Clinical Trial Assistant / Senior Clinical Trial Assistant

Job not on LinkedIn

🔥 0 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟠 Senior

👨‍💼 Executive Assistant

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Support the planning, start-up, execution, maintenance, and close-out of clinical trials • Manage essential clinical trial documentation and support site and study activities • Maintain study, country, and site-level information in CTMS and other clinical systems • Collect, review, track, and file essential study documentation throughout the trial lifecycle • Maintain and quality-review TMF/eTMF documentation • Support regulatory submissions and ethics committee documentation collection • Review documents for completeness, consistency, and compliance • Coordinate distribution of study materials, safety communications, and site documentation • Track study progress and maintain operational metrics and reports • Support investigator sites with document collection, issue resolution, and communications • Assist with financial disclosure documentation and study administration • Support study meetings, training sessions, and stakeholder communications • Ensure inspection and audit readiness • Coordinate document archiving and study close-out • Identify process improvements to enhance study efficiency and quality • Partner with Clinical Operations, Regulatory Affairs, Quality, Finance, and external study sites • Use AI-enabled tools and digital technologies to improve 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 discipline; or equivalent combination of education and experience • 2+ years of experience in clinical research, clinical operations, or clinical trial support activities • Working knowledge of ICH-GCP guidelines, clinical trial regulations, and industry standards • Experience supporting clinical trial documentation, study start-up, TMF/eTMF management, or study coordination activities • Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment • Excellent communication, stakeholder management, and interpersonal skills • Strong attention to detail and ability to perform activities accurately and within timelines • Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook • Experience using AI-powered productivity tools such as Microsoft Copilot, ChatGPT, Gemini, or similar solutions • Professional proficiency in English, both written and verbal • Employment contingent upon having the legal right to work in Malaysia • Preferred: Clinical Trial Assistant, Study Coordinator, Site Coordinator, Clinical Research Coordinator, or Clinical Operations support experience • Preferred: Experience with CTMS, eTMF, and document management platforms • Preferred: Experience with Veeva Vault TMF or similar TMF systems • Preferred: Understanding of study start-up, ethics committee submissions, investigator site documentation, and regulatory processes • Preferred: Experience supporting global or regional clinical trials • Preferred: Senior-level mentoring, coaching, or leadership experience

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Remote or hybrid working arrangement • Reasonable accommodations during the recruitment process