Clinical Study Specialist

About the role

Join our Clinical Trial Management team at Regeneron, a science-driven organization dedicated to developing life-changing medicines for people with serious diseases. This role offers the opportunity to contribute to a fast-growing organization making a meaningful difference to patients worldwide.

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
• Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
• Bridges gaps between study teams and stakeholders, ensuring smooth execution of clinical trials

Requirements

• Bachelor's degree with 2+ years of industry-related work experience in a clinical setting
• Working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP

Qualifications

• Proactive, self-disciplined, and effective at managing deadlines and priorities
• Attention to detail and resourcefulness in problem-solving

Skills

• Strong organizational and communication skills
• Ability to manage multiple tasks and projects simultaneously
• Proficiency in MS Office applications
• Understanding of clinical trial processes and regulatory requirements

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include:

• 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
• Family support benefits

Pay

$93,900.00 - $153,300.00 annually

Schedule

Hybrid: 4 days per week onsite