| 作者 |
 [分享]Clinical Data Management Leader |
 |
sunnygirl
头衔: 海归上士
性别: 
加入时间: 2009/11/06
文章: 16
来自: 上海
海归分: 1522
|
|
|
作者：sunnygirl 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
Data Management Project Leader (Operations Department)
Department: Operations Function: Clinical Development
Reports To: Operations Group Manager Date: Nov 2010
Global Reports To: None Location: China
Number of Positions: 5 Banding: 5(US)/D(UK/SE)
Description:
Provide leadership in the planning and delivery of Data Management deliverables to time, cost, and quality and DM strategic direction to drug projects in the use of DM standards and technology. To interface between the CPT, SDT and the DM Centre to ensure seamless delivery of project DM components and quality delivery and adherence to global and project standards. The DM Project Leader will be aligned to one or more drug projects dependant on size and scale of the project DM deliverables and will take global accountability.
Accountabilities/Responsibilities:
• Provide support and expert DM advice to the CPT, SDTs and DMC roles regarding the DM activities and deliverables to ensure effective delivery of the DM service. Provide expert DM activities and project standards advice to EPMT, CPA as required (to include project standards definitions)
• Project related DM activities, technology and standards:
o Ensure quality and consistency of DM components across the project(s)
o Provide DM input to the development of clinical project Standards and information regarding DM standards and technology
o Ensure DM deliverables align with the required information standards for CPT deliverables, eg Programming standards and Information Strategy Provide DM and data collection standards expertise to project standards team Coordinate development of project DM standards and ensure utilisation by the SDTs
o Provide DM technical expertise and consultancy in the selection and use of systems (e.g. WBDC, ePRO, dECG and other data capture tools) as appropriate
o Review project DM documentation and specifications as needed to ensure consistency with AZ strategies and standards
• Review, assess and manage DM Centre delivery against KPIs , the SDTs delivery of rKPIs and overall AZ and DM Centre performance for the studies within the project(s).
• Working with the DMC, input to the production of the DM Service Order and study costs for studies being processed at the DM Centre
• Manage escalation of DM issues to the DM Operational Review Board and implementation of solutions within AZ
• Ensure study teams utilize project standards by:
Working with study teams to understand, explain and resolve variances from global and project standards when study requested variances arise
Working with standards governance organization to handle project (study) standards variance requests
• Lead, coordinate and ensure transparency and consistency of CPT, SDT and DM center activities including:
o Provide the DM Centre with AZ project planning information (scheduling of the studies, volumes, timelines etc.) Facilitate DM related requests and issue escalation/resolution between the SDTs and the DM Center e.g. audit requests, quality issues
o Monitor, manage and resolve escalated issues related to delays to DM Centre deliverables
o Input to the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance (CQA)
• Assess AZ Clinical DM needs and improvement potential and recommend changes to operating model
• Retain/Build intellectual property as it relates to DM activities/standards for input into strategic decisions (e.g. input into System and tool strategies)
• Provide input to the provision and prioritization of business requirements for process & technology enhancements
• Provide input to the global development and application of DM standards
• Provide strategic DM expertise to global Clinical Initiatives
• Lead/input to global DM capability initiatives
• Maintain a constant awareness of trends/changes in external DM Strategies and technologies and advise management on areas of improvement
• May be asked to take on a global standards role to support the CISGO
Minimum Requirements –Education and Experience
• University degree or equivalent experience
• Minimum of 7-10 years experience of working in Data Management in the pharmaceutical industry
• Demonstrated comprehensive knowledge and experience of most (or relevant ) aspects of Data Management in the Pharmaceutical industry
• Experience of working with external partners
• Demonstrated project management skills
• Demonstrated leadership skills
• Proven experience in developing tactical/operational plans
• Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP
• Comprehensive knowledge of regulatory requirements as they relate to DM activities
• Comprehensive knowledge of database structures and of capturing and storing clinical information
• Comprehensive knowledge of clinical data standards eg SDTM
• External awareness of DM technologies and technical expertise in industry
• Multi-phase experience in Clinical Research and experience of different Therapeutic Areas
Skills and Capabilities
• Excellent organisational and analytical skills
• Ability to work with a large degree of independence
• Demonstrated expertise in risk management and contingency planning
• Ability to work effectively with external partners
• Ability to negotiate and influence others across multiple organisational areas
• Excellent written and verbal communication skills
• Effective problem and conflict resolution skills
• Ability to understand the impact of technology on projects
• Strategic thinking
• Ability to work in a global team environment
• Cultural sensitivity and diplomacy
• Ability to manage change
Organizational Behaviors
• Customer Focus
• Planning and Organizing
• Delivery Focused
• Performance Driven
• Passionate About Winning
• Results Orientation
• Conflict resolution
Internal and External Contacts/Customers
Internal Customers
• CPT members
• SDT members
• EPMT
• DM Executive Steering Committee members
• DM Operational Review Board members
• Clinical Information Science staff and line managers
• Marketing companies
• Standards organization members
• Information Strategy Directors
• BA organisation
External Customers
• External DM providers
作者：sunnygirl 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
|
|
|
| 返回顶端 |
|
 |
|
-
 [分享]Clinical Data Management Leader -- sunnygirl - (6457 Byte) 2011-4-15 周五, 16:57 (1335 reads)
|
|
|
|
您不能在本论坛发表新主题, 不能回复主题, 不能编辑自己的文章, 不能删除自己的文章, 不能发表投票, 可以 发表活动帖子, 不能添加附件不能下载文件, |
|
|
