上海招聘

Function lead for Risk Based Monitoring (Clinical  Risk Identified, Facilitating successful implementation of those strategies to address the issue)

参与Global / Regional 大型临床研究，并对以下等方面提供支持。

- 对职责范围内的Site和临床试验的执行情况 进行远程管理和评估- 主要通过Site Pack等工具来整理汇总各项临床数据信息, 并进行相应的评估管理

- 结合临床试验的设计方案和目前各Site的实际进展状况，对Onsite CRA 后面的Site Visit做进一步的规划和重点事项的安排

-利用QIMS所提供的系统，对临床项目中的重点数据进行及时审查和监控（AI Compliance/Missing Page/Aging Query...),如有需要（Risk alert），及时安排相应的Onsite CRA做Site Visit来把实际问题解决掉。

-Review clinical study相关文件，协助管理eTMF文档.

(最新的“国家药物临床试验质量管理规范- 2016”已明确提出了”中心化监查”的概念和意义，并提出 ”中心化监查和现场监查应基于实际的临床试验风险结合进行” – 详情参见 第四十八条临床试验的监查)

职位特点:

- 不需要出差，可以有更多的个人家庭时间

- 能够参与到Global/Regional 大型临床研究项目中，有机会与国外的同事进行相互交流

- 可以提高临床研究管理和整体把控能力以及全局观的思考能力

-领先的临床试验管理方式及更多的学习机会

职位要求：

- 3 年以上CRA/CRC 等临床研究领域相关工作经验，熟悉Site Visit的具体工作内容；

- 英语六级或相当, 良好的沟通能力

- 积极上进，有较强的学习能力

- 本科以上学历

- 有Senior CRA 或者 CRC PM 经验者优先考虑

PURPOSE

Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines

Establish and maintain effective project/ site communications

Create and maintain relevant project documents// trackers

Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information

Review, evaluate and recommend modifications to designated processes

Oversee and participate in document management (creation, review, maintenance, storage, as applicable)

Participate in (study) team meetings and implement action items

Collaborate with the project lead/team members in creation/review of study documents

Act as point of contact for assigned deliverables for specific customers or projects

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

Escalate quality issues to relevant stakeholders and/or line manager.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements;

     i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software utilized in clinical operations.

Strong written and verbal communication skills including good command of English language

Results and detail-oriented approach to work delivery and output

Good problem solving skills

Good planning, time management and prioritization skills

Ability to handle conflicting priorities

Attention to detail and accuracy in work

Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Proven ability to work on multiple projects balancing competing priorities Good leadership skills

Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in life sciences or related field and min 3 years with relevant clinical research experience; or equivalent combination of education, training and experience

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