Head of Clinical Research
Our Sligo based client is 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 ensure 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.
Responsibilities Develop and execute clinical research strategies, plans, and budgets for our product in compliance with regulatory requirements.
Oversee the design, implementation, and management of clinical trials, including protocol development, site selection, patient recruitment, and data collection and analysis.
Collaborate with cross-functional peers including regulatory affairs and product development to ensure alignment of clinical research activities with overall business goals and objectives.
Ensure that all clinical research activities are conducted in compliance with applicable regulatory requirements and ethical standards.
Manage relationships with clinical research organizations, investigators, and study sites to ensure high-quality, timely, and cost-effective execution of clinical trials.
Prepare and submit clinical study reports and other regulatory documents to regulatory authorities and other stakeholders.
Manage the clinical research budget and resource allocation to ensure efficient and effective use of resources.
Present clinical study data and results to internal and external stakeholders, including peers, regulatory agencies, and scientific conferences.
Respond to changing priorities and timelines in an efficient and effective manner while maintaining structure under pressure.
Requirements Advanced degree in life sciences, health sciences, or a related field.
Minimum of 5+ years of experience in clinical research, including at least 5 years of experience in in-vitro diagnostic devices with direct leadership experience.
Strong knowledge of FDA regulations, ISO standards, and GCP guidelines related to clinical research.
Experience in designing and conducting clinical studies for medical devices, including De Novo, IDE, and PMA studies.
Excellent communication skills, with the ability to communicate complex scientific and clinical concepts to a variety of audiences.
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