Manager Clinical Study Lead

Overview

Build our future together:
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight.

• Accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out.
• Accountable for the study timelines and budget and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
• Lead the cross‑functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversee 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.
• Provide operational input into protocol development; lead feasibility assessments to select relevant regions and countries; oversee or conduct site evaluation and selection; and lead investigator meeting preparation and execution.
• Oversee and contribute 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.
• Oversee set‑up and maintenance of study systems (e.g., CTMS, TMF) and ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs and lead vendor engagement, contracting, and management; ensure CROs and third‑party vendors are aligned and delivering per scope of work.
• Provide input into baseline budget and timeline development and management; ensure accurate budget management and scope change control for internal and external studies.
• Lead study‑level risk assessment and mitigation; monitor site activation and monitoring visits and act on deviations; lead development and oversee implementation of patient recruitment and retention strategies and respond to deviations from plan; and monitor data entry and query resolution against agreed metrics.
• Manage study close‑out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contribute to clinical study report writing and review; and facilitate study‑level lessons learned.
• Assign tasks to Clinical Study Management staff and support their deliverables; directly supervise CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommend and participate in cross‑functional and departmental process improvements; and identify innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• May be assigned unmasked tasks for studies, which may include but are 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.

• 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; 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.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.

Regeneron offers a comprehensive benefits package. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family…