长沙招聘

工作职责:

ROLE SUMMARY

As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management organization, the Associate, Data Acquisition Assistant is responsible for the provision of operational assistant in data monitoring and management with an emphasis on Third Party Vendor data, PK/PD, Medical Lab Normal Ranges, supporting assigned studies within the Pfizer portfolio. Accountabilities to include define data file specifications, setup data loading, ensuring the integrity of clinical data, application of standards, supporting consistency in asset/submission data. The Associate, Data Acquisition Assistant works closely with Associate Director, Group Lead; Manager, Data Acquisition Lead, other Data Acquisition Analysts, Clinical Data Scientists, Clinical Data Trial Leads and Data Managers to ensure Third Party Vendor Data appropriate loaded to Pfizer clinical databases supporting the Pfizer portfolio with consistent, timely and high quality application of technology, data standards and processes. 

任职资格:

ROLE RESPONSIBILITIES

Provide technical solution in assigned functional areas, including but not limited to: Vendor Qualification Assessment, Data transfer specifications creation, Test Data Review, Data review model creation and Data loading monitoring, LNMT Setup under supervision

Ensure vendor consistent use Data Transfer Specifications per data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.

Collaborate with other Data Acquisition Analysts to develop and maintain a support model and to facilitate issue resolution and capture corrective actions; and to ensure operational efficiencies such as sharing of best practices across work areas, functions and sites.

Monitor vendor data loading to align with data flow activities and create data input model for DM to perform reconciliation 

Resolve and report any data loading quality issues to ensure data quality

Able to resolve conflicts, influence and communicate with key stakeholders and customers.

Technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

BASIC QUALIFICATIONS

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

Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design

Knowledge of clinical trial database and its applications

Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)

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。