GxP Computerised Systems Validation Consultant

Intelance

. Review validation approaches, records and evidence for platforms producing clinical trial and real-world evidence outputs .

Posted 11/11/2026contractLondon • United KingdomMid-LevelSenior💰 £550 - £700 per dayWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in computerized system validation within GxP settings, with a strong focus on compliance with 21 CFR Part 11 and EU GMP Annex 11. Proficient in assessing validation approaches and providing clear remediation recommendations for clinical trial outputs and AI-driven systems.

Highest-signal resume keywords

Computerized System ValidationGxP ExperienceGAMP 5 ProficiencyCDISC Data Standards KnowledgeAI Workflow Validation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Approaches ReviewAudit Trail CheckingAccess Control AssessmentChange Control VerificationRisk Assessment Using GAMP 5Clinical Trial Output ValidationRegulatory Submission ValidationMachine Learning System ValidationRemediation Recommendation WritingData Standards Compliance

Soft Skills

Clear WritingPractical Communication

Industry Keywords

21 CFR Part 11EU GMP Annex 11GxPClinical Trial OutputsReal-World EvidenceComputer Software AssuranceAuditRegulatory ComplianceFreelance ArrangementTechnology Due Diligence

About the role

Key responsibilities & impact

Review validation approaches, records and evidence for platforms producing clinical trial and real-world evidence outputs
Check audit trails, access controls, electronic records and change control against 21 CFR Part 11 and EU GMP Annex 11
Assess whether validation is proportionate to risk using GAMP 5 and Computer Software Assurance principles
Check how validation remains current when AI workflows and machine learning models change
Check outputs against data standards such as CDISC SDTM and ADaM
Rate findings according to their potential effect on a deal
Write clear, practical remediation recommendations
Report to an Intelance engagement partner
Work with the pharma specialist and technology due diligence lead to support final reports

Requirements

What you’ll need

At least five years of computerised system validation in a GxP setting
Hands-on use of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11
Experience validating or auditing systems that produce clinical trial or regulatory submission outputs
Working knowledge of CDISC data standards
Clear, plain writing that founders, buyers and lawyers can follow
Experience validating systems that use machine learning or AI is a strong plus
Freelance or own limited company arrangement
Occasional meetings in London
Availability for around 3 to 5 days between late November 2026 and the end of January 2027

Benefits

Comp & perks

Reasonable travel costs for client meetings are covered
Remote work within the UK
Use of an Intelance mailbox, evidence log and report templates
Panel agreement, NDA and statement of work signed before client details are shared