Kendle International
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Kendle International Employees
Astellas Pharma August 2015 - Present
Pfizer February 2014 - August 2015
Hospira April 2013 - February 2014
Abbott/ Abbvie May 2009 - April 2013
Kendle International September 2007 - April 2009
Clinical medicine March 1991 - September 2007
Skills
Medical Affairs, Oncology, Clinical Development, Clinical Trials, Pharmacovigilance, Clinical Research, Protocol, Medicine, Translational Medicine, Drug Development, Sop, Pharmaceutical Industry, GCP, Infectious Diseases, CRO, Immunology, Biotechnology, FDA, Pharmaceutics, Hematology, Medical Writing, Therapeutic Areas, CTMS, Regulatory Submissions, Dermatology, Endocrinology, Cardiology, Neurology, SOP
Education
Hematology Oncology 1989 — 1991
The Maharaja Sayajirao University of Baroda 1980 — 1991
MD, Medicine
Medical college 1980 — 1985
Graduation, Medicine
Covance 2015 - Present
ICON plc 2005 - 2014
Lilly Venture (i3 Statprobe) 2001 - 2005
Kendle International 1998 - 2001
Clintrials Research 1996 - 1998
Skills
Clinical Monitoring, CRO, Clinical Trials, ICH-GCP, CTMS, EDC, Clinical Development, Oncology, Clinical Data Management, GCP, Patient Recruitment, Regulatory Submissions, Medical Writing, Trial Management, Sop
Education
Trevecca Nazarene University
BS, Biology
Vanderbilt University
BS, Medical Technology
Reliable Research Results 2009 - Present
Kendle International 1999 - 2009
University of Cincinnati September 2004 - December 2005
Hartford Research Group 1997 - 1999
VA Medical Center 1988 - 1997
Skills
GCP, Clinical Trials, Clinical Development, CRO, Pharmaceuticals, Clinical Data Management, Data Management, SOP, FDA, Clinical Trial..., Clinical Monitoring, Neurology, Clinical Research, CTMS, Pharmaceutical Industry, Oncology, Cardiology, Orthopedic, Nursing, Regulatory Affairs, Dermatology, Biotechnology, Diabetes, EDC, Infectious Diseases, Medical Devices, Informatics, Medicine, Lifesciences, Pediatrics, Pain Management
Education
The George Washington University School of Medicine and Health Sciences 2004 — 2008
MSHS, Clinical Research Administration
University of Cincinnati-Blue Ash Campus 2002 — 2004
Professional Certificate, Clinical Research
University of Cincinnati 1983 — 1988
BSN, Nursing
Phlexglobal May 2015 - Present
NextDocs February 2012 - May 2015
Kendle International April 2010 - February 2012
Kendle International April 2008 - March 2010
Kendle International January 2006 - March 2008
Kendle International December 2003 - January 2006
Kendle International September 2001 - December 2003
Medpace October 2000 - July 2001
Metabolic and Atherosclerosis Research Center (MARC) September 1987 - September 2000
University of Cincinnati Lipid Research Center August 1986 - August 1987
Skills
Global Leadership, Clinical Trial..., Clinical Information..., Trial Master File..., Personnel Leadership, Regulatory Requirements, CTMS, Cross-functional Team..., Leadership, Oncology, Trials, Software Documentation, Quality Assurance, Clinical Research, 21 CFR Part 11, CRO, Document Management
Education
The George Washington University 2009 — 2012
Clinical Research Administration
Henry Ford Hospital 1980 — 1980
Dietetic Internship, Dietetics
University of Dayton 1975 — 1979
BS, Dietetics
Halozyme Therapeutics, Inc. August 2015 - Present
PRA Health Sciences June 2012 - August 2015
PRA Health Sciences June 2011 - June 2012
PPD July 2010 - July 2011
Clinical Innovations l CiTrials 2010 - 2010
Kendle International November 2007 - December 2009
PPD April 2004 - November 2007
Skills
