Manager, Global Study Start-Up

Regeneron Pharmaceuticals • Armonk, NY

2d • $114,800 - $187,400

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, ensuring efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. The role partners with cross-functional teams and CROs, combining strategic oversight with hands-on leadership to resolve challenges and meet study objectives. Responsibilities include developing site activation projections, mitigating risks, monitoring CRO performance through metrics, and leading site start-up activities such as fast-track initiation, milestone tracking, and document collection. The role also ensures timely submissions and uses country intelligence to inform decisions.

The position is based primarily in Armonk, New York, with an additional location in Warren, New Jersey. Travel may be required up to 25%. The role represents Site Start-Up on cross-functional teams, acts as an escalation point for CRO and internal teams, and recommends and participates in process improvements.

Regeneron describes its total rewards package as potentially including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits, depending on country and role. Many roles are required to be performed on-site; applicants should discuss on-site expectations with the recruiter and hiring manager.

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 and self-disciplined, with the ability to meet deadlines, use 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 study-specific site start-up strategies, identify dependencies, and mitigate or escalate risks affecting site activation.
• Track and analyze study metrics, including risks and mitigation strategies, to evaluate CRO performance and implement corrective actions.
• Advocate for optimized, data-informed site selection strategies and guide cross-functional decision-making.
• Lead the development, assessment, and alignment of site activation projections with cross-functional and CRO partners.
• Ensure site start-up materials are comprehensively and compliantly documented in the Trial Master File (TMF) and maintain inspection readiness.
• Partner with cross-functional and CRO partners to develop global country start-up strategies, identify dependencies, and mitigate or escalate risks.
• Monitor and maintain country intelligence data to support decisions, projections, and strategic plans.
• Support regulatory submissions by providing site documentation, coordinating Central Institutional Review Board (CIRB) submissions, supporting Local Institutional Review Board (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 and oversee 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 teams and sites with 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 strategic site selection and site start-up.
• Oversee preparation and approval of site regulatory packages, ensuring compliance with country-specific 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 ensure 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, depending on country and role.

What This Job Offers

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