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