PharmaNet/i3 Company
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PharmaNet/i3 Employees
InClin, Inc January 2008 - Present
Self-employed June 1999 - Present
PharmaNet/i3 April 2012 - September 2012
ICON Clinical Research 1999 - 2002
Skills
Clinical Research, Clinical Research..., Clinical Monitoring, CTMS, CRO, GCP, EDC, ICH-GCP, Clinical Trials, Clinical Development, Therapeutic Areas, Regulatory Submissions, Infectious Diseases, Biotechnology, Pharmaceutical Industry, Clinical Data Management
Education
Columbia University in the City of New York 1989 — 1991
Master of Science (M.S.), Adult Psychiatric and Mental Health Nursing
Gwynedd-Mercy College 1987 — 1989
Bachelor of Science (B.S.), Nursing Science
inVentiv Health August 2015 - Present
PRA Health Sciences December 2012 - August 2015
PharmaNet/i3 March 2012 - September 2012
Kforce Clinical Research, Inc. September 2011 - March 2012
PAREXEL May 2011 - September 2011
Takeda Pharmaceuticals June 2008 - January 2011
TAP Pharmaceuticals May 2004 - June 2008
Skills
CTMS, Clinical Monitoring, GCP, EDC, CRO, Clinical Trials, ICH-GCP, Clinical Development, Clinical Data Management, Endocrinology, Clinical Research, Pharmaceutical Industry, Rheumatology, Regulatory Submissions, Infectious Diseases, FDA, Protocol
Education
Concordia University-Wisconsin
BA, Business & Communication
Valley National Bank September 2015 - Present
Bank of America Merrill Lynch March 2014 - September 2015
Lexicom Pharmaceuticals June 2013 - January 2014
Pharmanet/i3 May 2007 - May 2013
C3i February 2005 - May 2007
Skills
Software Documentation, SharePoint, Project Management, Visio, Windows Server, ITIL, Active Directory, Data Management, SAS, Lotus Notes, Oracle Clinical, System Administration, Citrix Metaframe, VMware
Education
Anthem Institute-Parsippany 2003 — 2005
Network and System Administration/Administrator
Novella Clinical, Inc. September 2012 - Present
PharmaNet/i3 October 2011 - September 2012
inVentiv Clinical Solutions March 2008 - October 2011
Skills
CDISC, Biostatistics, Clinical Trials, CRO, SAS programming, Clinical Data Management, Oracle Clinical, SAS, Clinical Development, Oncology, Therapeutic Areas, Pharmaceutical Industry, ANOVA, Regulatory Submissions, Statistical Modeling, R, Protocol, Clinical Research
Education
Georgia State University 2006 — 2008
Master of Science (MS)
University of Alabama at Birmingham 2000 — 2002
Bachelor's degree, Computer and Information Sciences and Support Services
PharmaNet/i3 September 2008 - Present
Education
HEC Montréal 2012 — 2015
Certificat
Independent Consultant April 2014 - Present
PAREXEL August 2013 - April 2014
Cerafor October 2012 - July 2013
PharmaNet/i3 July 2009 - September 2012
PharmaNet March 2006 - June 2009
Pharmanet February 2005 - February 2006
D&O October 2003 - February 2005
Quintiles August 2001 - September 2003
Decision Support August 1999 - August 2001
Skills
Clinical Data Management, Clinical Trials, EDC, CRO, GCP, CTMS, Clinical Development, Oracle Clinical, Clinical Research, CDISC, 21 CFR Part 11, SAS, CRF design, Project Management, Training, Staff Mentor, Data Management, Software Documentation, Sop, Therapeutic Areas, FDA, Protocol, ICH-GCP, Biostatistics, Clinical Study Design, Inform, Medidata, MedDRA, SDTM, Mentoring, Pharmaceutical Industry, SOP
Education
Alagappa University 2007 — 2009
Master of Science, Mathematics
University of Mumbai 1996 — 1999
Bachelor of Science, Statistics
New English School 1979 — 1992
Pharmanet/i3 January 2012 - November 2013
SHR-Group August 2007 - March 2011
Walgreens July 2002 - July 2008
Walgreens Pharmacy June 2002 - July 2006
Skills
CRO, CTMS, Clinical Monitoring, Clinical Research, Clinical Trials, GCP, ICH-GCP, Pharmaceutical Industry, Project Management, Regulatory Affairs, Research, Sop, Therapeutic Areas, EDC, Medical Writing, Infectious Diseases
Education
Beloit College 1998 — 2002
Sociology, Business and Management
Tyco International September 2013 - Present
ReSearch Pharmaceutical Services June 2013 - August 2013
Sandoz 2012 - 2013
PharmaNet/i3 2011 - 2012
Wolters Kluwer Pharma Solutions 2009 - 2011
Wolters Kluwer Pharma Solutions 2007 - 2009
Thomson Scientific 2006 - 2007
Novartis Consumer Health 2003 - 2005
Bristol-Myers Squibb - ConvaTec 2000 - 2002
Bristol-Myers Squibb - International Finance 1998 - 2001
Skills
Process Improvement, Analysis, Business Planning, Budgets, Finance, Management, Strategic Planning, Financial Reporting, Strategic Financial..., Leadership, Project Management, Mergers & Acquisitions, Business Development, Cash Flow, ERP, Financial Planning, Production Planning, Product Management, Project Planning, Consolidation and..., Financial Analysis &..., Business Transformation, Procurement Outsourcing, Productivity Tools, Make vs Buy, Business Case Modelling
Education
Harvard Business School
Finance Excellence Program
New Jersey Institute of Technology 1996 — 1999
MS, Finance
The College of New Jersey 1984 — 1989
BS, Business Administration
inVentiv Health Clinical August 2013 - Present
ReSearch Pharmaceutical Services December 2012 - July 2013
PharmaNet/i3 January 2006 - November 2012
LabCorp / Esoterix 2001 - 2006
Intel / Dialogic Corporation 1994 - 2001
Spencer Gifts 1992 - 1994
Bellcore 1990 - 1992
Skills
Forecasting, Financial Analysis, Budgets, Sop, Financial Reporting, Analysis, Accounts Payable, Pharmaceutical Industry, Clinical Trials, Variance Analysis, Cross-functional Team..., Finance, Data Management, CTMS, Auditing, Oncology, Clinical Research, Process Improvement, Management, CRO, Project Management, SDLC, Clinical Development, Protocol, GCP, Training
Education
East Stroudsburg University of Pennsylvania
BA
PharmaNet/i3 September 2012 - Present
Education
American InterContinental University
Gilead Sciences November 2014 - Present
Amgen February 2013 - November 2014
PharmaNet/i3 April 2012 - February 2013
Kforce Clinical Research, Inc. May 2009 - April 2012
StemCyte January 2006 - March 2009
VA Medical Center June 2005 - June 2006
Skills
Biostatistics, SAS, SAS programming, Biotechnology, Clinical Trials, CRO, Statistical Programming, Survival Analysis, Clinical Study Design, Clinical Data Management, GCP, Clinical Development
Education
University of California, Los Angeles 2004 — 2006
MS, Biostatistics
Caltech 1998 — 2002
BS, Geology
EMC Corporation - Information Intelligence Group June 2013 - Present
Sitrof Technologies, Inc. November 2011 - Present
PharmaNet/i3 July 2011 - August 2012
i3 Ingenix (Division of United Health Group) - representing Arborsys Group October 2010 - April 2011
Pfizer Inc. February 2005 - July 2010
Pfizer Inc. February 2001 - February 2005
Zen and Art of Client Server Computing Inc. April 1998 - January 2001
Skills
Data Migration, Change Management, Resource Management, Documentum, Data Interfaces, Captiva, Unix, IT Project Leadership, 21 CFR Part 11, Pharmaceutical Industry, Database Administration, MBA, Windows, Linux, Disaster Recovery, Experienced Business..., Systems Analysis, Solution Architecture, Content Management, Interfaces, Enterprise Content..., ITIL, IT Strategy, Oracle, Business Intelligence, SDLC, SharePoint, Project Management, Integration, Requirements Analysis, Visio, Software Project..., Requirements Gathering, Testing, Business Analysis, Software Documentation, Vendor Management, IT Management, Virtualization, Analysis, Document Management, Enterprise Architecture, VMware
Education
Centenary College 2005 — 2007
MBA
Point Research Services, LLC September 2013 - Present
PAREXEL October 2012 - March 2013
PharmaNet/i3 March 2007 - October 2012
Wake Forest Baptist Health April 2002 - March 2007
Piedmont Hematology Oncology Associates January 1994 - March 2002
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, GCP, CRO, Clinical Trials, Therapeutic Areas, Trial Management, Oncology, Oracle Clinical, Infectious Diseases, Phase I, Clinical Operations, Clinical Research, Clinical Development, Clinical Research..., Patient Recruitment
Education
Winston-Salem State University 1992 — 1995
Bachelor's degree, Registered Nursing/Registered Nurse
Forsyth Technical Community College 1974 — 1976
Associate of Science (AS), Registered Nursing/Registered Nurse
Chiltern January 2015 - March 2015
GSK July 2014 - September 2014
BASF November 2013 - March 2014
Biogen Idec August 2013 - September 2013
Corning Life Sciences March 2013 - April 2013
PPD August 2012 - September 2012
Eisai Pharmaceuticals October 2011 - May 2012
inVentiv Clinical Solutions April 2011 - June 2011
PharmaNet/i3 October 2010 - March 2011
Abraxis BioScience January 2010 - July 2010
Skills
MSOffice, Mac OS X, Adobe Acrobat, Lotus Notes, Lotus 123, ICH-GCP, Clintrials, Novell, WordPerfect, SAP, Access, Groupwise, Microsoft Word, PowerPoint, Outlook, Outlook Express, Microsoft Excel, Human Resources, Microsoft Office, OS X, Prezi, Training, Clinical Trials, Applicant Tracking..., Customer Service, Administration, Employee Relations, Software Documentation
Education
East Carolina University
Bachelor of Arts (BA), Music Pedagogy
PharmaNet/i3 May 2012 - Present
PharmaNet/i3 May 2006 - May 2012
Quintiles, Inc. March 2000 - May 2006
PPD January 1995 - February 1997
Skills
CRO
Education
Concordia University-Austin 2008 — 2011
Bachelor of Arts, Health Administration
Catalent Pharma Solutions July 2014 - Present
Catalent Pharma Solutions May 2012 - July 2014
PharmaNet/i3 February 2011 - May 2012
Catalent Pharma Solutions August 2007 - February 2011
Baxter Biopharma Solutions June 2006 - June 2007
Baxter Biopharma Solutions March 2004 - June 2006
Skills
Relational Databases, Operational Excellence, Process Excellence, Project Portfolio..., GMP, GCP, Clinical Trial..., Clinical Research, Analytical Chemistry, Highly Analytical, Pricing Strategy, Quality Control, Analytical Skills, CTMS, Clinical Trials, Chromatography, FDA
Education
Indiana University Bloomington 1998 — 2002
BS, Chemistry
Indiana University Bloomington 1998 — 2002
Minor, Business
inVentiv Health Clinical October 2014 - Present
Duke Clinical Research Institute July 2012 - October 2014
PharmaNet/i3 August 2011 - July 2012
PharmaNet Development Group, Inc. August 2010 - August 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Cato Research September 2006 - March 2009
Island Training Solutions June 2005 - September 2006
Skills
Clinical Trials, Strategy, CRM, Proposal Writing, Analysis, Program Management, Management, Project Management, Business Development, Budgets, CRO, Market Research, Clinical Development, Pharmaceutical Industry, Contract Negotiation, GCP, EDC, Clinical Data Management, Oncology, Biotechnology
Education
Wake Forest University 2001 — 2005
BA, Communication, Statistical Math
Campbell University
Master of Business Administration (MBA)
UPMC Cancer Center April 2013 - Present
Precision Therapeutics February 2011 - April 2013
PharmaNet/i3 April 2012 - September 2012
Kforce Clinical Research, Inc. February 2012 - April 2012
Precision Therapeutics August 2010 - February 2011
Kforce Clinical Research, Inc. September 2007 - August 2010
Bristol-Myers Squibb August 2005 - August 2007
UPMC January 1996 - August 2005
Skills
Clinical Trials, Data Management, Oncology, Clinical Development, Process Improvement, CRO, Clinical Research, Sop, EDC, Protocol, Clinical Monitoring, Pharmaceutical Industry, FDA, Biotechnology, ICH-GCP, GCP, Data Entry, Medical Devices, CTMS
Education
University of Pittsburgh 2002 — 2004
MSN, Clinical Nurse Specialist
Clarion University of Pennsylvania 1991 — 1993
BSN, Nursing
Washinton Hospital School of Nursing 1982 — 1984
Diploma, Nursing
PharmaNet/i3 August 2009 - Present
Bristol-Myers Squibb November 2008 - August 2009
Smith Hanley Consulting 2008 - 2009
UMDNJ November 2005 - November 2008
UMDNJ January 2004 - November 2005
Skills
SAS, R, GCP, Grant Writing, Clinical Research, Clinical Trials, Bioinformatics, Biostatistics, Programming, French, Genomics, Genotyping, SNP genotyping, Oncology, Autoimmune Diseases, Diabetes, Neuroscience, Database Administration, Statistics, Experimental Design, Microarray, Proteomics
Education
New Jersey Institute of Technology 2000 — 2004
PhD, Computational Biology
Rutgers, The State University of New Jersey-Newark 2000 — 2004
Doctor of Philosophy (Ph.D.), Compuational Biology
North Carolina State University 1997 — 1999
Ms., Plant Pathology
Ecole nationale supérieure des Industries agricoles et alimentaires 1994 — 1997
Engineering, Agronomy and Food Industries
Johnson & Johnson (Integrated Resources) January 2015 - Present
Celgene (Aerotek) February 2013 - December 2014
Merck (ClinForce) March 2011 - December 2012
PharmaNet/i3 October 2010 - December 2010
University of Massachusetts Lowell September 2009 - May 2010
University of Massachusetts Lowell September 2008 - December 2009
New England Biolabs June 2008 - December 2008
University of Massachusetts Lowell January 2008 - May 2008
Skills
Clinical Trials, Molecular Biology, Biotechnology, Clinical Research, Pharmaceutical Industry, Research, Life Sciences, SOP, Regulatory Affairs, FDA, Cell Culture, Oncology, GCP
Education
Goldey-Beacom College 2012 — 2014
MBA, Healthcare Management
University of Massachusetts at Lowell 2007 — 2010
MS, Biomedical/biotech Engineering
Clinipace WorldWide formerly Paragon Biomedical May 2012 - Present
PharmaNet/i3 September 2005 - May 2012
Pfizer August 1999 - September 2005
Pfizer October 1994 - August 1999
Skills
Clinical Trials, Clinical Development, CRO, Medical Writing, CTMS, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, Pharmacovigilance, GCP, Protocol, Biotechnology, FDA, Infectious Diseases, Sop, SOP
Education
Brown University 1995 — 2000
MA, Biology
Syracuse University 1988 — 1992
BS, Biology, research
PharmaNet/i3 March 2012 - Present
Kforce May 2005 - March 2012
Ortho-Clinical Diagnostics 2004 - 2005
PAREXEL 2003 - 2004
Wyeth Vaccines 1999 - 2003
Academic Services Consortium of the University of Rochester 1997 - 1999
Fisons Pharmaceuticals 1988 - 1996
Skills
Therapeutic area...