Endocrinology, Neurology, Clinical Monitoring, CRO, ICH-GCP, GCP, CTMS, EDC, Clinical Trials, Oncology, Therapeutic Areas, Clinical Research, Cardiology, Protocol, FDA, Sop, Rheumatology, Clinical Research..., Regulatory Submissions, Clinical Development, Clinical Data Management, Clinical Operations, Pharmacovigilance, Oracle Clinical, SOP
Education
Universidade Estadual Paulista 'Júlio de Mesquita Filho' 1998 — 2002
Bachelor of Science, Pharmacist
Quintiles January 2015 - Present
Quintiles October 2014 - January 2015
Quintiles November 2012 - October 2014
PRA International November 2010 - November 2012
Kendle International 2007 - 2010
Skills
GCP, CTMS, CRO, Clinical Trials, ICH-GCP, EDC, Clinical Monitoring, Clinical Research, Clinical Development, Oncology, Clinical Data Management, Therapeutic Areas, Infectious Diseases, Pharmaceutical Industry, Sop, Regulatory Submissions, IRB, Medical Writing, Regulatory Affairs, Neurology, Clinical Operations, Patient Recruitment, Oracle Clinical
Education
The George Washington University School of Medicine and Health Sciences 2011 — 2013
MS, Health Sciences, magna cum laude
University of North Carolina at Wilmington 2006 — 2009
MA, Psychology, cum laude
University of North Carolina at Wilmington 2003 — 2006
BA, Psychology
INC Research November 2010 - Present
Kendle International August 2008 - November 2010
Kendle International January 2008 - August 2008
Kendle International August 2007 - January 2008
Kendle International July 2006 - August 2007
Kendle International April 2005 - July 2006
Kentucky Employers' Mutual Insurance (KEMI) July 2004 - April 2005
Skills
Software Documentation, Sop, Quality Assurance, Training, Management, Document Management, Pharmaceutical Industry, SOP development, Work Instructions, HR Policies, Open Text Livelink, SharePoint, Six Sigma, GCP, Clinical Research, Clinical Data Management, Clinical Pharmacology, FDA
Education
Sullivan University 2007 — 2009
Bachelor, Magna Cum Laude, Human Resource Leadership
SouthWestern College of Business 2005 — 2007
Associate, Magna Cum Laude, Medical Administration
Expert Rating 2011 — 2012
Certificate, Six Sigma Green Belt
Novella Clinical, Inc. August 2013 - Present
PRA International September 2012 - April 2013
INC Research September 2011 - April 2012
Kendle International (acquired by INC Research) December 2007 - August 2011
Kendle International October 2006 - November 2007
Inveresk Research (acquired by Charles River Labs., Aug. 2004 and Kendle Intl., Oct. 2006) October 2002 - September 2006
ClinTrials Research (acquired by Inveresk Research) August 1995 - September 2002
ClinTrials Research February 1995 - July 1995
ClinTrials Research February 1992 - January 1995
National Testing Laboratories May 1989 - January 1992
Skills
Microsoft Office, Excel, Customer Service, Word, Customer Relations
Education
The Catholic University of America
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
Flight Nurse School, Brooks AFB, TX 1983 — 1983
Flight Nurse Certification, Flight Nurse
Everest Clinical Research July 2015 - Present
SynteractHCR, Inc. March 2014 - June 2015
SynteractHCR, Inc. December 2012 - March 2014
Covance Inc. 2008 - November 2012
Quintiles 2003 - 2008
eResearch Technology 2002 - 2003
TKL Research 1999 - 2002
Kendle International 1998 - 1999
ACER/Excel Inc. 1991 - 1998
Skills
Clinical Trials, CRO, Clinical Data Management, Clinical Monitoring, Oncology, Infectious Diseases, Clinical Research, Therapeutic Areas, Dermatology, Biostatistics, 21 CFR Part 11, GCP, CTMS, Clinical Study Design, Clinical Operations, Clinical Development, EDC, Pharmaceutical Industry, Drug Development, Medical Devices, Regulatory Submissions, Medical Writing, Gastroenterology, Regulatory Affairs, Protocol, Pharmacovigilance, FDA, Sop, Biotechnology, Vaccines, SOP, Biometrics
Education
Texas A&M University
Ph.D.
