Clinical Study Associate

ICON plc

. Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with FSP CTA Manager(s) .

Posted 10/9/2026full-timeRemote • India, Costa Rica, Kenya, MexicoJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study support, regulatory compliance, and risk-based monitoring, with a strong focus on collaboration and communication across cross-functional teams. Proficient in managing clinical trial systems and documentation while ensuring adherence to established protocols.

Highest-signal resume keywords

Clinical Research ExperienceVeeva System ProficiencyRegulatory Compliance KnowledgeTask Management ExcellenceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study SupportRegulatory Inspection ReadinessRisk-Based MonitoringStudy Documentation ReviewFinancial Reconciliation

Soft Skills

Excellent Communication SkillsTeamworkOrganizational SkillsInterpersonal SkillsProblem-Solving Skills

Tools & Technologies

CTMSTMFVeeva System

Industry Keywords

Pharmaceutical IndustryClinical Research OrganizationPhase 2 StudiesPhase 3 StudiesOncology

About the role

Key responsibilities & impact

Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with FSP CTA Manager(s)
Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model
Perform departmental tasks as needed
Review study documentation, including essential document packets, study plans, and informed consent forms
Support and oversee risk-based monitoring
Attend key team meetings as required, including preparing minutes for selected studies
Support regulatory inspection readiness, including SOP lists and storyboard collation
Support clinical trial systems such as CTMS/TMF and associated activities for selected studies
Support vendor contract administration as required
Support study close-out activities, including financial reconciliation
Support additional ad-hoc activities as needed, as agreed with Manager(s)
Collaborate with internal departments, CROs, and external vendors

Requirements

What you’ll need

Bachelor's degree in a scientific or healthcare-related field or equivalent international degree required
1-2 years’ experience in pharmaceutical industry, clinical research organization, or related role
Experience in Phase 2 and 3 studies and global/international studies is advantageous
Must have experience in Veeva system
Experience working across multiple therapeutic areas (including oncology) is advantageous
Knowledge in global/regional regulatory and compliance requirements for clinical research
Demonstrated excellence in task management and cross-functional collaboration
Excellent communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Fluent business English (oral and written)
Ability to work collaboratively in a fast-paced environment with attention to detail
Willingness to travel as required (approximately 10%)
Employment with ICON is contingent upon having the legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways