Remote CTA: Trial Start-Up & TMF Management

ICON Strategic Solutions; Malaysia; Hybrid; MYR 50,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Retirement planning offerings

Global Employee Assistance Programme (

LifeWorks

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re committed to inclusion and driving innovation in clinical development.

The Clinical Trial Assistant (CTA) supports planning, start-up, execution, and close-out of trials, handling essential documentation, site activities, and ensuring GCP compliance. The role involves collaboration with Clinical Operations, Study Management, Regulatory, and QA, with opportunities to use AI-enabled tools to enhance

Qualifications

• 2+ years of experience in clinical research or related roles.
• Experience with TMF/eTMF management or study coordination.
• Knowledge of ICH-GCP and regulatory standards.
• Proficiency with MS Office applications.
• Experience using AI-powered productivity tools for document review and reporting.
• Experience with CTMS/eTMF systems.

Responsibilities

• Support clinical trial activities from start-up through close-out.
• Maintain study, country, and site-level data in CTMS and other systems.
• Collect, review, and file essential study documentation.
• Ensure TMF/eTMF completeness and accuracy.
• Assist with regulatory submissions and ethics documentation.
• Coordinate distribution of study materials and safety communications.
• Monitor study progress and generate operational reports.

Skills

Excellent communication

Stakeholder management

Organizational skills

Attention to detail

MS Office

AI productivity tools

English proficiency

Education

Bachelor's Degree in Life Sciences / related

Tools

CTMS

eTMF

Veeva Vault TMF

Document management platforms

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re committed to inclusion and driving innovation in clinical development.

The Clinical Trial Assistant (CTA) supports planning, start-up, execution, and close-out of trials, handling essential documentation, site activities, and ensuring GCP compliance. The role involves collaboration with Clinical Operations, Study Management, Regulatory, and QA, with opportunities to use AI-enabled tools to enhance