Texas A&M University
M.S.
University of Minnesota-Twin Cities
B.S.
PPD April 2013 - Present
PPD April 2012 - Present
PPD October 2010 - March 2013
Orchard Healthcare Research December 2008 - October 2010
RPS inc/ Tap pharmaceuticals July 2007 - July 2008
Astellas Pharma February 2007 - July 2007
NeoPharm, Inc. March 2006 - December 2006
Kendle International October 2004 - March 2006
Skills
Oncology, ICH guidelines, Clinical Research
Education
The University of Chicago Booth School of Business 2003 — 2004
Certification in Clinical Trials Management, Clinical Trials
Università di Bologna 1994 — 2000
Pharmaceutical Chemistry and Technology, Pharmacy
ICON plc February 2013 - Present
PRA International June 2012 - November 2012
INC Research August 2011 - March 2012
Kendle International March 2011 - August 2011
Kendle International March 2010 - February 2011
Kendle International July 2008 - February 2010
Kendle International Inc. August 2006 - July 2008
Charles River Laboratories June 2005 - August 2006
PRA International 2001 - 2005
Innovex 1988 - 1996
Skills
Clinical Development, Clinical Trials, CRO, Clinical Trial..., Clinical Monitoring, Metrics Definition, Metrics Analysis, Performance Metrics, Process Improvement, Resource Management, Resource Allocation, Quality, Standardization, Operations Management, Operational Excellence, Project management, CTMS
Education
University of Kansas 1997 — 1999
MBA
University of York 1980 — 1983
BSc. Biology
INC Research May 2011 - February 2015
Kendle international, Inc. 2006 - May 2011
Kendle International 2003 - 2006
IMIC (Mexican Instutue for Clinical Research) 2001 - 2003
Skills
Clinical Monitoring, CTMS, ICH-GCP, Clinical Trial..., CRO, GCP, EDC, Clinical Research, Therapeutic Areas, Pharmacovigilance, Clinical Data Management, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Infectious Diseases, Oncology, Clinical Development, Oracle Clinical, Clinical Operations
Education
The George Washington University School of Medicine and Health Sciences 2010 — 2014
MSHS, Clinical Research Administration
National Autonomous University of Mexico (UNAM 1994 — 2001
MD
Quintiles September 2015 - Present
Quintiles May 2014 - September 2015
Quintiles April 2011 - May 2014
PPD May 2010 - April 2011
Kendle International July 2007 - May 2010
Kendle International April 2006 - July 2007
Domin-8 Enterprise Solutions January 2005 - April 2006
Skills
Oncology, Neurology, Gastroenterology, Dermatology, Cardiology, Clinical Trials, Psychiatry, Asthma, Osteoporosis, Clinical Research, Pharmaceuticals, Pharmaceutical Industry, Dependable Team Player, GCP, EDC, Infectious Diseases, ICH-GCP, Medical Devices, CTMS, Pulmonology, Collaborative Problem..., Therapeutic Areas, Clinical Development, CRO, Clinical Data Management, Endocrinology, Protocol
Education
University of Cincinnati 1999 — 2003
Bachelor of Arts, Communication
ICON plc June 2014 - Present
INC Research May 2012 - December 2013
i3 Research September 2009 - May 2012
Kendle August 2008 - September 2009
Kendle International September 2007 - September 2008
Kendle International September 2005 - September 2007
Kendle International September 2003 - September 2005
Kendle International November 1999 - September 2003
Oncology/Hematology Care, Inc. January 1994 - November 1999
Skills
Clinical Trials, Regulatory Affairs, Clinical Research, Vendor Management, Regulatory Submissions, Leadership, CRO, Strategy, Therapeutic Areas, GCP, Clinical Development, CTMS, Clinical Monitoring, EDC, ICH-GCP, Pharmaceutical Industry
Education
University of Cincinnati College of Pharmacy 2007 — 2009
MS, Pharmaceutical Sciences
