Clinical Study Specialist

Regeneron

. Organizes and delivers analyzable reports and metrics .

Posted 10/9/2026full-timeUnited StatesJuniorMid-Level💰 $93,900 - $153,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including data analysis, site coordination, and vendor oversight. Proficient in trial management systems and MS applications, with a solid understanding of clinical drug development and regulatory standards.

Highest-signal resume keywords

Clinical Trial ManagementData AnalysisTrial Management SystemsICH/GCP AwarenessVendor Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data CollationReport GenerationTMF ReconciliationSite Activation TrackingFeasibility Assessment

Soft Skills

ProactiveSelf-DisciplinedEffective Time Management

Tools & Technologies

MS ProjectMS PowerPointMS WordMS ExcelIVRS/IWRSEDCTMF

Industry Keywords

Clinical SettingClinical Drug DevelopmentStudy DocumentationSOP RevisionsProcess Improvements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Organizes and delivers analyzable reports and metrics
Coordinates study team meetings, agendas, and minutes
Collates data for feasibility and site selection assessments
Contributes to review of study documents and reference materials
Tracks site activation, enrollment, and monitoring visits against projected plans
Escalates issues or delays and monitors investigator/site status and registry postings
Ensures timely receipt of scheduled reports
Performs TMF reconciliations with study lead guidance
Communicates with sites and maintains site contact information and relationships
Contributes to close-out activities
Supports oversight of third-party vendors as needed
Investigates the impact of new information on trials
Participates in SOP revisions and departmental initiatives
Recommends 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 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
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
Hybrid flexibility
Reasonable accommodation during the recruitment process where required