长沙招聘

TMF Document Specialist

Position Title: TMF Document Specialist
Reports To: Lead TMF Document Specialist
Assignment Duration: Contracted resource
Zone / Line: Development Operations, WRDC
Location: Wuhan

Position Purpose:
The TMF Document Specialist is responsible for quality control of TMF documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any incomplete, mis-indexed, or inaccurately scanned documents with the Document Owners/TMF Study Owners or other end users.

Organizational Relationships:
Report directly to the Lead TMF Document Specialist
Liaise with TMF Study Owners, Document Owners, and Document Submitters, as needed

Resources Managed (budget and FTEs):
N/A


Major Duties:
Perform quality control on all documents received per In-line QC checklist and other reference documents.
Demonstrate understanding on document types, properties and indexing requirements
Ensure overall TMF quality by checking document completeness, indexing and scanning accuracy
Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
Communicate document inquiries with responsible users as needed
Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
Communicate and escalate issues to the Lead TMF Document Specialist and TMF Operations
Contribute to special projects related to document management as needed
Ensure that documents are transferred correctly within the TMF system per SOP and TMF related reference documents
Prepare, upload, and process documents including application/verification of document indexing within the TMF system

Training & Education:
Minimum of a Bachelor’s degree or equivalent
Good English skills
Basic computer literacy

Prior Experience Preferred:
Strong oral and written English communications skills
Hands-on experience with electronic documentation management systems and/or web based data management systems. Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records
Experience/knowledge of ICH/GCP documentation requirements
History of achievement in a customer service role with demonstration of meeting customer needs and concerns

Technical Competencies:
Competency Detail / Comments (specific skills, etc.)
Computer savvy with widely used systems (e.g., Microsoft Office)
Working knowledge of electronic document management systems
Understanding of a Trial Master File and it’s components
Knowledge of the principles and practices of traditional and electronic records management as applied to the pharmaceutical or related industry
Organization Skills
Ability to work independently; ability to manage tasks, time and priorities; ability to multi-task.
Communication Skills
Ability to communicate effectively and appropriately with internal & external colleagues on a local and global scale
Administrative Excellence
Attention to detail evident in a disciplined approach to document maintenance and management
Clinical/Scientific Aptitude
Understanding of scientific/clinical principles across different therapeutic areas
Technology Management
Understanding of technologies to support document collection and archiving; awareness of CFR 21 Part 11
Decision Making
Ability to make routine decisions based on pre-set guidelines and procedures
Problem Solving
Ability to recognize incorrect document information and work within the team to resolve problems
Behavioral Competencies:
Competency Detail / Comments (specific skills, etc.)
Quality Awareness
Ability to develop and carry out plans to improve one’s work
Collaborative, supportive
Work with others to ensure team effectiveness and demonstrate Pfizer values Innovation
Ability to identify opportunities and recommend continuous process enhancement
Motivation to develop self, meet and exceed expectations, and achieve performance goals
Networking and Alliance Building
Contribute to a learning environment by sharing knowledge and best practices within and across teams
Assist with mentoring other team members in core disciplines
Learning Organization
Ability to learn fast in an environment that demands excellence, time, and energy
Willingness to take on new projects and adapt to new processes and procedures
Flexibility
Ability to deal with ambiguity and changing priorities
Ability to work both independently and within teams; show respect and support for all team members
Teamwork
Drive, enthusiasm, creativity and excellent interpersonal skills
Initiating and Implementing change
Advocate and encourage actions that improve existing approaches and systems
Customer Focus
Identify and build 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。