Clinical Trial Assistant / Senior Clinical Trial Assistant

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Clinical Trial Assistant (CTA) or Senior CTA in Kuala Lumpur. Working with Clinical Operations, Study Management, Regulatory, Quality and cross-functional study teams, the CTA supports the planning, start-up, execution, maintenance and close-out of clinical trials, manages trial documentation, maintains trial management systems and ensures compliance with regulations, SOPs and Good Clinical Practice (GCP).

Key responsibilities

• Maintain study, country and site-level information in Clinical Trial Management Systems (CTMS) and other clinical systems.
• Collect, review, track and file study documentation throughout the trial lifecycle, keeping the TMF/eTMF complete, accurate and timely.
• Support study start-up, including regulatory submissions and ethics committee documentation.
• Coordinate distribution of study materials, safety communications and site documentation, and track study progress and operational metrics.
• Facilitate document collection and issue resolution with investigator sites, and support study meetings, training and stakeholder communications.
• Prepare for inspections and audits, coordinate document archiving and close-out, and propose process improvements.
• Partner with Clinical Operations, Regulatory Affairs, Quality, Finance and external sites, and use AI-enabled tools to improve document management and reporting.

Required profile

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Biotechnology or a related discipline, or equivalent education and experience.
• 2+ years of experience in clinical research, clinical operations or clinical trial support.
• Working knowledge of ICH-GCP guidelines, clinical trial regulations and industry standards.
• Experience with clinical trial documentation, study start-up, TMF/eTMF management or study coordination.
• Strong organisational, communication and stakeholder management skills, attention to detail and professional English.
• Remote or hybrid work; legal right to work in the country of the role.

Required skills

• Microsoft Office (Word, Excel, PowerPoint, Outlook)
• AI-powered productivity tools such as Microsoft Copilot, ChatGPT, Gemini or similar
• Preferred: CTMS, eTMF and document management platforms, Veeva Vault TMF, and experience with global or regional trials

What we offer

• Competitive base salary and performance-related incentives
• Health, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities