天津招聘

Position Summary:
Lead the team to develop and implement the clinical project data management plan to ensure the data quality, quantity and scientificity.

Job Descriptions:
1 - Team Management
- Team Building and Management
Including: recruitment,talent selection,personnel appointment , performance management, collection of member project performance, etc;
-Team Development
Provide training guidance or learning resources for team members;

2 - Clinical R & D Strategy
- Assiste in Developing Capacity Building Plan for Clinical Data Management
Assiste in designing data management system, process, policy and specification according to clinical R&D strategy and regulatory requirements;

3 - Clinical Trial Protocol
- Review the Clinical Trial Protocol (Data Management Part)

4 - Data Management and Statistical Analysis
- Project Management
Serve as the project manager of data management in the project and support the data management of the project
- Conduct Data Verification
Review documents related to data management and statistical analysis provided by CRO,and evaluate the documents' quality、quantity、scientificity
- Write Materials Related to Data Management
Including: data management report, clinical trial evaluation report (data management part);
- Communication & Problem Solving
Communicate effectively with internal and external partners to solve data management problems in the project;
- Data Support
Provide data management related support to other departments;

Job Requirements:
1.Bachelor degree or above, major in computer science，information science，software engineering，mathematics or statistics
2.At least 5 years of relevant work experience in data manegement or statistical analysis of clinical trials, preferred with team management experience.
3.Familiar with SOP or guidelines, ich-gcp and other applicable regional and international regulations. Have experience in CRO and pharmaceutical companies.
4.English: Strong reading skills in English literature, as well as some English writing skills.
5.Computer: familiar with office software: word / excel / ppt
6.Good team management skills
7.Good communication and cooperation skills
8.Good analytical and problem solving skills
9.High sense of responsibility

Travel frequency: about 10% of working time

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。