Manage mid-study changes through formal change control process for protocol amendments by assessing cross-functional impact, updating specifications, retesting, and securing approvals and budget allocation before implementation, with clear communication to study teams and sites. • Partner with IT and study teams to translate protocols into User Requirement Specifications (URS), confirming that the randomization design, visit schedule, dosing regimens, stratification factors, unblinding rules, and drug supply configuration are captured accurately before the build begins.