Clinical Study Specialist

Regeneron

. Provide technical and administrative support to clinical study teams executing trials across a program .

Posted 9/22/2026full-timeUnited StatesJuniorMid-Level💰 $93,900 - $153,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial support, including site activation, monitoring, and close-out activities, while effectively managing relationships with study teams and external vendors. Proficient in trial management systems and MS applications to ensure timely reporting and adherence to regulatory standards.

Highest-signal resume keywords

Clinical Trial ManagementSite Activation CoordinationTrial Management SystemsICH/GCP AwarenessData Analysis and Reporting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial SupportData CollationFeasibility AssessmentTMF ReconciliationReport Generation

Soft Skills

Proactive ManagementEffective CommunicationSelf-DisciplineDeadline Management

Tools & Technologies

MS ProjectMS PowerPointMS WordMS ExcelIVRS/IWRSEDC

Industry Keywords

Clinical SettingClinical Drug DevelopmentStudy DocumentationThird-Party Vendor OversightSOP Revisions

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide technical and administrative support to clinical study teams executing trials across a program
Help ensure studies stay on track from site activation through close-out
Collaborate with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites
Organize and deliver analyzable reports and metrics
Coordinate study team meetings, agendas, and minutes
Collate data for feasibility and site selection assessments
Contribute to review of study documents and reference materials
Track site activation, enrollment, and monitoring visits against projected plans
Escalate issues or delays and monitor investigator/site status and registry postings
Ensure timely receipt of scheduled reports and perform TMF reconciliations with study lead guidance
Communicate with sites as directed and maintain site contact information and relationships
Contribute to close-out activities and support oversight of third-party vendors
Investigate the impact of new information on assigned study activities and trials
Participate in SOP revisions and departmental initiatives
Recommend process improvements

Requirements

What you’ll need

Bachelor's degree with 2+ years of industry-related work experience in a clinical setting
Ability to acquire working knowledge of 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
Proactive, self-disciplined, and effective at managing deadlines and priorities

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required