Clinical 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:2015-06-12
- 工作地点:北京
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 职位月薪:15000-19999
- 职位类别:医药技术研发管理人员
职位描述
Responsibility:
? Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities
? Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
? Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
? Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics
? Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
? Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF)
completion / monitoring conventions
? Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
? Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
? Advanced planning and risk management for projects (issue escalation, resource management)
? Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
? Assist with goal creation and performance review assessment for data review project staff
? Maintain technical data management competencies via participation in internal and external training seminars
? Ensure project staff are trained and adhere to project-specific, global, standardized data management processes
? Identify areas for process and efficiency improvement and implement solutions on assigned projects
? Support achievement of project revenue and operating margin for data management activities to agreed targets
? Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
? Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
? Review literature and research technologies/procedures for improving global data management practices
? Perform other duties as assigned by management.
Requirements:
? University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
? Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
? Demonstrated skill for technical management of staff exceeding 5 employees.
? Financial management of gross revenues in excess of $250K per year
? Excellent oral and written communication and presentation skills.
? In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
? Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
? Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
? Demonstrated managerial and interpersonal skills.
You can refer and submit CV by system or email to calvin.xu@covance.com
You are strongly encouraged to visit our recruitment website as http://careers.covance.cn/
公司介绍
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