Job Description
- 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
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