Ensure GDPR/HIPAA-aligned processes, DPAs, data minimization, and participant withdrawal workflow
Maintain audit-ready documentation: protocol versions, approvals, consent, data dictionary, QC reports, and transfer/assignment rights where applicable
Own the project plan, milestones, RAID log, and weekly reporting
Requirements
5+ years in clinical research operations (CRO, sponsor, academic trials unit, or digital health)
Proven experience setting up multi-site collaborations: feasibility, budgets, contracting, start-up
Familiarity with ethics/IRB workflows and informed consent in at least one region (EU/UK strongly preferred; US a plus)
Comfort working with sensitive data (GDPR) and producing strong documentation