Clinical Affairs Lead

vor 3 Wochen

Council of the City of Sydney, Österreich Nanosonics Vollzeit

Clinical Affairs Lead Join to apply for the Clinical Affairs Lead role at Nanosonics . Nanosonics is an Australian-based global leader in infection prevention. Our breakthrough trophon® device transformed ultrasound probe reprocessing worldwide. Today, we continue to expand our portfolio, advancing innovative solutions that improve patient safety and elevate the standard of care. About The Role The Clinical Affairs Lead is responsible for leading the preclinical and clinical research activities that underpin the safety and efficacy of Nanosonics products. This includes literature reviews, protocol development, data interpretation, and the design and management of clinical studies across global markets. You will collaborate closely with internal cross‑functional partners and external clinical research stakeholders, ensuring that our evidence base is robust, compelling, and aligned with regulatory and market needs. What You’ll Be Doing Conduct literature reviews, state‑of‑the‑art assessments and guidelines analysis to inform safety and efficacy requirements. Lead preclinical research activities, including study design, protocol development, data analysis and reporting. Partner with internal teams to support hazard analysis, risk assessments, and test method development. Design and lead clinical research studies, including protocol development, statistical analysis plans, monitoring activities and reporting. Manage ethics and governance submissions, study budgets, contracts and site administration. Coordinate with external partners including CROs, laboratories, investigators, clinicians and research institutions. Maintain study documentation in compliance with ISO13485 and QMS requirements. Prepare publications, training materials and presentations to share insights with internal teams and the broader scientific community. Report on progress to internal stakeholders and contribute to strategic planning for research initiatives. What You’ll Bring 5‑10 years’ experience conducting and leading clinical or preclinical research. Background in infection control, epidemiology, microbiology or related fields. Expertise in designing and analysing preclinical and clinical studies is a must. Experience working within regulated environments and quality management systems. Strong data analysis and scientific writing capabilities. PhD in a life sciences research discipline. If you’re passionate about translating scientific evidence into real‑world clinical impact — we’d love to hear from you. Apply Now . #J-18808-Ljbffr

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