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