Temp Global Site Start Up Lead

Regeneron · Warren +1 more

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Clinical OperationsFull-timeCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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What RoleLantern checked

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Date posted2 days ago

Last source check1 day ago

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