Job Title:
Head of Clinical Research
We are seeking a highly experienced Head of Clinical Research to join our team at tn-ireland. As Head of Clinical Research, you will be responsible for overseeing all clinical studies related to products developed.
About the Role:
* 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.
Key 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:
* An advanced degree in life sciences, health sciences, or a related field.
* A 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.