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GCP Consultant, AI/ML Focus - Quality and Regulatory
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Consultant - AI/ML Validation & GCP Compliance
Company
Pharmaceutical/Biotech Quality and Regulatory Consultancy
Location
Remote (UK) - Multiple Positions
Package
Excellent hourly rates offered in line with experience, with the potential of a salaried position in the future.
The Role in 20 Seconds
AI is now embedded in clinical development - trial recruitment algorithms, risk-based monitoring tools, AI-assisted pharmacovigilance signal review, and EDC/eTMF/CTMS platforms with machine learning features bolted on.
Sponsors and CROs running trials under GCP now have to prove that AI touching their clinical systems is validated, governed, and inspection-ready - and most don't have anyone in-house who can do that credibly.
That's where you come in. This is not a data science role. You are a GCP-focused quality and regulatory consultant first, who happens to understand how AI/ML systems are built, trained, and changed - and who can turn that understanding into a validation approach, a risk assessment, and an audit trail that will survive an inspection. Broader GxP AI/ML work (GMP or GLP-adjacent systems) comes up too, for consultants who want it.
Our Client
A specialist GxP consultancy with a strong clinical-systems bias, built entirely on senior people. No juniors. No box-ticking. They're building out a dedicated AI/ML capability as demand from clinical-stage biotechs and CROs accelerates ahead of the EU AI Act deadline, and they need consultants who can get stuck into that work now.
The Company
A lean, specialist consultancy delivering GxP compliance and computer system validation services to a client base predominantly in the USA, EU and UK. The bulk of the work sits in the GCP space - clinical trial systems and clinical data quality - with AI/ML validation now one of the fastest-growing parts of that remit.
Most clients sit in the 30-200 employee range - organisations sophisticated enough to know exactly what they need, but lean enough that they don't have the internal QA or regulatory resource to work through what AI governance actually means for their trials. That's the gap this consultancy fills.
The model is deliberately small. Only experienced consultants are deployed. There's no layer of management between you and the client, and no junior to pass the awkward bits to. The team is small, friendly, and hardworking, and they are growing quickly.
What You'll Actually Do
The Bread and Butter:
- Assess whether AI/ML functionality embedded in clinical trial systems (EDC, IRT, CTMS, eTMF, ePRO, safety databases, risk-based monitoring tools) falls in scope of EU AI Act high-risk obligations or FDA's AI/ML SaMD framework, and help translate that into a proportionate compliance plan
- Contribute to validation of AI/ML-enabled systems used in GCP environments, applying a risk-based approach consistent with GAMP 5 and the FDA's Computer Software Assurance guidance
- Build and review model-side documentation - data provenance, training and validation datasets, performance monitoring, and change control - in a form that stands up to sponsor and regulator scrutiny
- Support clients through EU AI Act obligations relevant to their clinical systems: risk management documentation, technical documentation, human oversight design, logging, and AI literacy training for staff who operate or rely on these tools
- Where clients are on the medical device/SaMD side, support Predetermined Change Control Plan (PCCP) submissions and Good Machine Learning Practice (GMLP) alignment for adaptive algorithms
- Conduct GCP audits of AI/ML-enabled clinical technology vendors, from agenda to audit report to corrective action closure
- Pick up AI/ML validation work in wider GxP contexts (GMP, GLP) where it arises, for consultants who want to flex across service lines
- Act as a client contact on engagements - attending and sometimes chairing meetings, and presenting findings to clinical operations, quality, and IT stakeholders
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The Less Obvious Bits That Matter as Much:
- Explaining AI/ML risk to a clinical or quality audience without either dumbing it down or drowning them in model architecture
- Keeping pace with a regulatory landscape that is still moving - EU AI Act phased obligations, evolving harmonised standards, and FDA guidance that has shifted materially in the last eighteen months
- Having the judgement to flag when a client's AI tool genuinely needs formal validation and governance, and when it doesn't
Who We're Looking For
You'll be a natural fit if:
