Regeneron Pharmaceuticals

The role involves accountability for centralized monitoring activities, including analytical data review of key risk and operational performance data for global or complex trials, interpreting KRI/KPI data, and presenting findings to study teams. Responsibilities also include leading process improvement, innovation activities, and serving as a subject matter expert for Central Monitoring RBQM systems.

The TMF Manager will lead TMF Health initiatives to ensure accuracy and completeness while collaborating with CROs and internal teams to resolve documentation issues. Responsibilities also include presenting eTMF updates, developing TMF plans and inventories, and conducting reviews to confirm inspection readiness.

The role focuses on engaging strategically with key external US hematology thought leaders at academic centers and leading community practices to gather insights and share clinical information regarding the company's hematology bispecific product. This involves coordinating engagements for senior executives, supporting speaker bureau development, and liaising with thought leaders for advisory board planning while ensuring strict adherence to compliance guidelines.