Country Operations Manager, Sponsor Dedicated
Job Description:
• 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
Requirements:
• Strong clinical trial management (CTM) experience at country or regional level
• Demonstrated expertise across start-up, conduct, and closeout
• Deep knowledge of ICH/GCP and local regulatory requirements
• Experience driving recruitment and data quality performance
• Vendor oversight and cross-functional stakeholder leadership experience
• Strong analytical, organizational, and communication skills
Benefits:
• 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
Apply Now
Apply Now
• 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
Requirements:
• Strong clinical trial management (CTM) experience at country or regional level
• Demonstrated expertise across start-up, conduct, and closeout
• Deep knowledge of ICH/GCP and local regulatory requirements
• Experience driving recruitment and data quality performance
• Vendor oversight and cross-functional stakeholder leadership experience
• Strong analytical, organizational, and communication skills
Benefits:
• 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
Apply Now
Apply Now