- You've come up through clinical trial systems, clinical data management, or GCP-focused quality/regulatory roles - in a sponsor, a biotech, a CRO, or a consultancy - and you've built real fluency in how AI/ML systems are assessed and governed, whether through hands-on projects, formal training, or close partnership with data science teams
- You understand GCP well enough to know where AI genuinely changes the risk picture on a clinical system, and where it's business as usual
- You ask smart questions early rather than making assumptions, and your documentation doesn't come back needing heavy rework
- You're comfortable working independently in a remote model with real deadlines and defined accountability
- You'd be open to applying that same AI/ML lens to broader GxP systems occasionally, alongside your GCP core
Essential:
- 10+ years working with clinical trial systems or GCP-focused quality/regulatory compliance in a regulated environment
- Working knowledge of the EU AI Act's risk-based framework and its implications for high-risk AI in clinical decision support and clinical-quality-relevant systems
- Familiarity with the FDA/Health Canada/MHRA Good Machine Learning Practice guiding principles and the FDA's Predetermined Change Control Plan framework for AI-enabled device software functions
- Working familiarity with GAMP 5 concepts (software categories, V-model, risk-based testing) and core GCP-relevant regulations - ICH E6(R3), EU Annex 11, and 21 CFR Part 11
- Ability to write inspection-ready documentation: validation plans, risk assessments, qualification protocols, and audit reports
- Right to work in the UK without sponsorship
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Nice to Have:
- Direct involvement in an AI/ML validation project, PCCP submission, or EU AI Act gap assessment for a clinical trial system
- Experience with EDC, IRT, CTMS, eTMF, ePRO, or safety database platforms that have introduced AI/ML features
- Broader GxP AI/ML exposure - GMP or GLP systems with machine learning components
- Background in data integrity or algorithmic bias assessment
- RQA, ISPE, DIA, or IAPP AI governance involvement
- ISO 27001 or ISO/IEC 42001 (AI management systems) awareness
What's Actually In It For You
The Practical Stuff:
- Rates and salary based genuinely on experience - we won't be trying to lowball you at interview
- Remote working as the default - occasional client site visits, planned in advance
- Contract or permanent - both considered depending on what works for you
- Fractional engagements across multiple clients, usually 1-2 month assignments, with the option of a salaried role for the right person as the business grows
The Things That Don't Show Up in a Rate Card:
- A genuinely emerging specialism - you'll be helping shape how this consultancy approaches AI/ML validation in clinical systems, not slotting into a template someone else built years ago
- Clients who are building something - clinical-stage biotechs and CROs working out AI governance in real time, ahead of a regulatory deadline that is now weeks away
- Direct relationships with clinical ops leads, QA managers, and IT managers - because with staff rosters of 30-200 people, you're rarely more than one step from the decision-maker
- A client list where your name is on the work, not buried four layers down in a consulting pyramid
- No internal politics to navigate - small team, clear accountabilities
The Honest Bit
This is a genuinely new and fast-moving area, and you won't find a fully worn playbook waiting for you - part of the job is helping build it. Client deadlines are real, inspection windows don't move, and occasionally a deliverable needs to be right by Friday regardless of when it landed in your inbox.
Remote working in a fractional/contract model requires genuine self-management - there's no office to walk into and no one tracking your hours, so the only thing that matters is whether the work is good and the client is happy.
If your AI/ML exposure has been mostly theoretical - conference talks and policy papers rather than actual project work - this probably isn't the role yet. If you've been the person translating AI risk into something a clinical quality system can actually act on, you'll probably love it.
If you're more experienced than this ad suggests - closer to 20 years, with a track record of leading AI/ML or GCP systems engagements end-to-end - get in touch anyway. There's a Senior or Principal Consultant conversation to be had as well, and it's a five-minute chat to work out where you'd actually sit.
Apply
Apply via the link, or message Andy Clarke directly if you want to talk it through first - especially if you'
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