Regeneron
SeniorManagerGlobalStudyStartUp
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager Global Study Start Up at Regeneron. Skills: Site activation strategy, CRO performance monitoring. Drive global execution of site activation. Ensure efficient and compliant processes”
Industry & Context.
Problem solving
Up to 25% travel
What They're Looking For.
Must Have
Bachelor's degree, 8+ years industry experience
Nice to Have
Sponsor Site Start-Up role preferred
What You'll Do.
Drive global execution of site activation
Ensure efficient and compliant processes
Partner with cross-functional teams
Partner with Clinical Research Organizations
Develop site activation projections
Mitigate risks impacting site activation
Monitor CRO performance
Lead site start-up activities
Ensure timely submissions
Leverage country intelligence
Manage and support team
Develop site start up strategy
Outline dependencies impacting site activation
Mitigate and escalate risks
Oversee tracking and analysis of study metrics
Evaluate CRO performance
Implement corrective actions
Advocate for optimized site selection
Guide cross-functional teams
Lead development of site activation projections
Ensure cross-functional collaboration
Ensure CRO collaboration
Ensure compliant documentation of site start-up materials
Maintain inspection readiness
Develop global country start up strategy
Outline dependencies impacting country start up
Mitigate and escalate risks cross functionally
Monitor country intelligence data
Support regulatory submissions
Provide required site documentation
Coordinate submissions to Central IRBs
Support sites with Local IRB submissions
Handle insurance requests
Supervise insurance requests
Ensure timely country submission deliverables
Oversee site start-up activities
Lead fast-track site initiation
Oversee document collection
Oversee milestone tracking
Serve as subject matter expert for essential site
Provide training on regulatory requirements
Provide guidance on document management
Provide support on TMF filing
Oversee CRO site start up management
Oversee in house site facing regional SSU team
Lead collection of site intelligence
Analyze site intelligence
Oversee preparation of site regulatory package
Oversee approval of site regulatory package
Represent SSU on cross-functional teams
Provide updates on site start-up issues
Escalate site start-up challenges
Propose mitigation strategies for site start-up issues
Act as escalation point for CRO
Act as escalation point for internal team
Ensure timely SSU issue resolution
Recommend process improvements
Drive process improvements
Assign work to SSU staff
Manage performance of SSU staff
Provide ongoing training to SSU staff
Ensure compliance of SSU staff
Provide study support to SSU staff
Provide oversight to SSU staff
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical Research Organizations; CRO partners; Internal team
Communication Scope
Verbal abilities; Written abilities; Presentation abilities
Process & Methodology
Project management, Organizational skills
Full Job Description
The **Senior Manager, Global Site Start-Up Lead**(SSU Lead) is responsible for driving the global execution of site activation for complex, high profile clinical trials, performing the role with high-degree of independence to ensure efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. Partnering closely with cross-functional teams and Clinical Research Organizations (CROs), this role balances strategic oversight with hands-on leadership to address challenges and deliver study objectives. The SSU Lead develops site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics. Additionally, they lead all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision-making. This person will also be responsible for direct line management and supporting development of their team.**** **A typical day in this role looks like:** _Site Start-up Strategy_ * Develop the site start up strategy for each study assigned (complex, high profile), outlining all dependencies impacting site activation and actively mitigating and escalating risks. * Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions. * Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making. * Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives. * Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness. _Country Start-up_ * Partner with cross functional and CRO partners (where applicable)
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