长沙招聘

职位描述：
Position Purpose:
An experienced role. 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 site performance targets are achieved and the company’s image with its external customers are enhanced. To drive quality standards by acting as a mentor and providing support to less-experienced colleagues. To oversee and supervise contract and Pfizer CRAs as required. To support the Lead of Site Management by performing specific operational tasks as defined by business need.

Primary Duties (fundamental components of role—both strategic & operational):

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 number of studies and investigator sites commensurate with experience, so that studies are run efficiently and key study objectives are met (pro rata with available monitoring time).
? 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 with appropriate mentoring and support.
? 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.


Data Quality
? Ensure that data monitored meets target quality standards.
? Ensure that data are 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.
? Maintenance of ELARA and/or PTMF to ensure audit trail is complete and accurate.
? QC relevant documents in ELARA and/or PTMF in a timely manner.
? Generate site monitoring reports.
? Maintain all appropriate monitoring logs.


Mentoring
? Mentoring and supporting less experienced colleagues.
? Mentoring, Coaching and supporting other team members.

Supervision of Contract CRAs (as required)
? Involvement in selection and supervision of contract CRAs (cCRAs) as required.
? Ensure induction and appropriate Pfizer specific training of cCRAs is undertaken.
? Plan cCRA resources in such a way that their time is utilised optimally.
? To lead, motivate and drive the performance of cCRAs to achieve agreed objectives.
? To ensure that monitoring and site management activities are carried out to the highest standards in accordance with the appropriate regulatory and legal framework and company SOPs.
? Provision of ongoing feedback of performance issues to agencies/MSP.

Performing specific delegated tasks
? Perform designated tasks, delegated from the Monitoring Lead to the required standard.

CRO oversight
? To support oversight of monitoring by accompanied visits with CRAs including CRO/FSP/contractor staff as required.
? Provide feedback to CRAs and Study Managers on issues identified.
? Use findings and observations from oversight activities to proactively drive higher quality standards.

Training & Education
Required:
? Life Science/Nursing graduate or equivalent with at least 5 years of Clinical Monitoring/Site Management experience
? Experience of working across a variety of therapy areas and trial phases
? Demonstrated ability to adopt and promote new processes and systems
? Full driving license
Preferred:
? Experience of mentoring/oversight
? CRA management experience possibly via project management 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。