长沙招聘

职位描述：
Primary Duties:
? Manages team of Clinical Programmers to deliver clinical programming services in a high quality and timely manner, and within CPW metrics goals
? Ensures all clinical programming activities under remit conform to applicable standards, such as CDISC or PDS, and are in compliance with relevant regulatory requirements
? Accountable for the implementation of clinical programming activities for studies and submissions related to the drug programs
? Ensures appropriate resources are identified and engaged to support the project work
? Actively oversees Planisware project milestones and manages inconsistencies through networking with relevant CPMs
? Provides administrative and clinical programming technical and process oversight of team
? Accountable for timely reporting of relevant project metrics on quality, speed and compliance to Programming TA Lead and ensures timely cross-TA sharing for lesson learnt and accomplishment in CPW
? Performs Clinical Programmer activities as needed
? Manages risk appropriately to enable innovative solutions which maintain timely, quality deliverables
? Manages use of resources in line with short, medium and long-term goals
? Implements organizational design and develops succession planning for own group and for functional area under guidance of Programming TA Lead
? Actively develops people under guidance of Programming TA Lead:
o Recruits high caliber staff
o Provides focused career development
o Provides performance management
o Manages retention

Training & Education Preferred:
? Minimum of a B.S. Degree in either a Scientific or Business related field; Master Degree preferred
? Background in Clinical Programming strongly preferred

Prior Experience Preferred:
? At least 6 years of relevant industry experience
? Statistical programming and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trial data (e.g. study reports, safety updates, global regulatory submissions, etc.).
? Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills.
? Demonstrated experience managing projects and developing successful partnerships within study or asset teams.
? Demonstrated people management skills including recruiting and developing talent
? Proven ability to effectively operate in ambiguous situations.
? History of achievement in a customer service role demonstrating ability to meet customer needs and address concerns and in building strong customer relationships, evidenced by positive feedback from customers
? Experience in leadership, project management, and resource management

Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
? Strong technical knowledge of clinical programming processes is required.

? Ability to operate in a highly standardized environment.

? Project/process management.


? Understanding of Clinical & Regulatory processes.

? Scientific/administrative excellence.

? Systems technologies.





? Presentation/influencing/negotiation skills.


? Demonstrated knowledge and success in managing multiple clinical programs, clinical programming technologies and processes.
? Thorough understanding of Clinical Programming systems and Pfizer Data Standards.
? 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 clinical programming; 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 scientific audiences and non-science populations.


Behavioral Competencies:
Competency Detail / Comments (specific skills, etc.)
? Managing others/managing performance.

? Customer focus.


? Developing others.

? Innovation.


? Influencing.

? Networking and alliance building.



? Courage with decisiveness to act.

? Learning organization.


? Communication skills.




? Negotiation and conflict resolution skills ? Makes strategic use of business data to monitor & raise performance.
? Establishes strong relationships with customers, strives to understand and meet customer requirements.
? Initiates career and succession planning to build and sustain longer term capability.
? Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage.
? Lobbies key internal and external stakeholders to ensure success.
? Looks for opportunities for collaboration and acts upon them. Must be capable of building strong relationships with application and service providers.
? Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.
? Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance.
? Outstanding verbal and written communication skills; strong listening skills with the ability to proactively define and manage required communication channels internal and external to the organization.
? Very strong ability to remain calm and focused in high-stress situations.

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。