Development, Vaccines locations 3 Standorte time type Vollzeit posted on Vor 30 Tagen ausgeschrieben Device Regulatory Lead (Associate Director) locations 3 Standorte time type Vollzeit posted on Vor 30 Tagen ausgeschrieben.
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associate director jobs Title: director clinical in Waltham, Troy, New York
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