Clinical Trial Specialist, China, EC

Clinical Trial Specialist, China, EC Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies . With over 25 years of experience and a world-renowned focus in renal research , Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role The Associate Clinical Trial Specialist (ACTS), Clinical Trial Specialist (CTS), Senior Clinical Trial Specialist (SCTS) and Principal Clinical Trial Specialist (PCTS) are members of the Clinical Operations Group and project team responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines for the study team during project startup, maintenance, and close-out. Responsibilities Increase proficiency in Trial Master File (TMF) set-up, maintenance and close out (including QC and archival), filing and reconciliation and serves as TMF lead. Serve as second reviewer for TMF QC Prepare and participate in audit responses Experienced with process for tracking and submission for investigator payments as well as maintaining files for Emerald Clinical’s Clinical Trial Management System (CTMS) and other study-related shared drives, portals or SharePoint sites. Advance understanding in creating and maintaining project start-up and maintenance documents including trackers, reports, training logs and other site materials. Advanced understanding of the assembly, preparation or coordination of shipments and returns/destruction for site study materials and IP and performs tasks for drug room management, generating code break envelopes and escalating any IP issues to CL/PM. Maintains current project-specific training logs to ensure individual, group and site training forms and trackers are up to date and PIs / delegated staff are qualified and trained on the study. Work with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable and assists with presenting final feasibility results. Distribute, collect and track signed confidentiality agreements (CDAs) as needed under direction/guidance of the PM/PL Assists sites in preparation, planning, organising and collecting essential document packets (EDPs) and submitting final EDPs to study team as required. Supports site staff with submission to Central and Local IRBs/ECs, performing review of ICFs and submission to Central IRB on site’s behalf (if applicable), as well as confirming accuracy of IRB approval documents and tracking expiration dates. Provides site management and guidance to sites documenting per company SOPs and/or applicable project plans. Escalates any IP issues discussed with sites to CL/PM Accomplished in providing updates and reports to internal team during meetings and taking meeting minutes across projects. Manages and completes work activities according to study plans and timelines and communicates any delays Provides support to study team as needed Discuss or escalate sponsor issues or site issues including protocol noncompliance or GCP concerns as needed. Discuss or escalate internal team problems/issues with Line Manager or CL/PM as needed to assist with resolution when identified. Experienced with the identification and documentation of deviations from applicable regulatory and study protocol requirements and report non-compliance. Work with study team and sites (as applicable) to develop and implement corrective action plans or other alternative solutions for quality issues when identified. Assists with designing, developing and maintaining site materials, logs and study binders/investigator files. About You Tertiary qualifications in a related science or health care discipline and/or previous clinical research experience preferred Knowledge of ICH/GCP, ethical and regulatory requirements preferred At least 1 year of experience as a Clinical Trial Specialist (CTS) Sound English communication skills Ability and willingness to travel if required (SCTS or PCTS only) Perform general administration office duties as needed or required Perform other job functions or tasks as needed Driver's license preferred Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work : You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise : Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience. • Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates. Department Clinical Operations Role Clinical Trial Specialist Locations China - Beijing Remote status Hybrid Employment type Full-time