Skip to main content
検索

求人検索

Clinical Project Manager (FSP)

China, Remote
求人ID R0000034284 Category Clinical Trials
応募

About this Role

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

応募

JOBS FOR YOU

There is no jobs to view

現在、閲覧できる保存されたポジションはありません。

 

このサイトで保存されたポジションを表示できるようにするために、クッキーの受け入れを有効にしてください。このページにアクセスすると、保存されたポジションを確認することができます。

 

すべてのポジションを見る

More Than A Job

0
トップに戻る