Assistant 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
- 工作经验：三年以上
- 学历要求：本科
- 职位类别：临床研究员 医药技术研发管理人员
职位描述
Description
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 19,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of:
Assistant Clinical Data Manager
- Serve as Data Team Lead (DTL) on multiple global studies.
- Provide leadership to DM team.
- Manage DM customer relationship for DM project team including active participation in DM customer negotiation on
timeline, budgetary and other issues (with guidance).
- Provide marketing capabilities presentations and business development presentations.
- Or serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 20 operations staff
(excludes DE), or serve in a leadership role to a specific DM Task.
- With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership
and technical expertise to Operations team.
- Manage delivery of projects through full data management process life-cycle.
- With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify
out-of-scope.
- Provide input for negotiations with customer.
- Provide comprehensive data management expertise (including all operations tasks and DMP generation).
- Perform database designer activities for technologies not requiring extensive programming.
- Perform comprehensive quality control procedures.
- Independently bring project solutions to the CDM team.
- Solves issues through using the global issue escalation/communication plan.
- Consult with Standards Group for process issues; communicate ideas for process improvement.
- Assist in developing and implementing new technology.
- Understand and comply with core operating procedures and working instructions.
- Meet objectives as assigned.
- Develop and maintain good communications and working relationships with CDM team.
- Interact with CDM team members to negotiate timelines and responsibilities.
Qualifications
- Thorough knowledge of the data management process
- Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
- Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III)
- Comprehensive understanding of clinical drug development process
- Excellent organizational, communication, and data management skills (detail oriented)
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing
qualification with 3 years of related experience including clinical trials experience in a function similar to DM; or equivalent
combination of education, training and experience
The world's leading pharmaceutical services organization is powering the next generation of healthcare. If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 19,000 people throughout the world have already chosen to join Quintiles.
Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one. This is an outstanding opportunity to join Quintiles and become an integral part of our team.
We are looking for suitable individuals to fill the position of:
Assistant Clinical Data Manager
- Serve as Data Team Lead (DTL) on multiple global studies.
- Provide leadership to DM team.
- Manage DM customer relationship for DM project team including active participation in DM customer negotiation on
timeline, budgetary and other issues (with guidance).
- Provide marketing capabilities presentations and business development presentations.
- Or serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 20 operations staff
(excludes DE), or serve in a leadership role to a specific DM Task.
- With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership
and technical expertise to Operations team.
- Manage delivery of projects through full data management process life-cycle.
- With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify
out-of-scope.
- Provide input for negotiations with customer.
- Provide comprehensive data management expertise (including all operations tasks and DMP generation).
- Perform database designer activities for technologies not requiring extensive programming.
- Perform comprehensive quality control procedures.
- Independently bring project solutions to the CDM team.
- Solves issues through using the global issue escalation/communication plan.
- Consult with Standards Group for process issues; communicate ideas for process improvement.
- Assist in developing and implementing new technology.
- Understand and comply with core operating procedures and working instructions.
- Meet objectives as assigned.
- Develop and maintain good communications and working relationships with CDM team.
- Interact with CDM team members to negotiate timelines and responsibilities.
Qualifications
- Thorough knowledge of the data management process
- Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
- Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III)
- Comprehensive understanding of clinical drug development process
- Excellent organizational, communication, and data management skills (detail oriented)
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing
qualification with 3 years of related experience including clinical trials experience in a function similar to DM; or equivalent
combination of education, training and experience
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