Clinical Data Manager - Medical Imaging - SaMD - AU

Why join us?💜  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.💻  Flexible and remote-friendly working🚀 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 the role
As a Clinical Data Manager, at Annalise.ai, you will play a vital role supporting the clinical validation of software as medical device (SaMD) artificial intelligence (AI) products used in diagnostic medical imaging. This role is an exciting opportunity for a highly motivated, experienced Clinical Data Manager to join a uniquely talented Clinical Research and Medical Affairs team, who’s primary department focus is to conduct clinical studies in accordance with applicable standards and regulations and generate high quality clinical documentation supporting the regulatory and marketing strategy for Annalise.ai products. Reporting to the Senior Manager, Clinical Research, you will be responsible for assisting with the planning and conduct of research studies supporting the clinical validation of Annalise.ai SAMD, as well as informing the study design, statistical analysis, management and reporting of research study data. This end-to-end role will include study management and documentation of all associated study outputs, including the study protocol and report, and will see you coordinate interactions between a range of internal and/or external stakeholders and Subject Matter Experts (SMEs), so strong written and verbal communication skills are a must. You will have experience in research study management, statistical design, data management and writing clinical reports in accordance with applicable standards and regulations within a medical device setting. 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 role with the Clinical Research and Medical Affairs team here at Annalise.ai. 

What you'll do:

• Support the development of research study protocols and reports, as well as other associated study documentation,
• Assist with end-to-end study management activities, including development of study concept and design, site and SME engagement, study monitoring and ongoing risk management,
• Contribute to the statistical analysis plan and advocate for innovative strategies to evaluate the performance of Annalise.ai SaMD.
• Develop, maintain, and validate scripts for statistical analysis or formatting of study results,
• Contribute to the evidence dissemination strategy by presenting study results in conference abstracts and/or high-quality manuscripts for peer-reviewed publication,
• Effectively manage liaisons between internal and external stakeholders from cross-functional teams,
• Perform quality assurance and manage document reviews, ensuring all documents are well organized, scientifically accurate, consistent, and in compliance with applicable Standard Operating Procedures (SOPs), guidelines and regulations, and
• Complete research studies and associated documentation within a period that supports the product roadmap and deadlines.

What we're looking for?

• Bachelor’s degree in a scientific or related field (e.g., medical sciences, pharmacology, engineering, statistics),
• 1-3 years of experience in clinical research, biostatistics, or a related function within the pharmaceutical, biotechnology, or medical device industry,
• Knowledge of Good Clinical Practice or other harmonised standards,
• Understanding of clinical research study design, statistics, protocol development and study management activities,
• Experience in a statistical programming language such as R or Python,
• Demonstrable skills in data wrangling/cleaning, and analysis of clinical data; and in interpreting, critiquing, and synthesising statistical results,
• Excellent oral communication and technical writing skills,
• Able to work independently as well as collaborate within a larger team,
• Strong interpersonal skills and experience managing stakeholders from cross-functional teams, and
• Detail-oriented, organised with the ability to manage multiple projects simultaneously.

Nice to have but not essential:

• Masters/PhD or post-graduate qualification in a relevant area of medical science.
• Experience evaluating machine learning models, or working in SaMD, radiology or related medical imaging field.
• Familiarity with clinical evaluation processes and other regulatory compliance requirements in major markets (EU, US, and Australian Medical Device Regulations).
• Established publication record.

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. 
And we’re just getting started.  
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: people@annalise.ai. We look forward to hearing from you.