长沙招聘

Responsibilities
Position Title: Technical Operations Lead
Zone / Line: CDS, WRDC
Location:Wuhan, China
Career Ladder (Level):D3 - D4

Position Purpose

*Technical Operations Lead (TOL) provides technical leadership and management in assigned functional areas, including but not limited to: Study Start Up, Electronic Data Handling; Acquisition & Processing for Lab Data and PK/PD Data; Data Extract and Listing, Data Visualization; Coding; and training, etc.
*Accountable of delivery functional area goals, motivate and inspire staff, ensure alignment to agreed global and local Dev Ops strategic directions
*Create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment
*Identify, lead and support strategic initiatives within CDS to enhance operational efficiencies using systems and systems enabled processes.
*Collaborate with other Technical Processing Team Leads to develop and maintain a support model and to facilitate issue resolution and capture corrective actions; and to ensure operational efficiencies such as resource sharing, staff development, and sharing of best practices across work areas, functions and sites.
*Participate with other CDS Management and key customer leads to facilitate the delivery of services and effectively manage the coordination of services across specific process areas.


Organizational Relationships:
*Direct reporting relationship to Wuhan CDS Head; dotted line reporting relationship to TOL in CDS Shanghai
*Directly manages WCDS technical operations staff
*Strong Partnerships with key customers and other function leaders at all sites

Resources Managed (FTEs):

*Group consists of Pfizer headcount and contractors (this may vary depending upon workload requirements).
*Works closely with study teams and manages relationships with electronic data vendor/ service providers at study level.



Primary Duties:

Process and Standards
*Participate in standard forums (i.e., OPD zones, CDS initiatives, etc.) to further standardize and optimize CDS's processes and practices
*Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis
*Participate and lead efforts to training as it relates 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)
*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)
*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 CDS

General
*Provide administrative and technical oversight of group
*Develop people, including recruitment, retention, and career development and performance management
*Able to resolve conflicts, influence and communicate with key stakeholders and user groups
*Collaborate with key departments
*Support rapid response, audit and inspection needs

Training & Education Preferred:

Bachelor's degree or above of equivalent experience in a scientific discipline required


Prior Experience Preferred

*Technical expertise and business process support in systems supporting clinical trials (document management, data acquisition, data management, trial management, reporting, etc)
*Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations
*Leadership, project management, resource management (staff), 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.
*Demonstrated project management skills (multiple complex projects)
Technical Competencies
CompetencyDetail / Comments (specific skills, etc.)
Project Management*Demonstrated ability to lead multiple projects
Process Development*Proven ability to define clear, streamlined processes for technologies supporting clinical trials
Clinical Trial Processes*Demonstrated knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP
Systems Technologies*Knowledge/understanding of technologies to support clinical trials, familiarity with software lifecycle.
*Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
Communication/Influencing Skills*Understand customers and stakeholders and adapt messages appropriately
*Proven ability to communicate difficult messages to various levels within the organization.
Decision Making*Ability to make complex decisions that require choosing between multiple options
Problem Solving*Ability to work in ambiguous situations within the team to identify and resolve complex problems
Data Management Expertise*As applicable: Extensive knowledge of data management processes and principles in the specialty: CRF Design, Oracle Clinical Data Base Development, Randomization, Data Loading, EDC, e-Diaries, CRF Processing, Submission Assembly or Validation Procedures
Organizational Skills*Working knowledge of the principles and concepts of other disciplines
*Works independently and receives instruction primarily in unusual situations
*Ability to organize tasks, time and priorities of self and others; ability to multi-task

Pfizer Senior Leader Core Competencies
CompetencyDetail / Comments (specific skills, etc.)
*Customer Focus
*Collaborative, Teamwork
*Influencing
*Networking and Alliance Building*Demonstrated ability to understand customer perspective and deliver solutions that meet expectations
*Demonstrated ability to collaborate and negotiate across business lines to reach a common goal
*Works cooperatively with key internal and external stakeholders to ensure success
*Ability to successfully negotiate decision making
*Identifies possible synergies and actively pursues partnerships
*Proven ability to establish new partnerships
*Courage with Decisiveness to Act
*Learning Organization
*Flexibility and Resilience*Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
*Engages in appropriate experimentation, risk-taking and development in all aspects of work
*Explores new methodologies for application to business challenges
*Responds to changing situations and others' ideas that differ from own positively and constructively
*Personal Leadership*Demonstrates contributions to the achievement of business objectives; services as an advocate for others
*Consistently takes and encourages actions that are new or that improve existing approaches and systems
*Takes initiative to progress projects and tasks
*Consistently provides constructive input

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。