Clinical Trial Documentation Specialist

IQVIA LLC; Kuala Lumpur; On-site; MYR 36,000 - 60,000; Full time

Job summary

IQVIA in Kuala Lumpur seeks a detail-oriented administrative support professional to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams in maintaining the Trial Master File (TMF) and related documentation.

This role emphasizes accuracy, document handling, timely filing, and coordination across study teams to ensure regulatory compliance and project timelines, with potential on-site participation in monitoring activities after training.

Qualifications

• High School Diploma or equivalent with at least 3 years of administrative support experience.
• Equivalent combination of education, training and experience.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication in English.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships.
• Awareness of applicable clinical research regulatory requirements such as GCP and ICH.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF to track site compliance and performance.
• Prepare, handle, distribute, file and archive clinical documents and reports per SOPs.
• Conduct periodic review of study files for completeness.
• Assist with distribution of Clinical Trial Supplies and maintain tracking information.
• Track and manage Case Report Forms (CRFs), queries and clinical data flow.
• Serve as central contact for project communications and documentation.
• Attend on-site visits with CRAs to assist with monitoring duties after training.

Skills

Time management

Organizational skills

Written & Verbal communication

English proficiency

Relationship building

Adaptability

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA in Kuala Lumpur seeks a detail-oriented administrative support professional to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams in maintaining the Trial Master File (TMF) and related documentation.

This role emphasizes accuracy, document handling, timely filing, and coordination across study teams to ensure regulatory compliance and project timelines, with potential on-site participation in monitoring activities after training.