该职位来源于猎聘 Job Responsibilities: 1. 负责临床试验项目的全周期管理,包括方案设计、时间表制定、预算控制及资源协调; Lead end-to-end management of clinical trials, including protocol design, timeline planning, budget control, and resource allocation 2. 主导跨部门协作,确保试验符合GCP及当地法规要求; Coordinate cross-functional teams to ensure compliance with GCP and local regulations; 3. 识别项目风险,制定应急预案,确保试验进度和质量达标; Identify project risks, develop mitigation plans, and ensure trial milestones are met on time and with quality; 4. 参与监管机构核查及审计,确保试验文件完整可追溯; Support regulatory inspections and audits, maintain trial documentation traceability; 5. 总结项目经验,优化临床试验管理流程和SOP。 Improve clinical trial workflows and SOPs based on project learnings. 任职要求: Qualifications: 1. 本科及以上学历,临床医学、药学、生命科学等相关专业; Bachelor's degree or above in Clinical Medicine, Pharmacy, Life Sciences, or related fields; 2. 5年以上临床试验项目管理经验,完整主导过至少2个全球多中心试验(或3个国内试验;
5+ years of clinical trial project management experience, with at least 2 global multicenter trials (or 3 domestic trials) independently led; 3. 优秀的跨文化沟通能力、逻辑思维及抗压能力; Strong cross-cultural communication, problem-solving, and stress management skills; 4. 英语流利(CET-6或同等水平),可撰写英文报告及主持会议。 Fluent English (CET-6 or equivalent), able to draft reports and lead meetings in English.