Clinical Research Associate - Clinical Performance Studies Do work that matters. We're pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day.
Well-funded and global. annalise.ai has a global presence across APAC, EU and US regions. We're backed by I-MED radiology and harrison.ai (raised Australia's largest Series B of $129m in 2021).
Work with a bunch of awesome, genuine people who are passionate about what they do.
Make an impact. You won't be another 'cog in the wheel' here. We give full trust and autonomy for you to be heard, to work on big & complex projects – and to make a real difference.
Grow your career with us. We're big believers in lifelong learning. You'll be given a $1000 personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career.
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!
About your role As a Clinical Research Associate, at Annalise.ai , you will play a vital role in the generation of pre-market clinical evidence for Annalise software as medical device (SAMD) artificial intelligence (AI) products used in diagnostic medical imaging. This role is an exciting opportunity for a highly motivated clinical research professional to join a uniquely talented team.
Reporting to the Senior Manager, Clinical Research, you will have the opportunity to work within the pre-market and regulatory support team where you will manage/oversee the conduct clinical performance studies for Annalise SAMD products in accordance with GCP/ISO14155and author associated documentation such as study protocols, reports and performance evaluation summaries. Within this role you will be the clinical research representative on a cross functional team and have interactions with external stakeholders such as regulatory bodies so you will need to be highly collaborative and have strong verbal communication skills. You are a motivated and efficient self-starter with a proven track record of meeting project timelines and delivering results. Experience with medical writing and delivery of study and associated regulatory submission documentation in accordance with all applicable standards and regulations is highly desirable.
As we pioneer new ways of improving health delivery at scale using the most cutting-edge AI technologies, we invite you to consider an exciting, meaningful career with us here at Annalise.ai as a Clinical Research Associate.
What you'll do:Manage and author the development of pre-market clinical evidence documentation such as study protocols, reports and performance evaluationswith cross functional input. Assist in designing clinical performance studies adhering to relevant Good Machine Learning Practice Principles. Managethe planning, execution and reporting of clinical performance studies for Annalise SAMD products. Oversight of CROs and outsourced studies as required. Assist in writingresponses 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. What we're looking for?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 Highly regarded, but not essential:Experience with writing study protocols/reports and other medical device regulatory submission documentationas well as responding to questions from regulatory bodies such as PMDA, FDA, MDR and/or TGA. Strong understanding of Good Machine Learning Practice principles. PhD and/or post-graduate qualification in a relevant area of medical science Experience working in research involving artificial intelligence, SAMD and/or medical imaging. Experience performing statistical analysis and/or programming expertise. What we're about We're problem solvers, redefining what's possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day.
Yes, we're a technology company and yes, we're leveraging the latest AI technologies, but people are at the heart of everything we do.
annalise.ai was formed in early 2019 through a unique partnership between harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Since then, we've scaled rapidly and we're focused on creating AI solutions that help radiologists diagnose medical images.
Our first product, the world's most comprehensive AI clinical decision-support solution for chest x-rays, is already in made available to 1 in 4 radiologists in Australia and rolling out to hundreds more. This solution is capable of detecting 124 findings and was recently featured in peer-reviewed publication, Lancet Digital Health journal.
Help us shape the future of AI in medical imaging. And most importantly, help us make a real difference in people's lives.
What's next? If you're inspired by what we're up to, please apply now and we'll be in touch soon.
We are proud to be an Equal Opportunity Employer. Diversity's not a buzzword here, it's in our DNA. Diverse perspectives shape our culture and make our work better. That's why we're committed to building inclusive teams that represent a variety of backgrounds and skills. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, just contact us at accommodations: ******. We look forward to hearing from you.
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