长沙招聘

职位描述：
General
? Provide administrative and data management technical and process oversight of team.
? Implement strategies to ensure consistent processes in strong collaboration within CDS and with CO, CPW, CDQ, DMM and Alliance Partners
? Participate in Dev Ops initiatives with CO, CPW, CDQ, DMM and Alliance Partners.
? Develop charters, resource utilization and project plans to achieve CDS specific goals.
? Implement organizational design and develop succession planning for group.
? Develop colleagues, including recruitment, retention, and career development and performance management for staff.
Specific
? Ensures Conformance to Pfizer Data Standards.
? Actively participates in monthly project review meetings.
? May participate in Therapeutic Area (TA) specific process improvement initiatives.
? Manage the DM team to CDS metrics goals and work with CROSLs to resolve cross-functional barriers to achieving data management milestones.
? Actively oversees EPM project milestones and networks inconsistencies with relevant Asset Leaders and/or relevant project lead of APs
? Ensure appropriate resources are identified to support the portfolio.
? Ensure that all data activities are conducted in compliance with relevant regulatory requirements.
? Monitors and reports on implementation of functional area initiatives
? Is accountable for the implementation of team CDS data activities including Study Startup, Data Acquisition, Safety Data Management, Dictionaries, Standards and Discrepancy Management for site-based or global studies related to the drug programs.
? Partner with other CDS TA Lead, TechOps Lead, CO, and APs to promote the increased efficient use of EDC methods and technologies in clinical trials.
? Partner with other CDS Team Leaders, CO, and APs to implement strategies to ensure speed and quality of data acquisition and data management, query resolution, data access and database release.


Technical Skill Requirements
? Demonstrated knowledge and success in managing multiple clinical programs, data acquisition and management technologies and processes.
? Thorough understanding of Pfizer database and applications, Pfizer Data Standards (both data in and data out components).
? Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery.
? Demonstrated knowledge of clinical development and regulatory submission processes and requirements.
? Demonstrated success/results in prior scientific/administrative management roles
? Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology; strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
? Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations
? Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget


Qualifications (i.e., preferred education, experience, attributes)
? Minimum of a B.S. Degree in either a Scientific or Business related field.
? Extensive clinical development and business experience in order to have a thorough understanding of the processes including data management and reporting. .
? History of achievement in building strong customer relationships. Strong technical knowledge of data management processes is required.
? Extensive knowledge of vendor processes, contracting, and best practices in outsourcing are necessary.
? Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization.
? Experience supporting the data management components of regulatory submissions required.
? Very strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.
? Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers.


Preferred Additional Experience
? Previous experience leading a substantial group responsible for clinical data management and/or clinical study management function, or equivalent.
? Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. International experiences a plus.
? Experience supporting the data management components of regulatory submissions required. 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。