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Accountability, Biopharmaceutics, Chemistry, Clinical Pharmacology, Clinical Research, Clinical Trials, Critical Capabilities, Drug Development, Drug Discovery Process, Due Diligence, Electronic Components, Life Science, Mentorship, Non-Disclosure Agreements, Patient Care, Physics, Project Management, Quality Control (QC), Stakeholder Management, Translational Medicine, Well-Being, Workforce Planning.
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The position will work with investigators, the General Counsel’s Office, the Clinical Trials Office, the Technology Ventures Office, Institutional Review Board, and other institutional offices to oversee the negotiation of Subcontracts, Clinical Trial Agreements, Data Use Agreements, Billing Agreements, and other atypical agreements.
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Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex data sets emerging from clinical trials. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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The Director will have a continuous improvement mindset for SPC, focusing on quality improvements while maintaining the integrity of contracting management objectives. The Director will work closely with the Executive Director and the SPA senior management team to lead high quality research administration.
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The Director, Clinical Project Management works cross-functionally with the Epidemiology, Biostatistics, Clinical Informatics, Engineering, and Data Science teams to drive the scoping and execution of new projects.
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The Associate Medical Director, Global Safety Physicianwill be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
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Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues.
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The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
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Central Research Support Staff: 7 (4 Grant Administrators, 1 Sr. Lab Manager, 1 Clinical Trials Manager, 1 Data Quality Director) Supervise submission, compliance and conduct of industry supported clinical trials and other research.
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You will have experience in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully.
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Provide Trial Operations leadership across multiple studies to support the design, development, execution, and delivery of clinical programs in accordance with Clinical Development Plans and timelines for assigned program area; closely collaborate with Clinical Development, Biostatistics, Data Management, Regulatory, Medical Writing, Medical Affairs, Supply Chain, and Development Program Management to ensure highly integrated cross functional project plans for programs and trials.
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Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity.
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Solid well-grounded experience in setup, execution and operational management of US and global Phase 1, 2, and 3 clinical trials across an array of therapeutic areas; experience in cardiovascular, as well as in rare diseases or autoimmune disorders highly desired.
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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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Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
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data management clinical trials jobs Title: director in Cambridge, MA
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