Education
Alfred University
Bachelor's degree, Biology/Medical Technology
Rochester Institute of Technology
Master of Science (MS), Clinical Chemistry
INC Research August 2015 - Present
ForeSee January 2013 - August 2015
V2Soft March 2012 - October 2012
PharmaNet/i3 September 2002 - October 2011
Saint Joseph Mercy Health System June 1992 - September 2002
Skills
Proposal Writing, Strategy, Business Development, Editing, Leadership, Clinical Trials, Management, Data Management, Marketing Communications, Project Management, CRO, Strategic Communications, GCP, Clinical Development, Market Research, CRM, Marketing, Writing, Managerial, Team Building, CTMS, Strategic Planning, Employee Training, SharePoint, Marketing Strategy, Proposal Management, Time Management, Technical Writing, Cross-functional Team..., Salesforce.com, Training & Development, Library Management, Product Marketing, Qvidian RFP Database...
Education
Eastern Michigan University 1997 — 2002
Bachelor of Science, English, Technical Communication
Washtenaw Community College 1989 — 1992
Associate Degree, Radiography
inVentiv Health Clinical January 2014 - Present
PharmaNet/i3 September 2009 - August 2013
NSHMBA August 2009 - February 2012
i3 Statprobe > i3 Global April 2007 - August 2009
PPD 2006 - 2007
PPD February 2005 - 2006
Calsonic Kansei Mexicana August 2001 - August 2002
Skills
Inform, EDC, Oracle Clinical, Clinical Data Management, CRF design, Data Management, CRO, Data Validation, Therapeutic Areas, Medidata, Oncology, Clinical Trials
Education
University of Phoenix 2007 — 2009
MBA
Universidad Autónoma de San Luis Potosí 1996 — 2000
BsChE, Polymers
Austin Community College
BachUAA
Hayashi Telempu North America September 2013 - Present
PharmaNet/i3 June 2011 - January 2013
i3 (Division of UnitedHealth Group) 2005 - June 2011
STATPROBE 1999 - 2005
Underworld Comics & Games 1995 - 1999
Skills
Visual Basic, Microsoft Office, Windows, Customer Service, Security, Active Directory, Windows Server, Windows 7, System Administration, VMware, Disaster Recovery, Software Documentation, Computer Hardware, Virtualization, ITIL, Citrix Metaframe, Help Desk Support, SharePoint, Networking, Windows XP, Citrix, Technical Support, System Deployment, VMware ESX, Servers, IT Operations, Microsoft Exchange, VPN, Group Policy, Troubleshooting, Visio, Hardware, Operating Systems, Data Center, IT Management
Education
Washtenaw Community College 1996 — 1997
AS, Microcomputer Business Technology, General Studies
University of Oklahoma 1992 — 1993
Theater Arts
Hendrix College 1991 — 1992
Fine Art, Theater Arts
Apple January 2015 - Present
Apple June 2013 - December 2014
PharmaNet/i3 October 2007 - July 2012
Almac Group 2005 - 2007
Skills
Web Design, Photography, Video Production, EDC, Data Management, CTMS, Quality Assurance, Clinical Data Management, Software Documentation, Clinical Development, Sop, Validation, CRO, 21 CFR Part 11
Education
Art Institute of Philadelphia 2000 — 2002
Multimedia Design
Bucks County Community College 1993 — 1996
Music and Film
inVentiv Health Clinical September 2012 - Present
PharmaNet/i3 April 2009 - August 2012
PharmaNet October 2005 - March 2009
GSK March 1999 - October 2005
Skills
EDC, Clinical Data Management, CDISC, CRF design, CTMS, Oracle Clinical, Data Management, CRO, ICH-GCP, 21 CFR Part 11, GCP, Inform, Clinical Trials, Clinical Development, Medidata, ePRO, Oncology, FDA, e-PRO
Education
East Stroudsburg University of Pennsylvania 1995 — 1998
BS, Biology
ICON plc October 2014 - Present
ICON plc June 2012 - October 2014
PharmaNet/i3 June 2010 - June 2012
Quintiles June 2010 - June 2010
Quintiles Transnational March 2008 - September 2008
PPD October 2007 - March 2008
Catalent Pharma Solutions Formely Cardinal Health August 2005 - February 2007
Skills
Microsoft Office, Analysis, Project Management, Clinical Trials, Software Documentation, FDA, Budgets, CRO, Management, Sop, Microsoft Excel, Project Planning, CTMS, Business Development, PowerPoint, GCP, Program Management, Training, Research, Clinical Research, Healthcare, Strategic Planning, Pharmaceutical Industry, Biotechnology, Public Speaking, Data Analysis, Customer Service, Therapeutic Areas, Microsoft Word, Testing, Recruiting, Life Sciences, Process Improvement, ICH-GCP, Clinical Development, EDC, Proposal Writing, Database Administration
Education
Campbell University 2002 — 2005
Bachelors of Science, Pharmacetucial Science
Pfizer November 2012 - Present
PharmaNet/i3 April 2012 - November 2012
KForce/Pfizer 2011 - June 2012
Paragon Biomedical April 2004 - December 2010
American Association for the Advancement of Science November 2003 - March 2004
Georgia Health Policy Center May 2003 - November 2003
Georgia Centers for Advanced Telecommunications Technology, Office of Technology Policy and Program September 2002 - June 2003
Centers for Disease Control and Prevention September 2001 - July 2002
PAREXEL August 1999 - September 2001
Massachusetts General Hospital July 1997 - July 1999
Skills
Clinical Trials, Clinical Research, GCP, CTMS, Oncology, Infectious Diseases, ICH-GCP, Protocol, Biotechnology, Clinical Monitoring, FDA, Clinical Development, EDC, CRO
Education
The University of Georgia 2005 — 2005
Certificate in Regulatory Affairs, Regulatory Affairs
Georgia Institute of Technology 2001 — 2003
Master of Science, Public Policy
Wheaton College (MA) 1993 — 1997
BA, Psychology and Sociology
ICON plc August 2014 - Present
ICON plc September 2013 - August 2014
ICON plc January 2013 - August 2013
PharmaNet/i3 January 2010 - December 2012
i3 research January 2007 - December 2009
Sandoz February 2000 - November 2005
PLIVA July 1998 - February 2000
Skills
ICH-GCP, Clinical Trials, Protocol, Clinical Monitoring, CRO, GCP, Oncology, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, Rheumatology, Endocrinology, Diabetes, Regulatory Affairs, Infectious Diseases, Neurology
Education
Pharmaceutical faculty of Comenius University Bratislava, Slovakia 1989 — 1994
Master's degree
inVentiv Health Clinical January 2015 - Present
PharmaNet/i3 November 2011 - Present
inVentiv Health Clinical 2011 - 2013
i3 Research February 2011 - January 2012
inVentiv Clinical Solutions September 2009 - January 2011
Eli Lilly and Company March 2008 - September 2009
Barker Law Offices August 2005 - February 2008
Skills
Clinical Trials, Clinical Research, GCP, CRO, CTMS, Clinical Development, Oncology, EDC, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, Regulatory Submissions, Sop, Regulatory Affairs, Clinical Data Management, Medical Writing, Pharmacovigilance
Education
Indiana University-Purdue University at Indianapolis 2001 — 2004
BS, Psychology
Daemen College 1999 — 2001
PT
Covance October 2013 - Present
PharmaNet/i3 2012 - September 2013
Covance Laboratories January 2011 - September 2012
Merck May 2010 - January 2011
Millipore July 2007 - May 2010
Charles River Laboratories January 2001 - July 2007
Charles River Laboratories September 1999 - December 2000
Skills
Lean Six Sigma Green..., Root Cause Analysis, Quality Documentation..., Microsoft Office, Project Manager, Management, Process Improvement, Business Process..., Six Sigma, Laboratory, Drug Discovery, HPLC, Assay Development, GLP, Analytical Chemistry, Cell Biology, Pharmacokinetics, Documentations, Regulatory Submissions, Pharmaceutical Industry, Mass Spectrometry, Drug Development, Biotechnology, Chemistry, Protocol, Product Development, Biopharmaceuticals, LC-MS, Cross-functional Team..., Testing, Clinical Development, Bioanalysis, Sop, Biomarkers, CRO, Clinical Research, Project Management, V&V, ELISA, Validation, Immunology, FDA, Protein Chemistry, ADME, Quality Assurance, Pharmaceutics, GMP, Lifesciences, Regulatory Affairs, Clinical Trials
Education
Lindenwood University 2009 — 2010
MBA, Strategic Managment
Concordia University 2004 — 2006
MSc, Chemistry
Concordia University 1991 — 1996
BSc, Specialization Biochemistry
inVentiv Health Clinical November 2013 - Present
PharmaNet/i3 April 2011 - Present
Talecris Biotherapeutics July 2006 - April 2011
PPD January 2003 - September 2005
Cato Research 1999 - 2003
Skills
CRO, Regulatory Affairs, FDA, Clinical Research, GCP, Project Management, Quality Assurance, Clinical Trials, Biotechnology, Pharmaceutical Industry, Sop, GMP, Software Documentation, 21 CFR Part 11, Validation, Clinical Development, GLP
Education
Campbell University 1999 — 2002
Master of Science, Clinical Reseach, School of Pharmancy
North Carolina State University 1994 — 1998
BS, Food Science
Nanotherapeutics, Inc. May 2013 - Present
Clinical Pharmacology Research February 2012 - May 2013
PharmaNet/i3 August 2011 - January 2012
PharmaNet/i3 January 2008 - January 2012
PharmaNet/i3 January 2005 - January 2012
Clinical Pharmacology Research January 1998 - December 2004
Cato Research, Ltd. June 1990 - December 1997
Glaxo Research Laboratories June 1986 - July 1989
University of Kentucky College of Medicine July 1972 - June 1986
Skills
CRO, Clinical Research, Clinical Pharmacology, Pharmacology, Internal Medicine, Cardiovascular Disease, Drug Development, Biotechnology, Cardiology, Clinical Trials, Informatics, Protocol, GCP, Clinical Development, Medicine, CTMS, Pharmaceutical Industry, Toxicology, Endocrinology, Oncology, Therapeutic Areas, IND
Education
Vanderbilt University School of Medicine 1967 — 1972
Internal Medicine, Clinical Pharmacology, Cardiology
Virginia Commonwealth University School of Medicine 1963 — 1967
M.D., Medicine
Hampden-Sydney College 1959 — 1963
B.S., Pre-medical studies
PharmaNet/i3 April 2012 - Present
Eli Lilly January 2007 - September 2010
MedFocus LLC 2004 - 2007
TAP Pharmaceuticals June 2006 - December 2006
Boston Scientific January 2006 - June 2006
Eli Lilly July 2004 - December 2005
LSU August 2001 - December 2003
Skills
SAS, Data Management, Clinical Development, Clinical Data Management, Statistics, CRO, Pharmaceutical Industry, Data Analysis, GCP, Clinical Trials, Medical Devices, Biotechnology, Clinical Research, SAS programming, EDC, Oncology, Validation
Education
Louisiana State University 2001 — 2003
Master's Degree, Applied Statistics
Louisiana State University 1998 — 2001
B.S., Marketing
PPD August 2015 - Present
ACI Clin April 2014 - July 2015
Theorem Clinical Research March 2013 - April 2014
PharmaNet/i3 October 2010 - March 2013
i3 October 2009 - September 2010
i3 March 2007 - September 2009
i3 March 2005 - March 2007
i3 August 2001 - March 2005
Skills
Clinical Data Management, Clinical Trials, CDISC, CRO, SAS, Data Management, Pharmaceutical Industry, SAS programming, Biostatistics, Oracle Clinical, Oncology, 21 CFR Part 11, Clinical Research, GCP, FDA, EDC, Statistical Programming, Strategic Leadership, Clinical Development, ICH-GCP, Validation, Regulatory Submissions, Pharmacovigilance, CTMS, Protocol, SAS Programming, Management
