Clinical Trial Assistant / Senior Clinical Trial Assistant

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Assist in the planning, initiation, execution, maintenance, and conclusion of clinical trials.

• Oversee critical clinical trial documentation and facilitate site and study activities.

• Update and manage study, country, and site-specific information in CTMS and other clinical systems.

• Gather, assess, track, and archive essential study documentation throughout the trial lifecycle.

• Ensure the integrity and quality of TMF/eTMF documentation.

• Aid in the preparation of regulatory submissions and the collection of ethics committee documentation.

• Evaluate documents for completeness, consistency, and compliance.

• Organize the distribution of study materials, safety communications, and site documentation.

• Monitor study progress and maintain operational metrics and reports.

• Provide support to investigator sites with document collection, issue resolution, and communication.

• Assist with financial disclosure documentation and study administration tasks.

• Help facilitate study meetings, training sessions, and stakeholder communications.

• Ensure readiness for inspections and audits.

• Manage document archiving and the close-out process of studies.

• Recognize process improvements to enhance study efficiency and quality.

• Collaborate with Clinical Operations, Regulatory Affairs, Quality, Finance, and external study sites.

• Leverage AI-enabled tools and digital technologies to optimize document management, reporting, workflow automation, knowledge retrieval, and clinical trial efficiency.

⛳️ Requirements

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, Biotechnology, or a related scientific field; or an equivalent combination of education and experience.

• Minimum of 2 years of experience in clinical research, clinical operations, or supporting clinical trial activities.

• Familiarity with ICH-GCP guidelines, clinical trial regulations, and industry standards.

• Experience in managing clinical trial documentation, study start-up, TMF/eTMF management, or study coordination.

• Strong organizational abilities to handle multiple priorities in a dynamic environment.

• Excellent communication, stakeholder management, and interpersonal skills.

• High attention to detail and a proven track record of completing tasks accurately and on time.

• Proficiency in Microsoft Office applications such as Word, Excel, PowerPoint, and Outlook.

• Experience with AI-driven productivity tools like Microsoft Copilot, ChatGPT, Gemini, or similar technologies.

• Professional proficiency in English, both written and spoken.

• Employment contingent upon possessing the legal right to work in Malaysia.

• Preferred: Experience as a Clinical Trial Assistant, Study Coordinator, Site Coordinator, Clinical Research Coordinator, or in Clinical Operations support.

• Preferred: Familiarity with CTMS, eTMF, and document management systems.

• Preferred: Knowledge of Veeva Vault TMF or comparable TMF systems.

• Preferred: Understanding of study start-up processes, ethics committee submissions, investigator site documentation, and regulatory procedures.

• Preferred: Experience in supporting global or regional clinical trials.

• Preferred: Senior-level mentoring, coaching, or leadership experience.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Flexible remote or hybrid working arrangements.

• Reasonable accommodations available during the recruitment process.