Science & Research Jobs in Shanghai, China (Now Hiring) — 395 open — Page 14

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