Education
Kaplan University
MBA, Management
Andhra University 1988 — 1992
BE, Electronics and Communications
Dr. B.R.Ambedkar college, Hyderabad 1985 — 1987
Mathematics
Command Communication, PLLC January 2013 - Present
Toastmasters International July 2015 - Present
Toastmasters International April 2012 - Present
Toastmasters International July 2014 - June 2015
Toastmasters International July 2013 - June 2014
St. Michael’s Episcopal Church September 2001 - May 2014
Independent Contractor October 2010 - January 2013
Casa Esperanza Montessori Charter School February 2011 - June 2012
PharmaNet/i3 March 2009 - February 2010
Supplemental Health Care July 2009 - October 2009
Skills
Accent Modification, Speech Coaching, Speech Therapy, Public Speaking, Voice & Accent, Singing, Accent Reduction, Speech, Articulation, Training, Coaching, Teaching, Leadership Development, Leadership, Team Building, Mentoring, Event Planning, Organizational..., Public Relations, Consulting
Education
East Carolina University 1993 — 1996
MS, Speech-Language Pathology
Rhodes College 1987 — 1991
BA, Vocal Music Performance
The Film Yap March 2009 - Present
Self January 2001 - Present
ITT Technical Institute March 2012 - February 2013
PharmaNet/i3 May 2005 - March 2012
INtake Magazine/Indianapolis Star/indy.com April 2004 - November 2008
INtake/Indianapolis Star 2004 - November 2008
Trap & Field Magazine June 2001 - May 2005
IUPUI Sagamore September 2003 - May 2004
Skills
Writing, Editing, Interviewing, Freelance Writing, Research, Microsoft Office, Formatting, Blogging, Proofreading, Social Networking, Magazines, Publications, SEO, Corporate Communications, Creative Writing, Press Releases, Public Relations, Copy Editing, Technical Writing, Internal Communications, Social Media, Copywriting, Journalism, Strategic Communications, Editorial, Marketing Communications, Facebook, Content Development, AP Style, Content Management, Web Content, PowerPoint, Newspapers, Storytelling, Newsletters, Social Media Marketing, Marketing
Education
Indiana University-Purdue University at Indianapolis 1997 — 2004
English, Journalism
Indiana University Bloomington 1995 — 1996
Innovative Research Associates May 2014 - Present
Novella Clinical, A Quintiles Company November 2013 - May 2014
RAM Consulting Group, LLC July 2013 - October 2013
Integrium June 2012 - June 2013
PharmaNet/i3 June 2009 - June 2012
Advanced Research Corporation September 2003 - December 2008
Purdue Pharma LP 1997 - 2001
Skills
Clinical Research, Project Management, Clinical Monitoring, Staff Management, Budget Process, RFP Generation, Medical Writing, Quality Assurance, Contract Negotiation, Clinical Trials, CTMS, EDC, ICH-GCP, Therapeutic Areas, GCP, Clinical Operations, Protocol, Regulatory Submissions, Clinical Data Management, Clinical Development, Oracle Clinical, Oncology, Drug Development
Education
Long Island University
Master of Arts (M.A.), Psychology
State University of New York College at Buffalo
Bachelor of Arts (B.A.), Psychology
Johnson & Johnson January 2015 - Present
Johnson & Johnson January 2014 - January 2015
PharmaNet/i3 April 2012 - January 2014
PharmaNet/i3 April 2011 - March 2012
PharmaNet Development Group, Inc. June 2010 - March 2011
PharmaNet Development Group, Inc. December 2009 - May 2010
PharmaNet Development Group, Inc. December 2007 - December 2009
Nordstrom February 1996 - December 2007
Community National Bank 1988 - 1990
Skills
Recruiting, HRIS, Human Resources, Business Process..., Management, Employee Relations, Analysis, Performance Management, Leadership, Training, Customer Service, CRM, Personnel Management, Employee Benefits, Onboarding, New Hire Orientations, Software Documentation, Project Management, Time Management, Employment Law, Talent Management, Administration, PeopleSoft, UltiPro, OrgPlus, SuccessFactors
Education
Baruch College, City University of New York (CUNY)
BBA, Finance and Investments, Management
Kingsborough Community College
AAS, Business Administration
Accelovance, Inc. July 2015 - Present
ResearchPoint Global January 2012 - July 2015
inVentiv Clinical Solutions October 2010 - December 2011
PharmaNet/i3 October 2010 - December 2011
Omnicare Clinical Research August 2006 - October 2010
Omnicare Clinical Research August 2006 - October 2010
ICON Clinical Research November 2003 - July 2006
T. Rowe Price November 1999 - October 2003
Skills
CRO, Pharmaceutical Industry, Clinical Trials, CTMS, Biotechnology, Clinical Research, RFP, Clinical Development, Proposal Writing, Cross-functional Team..., Business Development, Lifesciences
Education
Anne Arundel Community College
AA
PharmaNet/i3 August 2010 - November 2012
Eli Lilly and Company October 2008 - July 2010
Eli Lilly and Company December 2005 - September 2008
PPD September 2004 - October 2005
Eli Lilly and Company July 2003 - September 2004
Hancock Regional Hospital June 1980 - May 2000
Skills
Clinical Data Management, Oncology, Therapeutic Areas, Endocrinology, Oracle Clinical, EDC, CRO, GCP, Clinical Trials, CTMS, CRF design, CDISC, ICH-GCP, 21 CFR Part 11, Inform, Clinical Development, Data Management, MedDRA, Data Validation, Protocol, SDTM, Clinical Monitoring, Pharmaceutical Industry, Clinical Research, FDA, SOP, Validation, Clinical Data
Education
Indiana University-Purdue University at Indianapolis 1999 — 2003
BS, Health Information Administration
Indiana State University 1977 — 1980
AS, Medical Laboratory Technology
PPD April 2015 - Present
Worldwide Clinical Trials January 2015 - April 2015
inVentiv Health Clinical August 2014 - January 2015
PharmaNet/i3 June 2012 - August 2014
INC Research July 2011 - June 2012
Kendle International July 2008 - July 2011
Eli Lilly February 2005 - June 2008
Eli Lilly September 2000 - February 2005
New Life Associates May 1997 - March 2000
Hendricks Community Hospital 1994 - 1997
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, GCP, Data Management, Clinical Research, EDC, CTMS, ICH-GCP
Education
Ball State University 2010 — 2012
General Studies
inVentiv Health December 2014 - Present
inVentiv Health October 2013 - December 2014
ReSearch Pharmaceutical Services October 2012 - October 2013
MedImmune July 2010 - September 2012
PharmaNet/i3 March 2009 - July 2010
PPD October 2004 - March 2009
Skills
Clinical Site Management, Clinical Site Monitoring, Data Entry, Oracle Clinical, Site Development, EDC, Oncology, Therapeutic Areas, CRO, CTMS, ICH-GCP, iVantage, IVRS, Biotechnology, GCP, Clinical Trials, Clinical Research, IVR, Rheumatology, Clinical Development, Clinical Data Management, Regulatory Submissions, Clinical Study Design, Clinical Operations
Education
Loyola College in Maryland 2000 — 2003
Master of Science (M.S.), Clinical Psychology
McDaniel College 1996 — 2000
Bachelor of Arts (B.A.), Psychology
inVentiv Health Clinical November 2012 - November 2013
PharmaNet/i3 October 2010 - November 2012
PPD February 2006 - October 2010
Skills
Regulatory Affairs, Clinical Research, Pharmaceutical Industry, Trial Management, Regulatory Submissions, CTMS, Pharmacovigilance, Clinical Development, Clinical Monitoring, Therapeutic Areas, EDC, Oncology, Clinical Data Management, IND, Medical Writing, Drug Development, CRO, Clinical Trials
Education
Durham Technical Community College 2011 — 2013
Clinical Trials Research Associate
Chiltern September 2012 - Present
Ockham March 2011 - May 2012
PharmaNet/i3 July 2010 - March 2011
PPD December 2006 - July 2009
Digital Infuzion July 2006 - December 2006
INC Research March 2005 - September 2005
PRA International November 2004 - March 2005
PAREXEL February 2001 - November 2004
Skills
Clinical Data Management, CDISC, CRF design, Review, Clinical Research, Clinical Trials, Data Management, Clinical, SOP, EDC, CRO, Data Entry, Oracle Clinical, SDTM, ICH-GCP, Phase 1, Infectious Diseases, Sop, Clinical Monitoring, Oncology, Protocol, GCP, Clinical Development, CTMS, Validation, Medidata, Inform, SAS, Data Validation
Education
Walden University 2014 — 2014
Graduate Certificate, Applied Project Management
Walden University 2011 — 2013
Graduate Certificate, Clinical Research Administration
American InterContinental University 2009 — 2010
MBA, Healthcare Management
Elizabeth City State University 1993 — 1997
BS, Biology Pre-Med
Howard University August 2014 - Present
Howard University August 2013 - Present
RTI International November 2012 - August 2013
Community College of Baltimore County November 2012 - July 2013
PharmaNet/i3 July 2012 - January 2013
SCO Family of Services July 2007 - March 2012
Weil Cornell Medical College August 2011 - January 2012
NYC Parks and Recreation June 2011 - August 2011
National School Climate Center (NSCC), formerly Center for Social and Emotional Education January 2011 - August 2011
Office of Campus Housing August 2007 - June 2008
Skills
Data Analysis, Mentoring, Research, Administration, Qualitative Research, data collection, Research Methods, Quantitative Analysis, Qualitatative, Independent Research, SPSS, Stata, SAS, Quantitative Analytics, Access, Teaching, Training
Education
Howard University 2013 — 2017
Doctor of Philosophy (PhD), Sociology and Anthropology
Queens College 2010 — 2012
Masters, Applied Social Research
State University of New York College at Old Westbury 2008 — 2010
Bachelor of Arts, Sociology
Farmingdale State College 2006 — 2008
Associates of Arts Degree, Liberal Arts and Sciences
PharmaNet/i3 November 2007 - Present
MDS Pharma Services May 1997 - October 2007
Skills
CRO, Pharmaceutical Industry, GLP, Sop, Clinical Trials
Education
Dawson College
Astellas Pharma February 2013 - January 2014
Quintiles March 2012 - June 2012
PharmaNet/i3 December 2008 - March 2012
Eli Lilly and Company May 1995 - October 2008
Skills
Data Management, Clinical, Training & Development, Technical Training, Travel, Employee Training, Clinical Data Management, GCP, Clinical Research, EDC, CRO, Therapeutic Areas, Clinical Trials, Clinical Development
Education
Indiana Business College 1989 — 1991
Associates Degree, Business
UBC - An Express Scripts Company February 2014 - Present
Premier Research January 2013 - June 2014
Premier Research September 2012 - December 2012
ReSearch Pharmaceutical Services April 2011 - September 2012
ReSearch Pharmaceutical Services March 2010 - April 2011
PharmaNet Development Group, Inc. December 2009 - March 2010
PharmaNet/i3 October 2007 - March 2010
Devon Family Practice, LLC January 2004 - March 2007
Skills
Clinical Research, Regulatory Affairs, Pharmaceuticals, GCP, Clinical Trials, FDA, ICH-GCP, Regulatory Submissions, PowerPoint, Word, Excel, Customer Service, Marketing, Self-starter, Business, Entrepreneurship, Training, Sop, Pharmaceutical Industry, Software Documentation
