Clinical Trial Admin & Documentation Specialist

IQVIA LLC; Kuala Lumpur; On-site; MYR 42,000 - 66,000; Full time

Job summary

IQVIA LLC in Kuala Lumpur is seeking a Clinical Trial Assistant to support daily administrative activities with CRAs and RSU teams. You will help maintain TMF documents, prepare and archive clinical reports, and assist with study file reviews to ensure timely, compliant delivery.

This role requires strong English communication, solid organizational skills, and knowledge of GCP/ICH guidelines. On-site in Kuala Lumpur, this position emphasizes collaboration with regulatory and start-up teams, with

Qualifications

• High School Diploma or equivalent.
• 3 years of administrative support experience.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal English communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain professional relationships with coworkers and clients.
• Awareness of GCP and ICH guidelines as provided in company training.

Responsibilities

• Perform daily administrative activities with CRAs and RSU teams.
• Maintain and update TMF documents and systems for site compliance.
• Prepare, handle, file, and archive clinical documentation and reports.
• Review study files for completeness on a periodic basis.
• Support distribution of Clinical Trial Supplies and tracking information.
• Track Case Report Forms, queries, and data flow.
• Serve as central contact for project communications and documentation.
• May accompany CRAs on site visits for monitoring duties after training.

Skills

Communication skills

Time management

Organizational skills

Written and verbal English

Relationship building

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA LLC in Kuala Lumpur is seeking a Clinical Trial Assistant to support daily administrative activities with CRAs and RSU teams. You will help maintain TMF documents, prepare and archive clinical reports, and assist with study file reviews to ensure timely, compliant delivery.

This role requires strong English communication, solid organizational skills, and knowledge of GCP/ICH guidelines. On-site in Kuala Lumpur, this position emphasizes collaboration with regulatory and start-up teams, with