上海招聘

Prepare a clinical trial plan including all elements listed in the clinical trial plan template as appropriate for the clinical trial (Time Schedule, Budget, Recruitment Plan, Roles and Responsibilities, Work Breakdown Structure, Management Service Provider, Communication Plan, Risk Management Plan, etc).

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 arranging and preparing of Advisory Board Meeting and Investigator Meeting.

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.

To be responsible for using CTMs in clinical trial and ensure that information entered into CTMs is accurate and updated on a regular basis.

To be responsible for public discloure of clinical trial according to the Reistone’s SOPs.

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.

Provides training and coaching to CRAs with regard to all aspects of the clinical trial process.

Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting.

Job Requirements:

1.Education: Bachelor’s degree or above in Medical, Pharmacy or related areas. Languages:Fluent English (oral and written). Experience: ·

2.Preferred substantial professional experience (approximately 6-8 years as a guide) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least one (1) year of them in clinical trial management; · 3.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 ·

4.Proven track record of having successfully led one or more multinational

瑞石生物医药有限公司于2018年1月创立，总部位于中国上海，在北京及美国波士顿设有分支机构，是一家创新的研发驱动型全球生物制药公司，立足于开发临床急需的创新药物以满足患者的需求。目前，瑞石专注于自身免疫类疾病创新药物的全球开发，一方面与国内领先的制药企业恒瑞合作将中国创新药物引入美国及欧洲，助力中国创新走向世界；另一方面还借助公司管理团队在中国开展创新药物研发的丰富经验，积极引进国际领先的创新药物解决中国患者的临床需求。