Accelerate the start of life-saving clinical trials. ICON is seeking a Study Start-Up (SSU) Specialist I in China to lead the critical regulatory and ethical submission process. In this office-based role, you will be the driving force behind preparing and submitting clinical trial applications, ensuring studies are initiated on time and in full compliance with local regulations and ICH-GCP guidelines.
Key Responsibilities
You will manage the end-to-end study start-up process, serving as the regulatory submission expert for clinical trials in China.
Regulatory Submissions & Approvals:
- Lead the preparation and submission of all regulatory documents, including Clinical Trial Applications (CTAs) and ethics committee submissions.
- Coordinate with internal and external stakeholders to secure all necessary approvals and authorizations for study initiation.
- Manage and maintain a comprehensive tracking system for all submission documents, approvals, and regulatory correspondence.
Stakeholder Coordination & Process Improvement:
- Act as the primary guide for study teams on local regulatory requirements and study start-up best practices.
- Collaborate effectively with cross-functional teams to ensure a seamless and efficient start-up phase.
- Participate in initiatives to streamline study start-up processes, enhancing overall speed and efficiency.
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 a specific focus on study start-up activities in China.
- Strong understanding of ICH-GCP guidelines and local Chinese regulatory requirements for clinical trials.
Required Skills:
- Excellent organizational and project management skills, with the ability to prioritize multiple tasks.
- Outstanding communication and interpersonal skills for effective collaboration with diverse teams.
- Meticulous attention to detail in document preparation and record-keeping.
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 and work-life balance.
- Health insurance and competitive retirement planning.
- Global Employee Assistance Programme and extensive well-being support.
- A diverse, inclusive culture that rewards high performance and nurtures talent.
Ready to shape the future of clinical development? We encourage you to apply even if you don't meet every single requirement. Your unique experience could be exactly what we need.
