Description du poste
About IntelanceIntelance is an independent technology, AI and cyber assurance firm based in the UK. We help organisations check, govern and improve their technology through enterprise architecture, AI governance, cyber assurance and data governance work. We are building a small panel of senior associates to deliver technology and AI due diligence on company sales and investments.
The roleYou will check whether software used in drug development is validated to GxP standards, as part of technology due diligence for clients who are selling, buying or investing in life sciences technology companies. Pharmaceutical buyers want proof that a platform producing trial and regulatory outputs works reliably, keeps a full audit trail and would stand up to an inspection.
You report to an Intelance engagement partner and work alongside our pharma specialist and technology due diligence lead, who bring your findings into the final report.
What you will doReview the validation approach, records and evidence for platforms that produce 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.
Judge whether the validation is proportionate to risk, using GAMP 5 and Computer Software Assurance thinking.
Check how validation is kept current when AI workflows and machine learning models change.
Check that outputs follow the expected data standards, such as CDISC SDTM and ADaM.
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