Senior CTA role in Beijing. Support site management, TMF maintenance & study coordination. 2-3+ yrs clinical research exp & knowledge of NMPA/ICH-GCP required. Office-based position.
Advance Your Clinical Research Career in Our Beijing Hub
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research, providing outsourced services to pharmaceutical, biotechnology, and medical device organizations.
We are seeking an experienced and proactive Senior Clinical Trial Associate (Senior CTA) to join our Site Management team in our Beijing office. This is an essential office-based role where you will provide critical operational and administrative support to ensure the smooth running of clinical trial sites. You will be the organizational backbone for monitoring activities, document management, and site performance tracking, playing a key role in maintaining compliance and efficiency. If you have a solid foundation in clinical research and are ready to take on greater responsibility in a collaborative office environment, this is your next career step.
Your Mission: The Operational Foundation for Site Excellence
As a Senior CTA, you will elevate site management support by handling complex administrative tasks, ensuring impeccable documentation, and acting as a reliable liaison between field monitors, sites, and internal teams. Your precision and proactive approach will directly contribute to the quality and timeliness of our clinical trials.
Key Responsibilities
1. Advanced Site Management & Monitoring Support
- Provide comprehensive support for site monitoring activities, ensuring all processes align with ICH-GCP guidelines and NMPA regulations.
- Prepare, track, and manage essential site documentation, including monitoring visit reports, confirmation letters, and follow-up communications.
- Assist in tracking site performance metrics (e.g., patient enrollment, data query resolution) and contribute to site management plans.
2. Trial Master File (TMF) & Document Management
- Take ownership of the TMF for assigned studies, ensuring timely, accurate, and compliant upload of all essential documents in the eTMF system.
- Perform quality reviews of TMF content and lead reconciliation efforts to maintain inspection readiness.
- Manage the collection, distribution, and archival of critical study documents.
3. Cross-Functional Coordination & Process Improvement
- Serve as a key point of contact for CRAs, Site Management, and internal cross-functional teams (Clinical, Regulatory, Data Management), facilitating clear communication.
- Proactively identify and help resolve site-related operational or administrative issues.
- Contribute to the development and improvement of departmental processes, templates, and training materials.
- Mentor and provide guidance to junior CTAs or new team members.
Who You Are: The Ideal Candidate
You are a detail-oriented, organized professional with substantial clinical research experience. You thrive in a structured office environment, take pride in flawless execution, and are ready to leverage your knowledge to support study success with greater independence.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related healthcare/science field.
- Minimum of 2-3 years of direct experience in a Clinical Trial Associate (CTA), Site Management Assistant, or similar clinical operations support role within a CRO, pharmaceutical, or biotech company.
- Solid understanding of clinical trial processes, ICH-GCP, and Chinese regulatory requirements (NMPA).
- Exceptional organizational skills and meticulous attention to detail, with proven ability to manage multiple competing priorities.
- Excellent written and verbal communication skills in both English and Mandarin.
- Proficiency with clinical trial systems (eTMF, CTMS, EDC) and the Microsoft Office Suite.
- A collaborative team player with strong interpersonal skills.
What Sets You Apart (Preferred):
- Experience with TMF management and audit/inspection preparation.
- Exposure to site monitoring activities or direct site interaction.
- Certification in clinical research (e.g., SoCRA, ACRP).
Why Build Your Career as a Senior CTA at ICON in Beijing?
1. Strategic Office-Based Role
- Gain deep, centralized expertise in clinical trial operations without the need for extensive travel.
- Be a vital part of our dynamic Beijing office, a key hub for clinical research in the region.
2. Clear Career Progression
- This role is a recognized stepping stone to Clinical Trial Manager (CTM), Study Start-Up Specialist, or Site Management Lead positions.
- Access structured training and professional development programs.
3. Comprehensive Office-Based Benefits
- Competitive salary and performance-based bonus.
- Generous annual leave entitlements.
- Comprehensive health, life, and disability insurance.
- Global Employee Assistance Programme for 24/7 support.
- Modern office facilities and a collaborative team culture.
Join Our Inclusive Mission in Beijing
At ICON, we believe that diversity drives innovation. We are committed to creating an accessible, inclusive environment and encourage all qualified candidates to apply.
Ready to take your clinical operations expertise to the next level in a supportive office setting?
Apply now to become the operational cornerstone of our Beijing Site Management team.
