Drive clinical trial activation from your home in Shenyang. ICON is seeking a Study Start-Up Associate II to lead regulatory submissions and ethics approvals for clinical trials in Northeast China. In this homebased role, you will leverage your expertise in Chinese regulatory requirements to manage document preparation and stakeholder coordination, ensuring timely study activation while maintaining full compliance with local regulations.
Key Responsibilities
You will serve as the regulatory submission expert, managing the complete start-up lifecycle for clinical trials in the Shenyang region.
Regulatory Submissions & Compliance:
- Lead preparation and submission of clinical trial applications, ethics committee submissions, and regulatory agency communications for Northeast China sites
- Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
- Ensure compliance with Chinese regulatory requirements and ICH-GCP guidelines
Process Management & Collaboration:
- Manage comprehensive records of all regulatory submissions, approvals, and correspondence
- Provide guidance to study teams on local regulatory requirements and study start-up best practices
- Participate in process improvement initiatives to streamline study start-up processes
- Serve as primary contact for regulatory and ethics committee communications in the Shenyang region
Your Profile
Essential Qualifications:
- Bachelor's degree in Life Sciences or related field
- Minimum 2 years of experience in clinical research or regulatory affairs with specific focus on study start-up activities in China
- Strong understanding of ICH-GCP guidelines and Chinese regulatory requirements
Required Skills:
- Excellent organizational and project management skills
- Ability to prioritize and manage multiple tasks simultaneously
- Strong communication and interpersonal skills
- Proven experience in regulatory document preparation for Chinese authorities
Why Join ICON?
Our success depends on our people. When you join ICON, you become part of a team dedicated to excellence in clinical development. We offer:
- Homebased Flexibility: Work remotely while managing clinical trial start-up in Northeast China
- Competitive Salary and comprehensive benefits package
- Health Insurance and retirement planning options
- Global Employee Assistance Programme and well-being support
- A diverse, inclusive culture that rewards high performance
Ready to accelerate clinical research in Northeast China? We encourage you to apply even if you don't meet every single requirement. Your regulatory expertise in the Chinese market is valuable to our mission.
