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.
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.
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.
Skills and Expertise
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