Site Specialist II role in Shanghai. Drive study start-up, site contracts & EC submissions. 3+ yrs SSU/site activation exp & NMPA/ICH-GCP knowledge required. Office-based.
Accelerate Clinical Trials: Be the Operational Engine of Site Activation in Shanghai
At ICON, we are pioneers in clinical development, dedicated to turning scientific discovery into life-changing therapies. The critical bridge between study design and patient enrollment is Site Activation—a complex, detail-driven process that sets the stage for trial success.
We are seeking a skilled and proactive Site Specialist II to join our high-performing Site Activation team in our Shanghai office. In this pivotal operational role, you will be the expert managing the essential tasks that transform a selected site into a fully activated, audit-ready partner. You will navigate regulatory submissions, contract negotiations, and essential document collection with precision, directly impacting our ability to initiate studies faster. If you are a process-driven professional who thrives on ownership and collaboration in a dynamic office environment, this is your opportunity to power clinical research in China’s leading hub.
Your Mission: Own the Pathway from Site Selection to Activation
As a Site Specialist II, you will manage a portfolio of site-level activation activities with increased independence. You will be the go-to expert for ensuring sites are fully prepared, compliant, and ready to enroll patients on schedule.
Key Responsibilities
1. Lead Study Start-Up & Regulatory Compliance
- Serve as the primary operational lead for site activation activities, including the preparation and submission of documents to Ethics Committees (ECs) and regulatory bodies in compliance with NMPA and ICH-GCP requirements.
- Customize and finalize site-specific essential documents, including Informed Consent Forms (ICFs), ensuring accuracy and regulatory compliance.
- Manage the collection, review, and quality control of all essential documents required for site green-light and activation.
2. Contract & Budget Coordination
- Support the end-to-end contract and budget process: assist in the preparation, negotiation, and finalization of Clinical Trial Agreements (CTAs) and site budgets.
- Liaise with legal, finance, and site personnel to resolve contractual queries and secure timely execution.
- Maintain accurate tracking of contract status and financial documentation.
3. Cross-Functional Collaboration & Process Excellence
- Act as the central coordination point between Feasibility, Clinical, Regulatory, and Site Management teams to ensure aligned timelines and seamless communication.
- Utilize and maintain clinical trial management systems (CTMS, eTMF) to ensure real-time accuracy of site status and document tracking.
- Proactively identify risks and delays in the activation pathway and implement solutions to keep studies on track.
- Contribute to process improvement initiatives to enhance the efficiency and quality of the site activation workflow.
Who You Are: The Ideal Candidate
You are a meticulous, organized professional with solid experience in clinical operations, specifically in the complexities of starting up clinical trials in China. You are a proactive problem-solver who excels in a collaborative, office-based setting.
Your Required Profile:
- Bachelor’s degree in Life Sciences, Business Administration, or a related field.
- Minimum of 3-5 years of direct, hands-on experience in Study Start-Up (SSU), Site Activation, or Clinical Trial Administration within a pharmaceutical, biotech, or global CRO in China.
- Strong understanding of NMPA regulations, ICH-GCP guidelines, and local EC submission processes.
- Proven experience with clinical trial agreements, budget negotiations, and essential document management.
- Exceptional organizational skills and attention to detail, with the ability to manage multiple studies and priorities simultaneously.
- Excellent communication and interpersonal skills; fluency in English and Mandarin is required for effective collaboration with global teams and local sites.
- Proficiency with Microsoft Office Suite and clinical trial systems (eTMF, CTMS).
Why Build Your Career as a Site Specialist at ICON in Shanghai?
1. Central Role in a Critical Hub
- Be at the operational heart of clinical trial activation in Shanghai, a key strategic hub for clinical research in Asia.
- Develop deep expertise in China-specific regulatory and site management processes.
2. Professional Growth & Development
- Clear career progression pathway to Senior Site Specialist, Team Lead, or Study Start-Up Manager roles.
- Gain exposure to a wide variety of therapeutic areas and complex global studies.
3. Office-Based Collaboration & Benefits
- Collaborative, modern office environment in central Shanghai.
- Competitive salary and performance-based bonus.
- Generous annual leave entitlements.
- Comprehensive health insurance and wellness programs.
- Global Employee Assistance Programme and a supportive, inclusive company culture.
Join a Team Dedicated to Operational Excellence
At ICON, we believe that a flawless start leads to a successful finish. We are committed to creating an inclusive environment and encourage all qualified operations professionals in Shanghai to apply.
Ready to be the driving force behind efficient, compliant site activation?
If you are a detail-oriented specialist passionate about process and execution, apply now to join our Shanghai team.
