for participation in a clinical trial, coordinates & tracks the patient journey, triaging any issues to appropriate stakeholders between apheresis & IP receipt on site.
• Acts as POC for CPC(s), in providing real-time capacity utilization per patient enrollment across the compound and works to resolve any site-level issues that might impact CPC. Escalates any needs for increase to capacity to CSI – CAR-T.
• Participates in GCP and GMP health authority inspections. Have previous experience managing work with Contract Manufacturing Organizations to perform capability assessments and provide technical expertise to influence and bridge gap analysis to meet Clinical Trial requirements.