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Experienced Clinical Research Professional with strong analytical, planning and project management skills. Able to successfully direct cross-functional internal and outsourced teams to meet company, team, and individual performance goals within budget. Excellence in fostering a culture of performance and accountability through open dialogue and exchange of ideas. Strong points: Detail oriented. Ability to understand and simplify complex ideas and issues, with eye towards options for resolution. Ability to multitask and work under pressure. Experienced in international trials. Experienced in mentoring and training. Strong ability to get people to work towards common goals within an environment of trust and accountability.


Current Experience

  • Director - Clinical Operations
    Since August 2013
    Provide leadership, expertise, and guidance in applying clinical trial and management experience, and working with outside vendors to complete assigned clinical trials on time. Provide management updates, and identify and resolve issues requiring escalation and/or intervention. Build and maintain relationships with team members, vendors, and cross-functional groups, as well as investigative sites.

Past Experience

  • Consultant
    January 2013 --- January 2013

  • Principal Quality Risk Analyst
    January 2008 --- January 2013
    Lead for Internal and External team responsible for the development of the Clinical Trial arm of the QRM tool - development of Key Risk Indicators, Base Risk Profiles, and Risk Priority Numbers and Reports. Lead for planning and roll out of the tool globally to the Operations group within Pharma Development allowing teams to assess relative risks of trial sites within a study, program or country. Conducted manual risk assessments where applicable, reviewed SOPS.

  • International Clinical Auditor
    January 2006 --- January 2008
    Conducted due-diligence audits as well as co-audited clinical trial sites, IMP suppliers, CROS, and internal process audits. Prepared audit reports and followed up to ensure Corrective and Preventative Actions Plans put in place.

  • Senior Clinical Study Manager
    January 1988 --- January 2006
    Management of Pegasys trials. Lead project manager for large Phase IIIb/IV study. Oversaw all aspects of project including, but not limited to, CRO selection process, investigator and training meetings, budget, timelines, and performance of Clinical Research Associates (CRAs) and contractors. Reviewed Clinical Study report and listed as author on ASCO abstract. Participated in a unique advisory panel forum by telecasting to HIV physicians at different locales for the HIV team. Worked on development of scope and definition of responsibilities for CSM position. Provided organization for communication between large internal and external groups for project.


LinkedIn Assessment :
GCPCTMSICH-GCPoncologyCROPharmaceutical IndustryClinical monitoringFDA21 CFR Part 11Drug DevelopmentClinical operationsGXPProtocolClinical researchQuality AuditingQuality AssuranceEDCSOPCAPAPharmacovigilanceSOPClinical Trial Management System (CTMS)Good Clinical Practice (GCP)U.S. Food and Drug Administration (FDA)Corrective and Preventive Action (CAPA)

Skills and Expertise

Self Assessment :
GCPclinical OperationsClinical perationsLead studiesLead teamsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredManage contractors


  • BA in Biology from Montclair State University in 0
  • MBA in Pharma from Fairleigh Dickinson University-Metropolitan Campus in 0
  • MT (ASCP) in Medical Technology from Mountainside Hosp Sch of Med Tech in 0


BrightOwl Assessment:
Self Assessment:

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Consultant
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    30 Hours per week
  • International:

Area / Region



Driving License
  • Yes