Marisela Vega

About Marisela Vega

I am a clinical project management professional with extensive experience in project…

Experience

1. Clinical Supplies Protocol Manager- Merck Embedded Team

   ICON plc

   Jul 2011 — Present

   Responsible for management of global clinical supply inventory for phase II-IV clinical studies. Monitor global clinical supply inventory for both IVRS and traditional studies Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions. Monitor study specific milestone dates and adjust drug distribution plan accordingly to periodic changes Manage clinical supply complaints received from investigator sites and/or subsidiaries Address and supply replacement requests and assess site supplies demandsMonitor re-evaluation (RED)/expiry dating for clinical study suppliesIdentify and manage clinical supplies reworks resulting from RED/expiry dating issuesInteract with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution. Review and maintain forecast for clinical supplies finished goodsManage clinical supplies finished goods, including sales order review, inventory clean-up and work order close-out tracking. Interpret packaging specification/CSPA to determine clinical supply needs

Skills

• Cgmp
• Clinical Development
• Fda
• Quality Control
• Ctms
• Protocol
• Manufacturing Operations
• Sop
• Gmp
• Clinical Trials
• Quality Assurance
• Pharmaceutical Industry
• Pharmaceuticals
• Drug Supplies Management
• Management
• Change Control
• Capa
• Cross-Functional Team Leadership
• Packaging
• CRO
• Gcp
• Clinical Research
• Standard Operating Procedure (Sop)