Clinical systems and quality
Supporting computer system validation
I supported my team in computer system validation, bringing a clinical data management perspective to the review of systems used in study workflows.
Audit participation as an auditee
I have participated as an auditee in tens of computer system validation audits. This experience sits alongside my supporting contribution to validation and hands-on clinical system QC and UAT.
Related testing experience
Alongside validation support, I performed post-build QC and UAT for eSource and CTMS workflows. This included checking study setup and workflow behaviour, with experience of lock and unlock processes, versioning and amendment rollouts.
Working across disciplines
My wider role involves coordinating with developers on system enhancements, troubleshooting and clinical requirements. That helps me explain an issue in terms of both the software behaviour and its effect on the study team.
A practical quality mindset
I focus on clear expected behaviour and observable test results. My clinical data management experience helps frame review around the records, workflows and user tasks that the system supports.