高级临床部经理

日期:2022-04-06

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

Wallaby Medical保留所有权利    沪ICP备19039499号-1     沪公网安备 31011502019052号 隐私声明      沃比医疗公众号

Wallaby Medical保留所有权利
沪ICP备19039499号-1     沪公网安备 31011502019052号 隐私声明
沃比医疗公众号