上海招聘

Job Description: 

1. Line supervision of DM staff, including recruitment, performance management, competence development, motivation and staff retention. The target is to provide ontime and high quality deliverables. The staff competence and knowledge must be at the same level as leading key CROs.Cooperate with Pls to enhance the project management process. Assessment of current/future needs of resources and the optimal deployment of human and technological resources is another key task.
2. Provide hands-on leadership on projects. Solve critical issues in technical problems. Improve productivity and efficiency along the way. Proactively seek ways to improve quality and efficiency of DM. Provide technical training on junior staff. Be a technical coach within the company for DM.
3. Develop and control the budget of DM part, so that the function realistically budgets for the resources necessary to provide the desired level of service to all projects. Expense tracking should be sufficiently detailed to accurately attribute costs to the projects being undertaken.
4. Participation in the strategic development of MacroStat (China), and to realize our aspirations for quality and exceed customer expectations. To contribute to the strategic view of the MacroStat (China) organization, the incumbent must be aware of the opportunities and threats presented by new technologies, plus the strengths and weaknesses of DM team in MacroStat (China). The incumbent must be capable of communicating strategy to his/her function, and to translate the strategy into the required actions.

                    

Qualification: 

1. Bachelor degree or above in medicine, clinical, life science, public health.
2. Prerequisite qualifications for employment as data management personnel in R&D or medical department in Pharmaceutical companies or Clinical Research Organizations (CROs).
3. 10 years’ experience of industrial experience at multinational pharmaceutical company or Clinical Research Organization (CRO) with proven abilities in communication, organization, strategic thinking, leadership mindset and management skills; (i.e., having knowledge of international GCP, of data management software applications, of the clinical trial process, and of regulatory requirements).
4. 8 years'   experience of team development and management
5. Communicate in English fluently.
6. Be familiar with the functions and capabilities of the software and hardware on which DM depends, as well as the concepts of DM and how they relate to available technology and to the other functions engaged in the clinical research process.
7. Communication skills.
8. Be careful and quality driven.
9. Familiarity of global and China health authority requirements.
10. Experience in other medical or clinical research roles.
11. Experience in project management.

美斯达（上海）医药开发有限公司于2005年11月成立，是一家合同研究组织（Contract Research Organization，简称CRO），提供专业化的临床试验（Clinical Trail）数据管理（Data Management）、统计分析（Statistical Analysis）和试验报告撰写等服务。美斯达在临床试验领域提供的服务包括: 临床试验方案设计，数据库设计和创建，病例报告表设计，数据管理，撰写统计分析计划 （SAP），创建分析数据集，用SAS程序进行统计学分析，制作统计表，统计图及数据列表，对新药综合疗效（ISE）及安全性（ISS）报告进行统计分析，撰写独立的统计学报告以及注册申报用的临床试验报告，出席美国或中国的药政机构审评会，回答数据统计问题，支持药品注册申报。公司具有丰富的医药及临床试验经验，尤其擅长下述治疗领域的临床试验数据管理和分析: 疼痛、癌症、心血管、呼吸系统、中枢神经系统、抗病毒， 抗生素、和消化系统等。