Clinical Trials Site Manager – Onsite in Malaysia

ICON Clinical Research; Malaysia; Remote; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks (EAP)

Life assurance

Flex benefits by country

Job summary

ICON Strategic Solutions in Malaysia is hiring an SMA I to support clinical trial site management and monitoring activities. You will help ensure protocol compliance and high operational efficiency while collaborating with cross-functional teams.

The role requires a life sciences degree and 1+ year in CTA/CTMA or related roles, with CTMS/eTMF experience preferred. On-site work at BeOne and travel about 25% are expected, alongside strong organization and communication skills.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare Administration, Clinical Research, or related scientific discipline.
• Minimum 1 year of experience in a Clinical Trial Assistant (CTA) or related role.
• Experience with CTMS and eTMF systems preferred.
• Understanding of ICH-GCP guidelines and regulatory requirements.
• Strong organizational skills with ability to manage multiple priorities.
• Excellent communication and interpersonal skills with a service-oriented approach.
• Proficient MS Office and clinical systems knowledge.
• Familiarity with AI-enabled tools is an advantage.
• Ability to work independently while collaborating in a cross-functional team.
• Willingness to work on-site at the BeOne office (5 days per week) and travel ~25%.

Responsibilities

• Assisting in monitoring and support of clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and GCP.
• Supporting site management and study administration activities, including minutes, trackers, and training record reconciliation.
• Coordinating with site staff and internal teams to obtain documents for timely study execution.
• Maintaining CTMS and eTMF platforms with accurate uploads, reconciliation, tracking and filing.
• Supporting site management activities, including documentation, data entry, and tracking site performance metrics.
• Collaborating with cross-functional teams to facilitate communication and address site-related issues.
• Maintaining records of site activities and contributing to monitoring and study reports.
• Providing administrative and operational support to the study team as required.
• Participating in training and development to enhance trial management knowledge.

Skills

Excellent communication

Strong organizational skills

Team collaboration

MS Office proficiency

Familiarity with AI-enabled tools

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

eTMF (Veeva Vault eTMF)

Job description

ICON Strategic Solutions in Malaysia is hiring an SMA I to support clinical trial site management and monitoring activities. You will help ensure protocol compliance and high operational efficiency while collaborating with cross-functional teams.

The role requires a life sciences degree and 1+ year in CTA/CTMA or related roles, with CTMS/eTMF experience preferred. On-site work at BeOne and travel about 25% are expected, alongside strong organization and communication skills.