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 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
• Applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight will vary accordingly
• Contributes 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 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
• 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, which may include but is 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
  • Support oversight of unmasked clinical monitoring

Requirements

• Bachelor’s degree
• At least six years of relevant industry experience

Qualifications

• Extensive budget management expertise
• A proven ability to build productive study teams and collaborations
• Demonstrated vendor management experience
• Strong technical proficiency with trial management systems and Microsoft applications, 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
• 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

Work location

Armonk, NY, Warren, NJ

25% Travel may be required

Pay

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