University of Cincinnati 1989 — 2004
BS, Business Management
Lehman Catholic High School
NexBank Capital Advisors April 2012 - January 2015
Kendle International June 2002 - February 2008
Brown-Forman June 1999 - September 2001
PwC September 1995 - April 1999
Skills
Technical Accounting, Revenue Recognition, US GAAP, SEC filings, Auditing, CPA, Financial Reporting, Financial Accounting, Internal Audit, FINOP, Finance, Big 4, Accounting, Internal Controls, Management, SEC Filings, Financial Analysis, Financial Modeling, Sarbanes-Oxley Act
Education
The University of Texas at Austin 1991 — 1994
BBA, Accounting
Hill-Rom March 2014 - Present
LexisNexis (through Populus) November 2012 - March 2014
Fifth Third Bank (through TEKsystems) September 2012 - November 2012
INC Research July 2011 - March 2012
Kendle International January 2008 - July 2011
Kendle International November 2006 - January 2008
Kendle International February 2002 - November 2006
Kendle International March 1999 - February 2002
Procter & Gamble (consulting for Belcan Engineering) January 1997 - February 1999
Procter & Gamble (consulting for Belcan Engineering) 1992 - December 1996
Skills
MS Project, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher, Scrum, QuickBooks, SharePoint, Project Management, Project Portfolio..., Risk Management, Agile Project Management, InfoPath Forms, Lotus Notes, Outlook, Mechanical Engineering, Change Management, FMEA, IT Strategy, Data Privacy, Visio, Capital Budgeting, Website Development, Business Process..., Technical Documentation, 21 CFR Part 11, Issue Management, PMP, Process Improvement, Project Engineering, Communication Skills, SDLC, Cross-functional Team..., Software Documentation, Quality Assurance, Business Intelligence, PowerPoint, Management, Testing, ERP, Strategy, Leadership, Team Leadership, Resource Management
Education
University of Cincinnati 1991 — 1993
MS, Mechanical Engineering
University of Cincinnati 1980 — 1985
BSMET, Mechanical Engineering Technology
Ora (Ophthalmic Research Associates) November 2010 - Present
Kendle International April 2008 - November 2010
PPD Global Central Labs April 2004 - April 2008
Cambrex April 2002 - April 2004
Dell Computer Corporation September 1999 - September 2001
Iomega July 1997 - September 1999
Johnson & Johnson (Ethicon Endo-Surgery) June 1992 - July 1997
Rockwell International June 1988 - June 1992
Skills
Forecasting, Financial Modeling, Analysis, Cross-functional Team..., Finance, Leadership, Management, Pharmaceutical Industry, Process Improvement, Strategic Planning
Education
The Ohio State University Fisher College of Business
MBA, International Business
University of Cincinnati
B.A., Economics
Certified Management Accountant
CMA - 1994
Diplomate in Laboratory Mgmt(ASCP)
DLM(ASCP) - 2010
Array Biostatistics January 2014 - Present
Independent Consultant May 2013 - December 2014
INC Research October 2011 - May 2013
Kendle International January 2011 - September 2011
Kendle International November 2006 - December 2010
Kendle International January 1999 - October 2006
PharmaResearch Corporation May 1997 - December 1998
University of Pittsburgh, Epidemiology Data Center August 1990 - May 1997
University of North Carolina at Chapel Hill, Collaborative Studies Coordinating Center August 1985 - August 1989
Skills
Biostatistics, CRO, Clinical Trials, GCP, SAS, Clinical Development, CDISC, SDTM, Clinical Data Management, Statistical Programming, Clinical Study Design, EDC, ICH-GCP, Statistical Computing, Therapeutic Areas, Pharmaceutical Industry, Clinical Research, SAS Programming, Drug Development
Education
State University of New York at Buffalo 1976 — 1978
