Senior Manager Global Study Start Up

About the role

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. This role involves balancing strategic oversight with hands-on leadership to address challenges and deliver study objectives.

Responsibilities

• Develop the site start-up strategy for each study assigned, 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 evaluate CRO performance to 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 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, ensuring task completion, all roles clarity, identification of critical path items, and effective communication pathways.
• 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.
• Responsible for direct supervision of SSU staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.

Requirements

• Strong interpersonal and leadership skills.
• Ability to provide and implement operational strategic direction and guidance for respective clinical trials.
• Demonstrates strong knowledge and a data-driven approach to planning, executing, and problem-solving.
• Strong communication skills via verbal, written, and presentation abilities.
• Proactive and self-disciplined, able to meet deadlines, effectively use time, and prioritize tasks.
• Ability to influence and negotiate across a wide range of stakeholders.
• Ability to lead and develop productive study teams and collaborations.
• Applies advanced negotiation and interpersonal skills to vendor management.
• Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel.
• Extensive experience in the clinical drug development process, including study start-up.
• Knowledge and understanding of ICH/GCP and regulatory guidelines/directives.
• Strong project management skills, cross-functional team interaction, and organizational skills.

Qualifications

• Minimum of a Bachelor's degree.
• 8+ years of relevant industry experience.
• Preference for a sponsor Site Start-Up role.

Skills

• Strong interpersonal and leadership skills.
• Ability to provide and implement operational strategic direction and guidance for respective clinical trials.
• Demonstrates strong knowledge and a data-driven approach to planning, executing, and problem-solving.
• Strong communication skills via verbal, written, and presentation abilities.
• Proactive and self-disciplined, able to meet deadlines, effectively use time, and prioritize tasks.
• Ability to influence and negotiate across a wide range of stakeholders.
• Ability to lead and develop productive study teams and collaborations.
• Applies advanced negotiation and interpersonal skills to vendor management.
• Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel.
• Extensive experience in the clinical drug development process, including study start-up.
• Knowledge and understanding of ICH/GCP and regulatory guidelines/directives.
• Strong project management skills, cross-functional team interaction, and organizational skills.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$134,400.00 - $219,200.00 annually

Schedule

Full time