Clinical Research Manager
默克雪兰诺有限公司
- 公司规模：5000-10000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-06-16
- 工作地点：北京
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：30-40万/年
- 职位类别：临床研究员 生物工程/生物制药
职位描述
职位描述：
Key Accountabilities
? Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
? Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
? Develop and monitor study budget and timelines
? Monitor work to ensure quality
? Ensures that trials are entered into the Clinical Trial Management System and other systems, if applicable
Main Tasks
? Understanding of local / country requirements for clinical trials
? Managing and steering CROs
? Networking skills to represent Merck Serono with key local stakeholders
? Proactive issue monitoring and management
? Manages the budget for all local clinical studies and Global Phase IV studies assigned
? Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials
? Support local organization in delivering local medical strategy across the portfolio within own country
? Work with CRO in county to ensure local trials are delivered within desired quality, timelines, and costs
? Overseeing external providers
? Act as interface between Global Clinical Operations and local organization (Global Operations
Pre-requisites
? Medical or Life Sciences degree or equivalent qualification
? At least 3 years of experience in clinical research in a CRO, pharma or biotech company
? Experience in clinical trial planning and conduct
? Thorough knowledge of ICH GCP and applicable local regulations
? Demonstrated good interpersonal skills
? Demonstrated good written and verbal communication skills
? Demonstrated good presentation skills
? Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
? Analytical skills, quick perception and good judgment
? Fluency in English (oral and written) plus local language
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Key Accountabilities
? Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
? Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
? Develop and monitor study budget and timelines
? Monitor work to ensure quality
? Ensures that trials are entered into the Clinical Trial Management System and other systems, if applicable
Main Tasks
? Understanding of local / country requirements for clinical trials
? Managing and steering CROs
? Networking skills to represent Merck Serono with key local stakeholders
? Proactive issue monitoring and management
? Manages the budget for all local clinical studies and Global Phase IV studies assigned
? Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials
? Support local organization in delivering local medical strategy across the portfolio within own country
? Work with CRO in county to ensure local trials are delivered within desired quality, timelines, and costs
? Overseeing external providers
? Act as interface between Global Clinical Operations and local organization (Global Operations
Pre-requisites
? Medical or Life Sciences degree or equivalent qualification
? At least 3 years of experience in clinical research in a CRO, pharma or biotech company
? Experience in clinical trial planning and conduct
? Thorough knowledge of ICH GCP and applicable local regulations
? Demonstrated good interpersonal skills
? Demonstrated good written and verbal communication skills
? Demonstrated good presentation skills
? Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
? Analytical skills, quick perception and good judgment
? Fluency in English (oral and written) plus local language
职能类别： 临床研究员 生物工程/生物制药
关键字： clinical research CRO phase IV ICH GCP trail
公司介绍
默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。
默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。
默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。
联系方式
- 公司地址：北京市朝阳区