临床项目管理岗位职责

职责描述：
· Ensure appropriate monitoring oversight plans are in place reflect adequate adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs policies.
· Lead in study planning to ensure appropriate study timeline, budget resource are in place.
· Obtain appropriate sufficient resources as required fthe studies.
· Lead the clinical core team in executing of study tasks in according to the study plan.
· Lead the selection, contracting oversight of CROs clinical trial related vendors in collaboration with key stakeholders within the Study Management Team(SMT).
· Oversee CRO in executing clinical operations related activities from study setup, sites startup, enrollment, study maintenance, interim/final analyses, study closeout, clinical study reports, annual reports, other clinical documents.
· MonitKey Performance Indicators (KPIs) study metrics to track the quality performance of the studies.
· Provide study status reports study presentations to management team.
· Oversee closely on study progress, study budget, study timeline.
· Identify quality deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
· Ensure the study team provide timely appropriate response resolution to study management issues
· Establish good working relationships with participating sites be the point of sponscontact on escalated site issues.
· Lead Clinical operations activities such as site identification, site selection, study startup, site activation, InvestigatMeetingganization, Site Engagements Booster Visits, study closeout.
· Conduct regular monitassessment visits to ensure sites are well monitored managed by the assigned CRAs.
· Support site inspections audits.
任职要求：
· Bachelors degree (equivalent) above in Clinical medicine, pharmacy, biology, nursing, other field related to human study
· With at least 15 years of relevant working experience in clinical operations and/clinical project management field, with at least 8 years of global trial management.
· Familiar with GCP, NMPA regulations, ICH-GCP regulations, other drugs clinical trial quality management specifications.
· Experience in clinical project supplier management, project management, financial management, quality control.
· Experience in managing global studies from Phase I to III.
· Demonstrate proficiency in ICH rules, regulations from key global regulators such as FDA NMPA, as well as relevant clinical trial guidelines governing conduct of clinical studies
· Extensive experience in oncology drug development, especially in immuno- oncology is an added advantage

1.项目规划 —负责所辖临床试验项目资源配置根据项目方案，合理安排所负责项目的资源配置（人/财/物/时间）；
2.项目实施管控 —项目执行组织项目团队开展临床试验，包括且不限于：
3.筛选临床试验基地、确定主要研究者、主持研究者会及研究方案讨论会，制定监查计划等；
4.项目协调在临床试验项目实施全过程中，与项目团队保持密切沟通，掌握项目进程，必要时为内外部团队提供指导/培训；
5.问题解决多方协同，解决项目执行过程中的各种问题；
6.过程审核审核所有临床研究核心文档；
7.审核并批准所有临床试验项目相关费用；
8.领导交代的其他工作
任职资格
1.本科或相等学历以上；临床医学、药学、生物、护理等相关专业
2.PM临床研究相关工作经验8年以上，至少具有5年以上项目管理经验；
3.熟悉GCP、NMPA法规、ICH-GCP条例等药物临床试验质量管理规范
4.具备临床项目供应商管理、项目管理、财务管理、质量控制相关经验
5.熟悉临床Ⅰ期、Ⅱ期、Ⅲ期、临床试验项目管理工作
6.英语能力：能够阅读各类英文资料；
7.计算机能力：熟练使用Office办公软件：Word/Excel/PPT
8.应具备的资格证：GCP证书，具有PMP证书者优先
9.其他要求：具有一定的领导能力、计划控制能力、分析评估能力、团队合作能力、沟通能力

工作职责
1. 负责临床试验项目的全流程管理，确保项目按时、按质、按预算交付，严格遵守GCP、ICH及相关法规要求；
2. 制定并管理项目预算、时间表及风险管控计划，及时识别并推动解决项目风险；
3. 作为客户主要对接人，主导区域/项目层面的沟通，定期汇报项目进展、关键指标及风险应对策略，主持并带领客户会议；
4. 领导跨职能团队及第三方供应商，协调资源、推动里程碑达成，确保项目合同交付物及成本控制到位；
5. 支持BDM业务拓展，参与项目交付相关的方案展示及客户提案；
任职要求
1. 本科及以上学历，医学、药学、生命科学等相关专业优先；
2. 6年以上临床试验执行经验，其中至少3年项目管理经验；
3. Global CRO或Global Pharma背景，具备至少1个完整项目（作为PM）的独立管理经验；有MRCT（国际多中心临床试验）经验者优先；
4. 有肿瘤或肾病领域项目经验者优先；
5. 优秀的英文书面及口头沟通能力，能作为工作语言与客户及研究者高效交流；具备出色的跨部门协调、风险识别及问题解决能力；
6. 熟练使用MS Office；熟悉CTMS、eDC、eTMF等临床系统；具备供应商管理经验；
7. 有BDM或项目交付展示经验者优先