Manager, Global Study Start-Up

Build our future together:

The Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight 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.

When & where:

• Primary Location: Armonk, NY
• Additional Locations: Warren, NJ

Discover Your Role

Site Start-Up Strategy

• Develop the site start-up strategy for each study, outlining all dependencies impacting site activation while actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics — including risks and mitigation strategies — 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) to develop a comprehensive global country start-up strategy, outlining all dependencies impacting country start-up while actively mitigating and escalating risks cross-functionally.
• Monitor and maintain country intelligence data to support informed decision-making and develop accurate start-up projections and strategic plans.
• Support regulatory submissions as needed, including:

• Providing required site documentation
• Coordinating submissions to Central Institutional Review Boards (CIRBs)
• Supporting sites with Local Institutional Review Board (LIRB) submissions
• Handling or supervising Clinical Research Organization (CRO) insurance requests

• Ensure timely country submission deliverables (task completion, role clarity, identification of critical path items, and effective communication pathways).

Site Start-Up Management

• Lead and oversee all aspects of site start-up activities, 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 the 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 packages, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.

Team Interactions

• Represent Site Start-Up (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 teams to ensure timely SSU issue resolution.

Process Improvement

• Recommend and participate in cross-functional and departmental process improvements.

Travel

• May require up to 25% travel

This role requires:

· Demonstrated interpersonal & leadership skills

· Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

· A data driven approach to planning, executing, and problem solving

· Effective communication skills via verbal, written and presentation abilities

· Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

· Ability to influence and negotiate across key stakeholders

· Ability to build productive study teams collaborations

· Experience in the clinical drug development process, with expertise in study start-up

· Demonstrated vendor management experience

· Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel

· Knowledge of ICH/GCP and regulatory guidelines/directives

· Effective project management skills, cross-functional team interaction and organizational skills

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