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 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)
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 is you have:
- 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
Why you should join Heidi
- Real product momentum
- Equity from day one
- 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
- 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
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 are proud to welcome all applicants as we’re committed to promoting a culture of opportunity for all.
#J-18808-Ljbffr…