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Regeneron

Temp Global Site Start Up Lead

Regeneron

. Drive global execution of site activation for clinical trials .

Posted 9/29/2026full-timeArmonk • New York • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in global site activation for clinical trials, including site start-up strategies, regulatory submissions, and compliance with ICH-GCP guidelines. Proficient in managing cross-functional teams and CRO performance through data analysis and effective communication.

Highest-signal resume keywords
Global Site Activation ExecutionRegulatory Submission ProcessesCRO Performance MonitoringSite Start-Up ActivitiesDocument Management and TMF Filing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Site Activation StrategiesRisk MitigationMetrics AnalysisMilestone TrackingRegulatory Package PreparationCIRB Submission CoordinationLIRB Submission CoordinationCountry IntelligenceInspection ReadinessSite Documentation Compliance
Soft Skills
Cross-Functional CollaborationProblem SolvingEffective CommunicationTraining and GuidanceEscalation Management
Industry Keywords
ICH-GCP GuidelinesClinical TrialsTrial Master File (TMF)Central Institutional Review Board (CIRB)Local Institutional Review Board (LIRB)Clinical Research Organizations (CROs)Regeneron SOPsSite Start-Up ManagementCountry-Specific RequirementsProcess Improvements

About the role

Key responsibilities & impact
  • Drive global execution of site activation for clinical trials
  • Develop site start-up strategies, identify dependencies, and mitigate or escalate risks
  • Track and analyze study metrics, risks, mitigation strategies, and CRO performance
  • Guide cross-functional teams on data-driven site selection strategies
  • Develop, assess, and align site activation projections with cross-functional and CRO partners
  • Maintain complete and compliant site start-up documentation in the Trial Master File (TMF)
  • Develop global country start-up strategies and maintain country intelligence data
  • Support regulatory submissions, including site documentation, CIRB/LIRB submissions, and CRO insurance requests
  • Ensure timely country submission deliverables and effective communication pathways
  • Lead fast-track site initiation, site calls, document collection, and milestone tracking
  • Provide training and guidance on essential site documents, regulatory requirements, document management, and TMF filing
  • Oversee CRO site start-up management or in-house regional SSU teams
  • Collect and analyze site intelligence for site selection and start-up
  • Oversee site regulatory package preparation and approval while maintaining inspection readiness
  • Represent SSU on cross-functional teams, provide updates, escalate challenges, and propose mitigation strategies
  • Serve as escalation point for CRO and internal teams
  • Recommend and participate in cross-functional and departmental process improvements

Requirements

What you’ll need
  • Moderate oversight of global site activation execution for clinical trials
  • Knowledge of Regeneron SOPs, ICH-GCP guidelines, and industry standards
  • Experience partnering with cross-functional teams and Clinical Research Organizations (CROs)
  • Ability to develop site activation projections and mitigate site activation risks
  • Ability to monitor CRO performance through metrics analysis and implement corrective actions
  • Experience with site start-up activities, fast-track initiation, milestone tracking, and document collection
  • Knowledge of country intelligence and regulatory submission processes
  • Ability to coordinate Central Institutional Review Board (CIRB) and Local Institutional Review Board (LIRB) submissions
  • Expertise in essential site documents, regulatory requirements, document management, and TMF filing
  • Ability to prepare and approve site regulatory packages in compliance with country-specific requirements
  • Ability to represent SSU on cross-functional teams and resolve escalated issues
  • Willingness to travel up to 25%

Benefits

Comp & perks
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during the recruitment process where required