• Country-Level Operational Leadership • Develop and maintain accurate country-level operational plans • Oversee execution of milestones from start-up through closeout • Ensure inspection readiness at country and site level • Lead the Regional/Country Operational Sub-Team • Study Start-Up & Activation • Coordinate IRB/IEC and regulatory submission strategies • Manage country-level translation and Informed Consent Document (ICD) development • Review PTAs and SIV documentation • Conduct country kick-off meetings • Oversee milestone tracking and start-up deliverables • Recruitment & Data Excellence • Drive recruitment performance at the regional/country level • Review study metrics and implement performance improvement actions • Lead country-level data cleaning activities during maintenance and database lock • Ensure protocol deviation follow-up and compliance monitoring • Vendor & Stakeholder Management • Provide oversight of local vendors • Review Site Care Partner reports and issue documentation • Ensure seamless bidirectional communication between global and local teams • Partner closely with the Global Study Manager (GSM), Study Operations Manager (sSOM), Site Care Partners, Regulatory, Medical Affairs, and Contracts teams • Risk & Issue Management • Identify and mitigate country-level operational risks • Ensure timely issue resolution • Maintain alignment with global timelines and deliverables • Closeout Leadership • Oversee site closure documentation and review • Support end-of-trial notifications • Ensure vendor closeout and supply reconciliation