Manager Clinical Study Lead

Accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close-out. You are responsible for study timelines, budget, and ensuring study conduct aligns with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to both internally sourced studies and those outsourced to Clinical Research Organizations (CROs), with varying levels of direct leadership versus oversight. Contributes to and drives ongoing process improvement initiatives.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight. Oversees execution against planned timelines, deliverables, and budget while raising and addressing issues related to conduct, quality, timelines, or budget.
• Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution.
• Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials.
• Oversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements.
• Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work.
• Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies.
• Leads study-level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies; and monitors data entry and query resolution against agreed metrics.
• Manages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study-level lessons learned.
• Assigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight).
• Recommends and participates in cross-functional and departmental process improvements; identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• May be assigned unmasked tasks for studies, including but not limited to assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.

Requirements

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise; proven ability to build productive study teams and collaborations; demonstrated vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel) and platforms such as IVRS/IWRS and EDC.
• Experience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives.
• Effective project management, cross-functional team leadership, and organizational skills.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.

Schedule

• Work Location: Armonk, NY or Warren, NJ.
• Up to 25% travel may be required.
• Many roles are required to be performed on-site.

Pay

Salary Range (annually): $128,600.00 - $210,000.00.

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, insurance benefits (e.g., medical, dental, vision, life, and disability), paid time off, and family support benefits.
• For U.S.-based roles, additional details are available at Regeneron Total Rewards. For other locations, benefits information will be provided during the recruitment process.