Senior Clinical Trial Assistant (CTA) – Hybrid, Kuala Lumpur
Your Mission: Be the Operational Anchor for Global Clinical Trials
At ICON, the seamless execution of a clinical trial relies on meticulous organization and flawless support. As a Senior Clinical Trial Assistant (CTA) in our Kuala Lumpur office, you will be the vital operational anchor for our study teams. This hybrid role combines in-office collaboration with remote flexibility, placing you at the center of trial administration where your precision and proactive coordination ensure essential documents are managed, regulatory submissions are on track, and sites are fully supported. You won’t just perform tasks; you will own critical processes that keep complex global trials moving forward smoothly and efficiently.
We are looking for an experienced, detail-driven professional to join our clinical operations team. If you excel in a structured environment, thrive on supporting team success, and are ready to take on greater responsibility in study start-up and maintenance, this hybrid Senior CTA role is your ideal career step.
Your Impact: Own Critical Trial Administration & Coordination
You will take ownership of key administrative and operational tasks, providing the foundation upon which clinical trial teams deliver successful outcomes for our clients.
1. Lead Study Start-Up & Regulatory Excellence
- Take a leading role in study start-up activities, including the meticulous preparation, compilation, and submission of regulatory and ethical approval dossiers to relevant authorities.
- Manage and maintain the Trial Master File (TMF), ensuring all essential documents are collected, reviewed for completeness, and archived accurately for real-time inspection readiness.
- Prepare and distribute critical study materials (e.g., protocols, consent forms, study plans) to investigative sites, ensuring they have the tools needed to begin and conduct the trial.
2. Drive Operational Coordination & Site Support
- Serve as a primary point of contact for assigned investigative sites, managing communications, tracking document flow, and ensuring timely responses to queries.
- Coordinate and document internal and client meetings, including agenda preparation, minute-taking, and tracking action items to completion.
- Monitor and track overall trial progress, managing the logistics of site payments, vendor setup, and shipment of clinical supplies to maintain uninterrupted site operations.
3. Collaborate for Quality & Continuous Improvement
- Work collaboratively with Clinical Research Associates (CRAs), project managers, and other cross-functional team members to resolve operational issues and support overall project goals.
- Identify opportunities to improve administrative processes and contribute to the development of tools and templates that enhance team efficiency.
- Mentor and provide guidance to junior CTAs, sharing best practices and fostering a culture of quality and excellence.
Who You Are: A Meticulous Organizer and Collaborative Partner
You are a proactive professional who believes flawless execution behind the scenes is what enables clinical breakthroughs. You are organized, communicative, and driven to support your team’s success.
Your Foundation
- A Bachelor’s degree or diploma in Life Sciences, Nursing, Pharmacy, or a related field.
- Proven experience (typically 2-4+ years) in a Clinical Trial Assistant or similar administrative support role within a CRO, pharmaceutical, or biotechnology company.
- Direct hands-on experience with study start-up activities, including regulatory dossier preparation and submissions.
- Strong understanding of ICH-GCP guidelines and clinical trial documentation requirements.
- Proficiency with clinical trial management systems (CTMS), electronic Trial Master File (eTMF) platforms, and Microsoft Office Suite.
- Must be able to work on a hybrid setup, with 3 days per week in our Kuala Lumpur office.
Your Core Strengths
- Process Owner: You take pride in owning administrative processes from start to finish, ensuring nothing falls through the cracks.
- Detail-Focused Executor: You have a keen eye for detail in document management and data tracking, ensuring the highest standards of accuracy and quality.
- Proactive Communicator: You maintain clear, professional, and timely communication with internal teams and external sites.
- Adaptable Team Player: You thrive in a dynamic, fast-paced environment, can manage shifting priorities, and work effectively both independently and as part of a global team.
- Problem-Solving Mindset: You approach challenges proactively and collaborate to find effective solutions.
Why Build Your Career as a Senior CTA at ICON in Kuala Lumpur?
Grow Your Expertise in a Global Hub
- Hybrid Flexibility: Benefit from the perfect blend of in-office collaboration in our modern KL office and the focus of remote work.
- Career Development: This senior role is a recognized stepping stone to advanced positions such as Study Start-Up Specialist, Clinical Trial Manager, or In-House CRA (IHCRA).
- Global Exposure: Support complex, international clinical trials while being part of a vibrant and growing ICON team in Malaysia.
Thrive in a Supportive, Inclusive Culture
- Join a diverse and dynamic team where your contribution is valued and your professional growth is supported.
- Participate in comprehensive training programs and benefit from ICON’s commitment to innovation and operational excellence.
Competitive ICON Benefits in Malaysia
- We offer a competitive salary and benefits package.
- Enjoy comprehensive health insurance, generous annual leave, and a global employee assistance program, all designed to support your well-being and work-life balance.
