{"id":2753905,"url":"https://alion.io/job/imcere-inchuangxiangmujingri","title":"临床项目经理","company":{"id":2823058,"name":"Simcere Pharmaceutical","domain":"simcere.com","url":"https://alion.io/company/simcere","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayee","truth_index":{"grade":"C","score":60,"open_postings":66,"ghost_share":0.667,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Management","role_family":"Management","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Nanjing, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":22000,"max_usd":61000,"period":"year","method":null,"sample_n":17739},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-09-17T13:04:01Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-10-23T05:35:44Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":35},"description":"工作职责 / Responsibilities\n岗位概述：\n作为临床项目经理，全面负责创新药I-IV期临床试验全流程项目管理，统筹项目进度、质量、预算、资源及供应商管理，严格遵循ICH-GCP、国内外药监法规及公司SOP体系。跨部门协同研发、医学、统计、QA、注册等团队，主导MRCT多中心项目落地，持续优化项目流程与交付质量，保障临床试验高效、合规、高质量推进，支撑管线项目顺利申报与上市。\n主要工作职责\n1、项目整体规划与方案管控：独立制定I-IV期临床试验项目整体计划，包含项目预算、整体时间轴、项目管理计划、质量保证计划、风险应急预案，统筹项目全生命周期落地管控。\n2、中心策略与入组管理：负责研究中心筛选、评估与启动规划，结合中心能力合理预估各中心病例入组体量与入组节奏，制定差异化入组推进策略，保障项目进度达标。\n3、临床试验文件筹备：统筹、起草、审核临床试验全套相关文件，推进伦理、备案、立项等前置流程，确保项目启动前所有合规文件齐全、流程闭环。\n4、会议组织与团队赋能：主导组织研究者会议、项目启动会、阶段性项目例会，完成研究者、CRA及项目相关人员方案培训、SOP培训，统一项目执行标准。\n5、项目质量与风险管控：全程监控临床试验执行过程，及时识别、跟进、解决项目进度、质量、合规风险，确保项目严格按照研究方案、公司SOP、ICH-GCP及NMPA/FDA/EMA法规执行; 定期复盘项目经验问题，持续优化临床试验执行流程与管理体系。\n6、跨部门协同推进：联动公司医学、统计、数据、注册、QA、药理等内部职能部门，高效解决项目卡点，保障项目各阶段节点按期交付。\n7、第三方供应商管理：负责CRO、中心实验室、IVRS、EDC、特殊物流等第三方供应商筛选、准入、合同落地及过程绩效管理，监督供应商交付质量与进度，确保符合项目及合规要求。\n8、团队人力与绩效管理协同：根据项目复杂度、工作量评估人力需求，向CRA直线经理输出人力配置建议; 同步反馈CRA工作表现，输出团队培训需求及人才发展建议，助力团队能力建设。\n任职要求\n1、本科及以上学历，临床医学、药学、临床药理、生物制药等相关专业，统招全日制学历; \n2、具备创新药企业3年及以上临床项目管理经验，完整跟进过I-IV期临床试验全流程，有MRCT国际多中心项目经验者优先; \n3、精通ICH-GCP、国内法规，熟悉FDA/EMA海外临床研发政策与申报逻辑，具备国际化项目管控思维者优先; \n4、英文听说读写流利，可独立处理英文方案、海外资料、对接海外合作方，具备优秀的书面及口头表达能力优先; \n5、具备优秀的项目统筹、风险预判、跨部门沟通及问题解决能力，执行力强，主动推进项目闭环; \n6、工作态度积极开放，具备良好的团队协作意识、抗压能力及持续学习能力。\n任职要求 / Requirements\n1、临床医学(优先)、临床药学/药学等相关专业,本科及以上学历。\n2、具备3项及其以上的上市前临床试验项目经验(非领域自免/中枢神经领域经验者优先)。\n3、具备1年及其以上的临床试验项目管理经验,项目管理有一定的前瞻性（需要公司及平台再次确认）。\n4、良好的执行力,能严格执行上级规定的目标任务。\n5、优秀的沟通能力、表达能力及良好的职业道德。 \n另外，工作地点上海/南京优先考虑，其他地区可以沟通。","description_format":"text","description_chars":1386,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"Chinese","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Government"],"lifecycle":[{"event":"open","at":"2026-10-17T01:03:10Z"}],"visa":[],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.34,"p_room":0.45,"age_days":34,"expected_fill_days":21,"reasons":["conf:0","stale_co","win:tail"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/imcere-inchuangxiangmujingri","json_url":"https://alion.io/job/imcere-inchuangxiangmujingri.json","meta":{"generated_at":"2026-10-23T05:56:04Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9620,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2823058},"rest":"https://alion.io/mcp/rest/get_company?id=2823058"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fimcere-inchuangxiangmujingri"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fimcere-inchuangxiangmujingri"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fimcere-inchuangxiangmujingri"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/imcere-inchuangxiangmujingri\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fimcere-inchuangxiangmujingri"}]}