-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