长沙招聘

Role Description
Position Title:Data Manager (CDS)
Zone / Line:CDS, CRDC
Location:Shanghai
Career Ladder (Level):D1-4

Position Purpose
*The Data Manager is responsible for ensuring the completeness, quality and integrity of the subject data stored within the clinical trial database.
*The Data Manager is responsible for data cleaning aspects of the data management role within a clinical trial, according to Pfizer Standards, Processes and Standard Operating Procedures (SOPs).
*The Data Manager works with the global study team to meet the study objectives in the release of databases.
*The Data Manager will ensure the consistent use and application of standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.

Organizational Relationships:
*Directly reporting relationship to DM Team Lead or Group Lead in CDS/CRDC/WRDC
*Strong partnerships with DBMs within Pfizer and technical functions with Alliance Partners and vendors
*Partnership with other related functions as needed.

Resources Managed (budget and FTEs):
NA
Primary Duties:
General
*Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
*Ensures Conformance to Pfizer Data Standards.
*Actively participates in monthly project review meetings.
*May participate in Therapeutic Area (TA) specific process improvement initiatives.

Data Manager:


*Create the Data Management Plan (DMP) for completeness and accuracy, including the Data Flow Activities Document, CRF Completion Guidelines, Data Quality Specification (Edit checks), Data Listing Documents, Data Handling Conventions (Permissible Changes), Data Quality Control Plan and Data Entry Guidelines.
*Set-up and test data review listings to verify the quality and completeness of data as specified in the Data Quality Specification (Edit checks) document.
*Ensure timely set-up of clinical data acquisition and management tools and data validation.
*Maintain a Study Tracking Spreadsheet to track the progress of CRF retrieval, data entry of CRFs and data cleaning activities.
*Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data and issue Data Clarification Forms (DCFs) as necessary to seek further clarification from sites.
*Ensure integrity of clinical data and update database with resolved DCFs as necessary.
*Reconcile the patient database (eg. Oracle Clinical) with the Serious Adverse Event database (Argus).
*Document all efforts in the cleaning and release of the database.
*Ensure filing of all clinical trial documentation.

Lead Data Manager:
*The single point of contact in CDS for the data management project manager at study level
*Accountable for the implementation of data activities including Study Startup, Data Acquisition, Safety Data Management, Dictionaries, Standards and Discrepancy Management for the responsible studies.
*Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the program.
*Provide technical oversight, guidance and coordination for all the data management activities
*Implement a Data Cleaning Strategy to ensure a smooth flow of data through the data cleaning process to facilitate database release within agreed timelines.
*Produce and track metrics as a tool to ensure that data management deliverables are on target.
*Implement and promote the use of consistent, efficient and quality processes to meet timelines and deliverables for the study teams.
*Assist in the development and implementation of new TA clinical data standards
*Ensure clear and timely communication with study team members to enable improvements to be implemented during the study and also the proactive planning of workload to ensure study timelines are met.
*Regular liaison with manager to assess workload and priority activities and status of assigned tasks and projects.
*Monitors and reports on implementation of functional area initiatives
*Perform final data cleaning activities and collaborate with study team members to ensure the database is released according to study objectives.
*Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross-study learning.

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。