⚡ Accelerate Clinical Trial Start-Up Across China
Join ICON plc as a Study Start-Up Specialist and drive the initiation of groundbreaking clinical trials from anywhere in China. This fully remote role offers the opportunity to leverage your regulatory expertise to streamline study start-up processes, ensure compliance with Chinese regulations, and contribute to bringing innovative treatments to patients faster.
🎯 Your Impact: Key Responsibilities
Regulatory Submissions & Compliance
- Lead preparation and submission of clinical trial applications and ethics committee submissions
- Ensure compliance with Chinese regulatory requirements and ICH-GCP guidelines
- Manage regulatory agency communications and documentation
- Maintain comprehensive records of all submissions and approvals
Stakeholder Coordination
- Coordinate with internal and external stakeholders to obtain necessary approvals
- Liaise with ethics committees and regulatory authorities across China
- Provide guidance to study teams on regulatory requirements and best practices
- Facilitate effective communication between cross-functional teams
Process Optimization
- Participate in process improvement initiatives to streamline start-up activities
- Enhance efficiency in study initiation processes
- Implement best practices for regulatory submissions
- Contribute to start-up timeline acceleration
Documentation Management
- Maintain accurate tracking of regulatory submissions and approvals
- Ensure complete and organized study start-up documentation
- Manage correspondence with regulatory authorities
- Support audit readiness and inspection preparation
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Bachelor's degree in Life Sciences or related field
- 2+ years of experience in clinical research or regulatory affairs
- Specific experience in study start-up activities within China
- Understanding of Chinese regulatory requirements and ICH-GCP
- Fluency in English and Mandarin
Technical Competencies
- Knowledge of Chinese clinical trial application processes
- Experience with ethics committee submissions
- Understanding of regulatory documentation requirements
- Familiarity with clinical trial start-up timelines and milestones
Professional Attributes
- Excellent organizational and project management skills
- Strong attention to detail and accuracy
- Ability to prioritize and manage multiple tasks
- Effective communication and interpersonal skills
- Collaborative team player with proactive approach
💫 Why Join ICON in China?
Career Development
- Specialized role in high-demand study start-up function
- Clear pathway to senior start-up and regulatory positions
- Exposure to diverse therapeutic areas and study phases
- Professional development and training opportunities
Work Flexibility
- Fully remote position with work-from-anywhere flexibility
- Competitive compensation package
- Comprehensive health insurance benefits
- Global employee assistance program
Strategic Impact
- Play critical role in accelerating clinical trial initiation
- Contribute to bringing innovative treatments to Chinese patients
- Work with leading pharmaceutical and biotech companies
- Support China's growing clinical research landscape
✨ Ready to Drive Clinical Trial Success in China?
If you're an experienced study start-up professional with knowledge of Chinese regulations and a passion for accelerating clinical research, we encourage you to apply. Join us in our mission to streamline study initiation and advance medical treatments across China.
Apply Now & Accelerate Clinical Development
