Clinical Operations
Clinical Project Manager
Posted:
You will organize the people, sites, plans and resources needed to run Innogen’s clinical trials. The role combines project planning with day-to-day decisions: keeping budgets and milestones under control, resolving study issues, supporting CRAs and giving management a clear view of progress.
Your work
- Run trials in accordance with GCP, applicable regulations and company standard operating procedures, maintaining study quality and progress.
- Organize the project team’s selection of trial sites, identify principal investigators with the Operations Director, and prepare protocol discussions and investigator meetings.
- Set project budgets, timelines, staffing requirements, management plans and monitoring plans. Manage key milestones and budgets against the approved project plan.
- Prepare ethics committee and human genetic resources application documents, help CRAs submit them, and register trial information on the drug clinical trial registration and information disclosure platform.
- Maintain timely communication with partners, investigators, subject experts and internal and external teams. Track progress and keep management informed.
- Run regular project meetings, resolve delivery issues and respond promptly to incidents and urgent problems during study execution.
- Review all project-related expenses, essential study documents, study agreements and CRA monitoring reports.
- Guide CRAs, provide the project training they need, and manage and assess the performance of your direct reports.
- Coordinate project documents, instruments, equipment and other resources to meet study needs.
What you bring
- A bachelor’s degree or above in medicine, pharmacy, nursing or a related discipline.
- At least eight years of experience in clinical research and clinical operations, including experience guiding or training colleagues.
- A strong command of GCP regulations and requirements, with knowledge of the relevant diseases and products.
- Strong English reading and writing skills.
- The ability to build effective partner relationships, communicate and coordinate clearly, and follow through on plans.
- A rigorous, detail-oriented and proactive approach, with the ability to work under pressure.
Original posting · Chinese
临床项目经理
岗位职责
1. 按照GCP等相关法律法规和公司SOP规定，执行临床试验，确保临床试验质量和进度； 2. 组织项目团队开展临床试验，包括筛选和确定临床试验中心、与运营总监一起确定主要研究者、准备研究方案讨论会及研究者会； 3. 负责公司临床试验的项目管理，制定临床试验项目预算、时限，所需要的人员数量及项目管理计划和监查计划； 4. 为伦理委员会和人类遗传资源管的项目申请准备资料，并协助CRA提交； 5. 负责将临床试验信息登记到药物临床试验登记与信息公式平台； 6. 负责与项目合作方、研究者及相关领域专家保持良好、适时的沟通，维护与合作伙伴及专家的良好合作； 7. 负责在项目推进过程中，及时且顺畅的与公司内外部相关部门进行沟通和协调； 8. 在临床试验项目实施的整个过程中根据批准的项目管理计划，管理重要里程碑节点和预算，与相关职能部门或团队保持密切的沟通，掌握项目进程并持续向管理层汇报； 9. 定期组织项目例会，解决项目执行过程中的各种问题； 10. 审核所有与临床试验项目相关的费用； 11. 指导CRA的工作，对CRA进行必要的项目相关的培训； 12. 审核所有临床研究重要文件、临床研究协议，CRA提交的监查报告； 13. 负责及时处理项目实施过程中出现的问题和应急突发事件； 14. 负责对项目相关文件、仪器设备等资源进行调配，使其满足项目需求； 15. 管理：管理考核下级员工的绩效； 16. 其他：完成上级交办或授权处理的其他事项。
任职要求
1.学历要求:本科及以上学历； 2.专业范围:医学、药学、护理等相关专业； 3.外语要求:较强的英语读写能力； 4.工作经验:8年及以上临床研究及临床运营工作经验，有一定的带教积累； 5.知识技能:熟练掌握GCP相关法规及要求；熟悉相关疾病及产品知识； 6.能力素质:能够与各合作方建立了良好的合作关系；良好的沟通、协调能力；良好的执行力； 7.性格特征:严谨、细致、积极主动、抗压。