Temp Global Site Start Up Lead
Regeneron Pharmaceuticals, Inc.
Regeneron seeks a Manager to lead global site activation for clinical trials. The role involves developing site start-up strategies, managing regulatory submissions, coordinating with CROs and cross-functional teams, and ensuring compliance with ICH-GCP guidelines and company standards.
Responsibilities
- Develop site activation strategies and projections for clinical trials aligned with company SOPs
- Monitor CRO performance using metrics analysis and implement corrective actions
- Lead site start-up activities including fast-track initiation, document collection, and milestone tracking
- Manage country start-up planning and regulatory submissions across global regions
- Serve as escalation point for site start-up issues and represent the function on cross-functional teams
Requirements
- Clinical operations or site start-up management experience
- Knowledge of ICH-GCP guidelines and regulatory requirements
- Project management and cross-functional team coordination skills
- Experience with Clinical Research Organizations (CROs) and vendor management
- Document management and Trial Master File (TMF) expertise
- Data analysis and risk mitigation capabilities
Vacancy posted 8 days ago
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