长沙招聘

Primary Responsibilities

 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.

Hands-on data management responsibilities (Data Manager):

? Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.

? Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.

? Ensure timely set-up of clinical data acquisition and management tools and data validation.

? Maintain study tracking to ensure timely CRF retrieval, data entry 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.

? Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.

? Reconcile the patient database with the Serious Adverse Event database.

? Document all efforts of data management and file all responsible documents.

Study management responsibilities (Lead Data Manager):

? The single point of contact for study team on data management

? Accountable for the implementation of all data activities for the responsible studies.

? Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized

? Provide technical oversight, guidance and coordination for all the data management activities

? 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.

? Assist in the development and implementation of new TA clinical data standards

? Ensure clear and timely communication with study team members to enable continuous improvements during the study

? Proactively plan, assess workload, and prioritize activities to ensure study timelines are met

? Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross-study learning.

Project management responsibilities (Project Data Management Lead):

? Work directly with CROSL/CPM as point of contact for data management at project level:

– Ensure sufficient and qualified study level resources and cost effectiveness

– Ensure milestones achieved and project plans consistent across studies

– Ensure the quality standards and consistency of practices (especially safety data, i.e. SAEs) across studies and submission readiness

– Ensure that data activities are conducted in compliance with SOPs and relevant regulatory requirements;

– Serve as point of contact for internal and external audits and regulatory authorities of data management related processes and activities

– Ensure conformance to TA Data Standards by using data management expertise including new data standard creation and maintenance

? Develop and maintain TA specific knowledge base within data management practice

? Coordinate experiences (PDLs, PPLs or other related functional lines) sharing across studies, e.g. best practices, lessons learnt, metrics of trends analysis, etc.

? Help CROSLs/CPMs to have direct access to the most relevant biometrics expertise at anytime

? Partner with PPL to ensure full biometrics availability at anytime during different study stages

? Partner with CROSLs/CPMs ,PPLs and Pfizer/AP front-end lines to promote the increased efficient use of data collection methods (CRF and non-CRF data collection instruments, site training, vendor selection) and technologies in clinical trials at project level

Technical Skill Requirements

? Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP

? Demonstrated knowledge of data management processes and principles in area of responsibility.

? Works independently, receives instruction primarily on unusual situations

? Ability to organize tasks, time and priorities; ability to multi-task

? Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally

? Ability to work in ambiguous situations within teams to identify and articulate complex problems

? Demonstrated knowledge of clinical development and regulatory submission processes and requirements.

? Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology

? Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

Qualifications (i.e., preferred education, experience, attributes)

? Bachelor degree or equivalent in a natural/medical science, data management or related discipline.

Preferred Additional Experience

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

? Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities

? 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。