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Manger or senior manager for clinical operations

3-5万/月

安萌得医药科技(上海)有限公司 查看所有职位

上海-闵行区  |  5-7年经验  |  博士  |  招1人  |  04-13发布

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职位信息

Primary Function主要职能:

Be accountable for the implementation, management and reporting of assigned clinical trials, drive the execution of the clinical studies in compliance with ICH-GCP, including but not limited to study planning, study start-up, execution, control study budget and quality, monitor progress, CRO/vendor selection and management, develops and manage all study plans in collaboration with the CRO if applicable.

Be a key member of product project team working closely with R&D key functions on product development plan and execution, provide input and contribute from clinical operation function.


Major Responsibilities and Duties主要职责和任务:

Ensure successful clinical trial startup and conduction, accountable for all study aspects and ensuring meeting timeline, budget and quality requirement.

1. Support IND filing on study related documents preparation, e.g. protocol, ICF, IB etc.

2. Manage study planning and startup all activities including not limited to country/site selection, FDA/NMPA submission, study TMF preparation, vendor/system set

-up, Clinical trial materials planning and readiness at depot, study plan development etc.

3. Manage trial enrollment and monitor overall progress, make mitigation/action plans and execute ensuring enrollment hit target.

4. If applicable, lead company functional team on CRO selection, manage and monitor performance of all CROs ensure delivering on time and high quality.

5. Manage several of clinical vendors’ contract and overseeing their performance

6. Have responsibility for the financial management of the clinical trial including budget planning, resource allocation and preparation of quarterly reports.

7. Train and coach CRAs in various aspects of management (e.g. HR, budgets, and resource allocation) that are relevant to project issues

8. Work as product level project team member and contribute from clinical operation perspective.

9. Identify/monitor risks, and develop mitigation, contingency plans as necessary

10. Serve as a liaison for company with our overseas or domestic clinical CROs


Qualifications资格要求:

1. Medical degree and above

2. Major in clinical medicine, pharmacy or relevant;

3. Experienced in clinical trial area and preference on

? >6 years clinical trial related experience & >3 years trial management

? previously worked in global pharma or CRO and/or early development functions

4. Knowledgeable to China regulatory and clinical requirements, with experience of interacting with regulatory agencies, e.g. FDA, NMPA

5. Solid understanding of GCP and Drug development

6. Ability to work independently and collaborate

7. Strong communication skills and leadership

8. Strong oral and written communication skills in Chinese and English 


联系方式

上班地址:新骏环路760号1号楼402

地图

公司信息

安萌得医药科技(上海)有限公司(简称:安萌得)是南京艾美斐生物医药科技有限公司(简称:艾美斐)的全资子公司。安萌得坐落于上海市临港浦江国际科技城,是艾美斐在上海的研发中心,主要从事治疗恶性肿瘤、自身免疫性疾病、神经退行性疾病等重大疾病的新药开发,从事靶点认证、高通量筛选、先导化合物优化以及候选分子的药效学、药代动力学、毒理学、IND申报等临床前研发的工作。
安萌得现有全职员工30余人,其中硕士及以上的研发人员占总研发人员的90%。自2018年成立以来,安萌得已有两个First-in-Class项目进入IND阶段,另有三个项目进入候选分子阶段。
安萌得坚持“关注生命,造福人类”的理念,注重从源头创新,致力于为广大患者提供最有的治疗方案。我们诚恳地欢迎各方英才加盟安萌得,共创辉煌!
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