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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities. The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams.
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Research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, commercial operations. Experience providing scientific support for the development and implementation of cell therapy studies, including protocol and ICF development, electronic data capture database development, safety assessment, IB/DSUR submissions, and clinical data review.
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REPORTS TO: The position reports to the Assistant Director of Related Services and Site Coordinator, who works in close collaboration with the Director of Extended School Year and Expanded Learning in the Office of Special Education.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies.
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Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment.
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The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical programs.
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Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week) At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases.
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With a bridging seat on the leadership team of DSI, the Head of Computational Science & Data Strategy, Research, ensures a seamless connection with the data infrastructure and governance responsibilities of DSI and its responsibility for enterprise data solutions in partnership with Takeda’s corporate Data & Technology function.
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This includes collaborating with Clinical Research, Clinical Operations, Medical Scientific Affairs, and/or vendors to develop and monitor the clinical trial safety. The Global Safety Physician (GSP) is a leadership role within the Global Patient Safety organization accountable for executing the safety and risk management activities for clinical development and marketed products to enable the safe and effective use of Ironwood's products by patients and healthcare providers.
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Similar Jobs (4) Assistant, Associate, or Full Professor of Technology and Social Power locations Boston, MA (Main Campus) time type Full time posted on Posted Yesterday Assistant, Associate, or Full Professor of Ethics and Values in Design locations Boston, MA (Main Campus) time type Full time posted on Posted Yesterday About Us Founded in 1898, Northeastern is a global research university and the recognized leader in experiential lifelong learning.
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Our client, a major academic medical center in Boston and the nation's largest hospital based research program, is looking for a Clinical Research Project Manager to join a major study group dedicated to the further research and care of cardiovascular disease patients.
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As part of our dedication to student success, we are seeking a passionate Occupational Therapist or Certified Occupational Therapy Assistant (COTA) to join our team for the 2024-2025 school year.
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The Body Radiologist will work with the Division Chief to support the clinical, education, and research missions of the section and the department as we seek toseek to improve health and patient care throughout Boston and the Commonwealth of Massachusetts.
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Awesome opportunities to volunteer through Mars Volunteer Program, like volunteering at coral reef cleanups or on research vessels! Optimum Wellness Plans® for up to three pets plus discounts on Mars, PetSmart, Royal Canin, and more.
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on site clinical research assistant jobs in Boston, Holdrege, Nebraska
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