Manager, Global Study Start-Up

Regeneron Pharmaceuticals • Warren, MI

1d

About The Position

The Manager, Global Site Start-Up Lead (SSU Lead) drives the global execution of site activation for clinical trials with moderate oversight. The role ensures efficient, compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. Working closely with cross-functional teams and CROs, the SSU Lead provides strategic oversight and hands-on leadership to address challenges and deliver study objectives. The role develops site activation projections, mitigates site activation risks, monitors CRO performance through metrics, and leads site start-up activities such as fast-track initiation, milestone tracking, document collection, and timely submissions, using country intelligence to inform decisions.

The position is based primarily in Armonk, NY, with Warren, NJ listed as an additional location. It may require up to 25% travel. The role represents Site Start-Up on cross-functional teams, serves as an escalation point for CRO and internal teams, and recommends and participates in process improvements.

Requirements

• Demonstrated interpersonal and leadership skills.
• Ability to understand and implement operational strategic direction and guidance for clinical studies.
• Data-driven approach to planning, execution, and problem solving.
• Effective verbal, written, and presentation communication skills.
• Proactive, self-disciplined approach, with the ability to meet deadlines, manage time effectively, and prioritize.
• Ability to influence and negotiate across key stakeholders.
• Ability to build productive study-team collaborations.
• Experience in clinical drug development, with expertise in study start-up.
• Demonstrated vendor management experience.
• Technical proficiency in trial management systems, including CTMS and TMF, and Microsoft applications including Project, PowerPoint, Word, and Excel.
• Knowledge of ICH/GCP and regulatory guidelines and directives.
• Effective project management, cross-functional team interaction, and organizational skills.

Responsibilities

• Develop each study’s site start-up strategy, identify dependencies affecting activation, and mitigate or escalate risks.
• Track and analyze study metrics, including risks and mitigation strategies, to evaluate CRO performance and implement corrective actions.
• Advocate for optimized site selection strategies using data-driven insights to support cross-functional decisions.
• Develop, assess, and align site activation projections with cross-functional teams and CROs.
• Ensure site start-up materials are documented in the Trial Master File (TMF) and support inspection readiness.
• Partner with cross-functional and CRO teams to develop global country start-up strategies, identify dependencies, and mitigate or escalate risks.
• Monitor and maintain country intelligence data to inform decisions, projections, and strategic plans.
• Support regulatory submissions by providing site documentation, coordinating CIRB submissions, supporting LIRB submissions, and handling or supervising CRO insurance requests.
• Ensure timely country submission deliverables, including task completion, role clarity, critical-path identification, and effective communication pathways.
• Lead site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking.
• Serve as a subject matter expert on essential site documents and provide training, guidance, and support on regulatory requirements, document management, and TMF filing.
• Oversee CRO site start-up management or the in-house site-facing regional SSU team, where applicable.
• Lead the collection and analysis of site intelligence to support site selection and site start-up.
• Oversee preparation and approval of site regulatory packages, ensuring compliance with country requirements, TMF standards, and ICH-GCP guidelines, and supporting inspection readiness and high-quality documentation.
• Represent Site Start-Up on cross-functional teams, provide updates, escalate challenges, and propose mitigation strategies.
• Act as the escalation point for CRO and internal teams to support timely resolution of site start-up issues.
• Recommend and participate in cross-functional and departmental process improvements.

Benefits

• Competitive and comprehensive total rewards package, which may include 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, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed