Temp Global Site Start Up Lead

Regeneron Pharmaceuticals, Inc.; Warren (MI); On-site; USD 110,000 - 170,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Manager to lead global site activation for clinical trials, developing start-up strategies and ensuring ICH-GCP compliance.

You will coordinate regulatory submissions, manage CROs and cross-functional teams, and drive milestones from initiation to TMF readiness, maintaining high standards and company SOP adherence across regions.

Qualifications

• 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 CROs and vendor management.
• Document management and Trial Master File (TMF) expertise.
• Data analysis and risk mitigation capabilities.

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.

Skills

Clinical operations

ICH-GCP knowledge

Project management

Vendor management

TMF expertise

Data analysis

Cross-functional coordination

Job description

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