长沙招聘

Position Purpose:
*Expand clinical research infrastructure in local market(s) to ensure sites utilized by Pfizer are operating in conformance with ICH/GCP and local regulatory requirements
*Mitigate systematic deficiencies in clinical trial conduct across sites and countries to improve quality in selected investigational sites.
*Shape local clinical research environment by promoting GCP ethics, regulatory process and investigator training
*Manage the relationship with local external stakeholder (investigators, regulators, ethics committees, etc)
*Provide Line Management to iSDLs, including ensuring training compliance

Organizational Relationships:
*Reports to Global Clinical Trial Support and Development Lead (see org chart)
*Partners with CTSC country level roles, e.g. Compliance Oversight Lead (COL) and Director of Compliance Oversight (DCO)
*Partners with the local platform lines (e.g.Safety & Regulatory Ops, etc.), Business Units (as appropriate), and enabling lines
*Partners with environment shaping and site selection roles in alliance partners.
*Partner with CORE site management line

Resources Managed (budget and FTEs):
*Provides input to the creation and management of budgets required for enhancing key sites and execution of environment shaping initiatives in alignment with CTSC Strategic Imperatives.
*Manages Investigator Site Development Leads (iSDLs) in a player/coach role

Primary Duties:
*In partnership with COLs, country management and strategic partners proactively identify areas of concern and sponsor root cause analyses to develop quality strategies for risk mitigation and continuous improvement.
*In the context of clinical trial execution, collaborate with MQA to ensure that the strategic partners create and execute risk mitigation plans / CAPAs in a timely manner.
*Build future investigational sites relationships through:
oMaintenance and management of in country relationships with Center(s) of Research Excellence (CORE) sites and Key Strategic Sites (KSS);
oConduct gap analysis and support accreditation at targeted investigational sites, where appropriate;
oPromotion of investigator/clinical research staff training on ethical research and GCPs in key markets.
*Participate in local industry forums to shape performance of ethical clinical research.
*Support mentoring and training initiatives to promote accreditation vehicles

Training & Education Preferred:
A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:

BS/BSc/MS/MSc or equivalent + 6 years of clinical research experience and/or quality management experience



Prior Experience
*Experience in developing and implementing quality management plans
*Experience with diverse needs of regulatory requirements from different countries preferred
*Experience with drug development, monitoring and/or QA experience, and inspection readiness
*Experience managing multiple complex projects
*Experience implementing centrally designed and developed initiatives on a local and regional basis
?Demonstrated People Management Capabilities

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
Instructional design, development and assessmentDemonstrated application of training principles, in clinical, technical and general areas
Demonstrated ability to assess, design, develop and evaluate training, and guide/assist SMEs to do the same
Training/adult learning design and delivery experience considered a plus
Project and process managementDemonstrated ability to manage projects and cross-functional processes
Communication and presentation skillsAbility to communicate effectively and appropriately with internal & external stakeholders
Administrative excellenceAttention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.
Organizational skillsWorks independently. Receives instruction primarily on unusual situations
Ability to organize tasks, time and priorities of self and others; ability to multi-task

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。