Clinical Operations

• 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.

Clinical Project Manager – FSP

Clinical Operations Program Lead