长沙招聘

职位描述：
Position Purpose
? Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode.
? Areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution.
? Ensure risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times.
? Familiar with supported systems (RBM system, etc) and able to troubleshoot and provide rapid response for all database issues.
? Work with the global study team to meet the study objectives.

Resources Managed (budget and FTEs)
NA

Primary Responsibilities
General
? Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
? Provide technical expertise to set up and test study level Risk-based Monitoring system
? Review study level system outputs to process for the signal and action management
? Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
? Able to resolve conflicts, influence and communicate with key stakeholders and customers.

System setup Functions:
? Set up and test RBM system at study level to ensure system quality.
? Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
? Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data review Functions:
? Work with Study Team to define the issue resolution for the reviewing findings as signal and action.
? Develop, implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.
? Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.
? Work with Clinical Data Scientist (CDS) to ensure all signal and actions are properly mitigated and RBM systems properly released.

Organizational relationships and interfaces:
? Interact with Clinical Data Scientist (CDS) at study level for deliverables.
? Interact with other study team members at study level for deliverables.

Technical Skill Requirements
? Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
? Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
? Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
? 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

Qualifications (i.e., preferred education, experience, attributes)
? Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.

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.)
? Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills. 举报 分享

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。