Dave Bernarducci
Clinical Trial Manager @MCRA, an IQVIA business
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WORK HISTORY
Clinical Trial Manager @MCRA, an IQVIA business
EDUCATION
Rensselaer Polytechnic Institute
Master's degree
Montclair State University
Bachelor's degree, Computer Science
Northeastern University
Graduate Certificate, Regulatory Affairs, Medical Devices
Rensselaer Polytechnic Institute
MS, Computer Science
Montclair State University
Bachelor's degree
SKILLS
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)
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