Senior Manager Clinical Study Lead

Regeneron Pharmaceuticals • Armonk, NY

394d • $148,300 - $241,900 • Remote

About The Position

The Senior Manager Clinical Study Lead (CSL) is responsible for the global execution of large and complex clinical trials, overseeing all phases from study design to closeout. This role ensures compliance with regulatory standards and manages study timelines and budgets, while also contributing to process improvement initiatives. The position requires a minimum of three days onsite and involves direct line management responsibilities.

Requirements

• Bachelor's degree with a minimum of 8 years of relevant industry experience.
• Direct experience managing global clinical trial operations.
• Technical proficiency in trial management software and MS applications.
• Expert knowledge of ICH/GCP and regulatory guidelines.
• Advanced project management skills and cross-functional team leadership experience.
• Strong budget management experience.

Nice To Haves

• Advanced degrees may be considered in lieu of relevant experience.
• Exceptional interpersonal and leadership skills.
• Ability to influence and negotiate across a wide range of stakeholders.
• Proactive and self-disciplined with effective time management skills.

Responsibilities

• Lead the cross-functional study team responsible for clinical study delivery.
• Provide operational input into protocol development.
• Oversee the development of study-specific documentation such as case report forms and monitoring plans.
• Ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs and manage vendor engagement and contracting.
• Provide input into baseline budget and timeline development.
• Lead risk assessment and mitigation strategies at the study level.
• Conduct site evaluation and selection.
• Monitor progress for site activation and monitoring visits.
• Develop and oversee patient recruitment and retention strategies.
• Monitor data entry and query resolution.
• Ensure accurate budget management and scope changes for studies.
• Oversee study drug and clinical supplies forecasting and accountability.
• Escalate issues related to study conduct to stakeholders.
• Ensure clinical project audit and inspection readiness throughout the study lifecycle.
• Manage study close-out activities including database lock and reconciliation of vendor contracts.
• Contribute to clinical study report writing and review.
• Facilitate study level lessons learned and recommend process improvements.
• Supervise Clinical Study Management staff and manage their performance.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree