annalise.ai
Clinician-led artificial intelligence organisation, developing comprehensive decision-support AI in medical imaging.
radiology • medical imaging • software as a medical device • artificial intelligence • deep learning
11 - 50
Clinical Research Associate - Clinical Performance Studies
May 1
annalise.ai
Clinician-led artificial intelligence organisation, developing comprehensive decision-support AI in medical imaging.
radiology • medical imaging • software as a medical device • artificial intelligence • deep learning
11 - 50
Description
• Manage and author the development of pre-market clinical evidence documentation such as study protocols, reports, and performance evaluations with cross-functional input. • Assist in designing clinical performance studies adhering to relevant Good Machine Learning Practice Principles. • Manage the planning, execution, and reporting of clinical performance studies for Annalise SAMD products. Oversight of CROs and outsourced studies as required. • Assist in writing responses to questions from regulatory bodies relating to performance of Annalise SAMD products. • Effectively manage liaisons between external and internal stakeholders e.g., lead clinicians, regulatory, quality, product, technical, systems. • Conduct or assist with literature reviews, manuscript submissions, conference abstracts, and publications as required. • Assist with SOP development as required.
Requirements
• Experience working within the medical device or pharmaceutical industry • Experience working within the field of clinical research • Bachelor’s degree in a relevant field (e.g., nursing, life sciences or medical science). • Strong understanding of ICH/GCP and/or ISO14155 2020
Benefits
• Generous parental support including 16 weeks gender-neutral paid parental leave and $10,000 support for egg or sperm freezing. • Do your best work and have fun doing it with unlimited well-being leave, monthly meditations, inclusive team events, and lots more!
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