Education
Saint Joseph's University 2010 — 2014
Bachelor, Professional and Liberal Studies, Minor in Health Administration, Junior
Community College of Philadelphia 2007 — 2009
Paralegal Studies, Legal Studies
Cittone Institute 2007 — 2008
Certificate of Pharmacy Technician, Pharmacy
inVentiv Health Clinical April 2014 - Present
PharmaNet/i3 April 2012 - January 2013
Kforce Clinical Research June 2007 - July 2012
BLC Consultants at Pfizer July 2003 - June 2007
Kelly Services May 2002 - July 2003
Skills
Microsoft Excel, Outlook, Protocol, Workshop Facilitation, PowerPoint, Microsoft Word, Business Operations, Strategy, Materials Management, Adobe Director, Process Engineering, Eclipse, Clinical Trials, Clinical Research, Quality Assurance, Clinical Monitoring, GCP, Clinical Operations, ICH-GCP, Data Management, CTMS, Clinical Development, EDC
Education
Chestnut Hill College 1980 — 1983
BA, American Studies
Chestnut Hill College 1979 — 1982
B.A., American Studies
inVentiv Health Clinical October 2010 - Present
PharmaNet/i3 July 2007 - Present
PAREXEL (Manpower Contractor) May 2006 - April 2007
Hudson Global Resources October 2003 - September 2005
Cato Research Ltd. 1997 - 2003
Lord & Taylor 1987 - 1992
Skills
Recruiting, Applicant Tracking..., Talent Acquisition, Clinical Research, Internet Recruiting, Technical Recruiting, Employee Relations, Human Resources, College Recruiting, Onboarding, Sourcing, Contract Recruitment, Executive Search, Benefits Negotiation, Pharmaceutical Industry, Talent Management, Clinical Trials, HRIS, Screening Resumes, Temporary Placement, Staffing Services, New Hire Orientations, Hiring, Interviews, Screening, Management, Taleo, Temporary Staffing, Time Management, Workforce Planning, Deferred Compensation
Education
City University of New York-Herbert H. Lehman College
BA, Sociology
inVentiv Health Clinical May 2013 - Present
PharmaNet/i3 July 2007 - May 2013
PharmaNet July 2007 - October 2010
Skills
Recruiting, Sourcing, Human Resources, Interviews, Hiring, Management, Strategy, Negotiation, Applicant Tracking..., Talent Acquisition, Onboarding, Talent Management, Employee Relations, Technical Recruiting, HRIS
Education
City University of New York-Herbert H. Lehman College
B.A., Sociology
PharmaNet/i3 May 2010 - Present
Eli Lilly and Company August 2000 - May 2010
Anthem May 1998 - August 2000
Skills
SAS, SDTM, Clinical Trials, CDISC, Computer System..., CRO, Pharmaceutical Industry, Validation, SAS programming, CTMS, GCP, 21 CFR Part 11, SDLC, Data Warehousing, Clinical Development, Clinical Research, Biostatistics, Business Analysis, Requirements Analysis, Statistical Programming, Change Control, SQL, Inform, ICH-GCP, Oncology, Data Analysis
Education
Indiana University - Kelley School of Business 1993 — 1998
BS, Computer Information Systems
Advaxis, Inc. January 2013 - Present
Bracco Diagnostics February 2009 - January 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2003 - 2008
PharmaNet/i3 1999 - 2002
Somerset County Prosecutor's Office 1996 - 1999
United States Marine Corps 1988 - 1992
Skills
GMP, CRO, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, Infectious Diseases, Cancer, Clinical Development, Oncology, Technology Transfer, Clinical Research, Medical Devices, Biopharmaceuticals, Protein Chemistry, FDA, Pharmaceutics, Regulatory Submissions, Lifesciences, Leadership, Clinical Trials, Commercialization, Corporate Law, Drug Development, GCP, Life Sciences, Regulatory Requirements
Education
The Dickinson School of Law 1992 — 1995
Doctor of Law (JD)
U.S.M.C. Officer's Candidate School 1988 — 1988
Officer's Commission from President, Military and Strategic Leadership
Boston University 1984 — 1987
Bachelor of Arts (B.A.), English Language and Literature, General
Bucknell University 1983 — 1984
Advanced Clinical February 2012 - Present
PharmaNet/i3 December 2006 - February 2012
Aerotek 2006 - 2006
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, EDC, CRO
Education
Illinois State University
BS, Food, Nutrition and Dietetics
Pfizer September 2013 - Present
Pfizer June 2012 - August 2013
Pfizer December 2010 - May 2012
inVentiv Health Clinical February 2006 - December 2010
COLLAGENEX PHARMACEUTICALS, INC September 2004 - February 2006
PharmaNet/i3 February 2004 - September 2004
COLLAGENEX PHARMACEUTICALS, INC May 2002 - January 2004
COLLAGENEX PHARMACEUTICALS, INC January 2000 - May 2002
LRP Publications September 1999 - December 1999
Skills
Study Management, Subject Enrollment, Monitoring, Quality Assurance, Data Management, Clinical Trial..., Regulatory Requirements, Budget Oversight, Quality Oversight, CRO Oversight, Vendor Management, Training & Development, Alzheimer's disease, Dermatology, Women's Health, Dentistry, Timeline Management, CRA Oversight, Protocol Training, Investigator Meetings, Clinical Trial Audits, Issues Management, Issues Resolution, Inspection Readiness, FDA Inspections, Site Initiations, Site Selection, Regulatory Documents, Investigator..., CTMS, Study Monitoring, CRO, Clinical Monitoring, Project Start-up, Subject Recruitment, FDA, Neuroscience, Osteoporosis, Compliance, Clinical Research, Project Management, GCP, ICH-GCP, Clinical Trials, Management, Protocol, Budgets, Pharmaceutical Industry, Sop, Clinical Data Management
Education
Holy Family University 1997 — 1999
B.A., Psychology, Research, Business, 3.9
West Chester University of Pennsylvania 1997 — 1997
Marketing/Managememt
University of Scranton 1995 — 1996
Biology, Pre-med
Villa Joseph Marie High School 1991 — 1995
High School Diploma, College Prep
St. Ignatius of Antioch School 1984 — 1991
Elementary School
Puma Biotechnology August 2015 - Present
Puma Biotechnology August 2012 - Present
PharmaNet/i3 October 2011 - August 2012
Abraxis BioScience May 2009 - November 2010
Exelixis April 2007 - January 2009
Bristol-Myers Squibb September 2002 - March 2007
Curagen Corporation 1998 - 2002
Case Western Reserve University 1987 - 1998
Skills
Medical Writing, Writing, Molecular Biology, Oncology, Biotechnology, Cell Culture, Clinical Development, Biochemistry, ELISA, Monoclonal Antibodies, Antibodies, Immunology, Infectious Diseases, Clinical Trials, Drug Discovery, Lifesciences, Pharmacology, Drug Development, GCP, IND, Pharmaceutical Industry, Regulatory Submissions, Clinical Research, Regulatory Affairs
Education
Imperial College London 1979 — 1983
PhD, Molecular Neurobiology
The University of Salford 1976 — 1979
B.Sc., Biochemistry
inVentiv Health Clinical October 2012 - Present
Trinity Health November 2011 - October 2012
PharmaNet/i3 September 2007 - October 2011
Pfizer Global R&D November 2003 - June 2007
St. John's Providence Hospital April 1985 - November 2003
McLaren Hospital June 1982 - April 1985
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, Oncology, Sop, GLP, GCP, CRO, Pharmacovigilance, Healthcare, Clinical Development, Hematology, Drug Safety, Validation, FDA, Regulatory Submissions, CTMS, EDC, Clinical Pharmacology, ICH-GCP, Clinical Data Management, Diabetes, Neurology, Regulatory Affairs, Drug Development, Lifesciences, Biotechnology, Medical Writing, SOP
Education
Eastern Michigan University 2007 — 2008
Clinical Research Administration
Michigan State University 1978 — 1982
B.S., Medical Technology
MMS Holdings Inc. February 2013 - Present
Pharmanet/i3 April 2004 - January 2013
i3 Statprobe April 2004 - January 2013
i3 2004 - January 2013
Parke-Davis/Pfizer 1978 - 2004
Parke-Davis/Pfizer 1978 - 2004
Pfizer/PD 1978 - 2004
Pfizer Global Research & Development 1978 - 2004
Pfizer 1978 - 2004
Warner Lambert 1978 - 2004
Skills
Clinical Data Management, Drug Development, Clinical Development, Biostatistics, GCP, CRO, Oracle Clinical, Oncology, Clinical Trials, EDC, Pharmaceutical Industry, Therapeutic Areas, CDISC, CTMS, Protocol, Validation, Clinical Study Design, Regulatory Submissions, Medical Writing, FDA, Statistical Programming, SAS, 21 CFR Part 11, CRF design, Data Management, SDTM, Infectious Diseases, ICH-GCP, SAS programming
Education
Columbia University in the City of New York 1976 — 1978
MPH, Biostatistics
PharmaNet/i3 February 1997 - Present
PharmaNet/i3 2007 - May 2012
PharmaNet/i3 1997 - April 2012
KMI/Ingenix 2000 - 2007
Skills
EDC, Clinical Monitoring, CRO, CTMS, Therapeutic Areas, GCP, ICH-GCP, Clinical Trials, Clinical Development, Oncology, Endocrinology, Vaccines
Education
College of Mount Saint Vincent
PharmaNet/i3 July 2012 - Present
Baker & Daniels August 2011 - July 2012
The Indianapolis Star February 1996 - June 2011
Skills
Research
Education
Indiana University-Purdue University at Indianapolis 1982 — 1989
Pharmanet/i3 August 2010 - Present
QUINTILES - Clinical Data Manager November 2009 - August 2010
AstraZeneca March 2007 - July 2009
AstraZeneca October 2003 - March 2007
AstraZeneca October 2000 - January 2003
DUPONT PHARMACEUTICALS COMPANY November 1998 - October 2000
Zeneca Pharmaceuticals November 1997 - November 1998
McNeil Consumer Products September 1990 - November 1997
McNeil Consumer Products September 1988 - September 1990
Karin Kolbe, CV July 1987 - September 1988
Education
Gwynedd Mercy University 1986 — 1997
Bachelors of Science, Business Management
AstraZeneca May 2013 - Present
inVentiv Clinical Solutions 2009 - February 2013
PharmaNet/i3 2011 - 2012
inVentiv Clinical Solutions 2005 - February 2009
Purdue Pharma October 1990 - May 2005
Skills
Lifesciences, Regulatory Submissions, Pharmaceutical Industry, Clinical Development, CRO, Pharmacovigilance, EDC, FDA, Vendor Management, Business Development, Vaccines, GCP, Sop, CTMS, Strategy, Clinical Trials, Biopharmaceuticals, GMP, Clinical Research, Therapeutic Areas, Data Management, Cardiovascular Disease, Oncology, Infectious Diseases, Drug Development, Clinical Data Management
Education
Columbia University in the City of New York 1976 — 1978
Master's degree, Biostatistics
Covance April 2014 - Present
PharmaNet/i3 November 2012 - Present
MedFocus March 2010 - March 2012
Premier Research January 2007 - October 2009
Ovation Pharmaceuticals 2004 - 2005
Pfizer 2002 - 2003
Pharmacia 2001 - 2003
Pharmacia / Searle August 1996 - January 2001
Premier Health Alliance 1993 - 1996
DeKalb Genetics 1995 - 1995
Skills
Clinical Trials, SAS, Data Analysis, Databases, Programming, Clinical Research, CRO, GCP, Pharmaceuticals, Clinical, Data Management, EDC, Oracle Clinical, Pharmacovigilance, Statistics, Healthcare, Therapeutic areas, Pharmaceutical Industry, Validation, CDISC, Infectious Diseases, Therapeutic Areas, Clinical Development, Protocol, Clinical Data Management, SDTM, Statistical Programming, SAS programming, SAS Programming
