Accelerate clinical trial initiation from your home office. ICON is seeking a Study Start-Up Associate II in China to lead regulatory submissions and ethics approvals for clinical trials. In this homebased role, you will be the expert in Chinese regulatory requirements, managing document preparation and stakeholder coordination to ensure timely study activation and compliance with local regulations.
Key Responsibilities
You will be the regulatory submission expert, managing the start-up lifecycle for clinical trials in China.
Regulatory Submissions & Approvals:
- Lead the preparation and submission of clinical trial applications, ethics committee submissions, and regulatory agency communications
- Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
- Manage and maintain comprehensive records of all regulatory submissions, approvals, and correspondence
Process Excellence & Collaboration:
- Provide guidance and support to study teams on Chinese regulatory requirements and best practices for study start-up activities
- Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency
- Serve as the primary point of contact for regulatory and ethics committee communications
Your Profile
Essential Qualifications:
- Bachelor's degree in Life Sciences or a related field
- Minimum of 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 for clinical trials
Required Skills:
- Excellent organizational and project management skills
- Ability to prioritize and manage multiple tasks simultaneously
- Strong communication and interpersonal skills for effective cross-functional collaboration
- Proven experience in regulatory document preparation and submission processes
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 across 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 drive clinical trial success in China? We encourage you to apply even if you don't meet every single requirement. Your regulatory expertise is valuable to our mission.
