长沙招聘

Position Purpose

Provides managerial oversight of both colleagues and deliverables

Performs duties of Clinical Programmer as needed

Responsible for consistent harmonized processes and high quality clinical trial data for clinical projects in partnership with the Programming TA Lead Provides leadership of strategies for the implementation of technology-enabled processes

Works closely with the Programming TA Lead in formulating strategies and standards to be implemented for all programs and takes responsibility for implementation.

Creates, maintains and assumes accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment

Resources Managed

Team consists of up to 8 Pfizer Colleagues and contractors (this may vary depending upon workload requirements)

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:

Recruits high caliber staff

Provides focused career development

Provides performance management

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

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。