Education
Northwestern University 1987 — 1989
MS, Advertising
Loyola University of Chicago 1980 — 1983
Bachelor of Science, Pyschology
TFS Trial Form Support May 2014 - Present
PharmaNet/i3 May 2005 - May 2014
Discovery Labs May 2000 - May 2005
ICON Clinical Research 1999 - 2000
Skills
COPD, Pediatrics, Asthma, Medical Devices, Infectious Diseases, Clinical Trial..., CRO, Hospitals, Clinical Trials, Clinical Research, Acute Care, Acute Respiratory..., Womens Health, CTMS, Clinical Development, GCP, Oncology, Clinical Monitoring, EDC, ICH-GCP, Clinical Data Management, Therapeutic Areas, Women's Health, Pharmaceutical Industry
Education
Saint Joseph's University 1990 — 1994
BS Business Administration
Community College of Philadelphia 1979 — 1981
AAS, Respiratory Therapy
PharmaNet/i3 2011 - 2012
PharmaNet/i3 2008 - 2011
PharmaNet/i3 2007 - 2008
PharmaNet/i3 2005 - 2007
OptumInsight (formerly Ingenix) 2004 - 2005
OptumInsight (formerly Ingenix) 2001 - 2004
OptumInsight (formerly Ingenix) 2000 - 2001
Park Cities Speech, Language & Learning Center 1999 - 2000
Gay Hess Speech & Learning Center 1998 - 1999
Skills
Analysis, Clinical Trials, Management, Project Management, Analytics, Business Process..., Clinical Research
Education
Auburn University
MCD, Communication Disorders
University of Louisiana at Lafayette
BA, Speech Pathology and Audiology
University of St. Thomas
MBA, Health Care Management
inVentiv Health Clinical October 2012 - Present
PharmaNet/i3 2006 - Present
PharmaNet/i3 June 1999 - October 2012
Skills
Clinical Trials, Data Management, SAS, Pharmaceutical Industry, FDA, Sop, 21 CFR Part 11, GCP
Education
Bucks County Community College 1995 — 2009
inVentiv Health Clinical April 2015 - Present
inVentiv Health Clinical May 2012 - Present
PharmaNet/i3 March 2010 - May 2012
i3 Research March 2008 - March 2010
i3 Research September 2006 - March 2008
Skills
CTMS, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Clinical Development, Clinical Monitoring, Clinical Research, Regulatory Affairs, EDC, Clinical Data Management, Sop, FDA, Protocol
Education
Elon University 1990 — 1994
BA, Political Science
Worldwide Clinical Trials March 2014 - Present
Worldwide Clinical Trials, Inc. December 2012 - March 2014
Worldwide Clinical Trials, Inc. April 2012 - December 2012
PharmaNet/i3 June 2011 - April 2012
i3 Research July 2007 - May 2011
i3 Research 2007 - May 2011
i3 Research January 2001 - July 2007
Johnson & Johnson PRD February 2005 - July 2005
i3 Research March 2000 - December 2000
i3 Research November 1996 - March 2000
Skills
GCP, CTMS, Clinical Research, Clinical Trials, Infectious Diseases, Neurology, CRO, Pharmaceutical Industry, Therapeutic Areas, Clinical Monitoring, Clinical Data Management, EDC, ICH-GCP, Clinical Development
Education
Seton Hall University 1995 — 1996
BSN, Nursing
Lehigh University 1987 — 1991
BS, Behavioral Neuroscience
PAREXEL November 2014 - Present
PAREXEL January 2014 - November 2014
PAREXEL March 2012 - January 2014
PharmaNet/i3 April 2008 - February 2012
PRA International October 2006 - March 2008
PRA International April 2006 - October 2006
PRA International January 2005 - March 2006
PRA International October 2003 - January 2005
PRA International January 2003 - October 2003
PRA International October 2001 - January 2003
Skills
Forecasting, Analysis, Management, CRO, Project Management, Leadership, Project Planning, Team Management, Pharmaceutical Industry, CTMS, Clinical Development, Clinical Trials, EDC, GCP, Process Improvement, Drug Development, Biotechnology, Cross-functional Team..., Oncology
Education
New York Institute of Technology 2001 — 2005
Master of Business Administration (M.B.A.)
Loyola College in Maryland 1994 — 1998
Bachelor of Arts (B.A.)
ICON plc February 2013 - Present
PharmaNet/i3 January 2012 - February 2013
Amgen/BioVex February 2011 - December 2011
Dana-Farber Cancer Institute April 2008 - February 2011
Harvard University May 2006 - May 2008
Skills
Clinical Trials, Oncology, GCP, Biotechnology, Clinical Research, CTMS, Immunology, Infectious Diseases, EDC, Clinical Monitoring, Clinical Development, Lifesciences, CRO, Regulatory Affairs, Pharmaceutical Industry, Clinical Data Management, Sop, ICH-GCP, FDA, PCR, Inform, Neurology, Diabetes, Data Management, Drug Development, Cancer, Clinical Operations, Vaccines, CRF design, IRB, Regulatory Submissions, Protocol, 21 CFR Part 11, Trial Management, Regulatory Requirements
Education
Harvard University 2007 — 2010
University of New Hampshire 2000 — 2004
Bachelor of Science
James Cook University 2002 — 2002
Study Abroad Program
Peabody High School 1996 — 2000
PharmaNet/i3 Sr. Clinical Research AssociateAbbvie2014 - Present
Schering-Plough January 2006 - 2011
Schering-Plough Research Institute January 2006 - 2011
i3 Research 2005 - 2006
PAREXEL 1998 - 2002
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Clinical Research..., Clinical Monitoring, GCP, ICH-GCP, EDC, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Regulatory Submissions, Oracle Clinical
Education
Boston University 1996 — 1998
Master of Public Health (MPH), Public Health/Epidemiology
PharmaNet/i3 February 2008 - Present
Skills
Clinical Monitoring, GCP, ICH guidelines, FDA Regulations, English-Spanish
Education
Universidad Metropolitana (CO)
PharmaNet/i3 February 2012 - Present
Theratechnologies January 2008 - June 2011
MDS Pharma Services June 2005 - January 2008
MDS Pharma Services June 2003 - June 2005
Skills
CRO, GLP, Sop, GCP, Clinical Development, FDA, 21 CFR Part 11, Clinical Trials, CTMS, Biotechnology, ICH-GCP, Lifesciences
Education
Concordia University 1994 — 1998
B.SC, Chemistry
McGill University
Certificate, Project Management
PMI
PMP
inVentiv Health Clinical December 2014 - Present
inVentiv Health Clinical October 2012 - Present
PharmaNet/i3 July 2011 - October 2012
IBM October 2003 - July 2011
IBM 2003 - 2010
Phil Moussally, CPA 2000 - 2009
Avaya October 2000 - October 2003
Skills
Revenue Recognition, Financial Reporting, Accounting, IFRS, Forecasting, Financial Analysis, Hyperion, US GAAP, Consolidation, Cash Flow Forecasting, Account Reconciliation, Accounts Receivable, Auditing, Budgets, Cash Flow, Finance, Hyperion Enterprise, Internal Controls, Management, Managerial Finance, Process Improvement, SAP, Sarbanes-Oxley, Sarbanes-Oxley Act, Variance Analysis
Education
Bryant University 1995 — 1997
Bachelor of Science (B.S.), Accounting
Saint Raphael Academy
PharmaNet/i3 January 2011 - Present
inVentiv Clinical Solutions January 2011 - September 2011
Sallie Mae October 2003 - June 2010
American Funds Service Company January 1999 - January 2003
Skills
Strategic Planning, Customer Service, Cross-functional Team..., Project Management, Marketing
Education
Indiana Wesleyan University 2000 — 2002
Master of Business Administration (MBA), Business/Commerce, General
Indiana University 1993 — 1997
Bachelor of Arts Degree, History and Political Science
Triton HS
Crobiopharma LLC September 2012 - Present
Pharmanet/i3 October 2012 - December 2012
Peachtree Bioresearch Solutions January 2009 - 2012
UCB January 2002 - January 2009
UCB Pharma January 2002 - May 2005
Ingenix formerlly Worldwide Clinical Trials January 2000 - September 2001
Worldwide Clinical Trials, Inc. March 1999 - January 2000
National Market Share/Campaign Tel March 1998 - November 1998
Skills
Clinical Data Management, Oracle Clinical, Clinical Development, SQL*Plus, CDISC, Clinical Trials, EDC, GCP, Clinical Data, CTMS, ICH-GCP, clinical data programmer, sas programmer, SAS, Oncology
Education
Florida International University 1986 — 1988
Bachelor of Science
AbbVie September 2012 - Present
PharmaNet/i3 April 2012 - September 2012
Kforce Clinical Research, Inc. October 2010 - April 2012
Therapeutics Inc. June 2006 - November 2010
3M Pharmaceuticals December 2002 - July 2006
Skills
RCRA, CTMS, Clinical Trials, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Clinical Research, EDC
Education
St. Catherine University 1998 — 2002
BS, Information Management
Century College
AAS, Medical Imaging
inVentiv Health Clinical November 2012 - Present
Community College of Allegheny County 2007 - Present
PharmaNet/i3 October 2010 - November 2012
Novum Pharmaceutical Research Services July 2007 - October 2010
Carnegie Mellon University October 2005 - June 2007
Skills
Clinical, Pharmacology, Oncology, Medical Writing, Clinical Trials, Clinical Development, Pharmaceutical Industry, GCP, Regulatory Affairs, CRO, Clinical Research, Drug Development, Medicine, Regulatory Submissions, Biochemistry, Cell Biology
Education
Vanderbilt University 1998 — 2005
PhD, Pharmacology
Duquesne University 2007 — 2010
PharmD, Phamacy
Notre Dame College 1993 — 1998
B.S., Biochemistry
Mapi - Real World Evidence July 2012 - Present
PharmaNet/i3 July 1997 - July 2012
STATPROBE, inc August 1997 - July 1998
Skills
Project Management, Clinical Trials, Clinical Development, Pharmaceutical Industry, Oncology, Drug Development, Clinical Research, Infectious Diseases, Data Management, CRO, Regulatory Affairs, Biotechnology, FDA, EDC, Clinical Data Management, Therapeutic Areas, GCP, Lifesciences, Validation, Neurology, Training, Contract Negotiation, Microsoft Excel, Research, ICH-GCP, Diabetes, Medical Writing
Education
Eastern Kentucky University 2004 — 2007
Master of Public Health (MPH), Environmental Health
University of Kentucky 1991 — 1995
B.S., Biology
inVentiv Health June 2013 - Present
PharmaNet/i3 March 2008 - June 2013
i3 Statprobe 2006 - 2008
i3 Statprobe 2002 - 2006
Skills
Clinical Data Management, EDC, CRO, Oracle Clinical, Data Management, Clinical Trials, GCP, Data Validation, Validation, Clinical Research, SAS, Pharmaceutical Industry, Sop, Inform, Oncology, Software Documentation, CRF design, FDA, Medidata, 21 CFR Part 11
Education
Sullivan University 2001 — 2001
none, Computer programmng
Kankakee Community College 1994 — 1996
Accounting
Duke Clinical Research Institute September 2014 - Present
INC Research June 2012 - September 2014
PharmaNet/i3 July 2011 - June 2012
Health Decisions January 2011 - July 2011
i3 Research October 2009 - January 2011
Novella Clinical September 2008 - August 2009
inc research August 2007 - September 2008
Quintiles June 2003 - August 2007
Duke University Medical Center 2000 - 2003
Skills
Regulatory Submissions, Clinical Monitoring, CRO, Leadership, ICH-GCP, Clinical Trials, Sop, Clinical Data Management, CTMS, Clinical Development, Clinical Study Design, EDC, GCP, Therapeutic Areas, Clinical Research, Pharmaceutical Industry, Oncology
Education
East Stroudsburg University of Pennsylvania 1998 — 1999
MS, Cardiac Rehabilitation & Exercise Science
