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

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time

Country Operations Manager, Sponsor Dedicated

Key skills