南京招聘

工作内容
1.对所负责的临床研究项目进行全面的管理；
2..按照要求筛选研究中心；组织临床试验方案讨论会及临床试验总结会；组织研究者代表及统计人员对药物进行编盲，协调PI与统计分析人员召开盲态审核会议；
3.培训CRA，内容包括试验方案、ICF、CRF、研究病历等；
4.审核监查计划书，对CRA的工作进行合理分工；审核CRA提交的进度及项目进展情况，并协调项目整体进度；
5.协调各研究中心、申办者、数据管理人员之间的沟通；
6.协助完成公司SOP的定期更新；
7.完成领导交办的其他工作。


任职资格
1.临床医学、药学专业本科以上学历；
2.完全具备3年CRA经验，1年以上管理经验；
3.具有优秀的团队组织能力和项目管理技能，如组织召开项目组会议，针对出现的问题能迅速反应并拿出解决方案；
4.具有独立工作能力，具团队合作精神；
5.具有良好的书面与口头表达能力；
6.英语熟练，听说读写流利；

上海百试达医药科技有限公司是为国内外医药和医疗器材企业提供高质量临床研究专业服务的合同研究组织（CRO），是国内领先的医药研发服务外包承接机构。公司临床研究服务分布在药品、医疗器械、生物制品等领域，为客户提供专业化的技术解决方案和技术服务。

上海百试达业务范围包括临床试验的设计、组织、运作和管理，如I-IV 期药物临床试验和医疗器械临床试验项目的策划和筹备、方案撰写、基地筛选、临床监查服务、药物管理、数据管理和生物统计、研究报告撰写。公司还提供药品和医疗器械注册和医学咨询和代理、流行病学观察性研究、医药市场研究和研究者、CRA 和其他临床研究专业人员的培训等。

上海百试达拥有资深的专业研究团队，主要研究人员均具有外资制药企业药物研发部和临床研究部工作经验。具有国际化、标准化的业务运作流程和科学严谨的质量保证体系，谙熟国际多中心临床试验和国内各种类型临床试验项目的运作和管理。此外，百试达还在临床医学，临床药理学和生物统计领域拥有一大批专家网络资源，并通过高质量的各类人员和项目培训不断扩大这一网络，从而保证各类临床项目的快速和高质量的完成。

公司的合作客户包括知名跨国制药公司和医疗器械企业、国内研发型制药企业、医药科研院所以及专业学术团体等。
公司总部位于上海，在北京、广州、成都设立分支机构，服务范围覆盖全国多个中心城市和区域；在美国波士顿设有联络处和QA 办公室。

Bestudy are one of the leading contract research organizations (CRO) that provides high-quality clinical studies service for domestic and overseas pharmaceutical and medical device enterprises in the country. We provide professional technical solutions and services for our customers' clinical studies in the fields of medicine, medical device and biological products.

We are specializing in design, organization, operation and management of clinical trials, eg, planning, preparation, protocol writing, site selection and due diligence, clinical monitoring service, investigational product management, data management, bio-statistics and study report writing for phase I-IV drug and medical device clinical trial project. It also provides medicine and medical device registration and medical consulting and agent, epidemiological observational research, drug market research and the training of study professionals including investigators, study nurse, CRAs and other clinical trial staffs.
We have professional research team with a majority of members who worked years in R&D and clinical research departments of multinational pharmaceutical companies. With the world leading and standard business process and scientific quality assurance system, Bestudy has accumulated proficient experience in the operation and management of multicenter clinical trial projects and other clinical trial projects in China. In addition, we boast a wealth of expert resources in clinical medicine, clinical pharmacology and bio-statistics and try to further extend through personnel development program and project training to make sure various clinical projects are completed with speed and high quality.

We have built the partnership with multinational pharmaceutical and medical device enterprises, R&D-oriented pharmaceutical enterprises and pharmaceutical research institutes and academic societies.

Headquartered in Shanghai, we have subsidiaries in Beijing、Chengdu and Guangzhou with business operations in many central cities and regions across the country and opened international business and QA office in Boston, USA.