Dave Bernarducci

About Dave Bernarducci

Senior Clinical Trial Manager with extensive experience designing, planning, and executing clinical research studies for both Clinical Research Organizations (CROs) and Sponsors. Skills and experience include:Management of multiple simultaneous studiesStudy design and protocol developmentConsent documentation developmentDevelopment of recruiting materialsIRB Submission/InteractionGood Clinical Practice (GCP)Clinical Trial Agreement (CTA) developmentStudy budget development and negotiationInvestigator/site recruitmentCRF/eCRF designData ManagementInvestigator Agreements/1572 formsClinical Event Committees (CECs)Development of clinical research SOPs Management of Investigator Initiated Trials (IITs)Data Monitoring (remote and on-site)Management/mentoring of CRAs and CTAsCorrective and Preventative Actions (CAPA)Vendor management (CRO, EDC, Biostatistics)Trial Master File (eTMF) setup and maintenanceFDA/Notified Body audits/inspectionsPremarket Approvals (PMA) and 510(k) submissionsInvestigational Device Exemptions (IDE)Clinical Monitoring Plans (CMP) developmentInvestigator financial disclosure reportingStudy Experience Includes:510(k) IDE studiesPMA IDE studies (class implantable)IND studiesNon-significant risk studies (IRB Oversight)Home use studiesReal World Evidence (RWE) studiesInvestigator Initiated Studies (IITs)

Experience

1. Clinical Trial Manager

   MCRA, an IQVIA business

   Sep 2025 — Present

Education

• Rensselaer Polytechnic Institute

  Master's degree

• Montclair State University

  Bachelor's degree, Computer Science

  1979 — 1983

• Northeastern University

  Graduate Certificate, Regulatory Affairs, Medical Devices

  2010 — 2011

• Rensselaer Polytechnic Institute

  MS, Computer Science

  1983 — 1985

• Montclair State University

  Bachelor's degree

Skills

• Clinical Monitoring
• Integration
• Microsoft Office
• Clinical Trials
• Fda
• Cross-Functional Team Leadership
• R&D
• Biomedical Engineering
• Design Control
• Telecommunications
• Analysis
• Program Management
• Embedded Systems
• Quality Assurance
• Ms Project
• Product Management
• Networking
• Management
• Policy
• Auditing
• Process Improvement
• Regulatory Affairs
• Software Documentation
• Biocompatibility
• Requirements Analysis
• Regulatory Submissions
• Leadership
• Professional Services
• Outsourcing
• Training
• Testing
• Contract Negotiation
• Start-Ups
• Medical Devices
• Clinical Research
• Project Management
• Iso 13485