Clinical Trials TMF & Site Operations Coordinator

IQVIA; Kampung Malaysia Tambahan; On-site; MYR 60,000 - 90,000; Full time

Job summary

IQVIA in Malaysia is seeking an administrative professional to support clinical trial operations, focusing on TMF/eTMF management, EC submissions, and site startup activities.

You will coordinate document collection, track payments, and assist with site materials distribution, under guidance from the project team. Strong organizational skills and English proficiency are essential to ensure compliant, timely delivery in a fast-paced CRO environment.

Qualifications

• Bachelor's degree in Pharmaceutical or related field.
• Minimum 0.5 years of clinical trial experience in the pharmaceutical or CRO industry.
• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and ICH guidelines
• Broad knowledge of applicable protocol requirements as provided in company training
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Good written and verbal communication skills including good command of English language
• Excellent organizational skills and ability to prioritize and multitask

Responsibilities

• TMF: Set up and maintain the site level TMF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.
• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.
• Process protocol amendments; may include ICF updates.
• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.
• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.
• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.
• Administrative: Business and department office administration support if required.
• To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience

Skills

GCP & ICH knowledge

Protocol knowledge

English communication

Organizational skills

Multitasking

Education

Bachelor's degree in Pharmaceutical or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA in Malaysia is seeking an administrative professional to support clinical trial operations, focusing on TMF/eTMF management, EC submissions, and site startup activities.

You will coordinate document collection, track payments, and assist with site materials distribution, under guidance from the project team. Strong organizational skills and English proficiency are essential to ensure compliant, timely delivery in a fast-paced CRO environment.