Clinical Data Manager (China-Shanghai)
昆泰医药发展（上海）有限公司
- 公司规模：150-500人
- 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：2012-08-23
- 工作地点：上海
- 招聘人数：若干
- 学历要求：本科
- 职位类别：临床研究员
职位描述
Description
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
If that is your passion, we have a place for you.
Clinical Data Manager
Job Responsibilities
• Serve as Data Team Lead (DTL) / customer site lead for multiple large global studies / programme of global studies.
• Provide leadership and senior support to DTLs on multiple large global studies / programme of global studies.
• Act as the main overall point of contact for internal and external customers for programme / multiple projects.
• Manage relationship with a customer on a DM site level.
• Manage delivery of multiple projects / programmes through the full data management study life-cycle independently.
• Independent management of programme / project timelines, quality, resources, SOW (scope of work) / budgets.
• Lead DM customer negotiations on complex timeline, budgetary and other issues.
• May serve as Project Manager for single service data management projects.
• Manage comprehensive data management tasks pertaining to the Data Management Plan.
• Manage comprehensive quality control procedures.
• Provide data management expertise and data coordination process improvement to CDM management.
• Mentor other team members and DTLs / DOCs in training and developing data management expertise.
• Independently bring project solutions to the CDM team and the CDM Department.
• Manage a focus team or a best practice team.
• Manage the development and implementation of new technology/tool.
• Present at professional conferences and/or publish articles in professional journals.
• Provide Data Management with technical expertise.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Develop and maintain good communications and working relationships with CDM team.
Qualifications
• Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 7 years experience in clinical trials within a similar function, including proven competence in managing delivery of multiple global projects / programs independently through full data management study life-cycle, including large trials >1000 patients; also including experience in handling complex customer negotiations and bid defense meetings; or equivalent combination of education, training and experience
• Advanced knowledge of the data management process / systems and experience in specialized data management skills
• Comprehensive understanding of clinical drug development process (detail oriented)
• Outstanding communication and organizational skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
If that is your passion, we have a place for you.
Clinical Data Manager
Job Responsibilities
• Serve as Data Team Lead (DTL) / customer site lead for multiple large global studies / programme of global studies.
• Provide leadership and senior support to DTLs on multiple large global studies / programme of global studies.
• Act as the main overall point of contact for internal and external customers for programme / multiple projects.
• Manage relationship with a customer on a DM site level.
• Manage delivery of multiple projects / programmes through the full data management study life-cycle independently.
• Independent management of programme / project timelines, quality, resources, SOW (scope of work) / budgets.
• Lead DM customer negotiations on complex timeline, budgetary and other issues.
• May serve as Project Manager for single service data management projects.
• Manage comprehensive data management tasks pertaining to the Data Management Plan.
• Manage comprehensive quality control procedures.
• Provide data management expertise and data coordination process improvement to CDM management.
• Mentor other team members and DTLs / DOCs in training and developing data management expertise.
• Independently bring project solutions to the CDM team and the CDM Department.
• Manage a focus team or a best practice team.
• Manage the development and implementation of new technology/tool.
• Present at professional conferences and/or publish articles in professional journals.
• Provide Data Management with technical expertise.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Develop and maintain good communications and working relationships with CDM team.
Qualifications
• Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 7 years experience in clinical trials within a similar function, including proven competence in managing delivery of multiple global projects / programs independently through full data management study life-cycle, including large trials >1000 patients; also including experience in handling complex customer negotiations and bid defense meetings; or equivalent combination of education, training and experience
• Advanced knowledge of the data management process / systems and experience in specialized data management skills
• Comprehensive understanding of clinical drug development process (detail oriented)
• Outstanding communication and organizational skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
公司介绍
ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY