长沙招聘

Responsibilities
Position Purpose(ADM02):
The Data & Document Processing Associate (DDPA) is responsible for providing accurate and efficient support for the data process of projects and document process tasks that are assigned to the Wuhan office. The DDPA enters and verifies clinical data into corresponding clinical trial databases from images or electric file (i.e. case report forms, laboratory reports, translation data list), performs data entry QC, resolves E-task, cleans index review queries, setup eclipse study specific structure and other data and document processes as instructed. The DDPA for clinical trials works closely with Clinical Data Management in CDS and may assist with other document handling and administrative tasks as necessary.

Organizational Relationships(ADM02):
Reports to team lead - Data and Document Processing

Key Result Areas (ADM02):
Data and Document process:

*Enter Clinical Data into Clinical Database with minimal errors based on quality standards and maintains an acceptable level of productivity to assist in meeting project deadlines.
*Perform data entry (1st & 2nd pass), including corrections to ensure that data entered into database accurately reflects the data recorded on the CRF or according to project guidelines as assigned.
*Fulfills requirements for tracking or documenting work processed.
*Perform QC in accordance with data entry guidelines and other project specific documents by comparing data listings to the data source (CRFs/hard copy documentation/scanned images) to establish accuracy rate.
*Resolve e-task and clean up Index Review queue on a daily basis.
*Communicate with Data Managers of all Pfizer Studies via e-mail and GCDStrack tickets to clarify standard eclipse process or execution of their request.
*Setup eclipse study specific structure and perform QC in accordance with ESS worksheet and give feed back to SSU with timelines for business continuity.
*Provide PGRD/PGP Submission Compilation Group with Case record documentation within given timelines.
*Ensure documents are properly labelled by drug, protocol, investigator, and subject, and that site personnel are aware of the requirements for submitting documents to Development Operations.
*Perform QC in CRT (Casebook Review Tool) & CXT (Casebook Exraction Tool ) in accordance with submission assembly guideline.
*Participates in the manual review of clinical data and identification and documentation of data errors, omissions and inconsistencies.
*Coordinates destruction of outdated, unnecessary confidential internal CDM and study specific documentation and prepares data for archiving.
*Follow instruction on document process and complete assignment in a timely matter.
*Performs other clinical trial data and document processing tasks as necessary to meet the needs of business.
General

*Perform data entry and other computer work for extended periods of time as the primary function of the position.
*Proactively seek to improve the efficiency and quality of work.
*Liaise regularly with supervisor to assess workload and priority activities and status of assigned tasks and projects.

Personal Development

*Attend and actively participate in personal development courses as required. Attend Pfizer in house training and workshops.
*Develop skills and experiences for broader role responsibilities in the data and document processing area such as working knowledge of database, electronic document management systemand other Data Processing tools and develop experience in second entry verification, quality control and/ or manual processes.
*Assist documentation tracking, project management, or solve issues and suggest solutions.
*Develop technical expertise and project management skills.


Education & Experience Preferred(ADM02):
Education:

*College graduates with good English skill both in writing and speaking.

Experience:

*Knowledge of Windows Environment and its applications, keyboard skills.
*Familiarity with medical terminology; Prior clinical data entry experience is preferred.


Competencies 技能要求(ADM02):
*Capability to communicate effectively in English, both verbally and written is required.
*Must be accurate and have an excellent attention to detail and a methodical approach to work.
*Must have a basic concept of the importance of data quality control.
*Must have ability to work on multiple projects with different processing guidelines.
*Demonstrated organizational skills.
*Must enjoy working with computers and technology.
*Must enjoy working with people and be interested in good customer service.

Desirable Requirement:
*Proficiency at typing or previous clinical data entry experience.
*Computer literate and the ability to understand and carry out detailed instructions.
*Medical environment work experience.

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。