上海招聘

Role Description
Position Purpose:
To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Pfizer SOPs, ICH/GCP and local laws so that site performance targets are achieved and that the company's image with its external customers is enhanced.

Organizational Relationships:
*Reports to the Lead of Site Management
*Dotted line (matrix) report to protocol specific Study Manager

Resources Managed (budget and FTEs):
*None

Primary Duties (fundamental components of role-both strategic & operational):
Site Selection

Monitoring
*Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.
*Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.

Management of Investigator Sites
*Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.
*Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.
*Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
*Inform the PI and site staff of all issues.
*Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.
*Responsible for all aspects of site management from collaboration on site selection to study closeout.
*Train site staff on the protocol, protocol amendments and Pfizer processes.
*Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.
*Interact with health care professionals in a manner, which enhances Pfizer's credibility with the customer.

Site Close Out

Data Quality
*Ensure that data monitored meets target quality standards.
*Ensure that data is entered into Pfizer systems in a timely manner.

Reporting
*Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.
*Ensure all issues are correctly identified and catalogued.
*Proactively manage issues to appropriate closure.
*Maintain accurate site-level information on corporate clinical trials registry.

Documentation
*Obtain critical information to enable generation of IIP documentation.
*Assist CTA in gathering IIP documentation where required to ensure timely site set up.
*Maintain the SMF and SMF log.
*Ensure ELARA is complete and accurate.
*QC relevant documents in ELARA in a timely manner.
*Generate site monitoring reports.
*Maintain all appropriate monitoring logs.

Training & Education
Required:Preferred:
*Life Science/Nursing graduate or equivalent with at least 2 years of Clinical Monitoring/Site Management experience
*Full driving licence

Training and Relevant Experience
*Computer literacy (word processing and spreadsheets)
*Knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research

Technical Competencies
CompetencyDetail / Comments (specific skills, etc.)
Quality requirementsDemonstrated knowledge of quality and regulatory requirements across a range of different countries.
Drug development processDemonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.
Scientific/technical/administrative excellenceDemonstrated success in prior scientific/technical/administrative management roles.
SOP ComplianceMaintain knowledge and expertise on all relevant SOPs.
Communication and presentation skillsAbility to communicate effectively and appropriately with internal and external stakeholders.
Administrative excellenceAttention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.
Organisational skills*Works independently. Receives instruction primarily on unusual situations.
*Ability to organize tasks, time and priorities of self and others; ability to multi-task.

Behavioral Competencies
CompetencyDetail / Comments (specific skills, etc.)
Understanding stakeholder needsSeeks to develop an integrated view of key colleague issues to shape decisions and strategy development.
Achieving quality and excellenceLooks across and outside the organization for better ways of working - receptive/willing to others ways of thinking.
Initiating and Implementing changeProactively manages change by identifying opportunities and coaching self and others through change.
Interpersonal communicationsDisplays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization.
Influencing*Demonstrated ability to introduce new ideas and get them implemented.
*Effectively overcoming barriers encountered during the implementation of new processes and systems.
TeamworkIs visible and well recognized across the Area for promoting collaboration across functional and geographic boundaries.
Learning organisationSeeks to clarify feedback non defensively to understand required improvement.
Customer FocusIdentifies and builds effective relationships with customers and other stakeholders.

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。