Lead TMF Document Specialist(职位编号：971410_1349932491)
辉瑞（中国）研究开发有限公司
- 公司规模：10000人以上
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2012-10-15
- 工作地点：武汉
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：文档工程师 临床数据分析员
职位描述
Responsibilities
Lead TMF Document Specialist
(Items identified with subscript(ADM02) are required by ADM-02. Any updates to this role description should include updating the date field in the footer.)
Position Title(ADM02):Lead TMF Document Specialist
Reports To(ADM02):Manager, TMF Processing Center
Assignment Duration(ADM02):
Contracted resource
Zone / Line:Development Operations/WRDC
Location:Wuhan
Career Ladder (Level):
Position Purpose(ADM02):
*The Lead TMF Document Specialist is responsible for supporting TMF completeness by reviewing documents for quality and completeness and indexing them accurately in the TMF system. The Lead TMF Document Specialist will sample document and indexing quality, use this information to identify quality trends. The Lead TMF Document Specialist will serve as the first point of contact for customers needing assistance with TMF indexing questions and issues, and will serve as a subject matter expert for the regulatory document process, related systems and tools. The Lead TMF Document Specialist will assist in training and mentoring others within the TMF Document Specialist group.
Organizational Relationships(ADM02):
*Reports directly to the Manager, TMF Processing Center
*Liaise with TMF Study Owners, Document Owners, and Document Submitters
Resources Managed (budget and FTEs) (ADM02):
*none
Major Duties (ADM02):
General
*Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
*Associate existing templates and program level documents to the TMF repository.
*Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
*Prepare and process/upload documents including application/verification of indexing terms within the TMF system.
*Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
*Review TMF repository to verify an exact duplicate of the document has not previously been activated.
*Follow-up with Document Owner with discrepancies and log errors.
*Activate document into the repository and inform Document Owner, as applicable
*Prepare processed paper documents for archival
*Archive documents per the archival process
*Generate and distribute required metric reports.
*Understand sources for each metric.
*Create custom metric reports as requested.
*Understand document types, document content, and indexing requirements
*Complete quality checks of TMF documents via sampling.
*Serve as the first point of contact for indexing questions and issues
*Function as subject matter expert for regulatory document systems and tools
*Mentor other TMF Document Specialists
*Assist in training new hires and assist in monitoring performance against this training
*Assist in training TMF Document Specialists on new processes and tools and assist in monitoring performance against this training
*Assist with managing the TMF Document Specialists work, track developmental progress, and monitor performance
Training & Education Preferred(ADM02):
*Minimum of Bachelor's degree or equivalent required.
Prior Experience Preferred(ADM02):
*Excellent English verbal and written communications skills and outstanding listening skills are required.
*History of achievement in a customer service role with demonstration of meeting customer needs and concerns required.
*Proven history of leadership roles within a team environment required.
*Experience with electronic documentation management systems preferred.
*Experience in management of medical/clinical study records and documentation preferred.
*Experience/knowledge of ICH/GCP documentation requirements preferred.
*Metrics management experience (preferably within the field of Clinical Research) preferred.
*Experience with web based data management systems preferred.
*Experience with database utilization preferred.
Technical Competencies(ADM02):
Competency Detail / Comments (specific skills, etc.)
*Computer savvy with widely used systems e.g. MicroSoft Office
*Understanding of a Trial Master File and it's components
*Organizational skills
*Administrative excellence
*Clinical/Scientific aptitude
*Technology management
?Decision Making
?Problem Solving
*Working knowledge of electronic document management systems.
*Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
*Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.
*Attention to detail evident in a disciplined approach to document maintenance and management
*Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
*Understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
*Ability to understand the sources of various data points, and how to mine that information for meaningful data
*Ability to make routine decisions based on following set guidelines and procedures
*Ability to proactively identify issues and work within a team to address.
Behavioral Competencies(ADM02):
Competency Detail / Comments (specific skills, etc.)
*Leadership skills
*Communication skills
*Quality Awareness
*Collaborative, supportive
*Innovation
*Networking and Alliance Building
*Learning Organization
*Flexibility
*Teamwork
*Initiating and Implementing change
*Customer Focus
*Ability to successfully provide leadership within a team environment.
*Advanced ability to communicate effectively and appropriately with internal & external colleagues, locally and globally
*Ability to communicate new concepts, assess effectiveness of communication, and develop different approaches as necessary
*Ability to develop and carry out plans for self-improvement.
*Ability to identify areas for improvement in team members, provide needed training and mentoring, and monitor improvement
*Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
*Recommend continuous process improvements
*Identify opportunities for collaboration to help deliver study goals
*Understand which groups or individuals to approach for guidance on processes or systems, and build relationships with those individuals or groups.
*Contribute to a learning environment by sharing knowledge and best practices within and across teams. Assist with mentoring other team members in core discipline.
*Demonstrate desire and ability to expand personal knowledge of Pfizer processes and systems.
*Maintain a positive learning environment by encouraging questions and providing answers in a supportive way
*Ability to take on new projects and adapt to new processes and procedures
*Respond positively and constructively to changing situations
*Assist other team members to ensure timelines are met
*Ability to work independently and within a team; show respect and support for all team members.
*Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
*Advocate and encourage actions that improve existing approaches and systems.
*Proactively manage change by identifying opportunities and coaching self and others through the change
*Identify and build effective relationships with customers and other stakeholders.
Lead TMF Document Specialist
(Items identified with subscript(ADM02) are required by ADM-02. Any updates to this role description should include updating the date field in the footer.)
