石家庄招聘

工作职责:

Position Purpose:The TMF Document Specialist is responsible for quality control of TMF documents in the PTMF system.  The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any incomplete, mis-indexed, or inaccurately scanned documents with the Document Owners/TMF Study Owners or other end users.

Major Duties:Perform quality control on all documents received per In-line QC checks and other reference documents.

Demonstrate understanding on document types, properties and indexing requirements

Ensure overall TMF quality by checking document completeness, indexing and scanning accuracy

Process documents in the TMF system(s) within specified timelines, based on document criticality/priority

Communicate document inquiries with responsible users as needed

Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues

Communicate, escalate issues to the TMF Document Specialist Lead and TMF Operations

Contribute to process improvements and additional special projects that may arise

Can be identified as a Subject Matter Expert where applicable

任职资格:

Training & Education:Minimum of a Bachelor’s degree or equivalent

Good English skills

Basic computer literacy

Prior Experience Preferred:Strong oral and written English communications skills

Hands-on experience with electronic documentation management systems and/or web based data management systems. Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records

Experience/knowledge of ICH/GCP documentation requirements

History of achievement in a customer service role with demonstration of meeting customer needs and concerns

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。