【Key Responsibilities】
• Manage day-to-day operational aspects of Phase I–III clinical trials from study start-up through closeout.
• Develop and maintain study timelines, project plans, and trial tracking tools.
• Coordinate activities among CROs, clinical sites, vendors, and internal stakeholders.
• Monitor study progress and identify risks, implementing mitigation strategies as needed.
• Review and execute according to essential study documents, including protocols, informed consent forms, monitoring plans, and study manuals.
• Oversee CRO and site activation, enrollment, patient retention, and data collection activities.
• Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
• Have experience in managing study budgets, forecasts, and review of vendor contracts.
• Lead study team meetings and provide regular updates to senior management.
• Review monitoring reports, protocol deviations, and CAPA plans.
• Support regulatory submissions, ethics committee approvals, and inspection readiness activities as needed.
• Collaborate with Data Management, Biostatistics, Medical Monitoring, Safety, Regulatory Affairs, and Clinical Operations teams.
• Contribute to process improvements and implementation of best practices across clinical programs.
【Qualifications】
• Bachelor's degree in the Sciences, Nursing, Pharmacy, Public Health, or related field.
• Approximately 3-5 years of clinical research experience, including experience managing clinical studies.
• Strong understanding of ICH-GCP guidelines and clinical trial regulations.
• Experience working with CROs and external vendors.
• Knowledge of CTMS, EDC, eTMF, and clinical trial systems.
• Excellent project management, communication, and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