Position Title(ADM02):Lead TMF Document Specialist
Reports To(ADM02):Manager, TMF Processing Center
Assignment Duration(ADM02):
Contracted resource
Zone / Line:Development Operations/WRDC
Location:Wuhan
Career Ladder (Level):
Position Purpose(ADM02):
*The Lead TMF Document Specialist is responsible for supporting TMF completeness by reviewing documents for quality and completeness and indexing them accurately in the TMF system. The Lead TMF Document Specialist will sample document and indexing quality, use this information to identify quality trends. The Lead TMF Document Specialist will serve as the first point of contact for customers needing assistance with TMF indexing questions and issues, and will serve as a subject matter expert for the regulatory document process, related systems and tools. The Lead TMF Document Specialist will assist in training and mentoring others within the TMF Document Specialist group.
Organizational Relationships(ADM02):
*Reports directly to the Manager, TMF Processing Center
*Liaise with TMF Study Owners, Document Owners, and Document Submitters
Resources Managed (budget and FTEs) (ADM02):
*none
Major Duties (ADM02):
General
*Upon direction, create and activate the initial TMF repository according to finalized study TMF specifications.
*Associate existing templates and program level documents to the TMF repository.
*Perform document completeness QC on all received documents per TMF Readiness Criteria including readability.
*Prepare and process/upload documents including application/verification of indexing terms within the TMF system.
*Review uploaded documents for readability and verify indexing terms were transferred correctly from the document into the TMF system.
*Review TMF repository to verify an exact duplicate of the document has not previously been activated.
*Follow-up with Document Owner with discrepancies and log errors.
*Activate document into the repository and inform Document Owner, as applicable
*Prepare processed paper documents for archival
*Archive documents per the archival process
*Generate and distribute required metric reports.
*Understand sources for each metric.
*Create custom metric reports as requested.
*Understand document types, document content, and indexing requirements
*Complete quality checks of TMF documents via sampling.
*Serve as the first point of contact for indexing questions and issues
*Function as subject matter expert for regulatory document systems and tools
*Mentor other TMF Document Specialists
*Assist in training new hires and assist in monitoring performance against this training
*Assist in training TMF Document Specialists on new processes and tools and assist in monitoring performance against this training
*Assist with managing the TMF Document Specialists work, track developmental progress, and monitor performance
Training & Education Preferred(ADM02):
*Minimum of Bachelor's degree or equivalent required.
Prior Experience Preferred(ADM02):
*Excellent English verbal and written communications skills and outstanding listening skills are required.
*History of achievement in a customer service role with demonstration of meeting customer needs and concerns required.
*Proven history of leadership roles within a team environment required.
*Experience with electronic documentation management systems preferred.
*Experience in management of medical/clinical study records and documentation preferred.
*Experience/knowledge of ICH/GCP documentation requirements preferred.
*Metrics management experience (preferably within the field of Clinical Research) preferred.
*Experience with web based data management systems preferred.
*Experience with database utilization preferred.
Technical Competencies(ADM02):
Competency Detail / Comments (specific skills, etc.)
*Computer savvy with widely used systems e.g. MicroSoft Office
*Understanding of a Trial Master File and it's components
*Organizational skills
*Administrative excellence
*Clinical/Scientific aptitude
*Technology management
?Decision Making
?Problem Solving
*Working knowledge of electronic document management systems.
*Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
*Ability to work independently. Ability to organize tasks, time and priorities of self ; ability to multi-task.
*Attention to detail evident in a disciplined approach to document maintenance and management
*Understanding of scientific/clinical principles, and ability to work across different therapeutic areas
*Understanding of technologies to support document collection and archiving, awareness of CFR 21 part 11
*Ability to understand the sources of various data points, and how to mine that information for meaningful data
*Ability to make routine decisions based on following set guidelines and procedures
*Ability to proactively identify issues and work within a team to address.
Behavioral Competencies(ADM02):
Competency Detail / Comments (specific skills, etc.)
*Leadership skills
*Communication skills
*Quality Awareness
*Collaborative, supportive
*Innovation
*Networking and Alliance Building
*Learning Organization
*Flexibility
*Teamwork
*Initiating and Implementing change
*Customer Focus
*Ability to successfully provide leadership within a team environment.
*Advanced ability to communicate effectively and appropriately with internal & external colleagues, locally and globally
*Ability to communicate new concepts, assess effectiveness of communication, and develop different approaches as necessary
*Ability to develop and carry out plans for self-improvement.
*Ability to identify areas for improvement in team members, provide needed training and mentoring, and monitor improvement
*Work successfully with others to ensure team effectiveness and demonstrate Pfizer values
*Recommend continuous process improvements
*Identify opportunities for collaboration to help deliver study goals
*Understand which groups or individuals to approach for guidance on processes or systems, and build relationships with those individuals or groups.
*Contribute to a learning environment by sharing knowledge and best practices within and across teams. Assist with mentoring other team members in core discipline.
*Demonstrate desire and ability to expand personal knowledge of Pfizer processes and systems.
*Maintain a positive learning environment by encouraging questions and providing answers in a supportive way
*Ability to take on new projects and adapt to new processes and procedures
*Respond positively and constructively to changing situations
*Assist other team members to ensure timelines are met
*Ability to work independently and within a team; show respect and support for all team members.
*Work collaboratively with group members and contribute to positive intra- and inter-team relationships both locally and globally; deliver on commitments to study team and line
*Advocate and encourage actions that improve existing approaches and systems.
*Proactively manage change by identifying opportunities and coaching self and others through the change
*Identify and build effective relationships with customers and other stakeholders.
公司介绍
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。
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。
联系方式
- Email：ChinaCPWTalent@Pfizer.com
- 公司地址：1 (邮编：200000)