Master of Science (MS), Statistical Science
State University of New York at Albany 1971 — 1975
Bachelor of Science (BS), Mathematics
OptumInsight February 2011 - Present
Kendle International March 1994 - December 2010
Hill Top Research February 1991 - March 1994
University of Cincinnati Medical Center, Hoxworth Blood Center June 1988 - July 1992
Education
Thomas More College 1983 — 1988
BA, Biology
Actelion August 2012 - Present
Bristol-Myers Squibb June 2010 - July 2012
P&G Pharmaceuticals December 2004 - June 2010
Kendle International October 2002 - October 2004
P&G Pharmaceuticals June 1994 - September 2002
Cincinnati Drug & Poison Information Center June 1990 - June 1994
Education
University of Cincinnati 1992 — 1994
Pharm.D., Pharmacy
University of Cincinnati 1985 — 1990
BS Pharmacy, Pharmacy
Vantiv November 2012 - Present
Vantiv November 2012 - September 2013
Vantiv March 2010 - November 2012
Fifth Third Processing Solutions November 2009 - May 2010
Kendle International May 2008 - December 2009
Fifth Third Bank December 2002 - May 2008
General Electric May 1999 - December 2002
Skills
Scripting, Cooking, Problem Solving, Vulnerability Assessment, Penetration Testing, Intrusion Detection, Perl, Log Management, Security, Vulnerability Management, Information Security, Active Directory, Computer Forensics, Incident Response, Application Security, Information Security..., IT Audit, ISO 27001, Computer Security, Business Continuity, Enterprise Architecture, PCI DSS, CISSP, General Awesomeness, Network Security, Data Security, CISM, Security Architecture..., Disaster Recovery, Payment Industry, Encryption, Security Audits, Malware Analysis, Firewalls, Identity Management, Enterprise Risk..., IPS, CISA, Security Policy, Checkpoint, Security Awareness, GLBA, COBIT, Incident Management, Cloud Security, IT Risk Management, Vulnerability Scanning, IDS, Network Architecture
Education
Transylvania University 1998 — 2002
Bachelor of Arts, Computer Science
Loveland High 1994 — 1998
InvaGen Pharmaceuticals Inc June 2014 - Present
InvaGen Pharmaceutical Inc. August 2010 - June 2014
Kendle International June 2007 - August 2009
Skills
Clinical Research, Clinical Trials, Pharmaceuticals, FDA, Pharmacovigilance, Drug Safety, Pharmaceutical Industry, Oncology, Clinical Monitoring, Pharmacology, Therapeutic Areas, CRO, GCP, ICH-GCP, Regulatory Affairs, Clinical Data Management, Protocol, Pharmaceutics, Quality Assurance, Regulatory Submissions, CTMS, GLP, Clinical Development, Pharmaceutical Research, Medical Affairs, Validation, ANDA, Clinical Operations, EDC, Clinical Pharmacology, Oracle Clinical, Regulatory Requirements, Generic Programming, Medical Writing, Pharmacokinetics, CRF design, Biotechnology
Education
Tamil Nadu Doctor M.G.R. Medical University 2005 — 2007
Post Graduate, M.Pharm (Pharmacology)
Uttar Pradesh Technical University 2001 — 2004
B.Pharmacy, Pharmacy
Gandhi College of Pharmacy 1999 — 2001
Associate, Pharmacy
Boehringer Ingelheim, Wien January 2012 - Present
Baxter Innovations GmbH, Vienna July 2007 - August 2011
Baxter Innovations GmbH September 2006 - June 2007
Kendle International January 2003 - August 2006
Ingenium Pharmaceuticals AG January 2001 - August 2002
MWG Biotech AG February 2000 - November 2000
Education
Universität Bremen 1994 — 1999
Diplom, Biologie
Universtity of Melbourne 1997 — 1998
Microbiology
IT Advisory Group September 2012 - Present
IT Advisory Group 2005 - Present
Kendle International September 2007 - May 2009
Luxottica Retail 2006 - 2006
Sun Microsystems 1997 - 2005
E. W, Scripps Company 1987 - 1997
Procter & Gamble 1977 - 1987
Skills
