Clinical Trial Assistant / Senior Clinical Trial Assistant

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

CTA/Sr CTA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Be Doing

Through collaboration with Clinical Operations, Study Management, Regulatory, Quality, and cross-functional study teams, the Clinical Trial Assistant (CTA) supports the planning, start-up, execution, maintenance, and close-out of clinical trials. The CTA is responsible for managing essential clinical trial documentation, supporting site and study activities, maintaining trial management systems, and ensuring compliance with applicable regulations, SOPs, and Good Clinical Practice (GCP) requirements.

Specifically, These Activities Will Include

• Clinical trial document management and tracking.
• Study start-up support and regulatory document collection.
• Trial Master File (TMF/eTMF) maintenance and quality review.
• Study tracking, reporting, and operational support.
• Investigator site document management.
• Inspection and audit readiness activities.
• Cross-functional coordination with internal and external stakeholders.
• Trial close-out and archiving support.

Your Responsibilities Will Include

• Work independently and proactively to support clinical trial activities from study start-up through close-out.
• Maintain study, country, and site-level information in Clinical Trial Management Systems (CTMS) and other clinical systems.
• Collect, review, track, and file essential study documentation throughout the clinical trial lifecycle.
• Ensure completeness, accuracy, and timeliness of Trial Master File (TMF/eTMF) documentation.
• Support study start-up activities, including preparation and collection of regulatory submissions and ethics committee documentation.
• Review study-related documents for completeness, consistency, and compliance with applicable requirements.
• Coordinate the distribution of study materials, safety communications, and site-related documentation within agreed timelines.
• Track study progress and maintain study-related operational metrics and reports.
• Support investigator sites by facilitating document collection, issue resolution, and operational communications.
• Assist with management of financial disclosure documentation and study administrative activities.
• Support study meetings, training sessions, and stakeholder communications as required.
• Ensure inspection and audit readiness through accurate maintenance of study documentation and systems.
• Coordinate document archiving and study close-out activities in accordance with company procedures and regulatory requirements.
• Identify operational challenges and propose process improvement opportunities to enhance study efficiency and quality.
• Partner effectively with Clinical Operations, Regulatory Affairs, Quality, Finance, and external study sites to achieve study milestones.
• Utilize AI-enabled tools and digital technologies to improve document management, reporting accuracy, workflow automation, knowledge retrieval, and overall clinical trial operational efficiency.

Minimum Qualifications

What we are looking for in you:

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, Biotechnology, or a related scientific discipline; or equivalent combination of education and experience.
• 2+ years of experience in clinical research, clinical operations, or clinical trial support activities.
• Working knowledge of ICH-GCP guidelines, clinical trial regulations, and industry standards.
• Experience supporting clinical trial documentation, study start-up, TMF/eTMF management, or study coordination activities.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, stakeholder management, and interpersonal skills.
• Strong attention to detail and ability to perform activities accurately and within timelines.
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
• Experience using AI-powered productivity tools (e.g., Microsoft Copilot, ChatGPT, Gemini, or similar solutions) to support document review, reporting, workflow efficiency, and operational excellence.
• Professional proficiency in English, both written and verbal

Preferred Qualifications

• Clinical Trial Assistant (CTA), Study Coordinator, Site Coordinator, Clinical Research Coordinator (CRC), or Clinical Operations support experience.
• Experience working with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and document management platforms.
• Experience with Veeva Vault TMF or similar TMF systems.
• Understanding of study start-up, ethics committee submissions, investigator site documentation, and regulatory processes.
• Experience supporting global or regional clinical trials.
• Strong customer-service mindset with the ability to collaborate across global matrix teams.
• Senior-level candidates may demonstrate mentoring, coaching, or leadership experience supporting junior team members.

Work Environment

• Remote or hybrid working arrangement.
• Ability to work independently while collaborating effectively within global cross-functional teams.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here