Manager, Clinical Study Lead

Clinical Study Lead Responsibilities

The Clinical Study Lead (CSL) 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 study timelines, study budget, and ensuring conduct in accordance with Regeneron SOPs, ICH/GCP.
• Contribute to and drive ongoing process improvement initiatives.
• Lead the cross‑functional study team responsible for clinical study delivery; serve as the primary point of contact for leadership and oversight; and oversee execution against planned timelines, deliverables, and budget, escalating issues to the Program Operations Lead and stakeholders.
• 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 such as CTMS and TMF, ensuring 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; monitor data entry and query resolution against agreed metrics.
• Oversee study drug and clinical supplies forecasting, drug accountability, and reconciliation.
• Oversee data quality, including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non‑compliance by sites.
• Ensure audit and inspection readiness throughout the study; support internal audits and external inspections and contribute to CAPAs as required.
• 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; identify innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• May be assigned unmasked tasks for studies, which may include assisting with masked investigational product, setting up and managing unmasked trial master file, reviewing unmasked data in the electronic data capture system, point of contact for IVRS issues, and supporting oversight of unmasked clinical monitoring.
• May require up to 25% travel.

• Demonstrated interpersonal and leadership skills.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.
• A data‑driven approach to planning, executing, and problem solving.
• Effective communication skills via verbal, written and presentation abilities.
• Proactive and self‑disciplined, ability to meet deadlines, effective use of time, and prioritization.
• Ability to influence and negotiate across key stakeholders.
• 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…