Senior Clinical Trial Associate (CTA), Office-Based (Shanghai)
Your Mission: Be the Operational Engine for Clinical Trials in China
At ICON in Shanghai, the seamless execution of a clinical trial relies on meticulous organization and flawless administrative support. As a Senior Clinical Trial Associate (CTA), you will be the essential operational engine for our clinical teams. This office-based role places you at the strategic heart of trial administration in China, where your precision and proactive coordination ensure regulatory submissions are compliant, essential documents are impeccably managed, and our investigative sites are fully supported. You won’t just complete tasks; you will own critical processes that ensure the smooth and efficient progress of complex global studies in one of the world's most dynamic markets.
We are looking for an experienced, detail-driven professional to join our clinical operations team. If you excel in a structured, fast-paced environment, thrive on enabling team success, and are ready to take on greater responsibility in trial start-up and maintenance, this Senior CTA role in our Shanghai office is your ideal career step.
Your Impact: Own Critical Trial Administration & Site Coordination
You will take ownership of key administrative and regulatory tasks, providing the robust foundation upon which our clinical trial teams deliver successful outcomes for our clients.
1. Lead Study Start-Up & Regulatory Submissions
- Take a leading role in China-specific study start-up activities, including the meticulous preparation, compilation, and submission of regulatory and ethical approval dossiers to the National Medical Products Administration (NMPA) and Ethics Committees.
- Manage and maintain the Trial Master File (TMF) for assigned studies, ensuring all essential documents are collected, reviewed for completeness, and archived accurately for real-time inspection readiness according to ICH-GCP and local requirements.
- Prepare, distribute, and track critical study materials (e.g., protocols, informed consent forms, study plans) to investigative sites across China.
2. Drive Operational Coordination & Site Partnership
- Serve as a primary point of contact for assigned investigative sites in China, managing all communications, tracking document flow, and ensuring timely responses to site queries to maintain strong, collaborative relationships.
- Coordinate and document internal and client meetings, including agenda preparation, minute-taking, and diligent tracking of action items to completion.
- Monitor and track overall trial progress, managing the logistics of site payments, vendor setup, and shipment of clinical supplies to ensure uninterrupted site operations.
3. Champion Process Excellence & Collaboration
- Work collaboratively with Clinical Research Associates (CRAs), project managers, and other cross-functional team members to resolve operational issues and support overall project goals.
- Identify opportunities to improve administrative processes and contribute to the development of tools and templates that enhance team efficiency and quality.
- Provide guidance and share best practices with junior CTAs, fostering a culture of excellence and knowledge sharing within the team.
Who You Are: A Meticulous Organizer and Trusted Partner
You are a proactive professional who believes flawless execution is what enables clinical breakthroughs. You are organized, an exceptional communicator, and driven to be the reliable anchor for your study teams.
Your Foundation
- A Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or a related field.
- Extensive experience in a Clinical Trial Assistant or similar administrative support role within a CRO, pharmaceutical, or biotechnology company, with a strong preference for experience in the China market.
- Solid understanding of China clinical trial regulations (NMPA), ICH-GCP guidelines, and local submission processes.
- Proficiency with clinical trial management systems (CTMS), electronic Trial Master File (eTMF) platforms, and the Microsoft Office Suite.
- Full professional proficiency in Mandarin and English (both written and verbal) is essential.
- Excellent organizational skills with the ability to manage multiple tasks and priorities effectively in a dynamic environment.
Your Core Strengths
- Process Owner: You take pride in owning administrative and regulatory processes from start to finish, ensuring accuracy and compliance at every step.
- Detail-Focused Executor: You have a keen eye for detail in document management, data tracking, and regulatory submissions, ensuring the highest standards of quality.
- Proactive Communicator: You maintain clear, professional, and timely communication with internal global teams and external sites across China.
- Collaborative Problem-Solver: You thrive in a team environment, can manage shifting priorities, and work proactively to find solutions to operational challenges.
- Cultural Bridge: You effectively navigate and connect international study requirements with local site practices and regulations.
Why Build Your Career as a Senior CTA at ICON in Shanghai?
Grow Your Expertise in a Global Clinical Hub
- Office-Based Collaboration: Immerse yourself in our professional Shanghai office, working alongside and learning from a talented local and international team.
- Strategic Career Development: This senior role is a recognized stepping stone to advanced positions such as Study Start-Up Specialist, Clinical Trial Manager, or In-House CRA (IHCRA).
- Market-Specific Impact: Gain deep, valuable experience in the critical and growing China clinical trials landscape while being part of a premier global CRO.
Thrive in a Supportive, Inclusive Culture
- Join a diverse and dynamic team where your contribution is valued and your professional growth is actively supported through training and mentorship.
- Be part of ICON’s mission to shape the future of clinical development from one of its most important global locations.
Competitive ICON Benefits in China
- We offer a competitive salary and benefits package.
- Enjoy comprehensive health insurance, generous annual leave, and a global employee assistance program, all designed to support your well-being and work-life balance.
