QC Manager

Study onsite and remote QC activities
• Conduct onsite QC and remote QC as per QC plan requirement.
• Draft related QC Report within timeline and keep the quality observations notified to CPM and QC head.
• Provide suggestions of CAPA and have a follow up if needed.
• Conduct TMF quality checks for studies with documentation as per QC plan.

Training delivery/support
• Lead/support the NEO training
• Deliver /support the routine training/on-demand training for EvGen teams which are to emphasize the procedural key points or the update of global/local procedures.
• Organize learning from QC checking, Audit and inspection for study teams which is aimed at increasing study team capability for study delivery.

Supporting Audits & Inspections Readiness
• Manage and supports activities during the preparation/ongoing/follow up phase of an audit or inspection.
• Support finding management in VQV, CAPA development and implementation.
• Case Sharing of results and training of local project team, if required.

Vendor Management