高级临床部经理

岗位职责：

• Perform study start-up activities, including study plan build-up, study protocol and CRF design, Investigator Meeting, EC and MOST approval, site selection, site initiation, E-Trial development, co-monitoring, study closure and other related activities ensuring compliance with NMPA regulation, GCP/ICH guidelines and company SOPs.

  开展临床研究启动相关活动，包括研究计划制定、研究方案和 CRF 设计、研究者会议、EC 和 MOST 批准、中心选择、中心启动、电子试验开发、共同监测、研究结束和其他相关活动确保符合 NMPA 法规、GCP/ICH 指南和公司SOP。

• Allocate the budget by project and conduct the daily management and update the usage status.

  按项目分配预算并进行日常管理以及更新。

• Document and updated the progress of assigned clinical studies through regular status report.

  定期更新临床研究的项目进度，做好报告和记录。

• Provide direction and oversight of outsourced activities to ensure Clinical Research Organization (CRO) and vendors delivery against contracted scope of work.

• 监督并指导外包活动的日常工作，以确保临床研究组织 (CRO) 和供应商根据合同规定的工作范围交付。

岗位要求：

• Bachelor or master in medical.

  本科或硕士学历，医学相关专业。

• 8 years clinical research experience, 5 years people management experience.

  8年临床研究经验，5年团队管理经验。

• Open minded, Able to work under pressure, Strong organizational, communication skill, high degree of accuracy and attention to detail.

  思维开放，能在压力下工作，有较强的组织能力，沟通能力，高精准度且注重细节。

• Collaborate with cross functional department such as Global Medical Science Affairs, Regulatory Affair, Sales & Marketing, IT, Finance and Legal to support project milestone achievement. Provide clinical Trial dossier for registration use.

  与全球医学科学事务、监管事务、销售与营销、IT、财务和法律等跨职能部门合作，以支持项目里程碑的实现，提供临床试验档案供注册使用。

• Coordinate Medical Affairs tasks such as Post Marketing clinical Projects, clinical Evaluation Report, publication. D1520.

  协调医疗事务工作，如上市后临床项目、临床评估报告、D1520出版。

• Understanding GCP.

  了解GCP法规要求。

• Fluent in English.

  流利的英语。

位置：

中国上海

发送邮件到：

hr@wallabymedical.com