Management, Process Improvement, ITIL, SDLC, Project Management, Business Analysis, Business Intelligence, Change Management, Strategy, PMP, ERP, Data Warehousing, CRM, Enterprise Architecture, Solution Architecture, Program Management, Outsourcing
Education
United States Naval Academy 1965 — 1969
BS, Engineering
Madeira High School
University of Southern California
MS, Systems Management
SynteractHCR, Inc. February 2012 - Present
ZymoGenetics/BMS October 2004 - Present
Serenity Pharmaceuticals January 2009 - November 2014
IBSA December 2008 - April 2009
Kendle International December 2005 - November 2008
Clinsys Clinical Research April 2004 - December 2005
Ferring Pharmaceuticals October 1999 - January 2004
Boehringer Mannheim 1993 - 1998
IBRD 1991 - 1998
Boehringer Mannheim 1989 - 1991
Education
The Johns Hopkins University 1984 — 1988
B.S, Business Management/Leadership
Theorem Clinical Research May 2014 - Present
CTI Clinical Trial and Consulting Services June 2008 - Present
Freelance January 2010 - May 2014
Kendle International 2007 - 2008
Advanced Biological Technologies 2005 - 2007
Cincinnati Childrens Hospital Medical Center 2005 - 2005
Skills
Clinical Trials, Diabetes, Molecular Biology, Immunology, Transplant, Cell, Drug Development, Genetics, Therapeutic Areas, Oncology, Research, Stem Cells, Protocol, Medicine, IND, Lifesciences, Data Analysis
Education
University of California, Los Angeles
PostDoc, Atherosclerosis/Genetics
University of Florida
Ph.D., Molecular Biology
University of Central Florida
B.S., Biology
INC Research October 2010 - Present
Kendle International September 2007 - April 2012
Kendle International January 2007 - September 2007
Kendle International January 2005 - December 2006
Skills
CRF design, Clinical Trials, Clinical Research, Validation, Clinical Data, Clinical Data Management, EDC, CRO, Oracle Clinical, ICH-GCP, GCP, CTMS, 21 CFR Part 11, Data Management, Phase I, Therapeutic Areas
Education
The George Washington University 2006 — 2008
MS, Clinical Research Administration
Tufts University 2000 — 2004
BS, Biopsychology
Alcon Laboratories, Inc. October 2013 - Present
Genentech June 2012 - October 2013
Actelion January 2012 - July 2012
Gilead Sciences April 2008 - January 2012
Kendle International April 2007 - April 2008
PPD January 2007 - April 2007
Grand View College August 2005 - December 2005
MedTrials, Inc. June 2003 - August 2004
Skills
Oncology, Ophthalmology, Pulmonary Hypertension, Glaucoma, Macular Degeneration, Gynecologic Oncology, Clinical Research, Biochemistry, Hypertension, Clinical Trials, GCP, CRO, Neurology, CTMS, Clinical Development, Infectious Diseases, Therapeutic Areas, Clinical Operations, Clinical Data Management, Clinical Study Design
Education
University of North Texas Health Science Center at Fort Worth 2002 — 2003
Master of Science, Biomedical Science, Clinical Research Management
The University of Texas at Arlington 2000 — 2002
Bachelor of Science, Pre-Med, Biology with Chemistry Minor
Crandall High School 1996 — 1999
HS Diploma, Valedictorian of Senior Class
Nationwide Childrens Hospital June 2015 - Present
University of Cincinnati November 2011 - May 2015
Pennsylvania MidAtlantic AIDS Education and Training Center 2007 - February 2012
Kendle International October 2010 - July 2011
Medpace February 2010 - July 2010
Statking Consulting September 2008 - January 2010
University of Cincinnati June 2003 - July 2007
Skills
