临床项目管理岗位职责

岗位职责：
1.负责公司所有新产品上市前临床试验，对临床实施的总体质量控制，确保项目符合国家相关法规要求；
2.负责临床试验项目实施的总体进程控制，确保项目进度符合研发计划要求；
3.参与新产品项目评审，出具医学相关建议；
4.负责公司与国家审评中心、受理中心等关系建立和维护；协助注册部完成注册咨询相关工作；
5.负责部门日常事务性管理，工作计划、预算制定、费用管理等文件审核和员工绩效考核，人员辅导和团队建设；
6.负责完成上级领导安排的其他事宜。
职位要求：
1.医药、临床、卫生及相关专业，硕士及以上学历；
2.3年以上临床试验相关工作经验，有上市前临床试验经验优先；
3.深入了解临床试验流程和相关法规要求，熟悉专业英语；
4.具备良好的沟通和应变能力及问题解决能力，情商高；
5.具有带团队经验，有良好的组织、协调、策划和管理能力；
6.适应出差；

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

职责描述:
工作职责：
我们寻求一位在制药行业具备临床医学背景和项目管理经验的项目管理人员，全面负责创新药肿瘤临床项目的内外部协调和项目管理工作。
1. 与项目负责人和项目组一起设定和实施项目策略、目标、跨部门工作计划、预算、里程碑等等。
2. 跟踪项目进展、协调内部和外部资源、及时发现并处理重大风险，以确保项目的成功实施。
3. 保持团队的高效运作，包括主持项目会议和团队会议，保证会议日程紧凑聚焦、会议结论简明清晰。
4. 负责内部的项目沟通，及时向高层汇报项目进展。
5. 负责与支持部门密切合作，确保项目资源的优化配置。
6. 负责与外部业务伙伴沟通和协调。
7. 定期监控团队状态，确保团队保持高绩效水平。采取措施及时解决因沟通错误、目标不一致、缺乏经验等引起的团队内部冲突和问题。
任职要求：
1. 医药、临床、卫生及其相关专业，本科及以上学历
2. 从事药物临床研究工作3年以上，具备项目管理技能和经验。
3. 具有专业项目管理和风险管理的知识，拥有相关证书者优先。
4. 了解新药研发的开发流程。
5. 优秀的中英文口头和书面沟通能力。
6. 较强的谈判和冲突管理的能力。
7. 较强的组织协调能力和区分工作优先级的能力。
8. 较强的计算机软件技能，包括Word、Excel、PowerPoint、SharePoint等。