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About the Role

Accountable for the global execution of assigned clinical trials from study design through close out, ensuring adherence to timelines, budget, and regulatory standards. This role involves managing study conduct for both internally sourced and externally outsourced studies.

Responsibilities

• Leads the cross-functional study team for clinical study delivery, acting as the primary point of contact.
• Oversees execution against planned timelines, deliverables, and budget, escalating issues and implementing corrective actions.
• Provides operational input into protocol development and leads feasibility assessments.
• Oversees or conducts site evaluation and selection.
• Leads investigator meeting preparation and execution.
• Oversees and contributes to study documentation, including case report forms and data management plans.
• Oversees study systems setup and maintenance, ensuring compliance with clinical trial registry requirements.
• Identifies outsourcing needs and leads vendor engagement, contracting, and management.
• Provides input into baseline budget and timeline development and management.
• Ensures accurate budget management and scope change control.
• Leads study-level risk assessment and mitigation.
• Monitors site activation and monitoring visits, acting on deviations.
• Leads development and oversees implementation of patient recruitment and retention strategies.
• Responds to deviations from plan and monitors data entry and query resolution.
• Manages study close-out activities, including database lock and reconciliation.
• Contributes to clinical study report writing and review.
• Facilitates study-level lessons learned.
• Assigns tasks to Clinical Study Management staff and supports their deliverables.
• Directly supervises CTM staff, including performance management and professional development.
• Recommends and participates in cross-functional and departmental process improvements.
• Identifies innovative approaches to study execution and continuous improvement of CTM SOPs.
• May be assigned unmasked tasks for studies, including investigational product support and trial master file management.

Requirements

• 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 management experience.
• Strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel).
• Proficiency with 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 operational strategic direction and guidance for clinical studies.

Skills

• Budget management
• Team leadership
• Vendor management
• Trial management systems
• Microsoft Project
• Microsoft PowerPoint
• Microsoft Word
• Microsoft Excel
• IVRS/IWRS
• EDC
• Global clinical trial operations
• Protocol development
• ICH/GCP
• Regulatory guidelines
• Project management
• Cross-functional team leadership
• Organizational skills

Location

• Armonk, NY
• Warren, NJ

Work Type

• On-site
• 25% Travel

Experience Level

• At least six years of relevant industry experience

Education Level

• Bachelor’s degree

Salary/Compensations

• $128,600.00 - $210,000.00

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron is committed to building a workplace with an inclusive culture.
• Regeneron offers a competitive and comprehensive total rewards package.

Equal Opportunity

• Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.