Katia Hiliopoulos

About Katia Hiliopoulos

Over twenty five years of Clinical Research experience including Clinical Project…

Experience

1. Sr Global Clinical Trial Manager

   ICON plc

   Jan 2020 — Present

   Lead clinical and start up teams during start up, conduct and close out of clinical trials • Ensures integrity of trial, assurance of patient safety in line with local/regional & country regulatory requirements • Provide oversight & create plan for CRA clinical management, recruitment, timelines, budget • Work closely with multidisciplinary, international teams & other internal and external stakeholders (i.e suppliers, vendors and investigational sites) • Work very closely with client & medical team for the clinical development, design, clinical protocols • Conduct data review & analysis • Leads the operational meetings with client, vendor, clinical trial staff • Participates in budget review with clinical project managers & proactively manage study to ensure it\'s being conducted within scope • Act as a liaison between departments (Budget/Finance, Data Management, Statistics, Medical, Safety, etc.) & clinical operations • Identify Risks & create Risk Management & Mitigation Plan • Represents company for the function at internal and external meetings, i.e, with clinical sites or regulatory agencies/inspectors • Contributes to development and/or improvement of departmental standard operations, procedures & are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable Standard Operating Procedures (SOPs) & applicable regulatory requirements • Provides timely status reports for Study Updates/reports to Project Team and/or Departmental team of clinical activities on assigned projects • Facilitate internal audit/correction and prevention action (CAPA involvement); create, write & assist in resolution of CAPA • Manage TMF filing of clinical operations documentation • Mentor junior clinical team managers & assist them in their professional growth • Contributes to Business Development Activities participating in proposals & bid defenses as needed • Liaises with Clinical Operations Managers to resolve resource & performance issues

Skills

• Therapeutic Areas
• Standard Operating Procedure (Sop)
• Clinical Study Design
• Clinical Operations
• Product Forecasting
• Oncology
• Ind
• Strategic Communications
• Hematology
• Ich-Gcp
• Diabetes
• Drug Development
• Global Management
• Marketing Strategy
• Project Management
• Clinical Data Management
• Clinical Trials
• Edc
• Protocol
• Reproductive Health
• Sop
• Global Operations
• Neurology
• Clinical Research
• Vendor Management
• Infectious Diseases
• Diabetes
• Clinical Development
• Regulatory Affairs
• CRO
• Regulatory Requirements
• Regulatory Submissions
• Clinical Trial Management System (Ctms)
• Business Strategy
• Clinical Monitoring
• Respiratory Disease
• Pediatrics
• CRO Management
• Gcp
• Rare Diseases