The Data Surveillance Analyst conducts data and operational reviews per project Data Surveillance Plans, helps develop DSPs (KRIs, QTLs, statistical parameters), configures surveillance technologies (e.g., CluePoints), documents findings and issues, and supports central monitoring reporting. Requires a university degree (medical/biological/pharmacy/data analytics), fluent English, hands-on experience with SAS/R/SQL, knowledge of RBQM and centralized/data-driven monitoring, and familiarity with CTMS/EDMS and SDTM concepts.

Provides quality oversight for technology solutions used in clinical trials, supporting computerized system validation (CSV), validation planning, risk assessment, change control, vendor audits and audit/inspection responses. Acts as a quality representative for the Parexel Quality System and supports development and continuous improvement of quality frameworks, training and compliance activities. Requires 2-3 years relevant experience and a degree in a related discipline.

Provide quality oversight across the technology solution lifecycle including independent review of validation packages (requirements, testing evidence, traceability, reports), monitor compliance with regulatory standards, support audits/inspections, facilitate root cause analysis and CAPA, assess AI-enabled solutions, and assist with vendor quality assessments. Requires 3–5 years' experience in computerized system validation, technology quality, clinical research, pharmaceutical quality, or other GxP-regulated environments.

Lead and execute GxP audits (including GMP/GLP/GCLP, TMF, safety/PV and supplier audits), manage audit programs and client relationships, provide QA consultancy, support regulatory inspections and mentor auditors. Role requires experience in quality assurance/auditing and clinical research regulations.