天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津医药技术研发管理人员招聘

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

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/

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