East Stroudsburg University of Pennsylvania 1995 — 1997
BS, Exercise Physiology
Millersville University of Pennsylvania 1995 — 1996
Millersville University of Pennsylvania 1987 — 1989
Quintiles December 2014 - Present
Covance January 2013 - December 2014
PAREXEL May 2012 - January 2013
PharmaNet/i3 July 1999 - May 2012
PPD June 1998 - July 1999
Theradex November 1990 - March 1997
Skills
EDC, Oracle Clinical, Data Management, Clinical Trials, Clinical Data Management, CRO, Line Management, CRF design, Inform, Oncology, CTMS, Therapeutic Areas, Project Management, Clinical Monitoring, Medidata, Software Documentation, Computer System..., Quality Assurance, Protocol, Biostatistics, Regulatory Affairs, GCP, Management, Vendor Management, Process Improvement, Databases, Clinical Operations, Data Validation, Quality Control, Clinical Study Design, Medidata Rave, Phase I, MedDRA, Testing, Oracle, SAE Reconciliation, Data Entry, Pharmacology, SOP development, SharePoint, Medical Coding, Resource Management, Database Design, Integration, Data Quality, Business Process, PL/SQL, OC RDC, Business Development, SQL
Education
California Coast University
BS, Business Administration
PharmaNet/i3 2012 - Present
inVentiv Health Clinical 2012 - Present
Warner Chilcott 2012 - 2012
Celgene 2011 - 2012
Celgene corp 2011 - 2012
Skills
Clinical Trials, GCP, Pharmaceutical Industry, FDA, Sop, Validation, GMP, Pharmacovigilance, Clinical Development, Oncology, Protocol, EDC, CRO
Education
Bangalore University
John tyler community college
PharmaNet/i3 September 2012 - Present
ICON Clinical Research April 2011 - October 2012
ICON Clinical Research May 2006 - January 2011
ICON Clinical Research January 2003 - April 2006
Skills
Clinical Trials, Clinical Research, Sop, CRO, CTMS, GCP, ICH-GCP, Therapeutic Areas, Oncology, Regulatory Submissions, Vaccines, Pharmacovigilance, Infectious Diseases, Endocrinology, Diabetes, Cardiology
Education
Temple University 1997 — 2001
MS, QA/RA
Gwynedd-Mercy College 1977 — 1981
RN, BSN, Nursing
Gwynedd-Mercy College 1977 — 1981
BS, Psychology
inVentiv Health Clinical July 2014 - Present
inVentiv Health Clinical November 2012 - July 2014
PharmaNet/i3 April 2007 - November 2012
Colorado Prevention Center October 2005 - April 2007
Abbott Laboratories October 2004 - September 2005
Abbott February 2002 - October 2004
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, GCP, CRO, Clinical Trials, Therapeutic Areas, Oracle Clinical, Clinical Data Management, CRF design, Oncology
Education
Florida State University 1997 — 2001
Bachelor of Science (B.S.), Biological and Physical Sciences
PharmaNet/i3 October 2010 - Present
Eli Lilly and Company March 2010 - October 2010
Eli Lilly and Company February 2010 - October 2010
Skills
Project Portfolio..., Process Management, Business Management, Business Strategy, People Management, CRO, Clinical Research, Clinical Trials, Cross-functional Team..., GCP, Management, Pharmaceutical Industry, Statistics, Therapeutic Areas
Education
Indiana Wesleyan University 1995 — 1997
Masters, Business Administration
PharmaNet/i3 October 2011 - Present
AGA Medical June 2010 - October 2011
AGA Medical June 2009 - June 2010
i3 Research 1999 - 2008
i3 Research 1999 - 2005
Education
Antioch University New England 1990 — 1992
MES, Resource Management and Adminstration
Hampshire College 1980 — 1985
BA, Environmental Studies
PharmaNet/i3 April 2012 - Present
Kforce, Inc May 2009 - April 2012
2005 - 2008 October 2005 - October 2007
2004 - 2005 February 2004 - October 2005
Skills
GCP, Clinical Monitoring, ICH-GCP, Clinical Trials, Quality Management, FDA, Auditing, Pharmaceutical Industry, CAPA, Project Management, Management, Quality Assurance
Education
Belmont University - Jack C. Massey Graduate School of Business 1997 — 2000
MBA
Belmont University
Master, Business Administration
Regis College 1992 — 1996
BA, Biochemistry
West Warwick High School 1990 — 1992
High School Diploma
Basic High School 1988 — 1990
Research Assistant, Vanderbilt University
Bachelor of Arts, Biochemistry
Novo Nordisk A/S March 2008 - Present
PharmaNet/i3 May 2006 - March 2008
Theradex May 2005 - May 2006
Synergistic Business Solutions 1999 - 2005
Skills
Talent Acquisition, Human Resources, Temporary Placement, Clinical Research, Pharmaceutical Industry, Recruiting, Performance Management, Employee Relations, Onboarding, Talent Management, HRIS, Applicant Tracking..., Training, Management, Healthcare, Organizational..., Change Management, HR Policies, Biotechnology, Sourcing, Taleo
Education
Caldwell College 2000 — 2004
Caldwell College
Cardinal Logistics Management May 2013 - Present
Technekes, LLC May 2008 - May 2013
Technekes LLC May 2008 - May 2013
US Air Force / NC Air National Guard April 1978 - April 2012
PharmaNet/i3 May 2002 - March 2008
Xerox 1999 - 2002
Fuchs Systems 1997 - 1999
Novant Health Presbyterian Medical Center 1991 - 1997
Instrumentation Laboratory 1982 - 1991
Skills
Windows Server, IIS, SQL, SharePoint, HTML, Project Management, Citrix, Microsoft Exchange, Symantec Endpoint..., Microsoft Certified..., Trend Micro Officescan, VMware vSphere
Education
Community College of the Air Force
Electronics Systems Technology, Electrical, Electronic and Communications Engineering Technology/Technician
MedTrials, Inc. March 2014 - Present
inVentiv Health January 2013 - March 2014
PharmaNet/i3 April 2011 - December 2012
PharmaNet/i3 2008 - 2010
PharmaNet/i3 July 2007 - 2008
Skills
CRO, Clinical Trials, GCP, EDC, Clinical Monitoring, ICH-GCP, CTMS, Oracle Clinical, Clinical Research, Pharmaceutical Industry
Education
Walden University 2009 — 2011
Masters, Clinical Research Administration
Goucher College 2002 — 2006
Bachelor of Arts (BA), Business Management
PharmaNet/i3 April 1998 - Present
i3 Statprobe April 1998 - February 2008
Difco Laboratories, Inc. 1986 - 1998
Education
Eastern Michigan University 1981 — 1983
MBA, Operations Research
PharmaNet/i3 September 2009 - Present
AB Project Services Inc. January 2001 - July 2009
AB Project Services, Inc. January 2001 - 2009
Skills
Validation, Computer System..., 21 CFR Part 11, Sop, GxP, Pharmaceutical Industry, Clinical Trials
Education
Full Sail University 1999 — 2001
Associate of Science (A.S.), Cinematography and Film/Video Production
County College of Morris 1995 — 1996
Eli Lilly and Company June 2014 - Present
PharmaNet/i3 June 2006 - 2014
inVentiv Clinical Solutions 2006 - 2011
Skills
Clinical Trials, CRO, SAS, EDC, Data Management, Pharmaceutical Industry, Clinical Development, Statistical Programming, SAS programming, Clinical Data Management, GCP
Education
Indiana University-Purdue University at Indianapolis 2006 — 2009
MA, Economics
Forest Laboratories September 2012 - Present
PharmaNet/i3 August 2010 - September 2012
ACL Medical Writing March 1999 - August 2010
Schering-Plough Research Institute September 1996 - March 1999
SCHERING-PLOUGH CORPORATION October 1991 - September 1996
Schering-Plough Research Institute 1986 - 1991
Skills
Sop, Clinical Research, Software Documentation, Protocol, Clinical Study Design, Medical Writing, Clinical Data Management, Editing, Oncology, Biostatistics, Medical Communications, Training, Regulatory Submissions, Clinical Trials, Pharmaceutical Industry, Diabetes, Medical Education, Clinical Development, Pharmacology, Neuroscience
Education
Fairleigh Dickinson University 1988 — 1994
MBA, Pharmaceutical Studies
Montclair State University 1982 — 1986
BS, Biology, Chemistry
PRA Health Sciences July 2012 - Present
PharmaNet/i3 May 2009 - Present
Omnicare Clinical Research April 2002 - April 2009
Covance 1990 - 2002
Education
Madison Area Technical College 1991 — 1995
RN, Nursing
inVentiv Health Clinical (formally PharmaNet i3) May 2012 - Present
PharmaNet/i3 October 2008 - May 2012
Eli Lilly and Company January 2004 - October 2008
Eli Lilly and Company January 1999 - January 2004
Various Pharmaceutical June 1986 - December 1999
Skills
Transfers via SFTP, Basic SAS programming..., Outlook, Lotus Notes, SAS Drug Development..., Unix, Reflection MVS, InForm, AS400/GLS, Microsoft Office, Excel, PowerPoint, Documentum, Clintrace, GDOCS, SINFOS, LSS, ISIS, NEXT system, Hummingbird, Axway (CYCLONE), Automation, Action Request System..., Collaboration Tools, Business Objects, many other database..., client tools such as..., Protocol, Inform, Data Management, Microsoft Excel, CTMS, Clinical Research, Clinical Trials, CRO, Clinical Data Management, GCP
Education
Indiana University-Purdue University at Indianapolis 1984 — 1986
Biology
inVentiv Health Clinical July 2012 - Present
PharmaNet/i3 April 2009 - August 2012
PharmaNet Development Group, Inc. October 2007 - April 2009
PharmaNet Development Group, Inc. April 2005 - October 2007
PharmaNet Development Group, Inc. September 2004 - April 2005
ClinForce May 2003 - September 2004
Fast Track Systems September 2002 - May 2003
Fast Track Systems January 1999 - September 2002
Fast Track Systems January 1998 - January 1999
Skills
Validation, Documentation, Testing, User Acceptance Testing, 21 CFR Part 11, EDC, Requirements Analysis, Clinical Data Management, Computer System..., SDLC, Databases, SQL, Software Documentation
Education
Albright College 1992 — 1996
B.S., Psycho-biology
PharmaNet/i3 January 2013 - June 2014
Theratechnologies January 2007 - December 2011
Caprion Pharmaceuticals January 2006 - September 2006
Pfizer May 2003 - December 2004
Bio-Inova Life Sciences North America March 2001 - April 2003
Skills
Biotechnology, Project Management, Clinical Research, Clinical Trials, Clinical Monitoring, Clinical Development, GCPs, SOPs, Pharmaceutical Research, Timeline Development, Cross-functional Team..., Risk Management, Process Improvement, Team Management, Sop, FDA, Regulatory Affairs, GCP, Oncology
Education
Université Hassan II Mohammedia 1987 — 2003
PhD, Microbiology
inVentiv Health November 2014 - Present
AstraZeneca / RPS November 2013 - November 2014
Quintiles April 2012 - October 2013
PharmaNet/i3 October 2009 - April 2012
Paragon Biomedical February 2008 - June 2009
Premier Research Group November 2006 - February 2008
INC Research September 2005 - November 2006
ICON Clinical Research January 2003 - September 2005
Skills
Endocrinology, Neurology, Rheumatology, Gastroenterology, Urology, CTMS, Clinical Monitoring, EDC, ICH-GCP, GCP, CRO, Clinical Trials, Neonatology
Education
Hampton University 1996 — 2000
B. S., Biology
Tandem Labs April 2014 - Present
PharmaNet/i3 June 2011 - April 2014
NVITAL (Medical Science and Computing) November 2010 - June 2011
NVITAL (Lockheed Martin) September 2009 - October 2010
NVITAL (Henry M. Jackson Foundation) August 2006 - September 2009
MicroBiotest February 2005 - August 2006
