Site Start-up Specialist (China - Beijing)
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：2015-06-10
- 工作地点：北京
- 招聘人数：若干
- 职位类别：数据库工程师/管理员 互联网软件开发工程师
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.
Site start-up specialist (China - Beijing)
Job Responsibilities:
Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
· Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and
budgets.
· Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
· Review and provide feedback to management on site performance metrics.
· Serve as contact for investigative sites, designated project reports, communications, and customer service.
· Resolve site issues and determine status for product shipment.
· Work with regulatory team members or sponsor to secure authorization of regulatory documents.
· Work with legal team members or sponsor to secure authorization of contracts.
· Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and
deliverables.
· Inform team members of completion of regulatory and contractual documents for individual sites.
· Work with team members in preparation of regulatory submissions per work instructions.
· May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of
specialization.
· May translate or review completed translations of critical documents.
· May participate in feasibility and/or site identification activities.
All responsibilities are essential job functions unless noted as nonessential (N).
Qualifications
Requirements:
· In-depth knowledge of clinical systems, procedures, and corporate standards
· Strong knowledge of medical terminology and regulations
· Broad knowledge of clinical research
· Strong knowledge of Microsoft Office and e-mail applications
· Effective communication, organizational, and interpersonal skills
· Ability to work independently and to effectively prioritize tasks
· Ability to manage multiple projects
· Attention to detail
· Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· Bachelor's Degree in a related field and 1 year clinical research experience; or equivalent combination of education,
training and experience
PHYSICAL REQUIREMENTS
· Extensive use of telephone and face-to-face communication requiring accurate perception of speech
· Extensive use of keyboard requiring repetitive motion of fingers
· Regular sitting for extended periods of time
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.
Site start-up specialist (China - Beijing)
Job Responsibilities:
Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
· Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and
budgets.
· Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
· Review and provide feedback to management on site performance metrics.
· Serve as contact for investigative sites, designated project reports, communications, and customer service.
· Resolve site issues and determine status for product shipment.
· Work with regulatory team members or sponsor to secure authorization of regulatory documents.
· Work with legal team members or sponsor to secure authorization of contracts.
· Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and
deliverables.
· Inform team members of completion of regulatory and contractual documents for individual sites.
· Work with team members in preparation of regulatory submissions per work instructions.
· May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of
specialization.
· May translate or review completed translations of critical documents.
· May participate in feasibility and/or site identification activities.
All responsibilities are essential job functions unless noted as nonessential (N).
Qualifications
Requirements:
· In-depth knowledge of clinical systems, procedures, and corporate standards
· Strong knowledge of medical terminology and regulations
· Broad knowledge of clinical research
· Strong knowledge of Microsoft Office and e-mail applications
· Effective communication, organizational, and interpersonal skills
· Ability to work independently and to effectively prioritize tasks
· Ability to manage multiple projects
· Attention to detail
· Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· Bachelor's Degree in a related field and 1 year clinical research experience; or equivalent combination of education,
training and experience
PHYSICAL REQUIREMENTS
· Extensive use of telephone and face-to-face communication requiring accurate perception of speech
· Extensive use of keyboard requiring repetitive motion of fingers
· Regular sitting for extended periods of time
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