长沙招聘

Responsibilities
Position Purpose(ADM02):
The TMF Document Specialist is responsible for supporting TMF completeness through the review, coding, tracking/validation of paper and electronic documents. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any mis-indexed or incomplete documents with the Document Owner. Upon direction, the TMF Document Specialist will create and activate the TMF repository and process corresponding templates and program level documents into the repository.

Organizational Relationships(ADM02):
oReports directly to the Lead TMF Document Specialist
oLiaise with TMF Study Owners, Document Owners, and Document Submitters, as needed

Resources Managed (budget and FTEs) (ADM02):



Major Duties (ADM02):
General
*Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
*Associate existing templates and program level documents to the TMF repository.
*Upon receipt of paper documents, review documents to for completeness (i.e. missing pages) and ensures criticality assignments and indexing terms are accurate on all documents received.
*Prepare and process/upload documents including application of full indexing terms within the TMF system within specified departmental timelines, based on document criticality. Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
*Prepare processed paper documents for archival
*Upon notification, archive documents as needed, per the archival process
*Retrieve electronic documents for processing per study assignment/criticality.
*Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
*Review documents for indexing accuracy; check submitted indexing terms and index document with full attributes as needed.
*Follow-up with Document Owner for discrepancies and log errors.
*Review TMF repository to verify an exact duplicate of the document has not previously been activated.
*Activate document into the repository and inform Document Owner, as applicable

Training & Education Preferred(ADM02):

In general, candidates for this job would have the following levels of experience:
Minimum of Bachelor's degree or equivalent required.
Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records preferred

Experience with the following applications types is preferred:
*Electronic documentation management systems
*Web based data management systems, as required
*Database utilization
Excellent English verbal and written communications skills, combined with outstanding listening skills are required.
History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
History of achievement in building strong customer relationships.


Prior Experience Preferred(ADM02):
*Hands-on experience with electronic documentation management systems.
*Experience in management of medical/clinical study records and documentation
*Experience/knowledge of ICH/GCP documentation requirements

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。