Clinical Trial Assistant / Senior Clinical Trial Assistant
ICON plc · Kuala Lumpur
CTA/Sr CTAICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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.
What we are looking for in you:
Minimum Qualifications
- 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply