Skip to main content
搜索

搜索职位

Clinical Project Manager (FSP)

China, Remote 职位编号 R0000034284 类别 Clinical Trials
立即申请

关于这个职位

Key Accountabilities:

Study Management

  • Forecast timelines, budget & FTE resource( if applicable).

  • Take a key leadership role in the management of studies’ timeline, quality, cost.

  • Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations. 

  • Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track. 

  • Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured .

  •  Timely update projects information to the Brand Team. 

  • Review and approve project relevant documents. 

  • Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.) 

  • Prepare and lead investigator and monitormeeting

  • Ensure AEs/SAE reporting according to GCP and regulation

  • Plan and lead activities associated with study level Quality Control plan. 

  • Develop & manage contingency risk plans to assuretimely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate

  • Provide operational support to the ESR investigators to ensure the on time delivery of ESR

Compliance with Parexel standards

  • Comply withrequired training curriculum. 

  • Complete timesheets accurately as required

  •  Submit expense reports as required

  • Update CV as required

  • Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.

Skills

  • Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out 

  • Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization 

  • Leadership skills 

  • Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software. 

  • Fluent in both oral and written English 

  • Proven ability to deliver training

Key Accountabilities:

Study Management

  • Forecast timelines, budget & FTE resource( if applicable).

  • Take a key leadership role in the management of studies’ timeline, quality, cost.

  • Ensures all activities must be in compliance with SOPs, applicable policies and related standards, and in line with GxP, local laws and regulations. 

  • Monthly track and manage the agreed studies’ timelines, budget and resource, highlight significant variance and take appropriate actions to get studies on track. 

  • Update study information into VCV, Evidence Connect system, Medical Tracking system, and update to global & regional team to ensure up-to-date information captured .

  •  Timely update projects information to the Brand Team. 

  • Review and approve project relevant documents. 

  • Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, studies’ related plans and forms, etc.) 

  • Prepare and lead investigator and monitormeeting

  • Ensure AEs/SAE reporting according to GCP and regulation

  • Plan and lead activities associated with study level Quality Control plan. 

  • Develop & manage contingency risk plans to assuretimely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate

  • Provide operational support to the ESR investigators to ensure the on time delivery of ESR

Compliance with Parexel standards

  • Comply withrequired training curriculum. 

  • Complete timesheets accurately as required

  •  Submit expense reports as required

  • Update CV as required

  • Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.

Skills

  • Advanced level project delivery skills, including experience of study start up, ongoing phase and study close out 

  • Strong interpersonal skills, with the ability to work effectively with others at all levels of the organization 

  • Leadership skills 

  • Excellent process, SOP, GCP and company policy competency, and drug regulations • Good computer skills in Microsoft and other software. 

  • Fluent in both oral and written English 

  • Proven ability to deliver training

 Knowledge and Experience

  • Minimum 2–3-year experience of project management experience. 

  • Prior experience not only as a clinical management staff, but responsible for training/ quality assurance/quality control/ procedural document development 

  • Read, write, and speak fluent English; fluent in host country language required.

Education

  • Bachelor’s or higher degree in Science, Medical or Pharmaceutical Background

立即申请

推荐职位

There is no jobs to view

当前无收藏任何职位。

 

请确保接受网页的cookies,当您再次访问时,即可在此查看您收藏的职位。

 

查看职位

进一步认识精鼎

0
返回页面顶端