Human Genome Sciences May 2003 - October 2004
Ortho Biotech (Johnson & Johnson) February 1999 - May 2003
Pharmaceutical Research Institute (Johnson & Johnson) / Kelly Scientific October 1997 - January 1999
Skills
Immunoassays, ELISA, Bioanalysis, Immunology, GLP, Sop, Cell Biology, Validation, GMP, Laboratory, Protein Chemistry, Technology Transfer, Analytical Chemistry, Method Development, Quality Control, V&V, Drug Discovery, Vaccines, Chromatography, Clinical Trials, SOP
Education
Case Western Reserve University 1982 — 1986
BS, Biochemistry
Rutgers University-New Brunswick
inVentiv Health Clinical March 2014 - Present
PharmaNet/i3 February 2012 - March 2014
PharmaNet/i3 February 2011 - February 2012
Tata Consultancy Services September 2007 - January 2011
Tata Consultancy Services September 2003 - September 2007
Skills
SAS, SAS programming, Statistics, Data Analysis, Databases, Clinical Research, Analysis, Validation, Business Analytics, Clinical Trials, Data Management, Pharmaceutical Industry, Quality Assurance, Biostatistics, Clinical Data Management, CRO, SAS Programming
Education
IIT Kanpur 2001 — 2003
M.Sc (Statistics), Statistics
St. Xavier's College 1998 — 2001
B.Sc(Honours), Statistics
M. G.D. Girls High School 1996 — 1998
Haryana Vidya Mandir
PharmaNet/i3 May 2012 - Present
Delta, a Randstad Company July 2011 - May 2012
i3 Statprobe 2009 - July 2011
Targanta Therapeutics 2006 - 2009
Eli Lilly and Company 2000 - 2006
Covance Laboratories 1998 - 2000
Skills
Project Management, Medical Writing, Management, Pharmaceutical Industry, Clinical Development, Oncology, Regulatory Submissions, CRO, GCP, FDA, Regulatory Affairs, Biotechnology, Infectious Diseases
Education
Ball State University 2003 — 2006
Master of Business Administration, Project Management/Business
Purdue University 1994 — 1998
Bachelor of Arts, English Literature
PRA Health Sciences October 2014 - Present
PSI-CRO February 2014 - October 2014
inVentiv Health Clinical (Formerly: PharmaNet/i3) July 2012 - February 2014
PharmaNet/i3 August 2007 - July 2012
Skills
•Excellent..., Effective written and..., Ability and willingness..., Strive for continued..., Clinical Trials, Clinical Research, Leadership, Human Resources, Outlook, GCP, Oncology, Software Documentation, Healthcare, FDA, Microsoft Office, Protocol, Sop, Biotechnology
Education
Drexel University 2015 — 2017
Master's degree, Clinical Research for Health Professionals
Philadelphia University 2010 — 2012
Bachelor of Science, Health Service Management, May 2012
Colonial Life December 2012 - August 2014
PharmaNet/i3 March 2011 - October 2012
codeArrow Limited June 2009 - February 2011
Bangladesh Internet Press Ltd March 2009 - May 2009
ASA June 2008 - March 2009
Skills
C#, Machine Learning, SAS, R, Hadoop, MySQL, Microsoft SQL Server, jQuery, ASP.NET, .NET, JIRA, Software Development, PHP, Drupal, AJAX, Subversion, Linux, LINQ, Zend Framework, HTML5, Firebug, SQL Server, Java, Oracle SQL, Doctrine, Sparx Enterprise..., Visual Studio, JavaScript, Databases, XML, HTML, Web Development, Python, OOP, ASP.NET MVC, SQL
Education
University of Massachusetts Lowell 2014 — 2016
Master's Degree, Computer Science
Dhaka Bishwabidyalaya 2006 — 2007
Master of Science (MS), IT, 3.67
Bangalore University 2000 — 2003
Bachelor of Science (B.Sc.), Computer Science, Mathematics, Statistics, 3.53
DataCeutics, Inc. February 2013 - Present
PharmaNet/i3 May 2011 - February 2013
Celerion March 2010 - June 2011
MDS Pharma Services June 2005 - March 2010
Skills
SAS, Clinical Development, CDISC, CRO, PK/PD, Biostatistics, Statistical Programming, GCP, Clinical Data Management, Data Management, Oracle Clinical, EDC, SAS programming, Clinical Trials, SDTM
Education
University of Nebraska-Lincoln 2002 — 2005
MS, Statistics
Concordia University, Nebraska 1992 — 1996
BA, Physics, Chemistry, Math, Biology
PRA Health Sciences June 2014 - Present
Quintiles September 2012 - June 2014
PharmaNet/i3 February 2012 - September 2012
UIM MUSC June 2011 - May 2012
Kforce Clinical Research, Inc. May 2007 - June 2011
Medical University of South Carolina November 2002 - February 2007
Skills
Clinical Trial..., Clinical Monitoring, Clinical Research, Vaccines, Oncology, Infectious Diseases, Immunology, Neurology, Pharmaceuticals, Psychiatry, Medical Devices, Quality Assurance, Research, Documentation, EDC, Excel, Outlook, ICH-GCP, PowerPoint, Microsoft Office, Word, Therapeutic areas, Ophthalmology, Endocrinology, Regulatory Affairs, Rheumatology, Urology, Asthma, Diabetes
Education
College of Charleston 1990 — 1995
inVentiv Health Clinical November 2013 - Present
inVentiv Health Clinical July 2012 - January 2014
PharmaNet/i3 May 2010 - August 2012
ICON Clinical Research 2008 - 2010
ICON Clinical Research 2003 - 2008
GloboMax 2001 - 2003
Skills
Medical Writing, CRO, Clinical Trials, Pharmaceutical Industry, Clinical Development, GCP, CTMS, Biotechnology, Clinical Data Management, EDC, Oncology, Protocol, Regulatory Submissions, Drug Development, Therapeutic Areas, Regulatory Affairs
Education
University of the Sciences in Philadelphia 2009 — 2009
Biomedical Writing - Regulatory
Hofstra University
BA, Literature and Publishing
Fairbanks Memorial Hospital/Banner Health Corporation December 2013 - Present
Project Manager Fairbanks Memorial Hospital/Banner Health December 2013 - Present
Pharmanet/i3 September 2010 - September 2013
Premier Research Group Atlanta March 2009 - March 2010
Premier Research Group Limited March 2009 - March 2010
Kimberly-Clark October 2008 - March 2009
Aerotek: UCB Pharmaceuticals February 2008 - October 2008
Eli Lilly and Company October 2005 - February 2008
Eli Lilly and Company January 2002 - October 2005
Eli Lilly and Company March 1999 - January 2002
Skills
Clinical Trials, EDC, Pharmaceutical Industry, Data Management, GCP, CRO, Clinical Data Management, Clinical Development, CTMS, SOP, Project Management
Education
Indiana Wesleyan University 2007 — 2012
Bachelor’s Degree, Business Management, 3.83
Indiana University-Purdue University
Porter Business College
Associate’s Degree, Business, Management, Marketing, and Related Support Services
Indiana Wesleyan University
BS, Business Management
PharmaNet/i3 2000 - Present
Skills
Clinical Trials, CRO, Clinical Development, GCP, ICH-GCP, Drug Development, Clinical Monitoring, Sop, Regulatory Affairs, Biotechnology, Clinical Research, Regulatory Submissions, Lifesciences, FDA, Clinical Data Management, 21 CFR Part 11, Protocol, Regulatory Requirements, Infectious Diseases, EDC, Medical Affairs, Phase I, Vaccines, Biopharmaceuticals, Clinical Study Design, Inform, Pharmacokinetics, Clinical Operations, Medical Writing, IND, Life Sciences, SOP, Pharmaceutical Industry
Education
Concordia University
Biochemistry
ApoPharma Inc. September 2012 - Present
PharmaNet/i3 June 2010 - September 2012
Sanofi Pasteur August 2000 - August 2010
Writer's Digest 2008 - 2010
IBM Canada Ltd. August 1989 - August 2000
Hogrefe & Huber Publishers May 1987 - July 1989
Editors' Association of Canada / Association canadienne des réviseurs 1985 - 1986
Skills
Medicine, Oncology, Medical Writing, Clinical Trials, Biotechnology, Regulatory Affairs, Clinical Development, Pharmaceutical Industry, Clinical Research, Protocol, CTMS, Proofreading, Regulatory Submissions, CRO, Pharmacovigilance, Therapeutic Areas, ICH-GCP, GCP
Education
Brandeis University
BA
University at Albany, SUNY
MA
West Hill High School
Grace Consulting June 2012 - Present
PharmaNet/i3 April 2011 - June 2012
CPEX Pharmaceutical Company November 2008 - June 2010
MannKind Corporation November 2002 - November 2009
Wyeth 1999 - 2002
PAREXEL 1997 - 2000
Skills
Clinical Trials, Clinical Research, CRO, Clinical Development, Pharmaceutical Industry, CTMS, GCP, Clinical Data Management, ICH-GCP, EDC, Oncology, Clinical Operations, Clinical Monitoring, Biotechnology, Drug Development
Education
Boston University 1993 — 1996
MPH
University of New Hampshire
University of New Hampshire
PharmaNet/i3 August 2012 - Present
Pharma Medica Research Inc. January 2012 - August 2012
Cetero Research November 2010 - January 2012
Lambda Therapeutic Research Inc. July 2010 - October 2010
Biovail Contract Research February 2009 - July 2010
Skills
SAS/SQL, SAS Macro, Programming, CDISC SDTM, CDISC ADaM, Clinical, Data Analysis, Statistics, Data Management, SAS programming, SAS, CDISC
Education
2006 — 2007
Master, MBA
2002 — 2004
Master, Human Ecology
PharmaNet-i3 June 2012 - Present
PharmaNet/i3 November 2007 - Present
Chelsea Community Hospital March 1994 - October 2007
St Mary Mercy Hospital June 1988 - March 1994
The Medical Center at Princeton June 1986 - March 1988
Education
Eastern Michigan University 2009 — 2012
MS, Clinical Research Administration
Eastern Michigan University 2000 — 2002
Bachelor Science, Health Care Management
Fayetteville Technical Institute 1979 — 1981
AAS, Respiratory Therapy
AbbVie January 2015 - Present
Krannert Institute of Cardiology September 2014 - December 2014
inVentiv Health Clinical August 2012 - April 2014
PharmaNet/i3 October 2010 - August 2012
St Vincent Wound Healing February 2010 - December 2010
Columbus Regional Hospital April 2008 - February 2010
Volt July 2006 - April 2008
St Francis Hospital June 1987 - February 2006
Skills
Clinical Research, Healthcare, Hospitals, Pharmaceutical Industry, GCP, Clinical Trials, Nursing, Pharmacovigilance, Management, Supervisory Skills, Drug Safety, FDA, Diabetes, Oncology, Medicine, Critical Care, CTMS, Education, Clinical, Quality Assurance, Treatment, Policy, CRO, Wound Care, ICU, Patient Education, MedDRA, Argus Safety, ARISg, Cardiology
Education
University of Phoenix 2006 — 2009
MSN/MBA HCA, Business/ Nursing in Health care adminstration
Indiana University-Purdue University at Indianapolis 1983 — 1987
BSN, Nursing
Whiteland High School
Diploma
PharmaNet/i3 February 2008 - Present
Pfizer, Inc November 2001 - February 2008
Pfizer, Inc January 1997 - November 2001
Skills
Clinical Trials, Pharmaceutical Industry, 21 CFR Part 11, Pharmacovigilance, Clinical Research, GCP, CRO, Clinical Development, Biotechnology, Informatics, EDC, Sop
Education
Dakota State University 1987 — 1992
B.S. in English for Information Systems
PharmaNet/i3 May 2011 - Present
OptumHealth August 2008 - May 2011
OptumHealth June 2007 - August 2008
CareCentrix September 2004 - June 2007
Broadridge Financial Solutions December 2002 - September 2004
Broadridge Financial Solutions February 1998 - December 2002
Salex Fleet Management May 1990 - October 1996
Skills
Financial Analysis, Trend Reporting, Process Development, Financial Forecasting, System Integration..., General Management and..., PeopleSoft/Hyperion..., Microsoft Office...
