📍 Accelerate Clinical Trials as Study Start-Up Specialist - China (Office Based)
Join ICON plc in China as a Study Start-Up (SSU) Specialist and play a pivotal role in launching groundbreaking clinical trials. This office-based position offers the opportunity to drive study initiation excellence while navigating China's dynamic regulatory landscape to bring innovative treatments to patients faster.
🎯 Your Impact: Key Responsibilities
Study Start-Up Leadership
- Lead end-to-end study start-up activities for clinical trials across mainland China
- Manage site identification, qualification, and initiation processes to ensure timely study commencement
- Coordinate ethics committee and regulatory submissions in compliance with NMPA requirements
- Develop and implement strategic SSU plans aligned with project timelines and objectives
Regulatory Excellence & Compliance
- Prepare and submit clinical trial application documents to Chinese regulatory authorities
- Ensure compliance with Chinese GCP requirements and local regulatory standards
- Maintain current knowledge of evolving clinical trial regulations and implementation guidelines
- Support regulatory inspections and maintain audit-ready documentation
Site Relationship Management
- Build and maintain strong relationships with investigative sites and institutions
- Facilitate effective communication between global study teams and local Chinese sites
- Coordinate site contract and budget negotiations in collaboration with legal and finance teams
- Ensure sites receive comprehensive training on study protocols and requirements
Cross-Functional Collaboration
- Work closely with clinical operations, regulatory affairs, and project management teams
- Participate in study team meetings to provide SSU updates and risk assessments
- Collaborate with global colleagues to align Chinese SSU activities with international standards
- Support continuous improvement of SSU processes and best practices
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Bachelor's degree in Life Sciences, Medicine, or related field; advanced degree preferred
- 2+ years of experience in study start-up, site activation, or regulatory affairs in China
- Comprehensive understanding of Chinese clinical trial regulations and NMPA requirements
- Experience with ethics committee submissions and site activation processes
Regulatory Expertise
- Knowledge of Chinese GCP and local regulatory requirements
- Experience preparing and submitting clinical trial applications
- Understanding of different provincial requirements and implementation variations
- Familiarity with regulatory timelines and approval processes in China
Professional Competencies
- Excellent project management and organizational skills
- Strong communication and negotiation capabilities in Chinese and English
- Ability to manage multiple studies and priorities simultaneously
- Detail-oriented with strong problem-solving abilities
Technical Skills
- Proficiency with clinical trial management systems and documentation tools
- Experience with electronic submission platforms and regulatory databases
- Strong computer skills including Microsoft Office applications
- Ability to work effectively in cross-cultural team environments
💫 Why Join ICON in China?
Strategic Impact
- Play crucial role in accelerating clinical research in China's rapidly growing market
- Contribute to bringing innovative treatments to Chinese patients faster
- Build relationships with leading medical institutions across China
- Influence study start-up strategies for global clinical development programs
Professional Growth
- Clear pathway to Senior SSU Specialist and Leadership roles
- Exposure to diverse therapeutic areas and complex study designs
- Opportunities for professional development in clinical research management
- Global networking within ICON's international SSU community
Office-Based Advantages
- Professional workplace environment with modern facilities
- Direct collaboration with local and international team members
- Structured work environment with comprehensive administrative support
- Access to cutting-edge SSU technologies and processes
Competitive China Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with 24/7 support
- Generous annual leave with Chinese public holidays
Career Development
- Retirement planning and financial security benefits
- Life assurance coverage
- Professional development allowance and training opportunities
- Health and wellness programs
- Transportation support and commuter benefits
✨ Ready to Drive Clinical Trial Acceleration in China?
If you're a study start-up professional with knowledge of China's clinical research landscape and passion for accelerating drug development, we encourage you to apply. This SSU Specialist role offers the perfect opportunity to grow your career while contributing to clinical research that addresses healthcare needs across China.
Apply Now & Lead Study Start-Up Excellence in China!
ICON is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
We welcome applications from all qualified study start-up professionals across China - your regulatory expertise and site relationship management skills might be exactly what we need at ICON!
