长沙招聘

职位描述：
? Provide subject matter expertise in the areas of technology and process being utilized within the strategic partnership model as they relate to the CDMS (Clinical Data Management) systems/Operations Support.
? Responsible for identifying and supporting strategic initiatives within COE-CTS to enhance operational efficiencies using systems and system enabled processes.
? Provide support and escalation for operational services for Next Generation Clinical Trials Platform.
? Collaborate with other Subject Matter Experts within COE, Alliance Partners, and other external vendors as appropriate.
? Be able to bridge gaps between Pfizer and vendor systems for technical and process related troubleshooting and has the ability to easily transition from project to project as needed while maintaining connections to the innovation team and other external groups to Development Operations. The IM works across vendor systems, applications and processes.
? Provide oversight and point of escalation to our niche providers as applicable. Help develop, maintain and improve processes associated with the Clinical System’s platform and operations support.
? Partner with the Information Management teams regarding the Clinical Aggregation layer, ensuring Clinical systems/processes are consistent with the needs of the CAL.
? Support and maintain all business related enterprise level activities regarding Pfizer’s use of the Clinical Systems platform and provide subject matter expertise and/or escalation support and guidance to CRDC, DJ and the Vendors.

Primary Responsibilities
Process and Standards
? Interface with CDQ organization, Business Process Owner Network and other COE colleagues to further standardize and optimize Pfizer’s processes and practices
? Actively identify continuous improvement opportunities for the team to enhance operational efficiencies through process and metrics analysis
? Participate efforts to develop processes, standards and training as they relate to the technology-enabled clinical trial processes
? Promote the use of consistent, efficient, and quality processes to meet timelines and deliverables

Customer Outreach
? Plan and execute communication plans & methods for engaging customer populations (e.g.,
newsletters, websites, user groups) in coordination with the IM Communication group.
? Interface with customers on solutions, requirements, continuous improvement, deployment change
management, user groups and workshops, etc.
? Understand customers and stakeholders and ensure they are satisfied with support services and
Systems
? Build & maintain knowledge-base (e.g., FAQ)
? Collaborates with IM Centralized Services as appropriate
? Communicate key project status and to various levels within the organization

Implementation
? Implement business strategies and technology-enabled processes and tools in close partnership with appropriate groups in Development and COE, CRDC, GCTE, Japan, Vendors (including business impact assessments and AIM deliverables)
? Assist Team Manager to oversee vendors across various needs (e.g., Tier 1 services, quality management, data management, study start up, electronic data, etc)
? Assist Team Manager to define scope of outsourced work and establish work instructions / task ownership matrices /
escalation paths / SLAs for vendors providing services to IM-CTS
? Assist Team Manager to establish oversight plans and metrics associated with outsources services

General
? Provide expertise in technology and process being utilized within the strategic partnership.
? Demonstrate the ability to follow information flow between vendor and Pfizer systems.
? Actively identify and bridge gaps between Pfizer and Partner systems for technical and process related issue management.
? Easily transition from project to project as needed while maintaining connections to the innovative team and other external groups to Development Operations.
? Work across Partner systems, applications and processes. Interact with and support CRDC and Japan as it related to eClinical suite
? Collaborate with business process owners and information technology, as appropriate, to support potential changes or improvements related to systems and processes.
? Manage queries from the organization related to technology and processes.
? Be able to resolve conflicts, influence and communicate with key stakeholders and user groups.
? Support rapid response, audit and inspection needs.
? Work proactively with Training representatives to develop training strategy including recommending curricula assignments, materials development and communications required to support the roll out of revised processes.


Technical Skill Requirements
? Programming SAS / PLSQL experience in the pharmaceutical industry, including an understanding of the drug development process
? Minimum 3-5 years’ experience in the clinical trial process is strongly desired
? Familiarity with UNIX/LINUX is a plus
? Experience with Sportfire, LSH, Inform is desired
? Knowledge of information system management and change control processes, application validation and implementation in a GxP environment
? Knowledge of Pharmaceutical metadata and standards

Qualifications (i.e., preferred education, experience, attributes)
? Minimum of Bachelor's Degree in life sciences, information management/technology. MS Computer Science desired.
? Demonstrated in depth knowledge of Pharmaceutical drug development environment and regulations.
? Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.
? Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region
? Strong demonstrated project management and technical capabilities
? Strong verbal, written communication and presentation skills. 举报 分享

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。