Clinical Trial Specialist, Malaysia

Emerald Clinical Trials Inc.; Selangor; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Competitive pay

Career growth

Wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials is seeking a Clinical Trial Specialist (CTS) to join the Clinical Operations team. The CTS will support clinical trial activities as the in-house site start-up and maintenance expert, ensuring trials are conducted in line with Federal Regulations, ICH guidelines, project plans, IRB/IEC requirements, and applicable SOPs.

You will coordinate essential documents for site initiation, submissions to central IRBs/IEC, and assist with local IRB/IEC submissions and ICF changes.

Qualifications

• College / University diploma / degree (or equivalent)
• Ability to perform general administrative duties as needed
• Exposure to medical terminology preferred
• Knowledge of ICH/GCP, ethical and regulatory requirements preferred

Responsibilities

• Increase proficiency in TMF set-up and maintenance (filing) for hard copy and electronic files
• Upload and maintain TMF files in Emerald Clinical’s file-sharing system by project
• Serve as second reviewer for TMF QC
• May function in TMF Lead Role and oversee TMF setup, maintenance and oversight
• Assist with end of study TMF filing (including site close out documents), QC and archival
• Develop skills in audit responses
• Perform QC of documents and emails prior to distribution
• Develop data entry skills for Clinical Trial Management System by project
• Assist with data entry support and tracking for investigator payments
• Work with CRA/CTM/PM during site start-up for feasibility
• Assist with presenting final feasibility results to PM team
• Assist sites in preparing essential document packets (EDPs)
• Submit final EDPs to sponsor or CTM/PM as required

Skills

TMF management

IRB submissions

Documentation control

QA/QC

Regulatory knowledge

Education

College / University diploma / degree

Job description

Who We Are

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.

With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Global Expertise. Local Insight. Real Impact.

Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.

1000+ employees that span across Asia-Pacific, Europe, and the Americasareembedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

About the Role

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. The CTS works closely with project team to help manage clinical trial feasibility processes, coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs).

Your Responsibilities

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project.

• Increase proficiency in uploading and maintaining TMF files and folders in Emerald Clinical’s file-sharing system by project as assigned

• Serve as second reviewer for TMF QC.

• May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.

• Assist with/complete end of study TMF filing (including site close out documents), QC and archival.

• Further develop skills in preparing and participating in audit responses.

• Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables .

• Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.

• Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.

• Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable .

• Assist with presenting final feasibility results to PM team and/or Sponsor.

• Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).

• Submit final EDPs to sponsor or CTM/PM as required

About You

• College / University diploma / degree; OR at least 2 years related experiences and / or training; OR equivalent combination of education and experience.

• Ability to perform general administrative duties as needed or required.

• Exposure to medical terminology preferred.

• Knowledge of ICH/GCP, ethical and regulatory requirements preferred.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s what makes us stand out:

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.

• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.

• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.

• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.

• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.

• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

We are an equal-opportunity employer and encourage applications from all qualified candidates.