PI manager
科文斯医药研发(北京)有限公司上海分公司
- 公司规模:500-1000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:2015-06-12
- 工作地点:北京-朝阳区
- 招聘人数:若干
- 职位月薪:面议
- 职位类别:生物工程/生物制药
职位描述
Responsibility:
? Ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices
? May supervise the Project Integration staff
? Has overall responsibility for assuring timeliness and quality of work for studies
? Ensure that the highest levels of client service are maintained
? Identify specific Project Integration requirements from clients
? Coordinate Data Management, Programming, and Statistics projects, teams, and deadlines
? Communicate on a regular basis with assigned clients regarding questions, concerns, and project status
? Organize, chair, and record minutes for all cross-functional Project Integration project meetings
? Facilitate meetings with Sponsors
? Ensure the relevant personnel are kept informed of problems that may affect the project performance
? Coordinate receipt, inventory, accountability, and disposal of study related information
? Ensure all appropriate documentation and procedures are performed upon project completion
? Communicate with the Data Management, Programming, Statistics, Pharmacokinetics, Medical Writing, and Quality Assurance departments regarding study progress and reporting requirements
? Update the Project Integration internal timelines for allocated projects in a timely manner. Renegotiate timelines as appropriate
? Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team
? Provide senior management with estimates of group capacity and needs
? Provide senior management with updates on timelines and projects
? Keep senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes)
? Assist Director of Project Integration in preparing proposals and attend client meetings as needed
? Assist QA and Client Services with client visits and interactions as appropriate
? Develop new business by building successful client relationships
? Liaise with Quality Assurance regarding regulatory compliance of study conduct and Sponsor audits
? Write and update SOPs as required
? Lead review and amendment of departmental processes and supporting documentation
? Motivate others to complete high quality work efficiently
? Perform other related duties as assigned
Requirement:
? BS or BSc in Science, Medical, or related field
? Knowledge/experience with drug development
? Knowledge/experience clinical research preferred
? Minimum of 5 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
? In lieu of the above requirements, candidates with >5 years supervisory experience in a health care setting and 4 years clinical research experience in the pharmaceutical or CRO industries will be considered
? Ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices
? May supervise the Project Integration staff
? Has overall responsibility for assuring timeliness and quality of work for studies
? Ensure that the highest levels of client service are maintained
? Identify specific Project Integration requirements from clients
? Coordinate Data Management, Programming, and Statistics projects, teams, and deadlines
? Communicate on a regular basis with assigned clients regarding questions, concerns, and project status
? Organize, chair, and record minutes for all cross-functional Project Integration project meetings
? Facilitate meetings with Sponsors
? Ensure the relevant personnel are kept informed of problems that may affect the project performance
? Coordinate receipt, inventory, accountability, and disposal of study related information
? Ensure all appropriate documentation and procedures are performed upon project completion
? Communicate with the Data Management, Programming, Statistics, Pharmacokinetics, Medical Writing, and Quality Assurance departments regarding study progress and reporting requirements
? Update the Project Integration internal timelines for allocated projects in a timely manner. Renegotiate timelines as appropriate
? Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team
? Provide senior management with estimates of group capacity and needs
? Provide senior management with updates on timelines and projects
? Keep senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes)
? Assist Director of Project Integration in preparing proposals and attend client meetings as needed
? Assist QA and Client Services with client visits and interactions as appropriate
? Develop new business by building successful client relationships
? Liaise with Quality Assurance regarding regulatory compliance of study conduct and Sponsor audits
? Write and update SOPs as required
? Lead review and amendment of departmental processes and supporting documentation
? Motivate others to complete high quality work efficiently
? Perform other related duties as assigned
Requirement:
? BS or BSc in Science, Medical, or related field
? Knowledge/experience with drug development
? Knowledge/experience clinical research preferred
? Minimum of 5 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
? In lieu of the above requirements, candidates with >5 years supervisory experience in a health care setting and 4 years clinical research experience in the pharmaceutical or CRO industries will be considered
公司介绍
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
联系方式
- 公司网站:http://www.covance.com
- Email:calvin.xu@covance.com
- 公司地址:上海市黄埔区西藏中路268号来福士广场1806室
- 邮政编码:200001
- 联系人:Vicky Qu