Associate Clinical Project Manager (China)临床项目经理
广州市科特杰咨询服务有限公司
- 公司规模:少于50人
- 公司性质:民营公司
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2012-08-31
- 工作地点:广州
- 招聘人数:1
- 学历要求:本科
- 语言要求:英语
- 职位类别:临床研究员 医药技术研发管理人员
职位描述
Associate Clinical Project Manager (China)
Expected Areas of Competence/Responsibilities
? Participate in the design and development of clinical study protocols, case report forms, source documents, electronic data capture devices, and other regulatory documents (e.g., Informed Consent).
? In collaboration with Medical Affairs Directors (Director-China and Associate Director-China), plan and manage the operational aspects of clinical studies to ensure delivery of high quality results in a timely manner.
? In collaboration with Medical Affairs Directors, carry out investigator identification, selection, evaluation, initiation, and training.
? In collaboration with Medical Affairs Directors, carry out identification and selection of central laboratories when needed. Work with central laboratory in developing lab kits, training materials and manuals for the study.
? Coordinate internal and external protocol approval processes, including IRB/Ethics Board submission and approvals with guidance from the Medical Affairs Directors.
? Collaborate with contract clinical monitors to ensure monitoring efforts occur within an appropriate schedule and result in high quality data and receipt of data meets established timelines. Assist monitor in diplomatically resolving difficult issues at study sites along with the Medical Affairs Directors.
? Establish, maintain, and cultivate working relationships with investigators and their staff to project Mead Johnson image and to enable high scientific standards and integrity.
? In collaboration with the Medical Affairs Directors, develop, negotiate and manage budgets for individual study sites.
? Collaborate with Medical Affairs Directors to resolve site related issues.
? Generate project documentation (including but not limited to) project specifications, project reports, communication records, and status reports.
? Update investigators and study staff on status of study and ensure that motivation and interest are maintained in the study.
? Proactively identify key issues in clinical trial execution and develop solutions to ensure delivery of project goals and timelines.
? Stay abreast of current developments in corporate, federal and international regulations and adjust internal procedures to ensure clinical study process is compliant.
Core Behaviors and Necessary Skills
? Solid leadership skills.
? Excellent communication and organizational skills. Ability to communicate and interact with a diverse audience within and outside the organization.
? Ability to identify deviations from project plan and to work with project team and management to develop corrective action plans.
? Ability to work in a team environment.
? Ability to anticipate problems relating to projects and to develop and implement solutions.
? Ability to understand and review detailed clinical reports.
? Knowledge of project management tools and practices.
? Ability to manage multiple projects at varying stages of completion, with a high level of accuracy and attention to detail.
? Effective in setting and meeting personal short- and long-term goals to complete assignments.
Qualifications and Experiences Desired
? BA/BS, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
? At least 2 years of clinical research experience, including field monitoring of clinical trials.
? Knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines for clinical research.
? Experience working with a range of technically and culturally diverse people to accomplish project objectives within a tight timeline.
? Practical experience in clinical trial methodology, particularly study design and operational aspects.
? Thorough understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning)
? Basic understanding of nursing and medical practices as they apply to nutritional clinical trials. Knowledge of medical terminology helpful.
? Strong information management skills, including proficiency with MS Office.
Please contact :ellen.wu@cost-killer.com for further information
Expected Areas of Competence/Responsibilities
? Participate in the design and development of clinical study protocols, case report forms, source documents, electronic data capture devices, and other regulatory documents (e.g., Informed Consent).
? In collaboration with Medical Affairs Directors (Director-China and Associate Director-China), plan and manage the operational aspects of clinical studies to ensure delivery of high quality results in a timely manner.
? In collaboration with Medical Affairs Directors, carry out investigator identification, selection, evaluation, initiation, and training.
? In collaboration with Medical Affairs Directors, carry out identification and selection of central laboratories when needed. Work with central laboratory in developing lab kits, training materials and manuals for the study.
? Coordinate internal and external protocol approval processes, including IRB/Ethics Board submission and approvals with guidance from the Medical Affairs Directors.
? Collaborate with contract clinical monitors to ensure monitoring efforts occur within an appropriate schedule and result in high quality data and receipt of data meets established timelines. Assist monitor in diplomatically resolving difficult issues at study sites along with the Medical Affairs Directors.
? Establish, maintain, and cultivate working relationships with investigators and their staff to project Mead Johnson image and to enable high scientific standards and integrity.
? In collaboration with the Medical Affairs Directors, develop, negotiate and manage budgets for individual study sites.
? Collaborate with Medical Affairs Directors to resolve site related issues.
? Generate project documentation (including but not limited to) project specifications, project reports, communication records, and status reports.
