Data Manager
科文斯医药研发（北京）有限公司上海分公司
- 公司规模：500-1000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：2015-02-24
- 工作地点：上海-浦东新区
- 招聘人数：若干
- 职位月薪：面议
- 职位类别：其他 其他
职位描述
The Data Manager is accountable for acting as the primary liaison between Covance Central Laboratory Services and Sponsors, to ensure the successful management of global projects through compliance with the Covance Central Laboratory Services Clinical Data Management strategy, in order to deliver outstanding customer satisfaction.
Responsibilities/Duties
1. Engage client data management during start up.
? Create protocol folder(s) for study documentation.
? Add entries into individual protocol spreadsheet.
? Review Statement of Work (SOW) for study scope.
? Ensure start-up packet delivery to clients.
? Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS).
? Provide recommendations and alternatives to optimize data quality.
? Collaborate with clients to finalize Data Transfer Specifications (DTS).
? Obtain final client approval on Data Transfer Specifications (DTS).
2. Act as a data liaison between Clinical Data Management and all other Covance departments and business units.
? Consult with Medical Affairs via a Med/Tech Affairs Request Form.
? Collaborate with Project Management proactively and reactively regarding study questions.
? Manage and resolve issues with Specimen Management.
? Initiate data changes with the appropriate department and revise all non-compliant requests.
? Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.
3. Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.
? Build and modify Data Transfer formats as needed.
? Create test data if needed.
? Quality Check (QC) test files.
? Deliver test files to clients and log into the metrics tool.
? Obtain client approval and store auditable documentation.
4. Provide ongoing client support (study maintenance).
? Create global transmission instructions.
? Schedule appropriate frequency of data transfers.
? Address errors and client issues including queries.
? Participate in study-related meetings.
? Collaborate with clients regarding study modifications.
? Confirm changes and send files as needed.
? Maintain auditable documents.
? Facilitate Data Management functions of end-to-end data lock processes.
? Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.
? Collaborate with clients regarding new service requests.
? Support billing of services as needed.
5. Attend training to increase Data Manager’s capabilities (including corporate, departmental and sponsor-related training).
6. Ensure uninterrupted client service.
? Support peers by sharing technical knowledge and customer service skills.
? Back up peers as needed.
7. Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.
8. Other duties as assigned.
Education/Qualifications Minimum Required:
? BS/BA four-year degree or equivalent education, or 4 years Covance experience
Experience Minimum Required:
? Strong organizational, planning and critical-thinking skills.
? Well-polished, inclusive, and engaging communication skills (written and verbal).
? Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
? Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
? Ability to use standard Microsoft suite of software products.
? Conversant with databases and database terminology.
? Strong technical aptitude.
? Customer Service experience.
? Data Management and/or Clinical Trials experience.
Responsibilities/Duties
1. Engage client data management during start up.
? Create protocol folder(s) for study documentation.
? Add entries into individual protocol spreadsheet.
? Review Statement of Work (SOW) for study scope.
? Ensure start-up packet delivery to clients.
? Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS).
? Provide recommendations and alternatives to optimize data quality.
? Collaborate with clients to finalize Data Transfer Specifications (DTS).
? Obtain final client approval on Data Transfer Specifications (DTS).
2. Act as a data liaison between Clinical Data Management and all other Covance departments and business units.
? Consult with Medical Affairs via a Med/Tech Affairs Request Form.
? Collaborate with Project Management proactively and reactively regarding study questions.
? Manage and resolve issues with Specimen Management.
? Initiate data changes with the appropriate department and revise all non-compliant requests.
? Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.
3. Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.
? Build and modify Data Transfer formats as needed.
? Create test data if needed.
? Quality Check (QC) test files.
? Deliver test files to clients and log into the metrics tool.
? Obtain client approval and store auditable documentation.
4. Provide ongoing client support (study maintenance).
? Create global transmission instructions.
? Schedule appropriate frequency of data transfers.
? Address errors and client issues including queries.
? Participate in study-related meetings.
? Collaborate with clients regarding study modifications.
? Confirm changes and send files as needed.
? Maintain auditable documents.
? Facilitate Data Management functions of end-to-end data lock processes.
? Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.
? Collaborate with clients regarding new service requests.
? Support billing of services as needed.
5. Attend training to increase Data Manager’s capabilities (including corporate, departmental and sponsor-related training).
6. Ensure uninterrupted client service.
? Support peers by sharing technical knowledge and customer service skills.
? Back up peers as needed.
7. Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.
8. Other duties as assigned.
Education/Qualifications Minimum Required:
? BS/BA four-year degree or equivalent education, or 4 years Covance experience
Experience Minimum Required:
? Strong organizational, planning and critical-thinking skills.
? Well-polished, inclusive, and engaging communication skills (written and verbal).
? Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
? Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
? Ability to use standard Microsoft suite of software products.
? Conversant with databases and database terminology.
? Strong technical aptitude.
? Customer Service experience.
? Data Management and/or Clinical Trials experience.
公司介绍
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
联系方式
- 公司网站：http://www.covance.com
- Email：calvin.xu@covance.com
- 公司地址：上海市黄埔区西藏中路268号来福士广场1806室
- 邮政编码：200001
- 联系人：Vicky Qu