临床运营优化经理(CTA Line Manager)

公司部门: 诺诚健华

工作地点:北京

发布日期:2022-06-30

招聘人数:1人

职位类型:生物制药/医疗器械

职位描述:

主要职能:

Key Objectives/Deliverables:

1. 打造专业的CTA团队,加强团队建设和能力提升。根据人员资源计划管理人员高效执行。并推动团队成员提高工作优先级和绩效的效率和有效性。

Build up a professional CTA team, strengthen team cohesion and capability improvement. Manage resource according to resource plan. Drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance.

2. 保持积极和结果导向的工作环境。

Maintain a positive and results orientated work environment.

3. 制定CTA团队相关培训计划以提高质量管理技能, 建立SOP和最佳实践,以优化CTA团队的交付速度、质量和合规性

Develop CTA team training plans and programs across Clinical Operations to enhance quality management skills. Establish SOPs and best practices to optimize the work speed, quality and compliance.

4. 监督团队的日常工作,制定明确的方向和绩效目标,确保清晰有效的流程设置、持续跟踪和数据分析,以识别潜在问题并加以改进以专业和协作的方式与内部和外部员工进行有效沟通。

Supervise CTA team at daily work, establish clear direction and performance targets, ensure clear and efficient process, on-going tracking, and data analysis to identify potential issue and improve it.

5. 管理和监督“中心化角色”,包括临床试验设备管理、预算和费用管理支持、项目会议管理支持、试验发布支持、其他试验支持、相关供应商管理、纸质TMF和eTMF管理,各种临床试验跟踪报告的运行和系统管理,监督和维护运营跟踪和报告系统和工具。

Manage and oversight the“centralization roles”, may including clinical trial equipment management, budget and expenses management support, project meeting management support, trial posting support, other trial support related vendors management, paper TMF and eTMF management, various clinical trial tracking report running and system management. Supervise and maintain operational tracking and reporting systems and tools.

6. 按照流程做好供应商准入的协调工作及文件管理。

Per process, coordinate for vendor access and documents management.

7. 主动发现潜在问题并寻求改进,在临床运营部内外主动解决问题,并及时向管理团队上报问题 Proactively identifies potential issues and seek improvement, take initiative for issue resolution within and outside the Clinical Operations department, escalate issues to Management team timely.

8. 协调风险管理流程,包括主动风险识别、评估(概率和影响)和缓解计划

Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans

任职条件:

岗位要求:

Basic Requirements:

1. 本科或硕士以上学历,医药相关专业最佳。

Bachelor or master degree or above,Major in medicine and biology is preferred;

2. 具备至少3年以上临床运营支持经验,以及至少1年以上临床运营支持管理经验。

At least 3 years of clinical operation supporting experience, and at least 1 year of management experience.

3. 较强的书面和口头沟通能力以及流利的英语口头和书写能力

Strong written and verbal communication skills, and fluent English in oral and writing

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