heidihealth.com.au - Trials Manager - Clinical AI Research
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• Proven experience managing clinical trials or research studies end-to-end, ideally in medical devices, digital health, or diagnostics • Familiarity with NHS research governance (HRA approval, IRAS, R&D sign-off processes) • Exposure to health-economic studies or NICE evidence review processes • Experience working with academic clinical partners or research networks • Experience preparing or contributing to regulatory submissions or technical documentation • Strong GCP certification (or willingness to certify immediately) • Excellent project management skills - able to hold multiple workstreams across geographies without dropping detail • Comfort operating in a fast-moving, ambiguous environment where not every • process is yet defined • Experience with AI/software as a medical device (SaMD) or digital therapeutics • Working knowledge of medical device regulatory frameworks — UKCA, EU MDR, and/or FDA — and their implications for clinical investigation design and documentation • WHAT SUCCESS LOOKS LIKE IN THE FIRST 12 MONTHS • All active trials have clean, audit-ready documentation and a clear status dashboard • No trial milestone slips for operational reasons within your control • At least one regulatory submission package coordinated end-to-end • A repeatable site onboarding process that can scale as the portfolio grows • WHAT DO WE BELIEVE IN? • Heidi builds for the future of healthcare, not just the next quarter, and our goals are ambitious because the world’s health demands it. We believe in progress built through precision, pace, and ownership. • Live Forever - Every release moves care forward: measured, safe, and built to last. Data guides us, but patients define the truth that matters. • Practice Ownership - Decisions follow logic and proof, not hierarchy. Exceptional care demands exceptional standards in our work, our thinking, and our character. • Small Cuts Heal Faster - Stability earns trust, speed delivers impact. Progress is about learning fast without breaking what people depend on. • Make others better - Feedback is direct, kindness is constant, and excellence lifts everyone. Our success is measured by collective growth, not individual output. • Our mission is clear: expand the world’s capacity to care, and do it without losing the humanity that makes care worth delivering.
Responsibilities
• Coordinating day-to-day operations across a portfolio of concurrent trials — pilots, safety simulations, academic deployment studies, and post-market surveillance • Owning trial documentation: protocols, TMFs, informed consent processes, site agreements, and regulatory submissions packages • Liaising with ethics boards, notified bodies, NHS/health system partners, and academic collaborators across multiple geographies • Supporting regulatory submissions for medical devices under UKCA, EU MDR, and FDA frameworks — preparing technical file contributions and clinical evaluation report inputs • Building and maintaining trial tracking systems so the research team and leadership have real-time visibility of status, risk, and milestones • Onboarding and managing external research sites; training site staff on protocol and data collection procedures • Working with clinical, product, and engineering teams to design study procedures that are operationally feasible and scientifically sound • As the programme matures: supporting health-economic evaluation work and evidence packages for national recommendation bodies (e.g. NICE, NHS England)
Benefits
• Real product momentum. We’re not trying to generate interest, we’re channeling it. • Equity from day one. When Heidi wins, you win. You’ll share directly in the success you help create. • Unmatched impact. Play a pivotal role in defining and scaling customer success at a critical growth moment - all while working on a product that delivers tangible value to clinicians and patients every day. • Work alongside world-class talent. Join a team of operators and builders who’ve scaled unicorns. • Global reach. Help shape our international expansion as we bring Heidi to key international markets. • Growth and balance. Enjoy a personal development budget, dedicated wellness days, one month work from anywhere in the world and your birthday off to recharge. • Flexibility that works. A hybrid environment, with 3 days in the office. • HEIDI’S COMMITMENT TO DIVERSITY, EQUITY AND INCLUSION
No credit card. Takes 10 seconds.