Hybrid Senior Manager, Clinical Study Lead – Hematology-Oncology

at Regeneron

• Job title: Senior Manager, Clinical Study Lead – Hematology-Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Dublin, Ireland

About the role

• Senior Manager Clinical Study Lead overseeing global execution of complex clinical trials. Leading cross-functional study team and ensuring compliance with regulatory requirements and budget management.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight
• Provides operational input into protocol development
• Oversees the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Ensures compliance with the clinical trial registry requirements
• Identifies outsourcing needs of the study and leads engagement, contracting and management of required vendors
• Provides input into baseline budget development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability

Requirements

• Minimum of a Bachelor's degree
• Minimum of 8 years relevant clinical trial experience
• Exceptional interpersonal & leadership skills
• Advanced project management skills, cross-functional team leadership and organizational skills
• Strong budget management experience
• Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
• Ability to build, lead and develop productive study teams and collaborations.
• Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)