Shape the Future of Clinical Trials: Study Start-Up Associate II (Remote - South Korea)
Accelerate Global Clinical Research from Your Home Base
ICON plc is a world-leading healthcare intelligence and clinical research organization driving the next wave of medical breakthroughs. Our mission to shape the future of clinical development is powered by inclusive teams where innovation and excellence thrive. We provide the intelligence to accelerate patient access to new therapies.
We are seeking a meticulous and proactive Study Start-Up Associate II to be a cornerstone of our clinical trial activation process in the APAC region. In this pivotal, home-based role in South Korea, you will ensure the seamless and compliant initiation of critical clinical studies, directly contributing to the advancement of new treatments for patients in Korea, Singapore, and beyond.
Your Mission: Ensure Flawless Clinical Trial Activation
In this role, you will be the operational expert responsible for the critical early-stage documents and processes that set our studies up for success. Your precision and expertise will keep complex, multi-country trials on track and in compliance from the very start.
Main Responsibilities & Accountabilities
- Essential Document Mastery: Lead the collection, thorough quality control (QC), and accurate filing of all essential regulatory and study-start up documents in designated systems (e.g., Veeva Vault, Box).
- Regulatory Compliance Stewardship: Apply your deep knowledge of ICH-GCP guidelines and local regulatory requirements in South Korea and Singapore to all document and process workflows.
- Project Coordination: Proactively manage and prioritize multiple study start-up tasks and timelines simultaneously, demonstrating excellent organizational skills.
- Strategic Feasibility Support: Contribute valuable local insights to study feasibility assessments, helping to shape successful trial strategies.
- Cross-Functional Collaboration: Serve as a key liaison, communicating effectively with internal teams, sites, and partners to ensure alignment and resolve start-up challenges efficiently.
Your Profile: Qualifications & Experience
Essential Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific field.
- A minimum of 2 years of direct clinical research experience, with a proven focus on study start-up activities for global trials.
- Fluency in English and Korean is required.
- Strong, practical understanding of clinical trial regulations (ICH-GCP) and specific regulatory landscapes in South Korea. Experience with Singaporean regulations is a significant plus.
- Demonstrated proficiency with clinical trial management systems and eTMF platforms.
- Exceptional attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced, fully remote environment.
Why Join ICON?
- Impact Patient Lives: Your work is the critical first step in bringing new therapies to market, making a tangible difference for patients worldwide.
- Remote-First Flexibility: Enjoy the balance of a home-based career with the support and resources of a global industry leader.
- Career Growth: Build a specialized career in clinical operations with clear pathways for advancement in a growing organization.
- Comprehensive Well-being Support: Benefit from our competitive salary and extensive package, including health insurance, retirement planning, and our global Employee Assistance Programme.
- Inclusive Culture: Thrive in an environment dedicated to inclusion and belonging, where your contribution is valued.
Ready to build the foundation for groundbreaking clinical research?
Apply now for the Remote Study Start-Up Associate II position in South Korea.
ICON is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We encourage all qualified applicants to apply. If you require reasonable accommodations during the application process, please let us know.
