Site Management Associate

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

SMA hiring in Malaysia

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a SMA I at ICON, you will support the management of clinical trial sites by assisting with site monitoring activities, ensuring compliance with study protocols, and maintain high standards of operational efficiency.

What You Will Do

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Assisting in the monitoring and support of clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

• Supporting site management and study administration activities, including generating meeting minutes, maintaining study trackers, and reconciling training records.

• Coordinating and collaborating with site staff and internal teams to obtain required documents and ensure timely study execution.

• Maintaining and updating clinical trial systems, including CTMS and eTMF platforms, ensuring accurate document uploads, reconciliation, tracking, and filing.

• Supporting site management activities, including documentation preparation, data entry, maintenance of essential study documents, and tracking site performance metrics.

• Collaborating with cross-functional teams to facilitate communication and address site-related issues effectively.

• Maintaining accurate records of site activities and contributing to the preparation of monitoring and study reports.

• Providing administrative and operational support to the study team as required.

• Participating in training and development initiatives to enhance knowledge and skills in clinical trial management.

Your Profile

You will bring relevant clinical research experience, along with the following qualifications and skills.

Required Qualifications and Experience

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare Administration, Clinical Research, or a related scientific discipline.

• Minimum 1 year of experience in a Clinical Trial Assistant (CTA), Clinical Trial Management Assistant (CTMA), Clinical Research, or related clinical operations support role.

• Experience working with CTMS and eTMF systems (e.g., Veeva Vault eTMF) preferred.

• Understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.

• Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively.

• Excellent communication and interpersonal skills with a service-oriented and proactive approach.

• Proficient computer skills, including Microsoft Office applications and clinical systems.

• Familiarity with AI-enabled tools and digital technologies is an advantage.

• Ability to work independently while collaborating effectively within a cross-functional team environment.

• Willingness to work on-site at the BeOne office (5 days per week).

• Willingness to travel as required (approximately 25%).

What ICON can offer you

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)