Social network you want to login/join with:Head of Clinical ResearchOur Sligo based client are currently looking for a Head of Clinical Research to join their team on a permanent basis. As Head of Clinical Research, you will be responsible for overseeing all clinical studies related to products developed. You will be responsible for ensuring the planning, implementation and management of clinical trials and other related activities by designing and executing studies to support regulatory submissions and post-market surveillance.ResponsibilitiesDevelop and execute clinical research strategies, plans, and budgets for our product in compliance with regulatory requirementsOversee the design, implementation, and management of clinical trials, including protocol development, site selection, patient recruitment, and data collection and analysisCollaborate with cross-functional peers including regulatory affairs and product development to ensure alignment of clinical research activities with overall business goals and objectivesEnsure that all clinical research activities are conducted in compliance with applicable regulatory requirements and ethical standardsManage relationships with clinical research organizations, investigators, and study sites to ensure high-quality, timely, and cost-effective execution of clinical trialsPrepare and submit clinical study reports and other regulatory documents to regulatory authorities and other stakeholdersManage the clinical research budget and resource allocation to ensure efficient and effective use of resourcesPresent clinical study data and results to internal and external stakeholders, including peers, regulatory agencies, and scientific conferencesRespond to changing priorities and timelines in an efficient and effective manner, while maintaining structure under pressureRequirementsAdvanced degree in life sciences, health sciences, or a related fieldMinimum of 5+ years of experience in clinical research, including at least 5 years of experience in in-vitro diagnostic devices with direct leadership experienceStrong knowledge of FDA regulations, ISO standards, and GCP guidelines related to clinical researchExperience in designing and conducting clinical studies for medical devices, including De Novo, IDE, and PMA studiesExcellent communication skills, with the ability to communicate complex scientific and clinical concepts to a variety of audiences
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