临床试验项目经理 ID158170
爱恩康临床医学研究(北京)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:2024-02-07
- 工作地点:北京·大兴区
- 工作经验:6年及以上
- 学历要求:本科
- 职位月薪:3-5万
- 职位类别:临床试验项目经理 ID158170
职位描述
As a Clinical Trial Manager, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
We are seeking an experienced Clinical Trial Manager to work as an integral part of our pharma client’s global study team. The key function of the Clinical Trial Manager is to provide operational country oversight and monitor progress of local activities of global studies by project managing a clinical team at a country level.
Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:
- To manage the local execution of study activities, leading the local trial team of on-site monitors (Site Managers) and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team
- To serve as the primary point of contact at a country level and report study progress to key stakeholders
- To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team
- To provide expert input into, or even independently create key study plans
- To develop and implement the use of local study tools (eg recruitment plans, risk management plans)
- To track the reporting of SAEs
- To maintain and update trial management systems (with the support of a Clinical Trial Assistant)
- To plan and participate in investigator meetings
- To review visit reports for completeness and adherence to the protocol and to identify site issues and trends
- To collaborate with other study team members as well as investigators and other site staff to build strong working relationships
A typical working day may include creating study documents, meeting with your team, sharing your expert local knowledge with other internal collaborates and even involvement with process improvement initiatives at a more global level. You will truly be a local study expert and will be expected to leverage your experience.
You are:
Organised, creative and confident in taking independent action.
To ensure success within this role, the following are required:
- 1 year plus project management experience, hematology and oncology/global study/audit experience is a must, inspection experience is a plus.
- An ability to combine creativity, leadership and experience to empower a team to succeed
- Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management
- Confidence in your decision-making abilities
- A working knowledge of a broad range of therapeutic areas
- A BA or BS degree in a health or science related discipline
- Fluency in English
We are seeking an experienced Clinical Trial Manager to work as an integral part of our pharma client’s global study team. The key function of the Clinical Trial Manager is to provide operational country oversight and monitor progress of local activities of global studies by project managing a clinical team at a country level.
Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:
- To manage the local execution of study activities, leading the local trial team of on-site monitors (Site Managers) and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team
- To serve as the primary point of contact at a country level and report study progress to key stakeholders
- To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team
- To provide expert input into, or even independently create key study plans
- To develop and implement the use of local study tools (eg recruitment plans, risk management plans)
- To track the reporting of SAEs
- To maintain and update trial management systems (with the support of a Clinical Trial Assistant)
- To plan and participate in investigator meetings
- To review visit reports for completeness and adherence to the protocol and to identify site issues and trends
- To collaborate with other study team members as well as investigators and other site staff to build strong working relationships
A typical working day may include creating study documents, meeting with your team, sharing your expert local knowledge with other internal collaborates and even involvement with process improvement initiatives at a more global level. You will truly be a local study expert and will be expected to leverage your experience.
You are:
Organised, creative and confident in taking independent action.
To ensure success within this role, the following are required:
- 1 year plus project management experience, hematology and oncology/global study/audit experience is a must, inspection experience is a plus.
- An ability to combine creativity, leadership and experience to empower a team to succeed
- Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management
- Confidence in your decision-making abilities
- A working knowledge of a broad range of therapeutic areas
- A BA or BS degree in a health or science related discipline
- Fluency in English
公司介绍
We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.
联系方式
- Email:sarah.ma@docsglobal.com
- 公司地址:北京市东城区北三环东路36号环球贸易中心 (邮编:100013)
- 电话:18810965020