Senior Manager Global Site Start-Up Lead

Overview

NOTE:

this role is required to be onsite in either Armonk, NY or Warren, NJ. This role is NOT eligible fully remote.

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 a 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.

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.

• Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.
• Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
• Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.
• Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).

• Lead and oversee all aspects of site start-up activities for complex, high profile studies, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
• Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
• Oversee CRO site start up management or in house site facing regional SSU team, where applicable
• Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
• Oversee the preparation and approval of site regulatory package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.

• Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
• Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution

• Recommends and drives cross functional and department process improvements.