职位详情
CRM/临床监查经理(CRA-LM)
2.5-3.5万
昆翎(北京)医药科技发展有限公司
广州
5-10年
本科
12-24
工作地址

白云大厦501C

职位描述
职责描述:
1.Manage staff in accordance with organization’s policies and applicable regulations, Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development; rewarding and discipline employees; address employee relation issues and resolving problems. Approve actions on human resource matters.
根据组织政策和适用法规管理员工,职责包括计划、分配和指导工作,评估员工绩效及指导其专业发展;奖励和惩戒员工;员工关系的处理及问题的解决。完成员工人力资源事务的审批。
2.Participate in the selection and onboarding process for new CRAs by conducting candidate review and participating in the interview process. Conduct onboarding training for new staff in conjunction with Human Resource and learning and Developing training programs.
通过对候选人的审查并参加面试过程,参与CRA的招聘和入职流程,结合人力资源制定培训计划,对新员工进行入职培训。
3.Ensure that staff has the proper materials, system, access and training to complete job responsibilities. Provide oversight for the execution of the training plan and SOP review.
确保员工有适合的资料、系统、权限和培训来完成工作职责。对培训计划和SOP阅读的执行进行监督。
4.Participate in allocation of resources to clinical research projects by assigning staff that are appropriate to their experience and training.
委派经验丰富和已完成培训的员工参与临床研究项目,分配项目资源。
5.Manage the quality of assigned staff’s clinical work through regular review and evaluation of the work product.
通过对工作成果的定期回顾和评估,监管员工的工作质量。
6.Ensure operational processes, systems and standards are adopted and implemented consistently across trials.
确保在整个试验中采用一致的操作流程、操作系统和实施标准。
7.Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff. Drives team members to improve their efficiency and effectiveness at prioritizing work and improving performance.
识别质量风险和问题,并制定适当的纠正措施计划,以避免或纠正员工在绩效方面的不足。推动团队成员提高工作效率和有效性,安排工作优先级,提高绩效。
8.Drive plans to resolve Clinical Operations issues escalated from team members. Drive team initiatives and develops solutions independently.
就团队成员提出的临床操作问题提出解决计划。能独立提出解决方案以推动团队的积极性。
任职要求:
1.A Bachelor (or above) degree in life sciences, pharmacy nursing or medical, at least 5 years’ experience in clinical trials.
本科及以上学历,生命科学、药学、护理或医学相关专业,5年以上临床试验行业经验。
2.Good knowledge of Clinical Operations processes and systems.
良好的临床运营流程及系统相关知识。
3.At least 1-year CRA management experiences in the position of CRM or Project management.
至少一年人员管理或项目管理岗位的CRA管理经验。
4.Demonstrate effective coaching/leadership/supervisory ability including excellent interpersonal skills.
具有优秀的辅导/领导/管理能力,以及出色的人际交往能力。
5.Good planning,organization and presentation skills.
良好的计划、组织能力与演讲能力。
6.Effective time management skills and ability to manage competing priorities.
高效的时间管理能力,能够管理冲突的优先级。

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