Clinical Trials Operations Assistant

PAREXEL APEX International Co., Ltd.; Selangor; On-site; MYR 39,000 - 61,000; Full time

Job summary

Parexel APEX International Co., Ltd. is seeking a Clinical Operations Assistant to support project teams in Malaysia. You will handle site activation tasks, TMF maintenance, and data tracking to ensure trial quality and timeliness within a global CRO environment.

The role requires strong organizational and communication skills, familiarity with CTMS/EDMS, and a proactive approach to compliance with ICH-GCP and Parexel SOPs. Japanese language ability is required.

Qualifications

• Strong command of written and spoken English; local language skills as required.
• Experience in clinical research or office management in an international environment is advisable.
• Knowledge of ICH-GCP guidelines and Parexel procedures preferred.

Responsibilities

• Assist site activation: access vendor systems and coordinate staff training.
• Maintain the Trial Master File (TMF) and update the EDL; resolve QA issues.
• Transfer documents to sponsor TMF systems as applicable.
• Support investigator payments and site issue resolution.
• Track trial progress in CTMS/EDC; update trackers with site data.
• Engage in study trainings and ensure timelines are met.

Skills

CTMS

EDMS

MS-Office

English proficiency

Japanese language

Organizational skills

Communication skills

Problem-solving

Teamwork

Education

High school diploma or higher – life science background preferred

Tools

CTMS

EDMS

MS-Office Suite

Job description

Parexel APEX International Co., Ltd. is seeking a Clinical Operations Assistant to support project teams in Malaysia. You will handle site activation tasks, TMF maintenance, and data tracking to ensure trial quality and timeliness within a global CRO environment.

The role requires strong organizational and communication skills, familiarity with CTMS/EDMS, and a proactive approach to compliance with ICH-GCP and Parexel SOPs. Japanese language ability is required.