Trials Manager - Clinical AI Research

Who We Are

Healthcare needs a better rhythm: one that keeps care continuous and deeply human. Heidi is building an AI Care Partner that works alongside clinicians to make that possible. We’re a team of doctors, engineers, designers, researchers, and creatives building tools that help clinicians stay focused on what matters most: their patients. In just 18 months, Heidi has given back more than 18 million hours to healthcare professionals – supporting 73 million patient visits in 116 countries. Today, more than ten million patient visits per month are powered by Heidi worldwide. Backed by nearly $100 million in funding, we’re growing in the US, UK, Canada, and Europe, partnering with leading health systems including the NHS, Beth Israel Lahey Health, and Monash Health.

The Role

Heidi Health is building the operating system for clinical care. Our Clinical AI Research team runs a growing global portfolio of studies – from internal evaluation and post‑market surveillance through to product pilots, safety simulation work, academic deployment trials, and the early stages of health‑economic and regulatory‑grade evidence generation. As Trials Manager, you will be the operational backbone of that portfolio: owning coordination across sites, regulators, academic partners, and internal teams to keep our trials running on time, on protocol, and audit‑ready. This is a hands‑on, high‑ownership role reporting directly to the Head of Clinical AI Research. It suits someone who is equally comfortable writing a trial management plan, chasing a site ethics submission, and building a Notion dashboard to track enrolment across five countries.

What You’ll Do

• 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 consents, site agreements, and regulatory submission 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)

What We’re Looking For

• 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

Bonus

• 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

Mission

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.

Values

• 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, thinking, and 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.

Why You Should Join Heidi

• Real product momentum – we’re channeling interest, not just generating it.
• Equity from day one – when Heidi wins, you win.
• Unmatched impact – play a pivotal role in scaling customer success at a critical growth moment 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 – shape our international expansion as we bring Heidi to key markets.
• Growth and balance – personal development budget, dedicated wellness days, one month work from anywhere in the world, and birthday off for recharge.
• Flexibility – hybrid environment with 3 days in the office.

Diversity, Equity & Inclusion

Heidi is dedicated to creating an equitable, inclusive, and supportive work environment that brings people together from diverse backgrounds, experiences, and perspectives. Our strength is in our differences. We’re proud to be an equal‑opportunity employer and welcome all applicants as we are committed to promoting a culture of opportunity for all.