上海招聘

• Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
• Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities.
• Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
• Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
• To be responsible for the co-ordination of timely trial supplies with IMP department.
• To be responsible for initialing, monitoring and closing the clinical study sites and ensure that the clinical trial progress according to quality standards, Reistone’s SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
• Perform co-mornitoring visits, if approprite.
• Ensure the quality of the data.
• Maintain appropriately and safely all necessary documents in Trial Master Files.
• To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding.

 

 

Role related Qualifications/ Skills:

1. Education: Bachelor’s degree or above in Medical, Pharmacy or related areas.
2. Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
3. Proven track record of having successfully led one or more multinational

Proclinial (璞凌珂)是一家英国人力资源咨询公司，致力于为全球医疗行业客户提供中高端人才咨询服务。目前我们的顾问团队在欧洲、北美、亚洲及大洋洲众多国家及地区设有办事处。 Proclinical Executive是隶属于Proclinical旗下的高端服务品牌，旨在利用公司全球共享数据库及全球Proclinical Executive各个合伙人自身的资源和丰富的行业背景，为各类高级行政管理层(C Suite)岗位提供专业定制服务。璞凌珂自2018年进入中国市场，由专业的顾问团队为中国医疗行业客户及候选人提供全球化的专业服务。