Education
Dowling College 2002 — 2003
Master of Business Administration (M.B.A.), Banking and Financial Support Services
New York Institute of Technology-Old Westbury 1996 — 1997
Bachelor of Applied Science (B.A.Sc.), Banking and Financial Support Services
Suffolk County Community College 1993 — 1995
Associate of Arts and Sciences (A.A.S.), Accounting
PharmaNet/i3 June 2011 - Present
Pharmanet-i3 2011 - 2012
M-Clinical March 2010 - June 2011
Pfizer April 1999 - June 2002
Pfizer Global Research & Development 1999 - 2002
Eli Lilly and Company August 1998 - March 1999
Meridian Gynecological Center August 1992 - August 1998
Skills
Pharmaceutical Industry, Clinical Research, Medical Writing, Clinical Trials, GCP, Pharmacovigilance, Signal detection
Education
Indiana State University 1988 — 1992
MD, Intership/OB/GYN
Wayne State University School of Medicine 1984 — 1988
MD, Medical
Wayne State University 1980 — 1984
BS, Biology, French
PharmaNet/i3 November 2012 - Present
RHA Howell September 2011 - November 2012
Quintiles September 2010 - January 2011
GlaxoSmithKline May 2005 - September 2009
Skills
GCP, EDC, CTMS, ICH-GCP, CRO, Clinical Trials, Therapeutic Areas, Infectious Diseases, Clinical Development, Oncology, Regulatory Submissions, Protocol, Clinical Research, Biotechnology, Diabetes, Lifesciences, Phase I
Education
California College of Health Science 1996 — 1998
Cerficate, Respiratory Care, Respiratory Care
Edgecombe Community College
Respiratory Therapy
Taiho Oncology, Inc. January 2015 - Present
Taiho Oncology, Inc. 2013 - December 2014
Hansa One 2012 - 2014
Princeton Pharmacovigilance and Medical Publishing, LLC 2011 - 2013
Merck 2009 - 2011
Schering-Plough Research Institute 2005 - 2009
Covance 2002 - 2005
PharmaNet/i3 1999 - 2002
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Medical Writing, Oncology, GCP, CRO, Therapeutic Areas, CTMS, Clinical Research, Pharmacovigilance, Drug Safety, Medical Translation, Clinical Monitoring, ICH-GCP, Regulatory Affairs, Clinical Data Management, Drug Development
Education
University of the Sciences in Philadelphia 2003 — 2005
Master of Science (M.S.)
NYU 2006 — 2008
Publishing
Lycoming College
Nursing Bachelor of Science (RN, BSN)
Sanofi August 2014 - Present
ICON plc March 2014 - August 2014
ICON plc September 2012 - March 2014
Pharmanet/I3 July 2011 - September 2012
MD Anderson Cancer Center September 2003 - June 2011
Beijing Jishuitan Hospital August 1997 - October 1999
Skills
Biostatistics, Clinical Trials, SAS, Oncology, R, Clinical Research, CDISC, CRO, Clinical Study Design, Statistics, Bayesian statistics, SAS programming, GCP, Clinical Data Management, Epidemiology, EDC, Statistical Programming
Education
The University of Texas Health Science Center at Houston 2007 — 2014
Doctor of Philosophy (Ph.D.), Biostatistics
University of Minnesota-Twin Cities 2001 — 2003
MS, Biostatistics
Capital University of Medical Sciences 1992 — 1997
MD, Medicine
Middle School
high school
hight school
McLean Professional Services LLC 2014 - Present
INC Research July 2012 - August 2014
PharmaNet/i3 October 2008 - July 2012
Eli Lilly and Company April 2001 - October 2008
Skills
Manuscript, Medical Writing, Oncology, Neuroscience, Regulatory Submissions, Pharmaceutical Industry, Clinical Trials, GCP, Project Management, Publication Planning, Diabetes, Infectious Diseases, CRO, Management, Time Management, Editing, Quality Reviews, Data Integrity, Protocol
Education
Ball State University
B.A., Journalism
PharmaNet.i3 October 2005 - Present
Durham NC February 1999 - October 2005
Philadelphia October 1993 - January 1999
Skills
CTMS, EDC, Oncology, Pharmaceutical Industry, Clinical Development, Infectious Diseases, Sop, FDA, Therapeutic Areas, Biotechnology, Clinical Data Management, Protocol, Medical Devices
Education
Greensboro College 1967 — 1971
Bachelor's degree
PharmaNet/i3 October 2012 - Present
Education
University of Texas School of Public Health 1999 — 2002
Master of Public Health (MPH), Health Services Organization
Fordham University Graduate School of Arts and Sciences 1980 — 1983
Master of Education (MEd), Adult Education and Human Resource Development
Adelphi University 1968 — 1972
Bachelor of Arts (B.A.), Chemistry, Secondary Education
Crescendo Bioscience February 2014 - Present
Crescendo Bioscience April 2013 - February 2014
New York City Economic Development Corporation September 2012 - January 2013
PharmaNet/i3 October 2011 - May 2012
Medex November 2010 - August 2011
Clinilabs October 2007 - October 2010
Admiral Courier Services May 2005 - August 2007
M. Hamel-Smith & Co. January 2000 - December 2000
Skills
Excel, Research, Data Analysis, Microsoft Office, Microsoft Excel, Clinical Trials, Data Entry, Social Media, Microsoft Word, Analysis, Statistics, PowerPoint, SPSS, Software Documentation, Clinical Research
Education
Touro College 2008 — 2010
Masters of Science, International Business Finance
St. Francis College 2004 — 2007
Bachelors of Science, Business Management
City University of New York-Baruch College - Zicklin School of Business 2001 — 2004
Holy Cross College (Trinidad and Tobago) 1997 — 1999
A'Levels
St. Mary's College (Trinidad & Tobago) 1992 — 1997
CXC O'Levels
inVentiv Health Clinical September 2013 - Present
PharmaNet/i3 February 2011 - July 2013
Quintiles July 2007 - February 2011
Quintiles September 2006 - July 2007
Mindy O'Neil, DC June 2004 - September 2006
Skills
CTMS, Clinical Trials, Clinical Monitoring, EDC, ICH-GCP, GCP, CRO, Clinical Development, Oncology, Oracle Clinical, Clinical Data Management, CRF design, Regulatory Submissions, Clinical Operations, Patient Recruitment, Pharmaceutical Industry, Pharmacovigilance, Clinical Trial Lead
Education
Cleveland Chiropractic College 2000 — 2004
Doctor of Chiropractic
Central Missouri State University 1994 — 1998
Bachelor of Science (BS), Bachelors of Science- Social Work
United BioSource Corporation June 2012 - Present
PharmaNet/i3 April 1998 - June 2012
Skills
CRO, EDC, Clinical Data Management, Clinical Trials, Oracle Clinical, GCP, Clinical Development, Regulatory Submissions, 21 CFR Part 11, Therapeutic Areas, CTMS, Oncology, Pharmaceutical Industry, Sop, Data Management, SAS programming, Clinical Monitoring, Regulatory Affairs, ICH-GCP, Drug Development, Pharmacovigilance, Protocol, FDA, Infectious Diseases, Validation, Medical Writing, Clinical Study Design, Biostatistics, Vaccines, Clinical Operations
Education
Eastern Michigan University
Master of Business Administration (MBA), Operations Research
Purdue University
Bachelor of Science (BS), Microbiology, General
SRA International 2009 - 2011
Drug Safety Alliance 2008 - 2009
PharmaNet/i3 2007 - 2007
ClinForce 2007 - 2007
PPD 2006 - 2007
Quintiles 2006 - 2006
Skills
Pharmaceutical Industry, Drug Safety, Clinical Research, Medidata, Oracle Database, Oracle RDC, Argus Safety, ARISg, AERS, VAERS, Vaccine Research, MedDRA, Medical Terminology, Oncology Clinical..., Pharmacovigilance, Clinical Data Management, Medical Coding, FDA, ICH-GCP, Cardiology, Oncology, CTMS, GCP, EDC
Education
Walden University 2009 — 2011
Master of Science, Clinical Research Administration
Elizabeth City State University 1995 — 1999
Bachelors, Biology/Chemistry
Novo Nordisk November 2013 - Present
Baxter Healthcare September 2012 - November 2013
PharmaNet/i3 October 2009 - September 2012
PharmaNet/i3 August 2005 - October 2009
Abbott Laboratories October 2004 - July 2005
Abbott Laboratories March 2002 - October 2004
Tulane University Hospital November 2000 - March 2002
Children's Hospital of New Orleans August 2000 - February 2002
Willis-Knighton Health System January 1999 - August 2000
Skills
Electronic Data Capture, Clinical Trial..., MS Word, MS Excel, MS Powerpoint, MS Project, MS Outlook, CTMS
Education
University of Chicago 2003 — 2004
Certification, Clinical Trials Management
Louisiana Tech University 1994 — 1999
Bachelor of Science (B.S.), Clinical Laboratory Science/Medical Technology/Technologist
PPD September 2012 - Present
Pharmanet/i3 August 2008 - September 2012
INC Research June 2006 - August 2008
CEDRA Clinical Research December 2004 - June 2006
Skills
Microsoft Office, CCRA, EDC, CTMS, GCP, CRO, Clinical Trials, Clinical Monitoring, ICH-GCP, Protocol, Sop, Oracle Clinical, Inform, Medidata, Phase I, Rheumatoid Arthritis, Informed Consent, Clinical Site Monitoring, eCRF, Therapeutic Areas
Education
University of Iowa 1996 — 1999
Bachelor of Arts (B.A.), Biology, General
Creighton University 1995 — 1996
PharmaNet/i3 April 2012 - Present
Kforce Clinical Research, Inc. March 2011 - June 2012
Kforce Clinical Research, Inc. January 2006 - March 2011
Pfizer July 2003 - January 2006
Skills
Quality and compliance..., Ensuring patient safety..., Monitoring clinical..., Site Selection, Inspection readiness, Overseeing data flow..., CRO oversight, Therapeutic experience..., CRO
Education
Eastern Michigan University 2004 — 2006
Master of Science (MS), Clinical Research Administration
Western Michigan University 1999 — 2001
Bachelor of Science (BS), Biomedical Sciences, General
Duke University Health System May 2013 - Present
PharmaNet/i3 March 2007 - May 2013
PPD Development December 2004 - February 2007
INC Research 2002 - 2004
Inveresk Research June 2001 - April 2002
Duke Image Analysis Lab (DIAL); Duke Dept of Radiology October 1999 - June 2001
Skills
EDC
Education
Duke University
BS, Biology, General
PharmaNet/i3 March 2012 - Present
Kforce Clinical Research, Inc. January 2007 - March 2012
Comprehensive Cancer Centers of Nevada June 2003 - December 2006
Education
University of Phoenix 2011 — 2013
Bachelor of Science (BS), Business Administration and Management, General
College of Southern Nevada 1999 — 2003
Associate of Science (AS), Registered Nursing/Registered Nurse
The University of New Mexico
PharmaNet/i3 November 2008 - Present
Eli Lilly and Company July 2000 - November 2008
Vectren Corporation October 1989 - June 2000
Indiana Gas Company - now Vectren 1989 - 2000
Skills
COBOL, PL/SQL, Systems Analysis, Project Management, Tutoring, Online Tutoring, Mathematics, Algebra, Clinical Data Management, SAS programming
Education
Indiana University-Purdue University at Indianapolis 1974 — 1985
Bachelor of Science (BS), Computer Technology/Computer Systems Technology