Accelerate the launch of groundbreaking clinical trials in China. ICON is seeking a Study Start-Up (SSU) Specialist to be the driving force behind our clinical trial site activation process. In this pivotal role, you will manage regulatory submissions and ethical approvals, ensuring studies are initiated on time and in full compliance with Chinese regulations and ICH-GCP guidelines. Your work will directly contribute to bringing innovative treatments to patients faster.
Key Responsibilities
You will be the central point for managing the study start-up lifecycle, from feasibility to site activation.
Regulatory Submissions & Site Activation:
- Lead the preparation, compilation, and submission of all regulatory documents for Clinical Trial Applications (CTAs) to Ethics Committees and Competent Authorities in China.
- Manage the collection and review of essential documents for the Critical Document Package (CDP) to ensure completeness and accuracy.
- Coordinate with investigative sites to facilitate timely site activation and maintain tracking systems for all submission milestones.
Compliance & Coordination:
- Ensure all start-up activities adhere to ICH-GCP, local Chinese regulations, and ICON SOPs.
- Serve as the primary liaison between ICON, clinical sites, and regulatory bodies during the start-up phase.
- Conduct quality control of Trial Master File (TMF) documents to ensure inspection readiness.
Stakeholder Management:
- Collaborate effectively with internal cross-functional teams (Clinical, Regulatory, Project Management) to align on timelines and strategies.
- Proactively identify and mitigate risks to the site activation timeline, ensuring successful study launch.
Your Profile
Essential Qualifications:
- Bachelor’s degree in Life Sciences or a related field.
- 2+ years of experience in Study Start-Up, Regulatory Affairs, or a related clinical operations role within the Chinese market.
- In-depth knowledge of Chinese regulatory requirements and ICH-GCP guidelines.
Required Skills:
- Excellent organizational skills and meticulous attention to detail.
- Strong communication and interpersonal skills for effective collaboration with diverse stakeholders.
- Proactive problem-solver with the ability to manage multiple tasks and deadlines in a fast-paced environment.
- Fluency in Chinese and professional proficiency in English.
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:
- Competitive salary and a comprehensive benefits package focused on well-being.
- Health insurance and competitive retirement planning options.
- Global Employee Assistance Programme and extensive well-being support.
- A diverse, inclusive culture that rewards high performance and nurtures talent.
Ready to be the catalyst for clinical trial success in China? We encourage you to apply even if you don't meet every single requirement. Your unique experience in Chinese regulatory processes is highly valuable to our mission.
