Lead clinical trial operations in South Korea. Home-based Country Study Ops Manager role at ICON. Manage local teams, budgets & ensure MFDS compliance. Korean/English fluency & 7+ yrs exp req.
Lead Clinical Trial Excellence from Your Home in South Korea
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.
We are seeking an experienced and strategic Country Study Operations Manager to lead our clinical trial delivery in South Korea. This is a 100% home-based leadership role where you will be the single point of accountability for the operational execution, quality, and financial performance of studies within the country. You will manage local teams, serve as the key client and stakeholder liaison, and ensure all activities comply with MFDS regulations and ICH-GCP. If you are a leader who combines deep local expertise with a passion for driving study success, this is your opportunity to shape the future of clinical development in South Korea.
Your Mission: The Strategic Leader for South Korean Operations
As the Country Study Operations Manager, you are the operational captain for South Korea. You will translate global study plans into local execution strategy, manage risks, lead your team, and ensure we deliver exceptional quality and performance for our clients.
Key Responsibilities
1. Country Leadership & Operational Delivery
- Serve as the primary operational lead for assigned clinical trials within South Korea, ensuring delivery on time, within budget, and to the highest quality standards.
- Develop and manage detailed country-level project plans, including site feasibility, patient recruitment strategy, and resource allocation.
- Manage and mentor a team of local CRAs and CTAs, fostering a high-performance culture and ensuring their professional development.
- Monitor country-level performance metrics, identify risks and issues, and implement effective mitigation strategies.
2. Stakeholder Management & Compliance
- Act as the key client contact in-country, managing expectations, providing updates, and ensuring alignment with study goals.
- Build and maintain strong relationships with investigative sites, key opinion leaders (KOLs), and local vendors.
- Ensure all study activities strictly comply with South Korean MFDS regulations, ICH-GCP guidelines, and ICON SOPs.
- Represent ICON during client meetings, audits, and regulatory inspections.
3. Financial & Resource Management
- Manage the country-level study budget, including forecasting, tracking spend, and ensuring financial objectives are met.
- Oversee the selection, initiation, and performance of local investigative sites.
- Collaborate with regional and global project leadership to align country strategy with overall study objectives.
Who You Are: The Ideal Leader
You are a seasoned clinical operations professional with a proven track record of managing and delivering clinical trials in South Korea. You are a natural leader, an excellent communicator, and a strategic problem-solver who excels in a remote leadership capacity.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or a related field. An advanced degree is a plus.
- Minimum of 7-10 years of experience in clinical research within a pharmaceutical company, biotech, or global CRO, with substantial experience managing clinical operations in South Korea.
- Proven experience in a country-level management or leadership role (e.g., Country Manager, Lead CRA, Local Project Manager).
- In-depth knowledge of MFDS regulations, ICH-GCP, and local ethical submission processes.
- Strong financial acumen with experience managing clinical trial budgets.
- Excellent leadership and people management skills, with a talent for mentoring and developing teams.
- Exceptional communication and interpersonal skills; fluency in Korean and English is mandatory.
- Proficiency in project management methodologies and tools.
Highly Advantageous:
- Project management certification (PMP, PRINCE2).
- Experience working in a fully remote or home-based leadership role.
- Established network within the South Korean clinical research community.
Why Lead South Korean Operations at ICON?
1. Strategic Impact & Autonomy
- Enjoy significant autonomy as the senior country leader with full P&L and operational accountability.
- Your leadership directly influences study success and ICON's reputation in a critical market.
2. Remote Leadership Career
- Lead a local team and manage high-impact studies from the comfort of your home office, with full remote-work support.
- Clear pathway to Regional Operations Director or other senior leadership roles within global clinical operations.
3. Comprehensive Home-Based Executive Benefits
- Competitive salary and significant performance-based bonus.
- Home office setup stipend and dedicated IT support.
- Generous annual leave and flexible working arrangements.
- Premium health insurance and comprehensive benefits package for South Korea.
- Global Employee Assistance Programme and leadership development opportunities.
Join a Global Culture that Values Local Leadership
At ICON, we believe that inclusive leadership drives global success. We are committed to creating an accessible environment and encourage all qualified leaders across South Korea to apply for this remote opportunity.
Ready to be the driving force behind clinical trial success in South Korea?
If you are a strategic leader with deep local expertise, apply now to become our Country Study Operations Manager.
