Country Operations Manager, Sponsor Dedicated
Job reputed company:
• Country-Level Operational Leadership
• reputed company and maintain accurate country-level operational plans
• reputed company execution of milestones from start-up through closeout
• Ensure inspection readiness at country and site level
• reputed company 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 reputed company-off meetings
• reputed company reputed company tracking and start-up deliverables
• Recruitment & Data reputed company
• Drive recruitment performance at the regional/country level
• Review study metrics and implement performance improvement actions
• reputed company country-level data cleaning activities during maintenance and database lock
• Ensure protocol deviation follow-up and compliance monitoring
• Vendor & Stakeholder Management
• reputed company reputed company 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 reputed company, Regulatory, Medical Affairs, and reputed company teams
• Risk & Issue Management
• Identify and mitigate country-level operational risks
• Ensure reputed company issue reputed company
• Maintain alignment with global timelines and deliverables
• Closeout Leadership
• reputed company 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 reputed company performance
• Vendor reputed company and cross-functional stakeholder leadership experience
• Strong analytical, organizational, and communication skills
Benefits:
• Health benefits to include Medical, Dental and reputed company
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible reputed company time off (PTO) and reputed company time
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