Frank Perrone

• Evaluate clinical trial needs to forecast material demand and coordinate packaging, labeling, and release strategies.
• Create Sales and Transfer Orders to move bulk materials for packaging, labeling and release
• Assist in invoice and import documentation for import/export of materials and coordination of material shipments.

• Administrator and Super User for Quality Systems databases (SAP, Trackwise, CRM and integrating databases)
• Generated and analyzed CAPA Metrics
• Completed Quality reviews of Client Complaint CAPAs
• Review, analysis and presentation of Business Unit CAPAs, Deviations and Out-of-specification
• Supported Regulatory and vendor audits
• Supported Regulatory Submissions
• Coordinated product recalls and reconciliations.

• Event, Deviation and CAPA Management Lead for Global Clinical Supplies Demand Planning
• Coordinate investigations with Quality and business unit leads
• Analyze metrics for GCS Demand Planning and present to leadership at monthly meetings.

• IRT Project Manager in multiple therapeutic areas
• ePRO Project Manager in oncology and diabetes (including pediatrics) therapeutic areas
• Associate Project Leader for Randomization and Medication Management in oncology and diabetes therapeutic areas
• Manage project plans, timelines and resources for Clinical Trials
• Primary oversight of Contract development, Study development, Change in scope and invoicing
• Primary point of escalation for RTSM and IRT issues and lead issue mitigation, root cause and CAPA
• Trainer and SME for invoicing, contract management and study budgeting; Trainer and SME for Change Management.

• Portfolio and Project Quality Management
• Generate and analyze Key Performance and Key Quality Indicators
• SME and Lead for Global Quality Issue, CAPA and Deviation management
• Perform Quality Evaluations (product and project risk and health assessments)
• Lead, host and provide Quality SME support for client, regulatory, 3rd party and vendor audits
• Quality Management System and CAPA Program
• Chair of CAPA Review Board and Triage management
• Lead cross functional teams for risk assessment and root cause investigation; Develop CAPA and effectiveness plans with cross-departmental teams
• Present CAPA plan and results with clients and key stakeholders
• Lead development and validation of Quality System databases and its governing procedures
• Qualification of commercial Quality and Validation databases
• Development and validation of Quality and Validation databases
• Author and review site specific procedures and work instructions