北京招聘

工作职责:

职位概述：按照要求提供数据管理方面的专业知识，参与所分配项目中与数据管理相关的服务。

主要岗位职责：

1. 协调临床数据管理过程，保证临床研究数据的及时性、真实性、准确性和完整性；

2. 进行病例报告表数据的日常检阅以及质疑表的处理；

3. 实施数据录入以及数据的双份录入和一致性比对；

4. 按照数据核查计划核查数据，对可疑数据发布数据质疑表，解决数据质疑，并更新数据库；

5. 为临床研究方案的设计提供数据管理支持和审阅；

6. 参与数据管理计划、核查计划等相关文档的撰写和审阅。

Position Purpose

1.Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database.

2.Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.

3.Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes.

4.Works with the global study team to meet the study objectives.

Primary Responsibilities

General

1.Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.

2.Ensures Conformance to Data Standards.

3.Actively participates in monthly project review meetings.

4.May participate in Therapeutic Area (TA) specific process improvement initiatives.

Hands-on data management responsibilities (Data Manager):

1.Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.

2.Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.

3.Ensure timely set-up of clinical data acquisition and management tools and data validation.

4.Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.

5.Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.

6.Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.

7.Reconcile the patient database with the Serious Adverse Event database.

8.Document all efforts of data management and file all responsible documents.

任职资格:

Technical Skill Requirements

1,Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP

2,Demonstrated knowledge of data management processes and principles in area of responsibility.

3,Works independently, receives instruction primarily on unusual situations

4,Ability to organize tasks, time and priorities; ability to multi-task

5,Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally

6,Ability to work in ambiguous situations within teams to identify and articulate complex problems

7,Demonstrated knowledge of clinical development and regulatory submission processes and requirements.

8,Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology

9,Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

Qualifications:

1.Bachelor degree or equivalent in a natural/medical science, data management or related discipline

2.Demonstrated basic knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design, principles of GCP, and regulatory submission requirements

3.Demonstrated basic knowledge of data management processes and principles in area of responsibility.

4.Demonstrated basic knowledge of clinical trial database and its applications

5.Demonstrated basic knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)

6.Good learning capability, self-motivated on adopting learning into practice under supervision towards working independently on routine responsibilities

7.Ability to organize multi-tasks, prioritize and deliver on time

8.Ability to communicate effectively and appropriately

9.Demonstrated good English comprehension skills, both reading and writing

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。