Manager, Clinical Study Lead

Responsibilities

• Accountable for the global execution of assigned smaller or less complex clinical trials, including Phase IV/Real World Evidence studies, from study design, through execution, to study close out.
• Accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
• Contributes and drives ongoing process improvement initiatives.
• Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions.
• 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 responds to deviations from plan; 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.
• Sets up and maintains 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.
• 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; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.

Requirements

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise; a proven ability to build productive study teams and collaborations; and demonstrated vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications is required, including 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; and effective project management, cross-functional team leadership, and organizational skills.
• Experience with Phase IV /RWE preferred.