Manager, Clinical Study Lead

About the role

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, including Phase IV/Real World Evidence studies, from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.

Responsibilities

• 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
• 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 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 manages unmasked trial master file; reviews unmasked data in the electronic data capture system; acts as point of contact for IVRS issues; and supports oversight of unmasked clinical monitoring

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
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
• Experience with Phase IV /RWE preferred

Qualifications

• Must be able to travel up to 25%

Skills

• Excellent communication and interpersonal skills
• Strong problem-solving and decision-making abilities
• Ability to manage multiple projects simultaneously
• Proficiency in Microsoft Office Suite
• Knowledge of ICH/GCP and relevant regulatory guidelines

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Hybrid; 4 days per week on site