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Remote Senior Clinical Project Manager (FSP) bei PAREXEL

PAREXEL ·  China-Shanghai-Remote, Vereinigte Staaten Von Amerika · Remote

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When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 monitor meeting 

  • 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 assure timely 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 with required 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 

 

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