? Update investigators and study staff on status of study and ensure that motivation and interest are maintained in the study.
? Proactively identify key issues in clinical trial execution and develop solutions to ensure delivery of project goals and timelines.
? Stay abreast of current developments in corporate, federal and international regulations and adjust internal procedures to ensure clinical study process is compliant.
Core Behaviors and Necessary Skills
? Solid leadership skills.
? Excellent communication and organizational skills. Ability to communicate and interact with a diverse audience within and outside the organization.
? Ability to identify deviations from project plan and to work with project team and management to develop corrective action plans.
? Ability to work in a team environment.
? Ability to anticipate problems relating to projects and to develop and implement solutions.
? Ability to understand and review detailed clinical reports.
? Knowledge of project management tools and practices.
? Ability to manage multiple projects at varying stages of completion, with a high level of accuracy and attention to detail.
? Effective in setting and meeting personal short- and long-term goals to complete assignments.
Qualifications and Experiences Desired
? BA/BS, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
? At least 2 years of clinical research experience, including field monitoring of clinical trials.
? Knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines for clinical research.
? Experience working with a range of technically and culturally diverse people to accomplish project objectives within a tight timeline.
? Practical experience in clinical trial methodology, particularly study design and operational aspects.
? Thorough understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning)
? Basic understanding of nursing and medical practices as they apply to nutritional clinical trials. Knowledge of medical terminology helpful.
? Strong information management skills, including proficiency with MS Office.
Please contact :ellen.wu@cost-killer.com for further information
公司介绍
Founded in 2002, CK3 (Cost-killer as our past name) is a fast-developed human resources service provider in PRC to offer a complete range of HR related services, including recruitment, Human Resources Management System (HRMS) and training. We provide integrated services that cover the entire talent lifecycle. Up to now, over 100 Fortune 500 companies have cooperated with us and sustained the partnership. Our success in the past makes us strong and confident in facing challenges.
CK3 focuses on Recruiting, E-managing & Developing talents---the greatest asset. We call our model RED. Red means passion and sense of mission. We aim to help our clients with our professionalism to achieve their business vision. With the success of our clients, CK3 has become one of the leading recruitment companies, HRMS providers and a rising star of the training industry.
科特杰公司于2002年成立,作为一家快速发展的人力资源服务提供商,我们在中国大陆提供一整套的人力资源服务,其中包括招聘、人力资源管理软件系统和培训。我们的服务涵盖了人才成长的整个生命周期。 到现在为止,超过100家全球500强的企业曾经接受过我们的服务并和我们保持伙伴关系。我们过去的成功让我们有充分的自信面对不断的挑战。
科特杰专注于招聘(Recruit),管理(E-manage),发展(Develop)最宝贵的资产-人才。我们是R-E-D,红色。我们有激情和理想。我们致力于通过我们的专业度和努力来帮助我们的客户实现他们的生意远景。随着和我们客户的共同成功,我们逐步成为了领先的招聘公司,人力资源软件提供商和培训行业的明日之星。
广州公司:天河北路183号大都会广场2501室,或电邮到headhunter@cost-killer.com 。请在信封上注明应聘职位。
北京公司:北京市朝阳区光华路甲8号A302室,或电邮到headhunterbj@cost-killer.com。请在信封上注明应聘职位。
CK3 focuses on Recruiting, E-managing & Developing talents---the greatest asset. We call our model RED. Red means passion and sense of mission. We aim to help our clients with our professionalism to achieve their business vision. With the success of our clients, CK3 has become one of the leading recruitment companies, HRMS providers and a rising star of the training industry.
科特杰公司于2002年成立,作为一家快速发展的人力资源服务提供商,我们在中国大陆提供一整套的人力资源服务,其中包括招聘、人力资源管理软件系统和培训。我们的服务涵盖了人才成长的整个生命周期。 到现在为止,超过100家全球500强的企业曾经接受过我们的服务并和我们保持伙伴关系。我们过去的成功让我们有充分的自信面对不断的挑战。
科特杰专注于招聘(Recruit),管理(E-manage),发展(Develop)最宝贵的资产-人才。我们是R-E-D,红色。我们有激情和理想。我们致力于通过我们的专业度和努力来帮助我们的客户实现他们的生意远景。随着和我们客户的共同成功,我们逐步成为了领先的招聘公司,人力资源软件提供商和培训行业的明日之星。
广州公司:天河北路183号大都会广场2501室,或电邮到headhunter@cost-killer.com 。请在信封上注明应聘职位。
北京公司:北京市朝阳区光华路甲8号A302室,或电邮到headhunterbj@cost-killer.com。请在信封上注明应聘职位。
联系方式
- 公司网站:http://www.cost-killer.com
- Email:headhunter@cost-killer.com