Job description

Are you a Clinical Research Scientist ready to take ownership of impactful, global studies within the medical device space? This is a fantastic opportunity to step into a senior role within a company driving innovation in infection prevention. You’ll lead the end-to-end clinical research process from protocol development through to analysis and publication supporting both regulatory needs and broader commercial objectives. You’ll work cross-functionally with internal R&D, Regulatory, and Medical Affairs teams, as well as external stakeholders like CROs and investigators, to ensure studies are designed and executed to the highest standards.

Responsibilities:

Design and lead clinical studies to generate evidence on the safety and efficacy of innovative medical device technologies, ensuring alignment with regulatory and commercial goals.

Develop study protocols and statistical analysis plans in accordance with international standards and clinical best practices, working closely with cross-functional stakeholders.

Collaborate with CROs, investigators, and labs to oversee study setup, conduct, monitoring, and data collection, ensuring compliance with ethical and regulatory requirements.

Manage ethics and governance submissions, site contracts, and budget coordination to support smooth study execution across both local and international sites.

Analyse clinical data and prepare study reports, presentations, and manuscripts for publication and regulatory submissions.

Provide clinical input into product development, including risk assessments, hazard analyses, and product claims substantiation to support global market entry.

Maintain high-quality study documentation, ensuring compliance with ISO 13485 and the company’s Quality Management System.

Skills:

Minimum 5 years’ experience in clinical research, ideally within medical devices, diagnostics, or infection control.

Demonstrated ability to design and lead clinical studies, including protocol development, data analysis, and reporting.

Solid understanding of clinical trial regulations, ethics and governance processes, and working within a QMS environment.

Strong communication skills, with the ability to collaborate across cross-functional teams and engage external stakeholders such as CROs and investigators.

Postgraduate qualification in a life sciences or biomedical field.

Apply directly now, or send your updated CV to Ben Byrne at [email protected] OR (04) 21776703