Clinical Trials, GCP, Clinical Research, Oncology, FDA, CTMS, Leadership, Clinical Monitoring, Clinical Study Design, Sop, Clinical Development, Medical Writing, Regulatory Affairs, Medical Devices, Healthcare, Management, Pharmacovigilance, Pediatrics, Regulations, Women's Health, Endocrinology, CRO, EDC, Regulatory Submissions, Phase 2, Infectious Diseases, ICH-GCP, Research, Project Management, Vascular Surgery, Hemodialysis, Phase I, Phase 3, Public Speaking, Medicine, Quality Assurance, Diabetes, Pharmaceutical Industry, Oncology Clinical..., Nephrology, Post Market Surveillance, Nursing Management, SOP
Education
University of Cincinnati College of Nursing 2013 — 2016
Doctor of Philosophy (PhD), Nursing Research
University of Cincinnati 2006 — 2008
MSN, Women's Health
University of Cincinnati 2000 — 2001
BSN, Nursing
Good Samaritan School of Nursing 1996 — 1998
Diploma, Nursing
Walnut Hills 1987 — 1993
PRA Health Sciences August 2015 - Present
PRA Health Sciences August 2013 - August 2015
PRA (previously ReSearch Pharmaceutical Services) January 2012 - August 2013
Advanced Recruiting Partners July 2010 - April 2012
Chiltern International 2008 - July 2010
Kendle International 2006 - 2008
PPD 2005 - 2006
James R Nelson, MD 2002 - 2005
Skills
Neurology, Myasthenia Gravis, Muscular Dystrophy, Duchenne, Clinical Research, Biotechnology, ICH-GCP, GCP, Clinical Trials, Musculoskeletal, Clinical Monitoring, Biologics, Ophthalmology, Infectious Diseases, CRO, Clinical Pharmacology, Pediatrics, EDC, Clinical Development, Therapeutic Areas, Oracle Clinical, CTMS, Gastroenterology, Immunology, Hematology, Pharmaceutical Industry, SOP, Inform, Regulatory Submissions, Regulatory Affairs, Drug Development, Protocol, Pharmacovigilance, Clinical Operations, Medical Devices
Education
University of California, Berkeley 2000 — 2005
Bachelor's Degree, Integrative Biology/Human Biodynamics
University of California, San Diego 2008 — 2009
Master's degree, Clinical Research
UC Health May 2013 - July 2015
UC Health February 2012 - May 2013
UC Health University of Cincinnati Medical Center July 2011 - February 2012
UC Health University of Cincinnati Medical Center March 2010 - July 2011
Kendle International 2007 - 2010
Skills
Healthcare Management, Leadership, Hospital Administration, Strategic Planning, Operations Management, Business Development, Team Building, Process Improvement, Medical Practice..., Customer Experience, Project Management, Clinical Research..., Patient Advocacy, Physician Relations, Physician Network..., Program Development, Team Facilitation, Professional Mentoring, Leading Change, Leadership Development, Contract Negotiation, Business Process..., Quality Management, Relationship Building, Conflict Resolution, Regulatory Compliance, Navigating Healthcare..., New Business Start-Up, Business..., Event Planning
Education
Thomas More College
Bachelor of Business Administration (BBA), Business Administration
University of Cincinnati
Health Care Administration
INC Research July 2012 - Present
INC Research November 2010 - July 2012
Independent Consultant February 2010 - December 2010
Kendle International April 2008 - February 2010
Kendle International February 2007 - April 2008
Exhibitgroup/Giltspur (EG, a Viad Corporation) July 2006 - February 2007
CTI - Clinical Trial and Consulting Services, Inc October 2005 - July 2006
CTI Clinical Trial and Consulting Services January 2005 - September 2005
CTI Clinical Trial and Consulting Services August 2003 - December 2004
CTI Clinical Trial and Consulting Services June 2002 - August 2003
Skills
Event Management, Event Planning, Trade Shows, CRO, Sop, Marketing Communications, Corporate Events, Team Building, Account Management, GCP, Meeting Planning, Pharmaceutical Industry, Healthcare, Clinical Trials, Sales, Strategic Planning, Management, Program Management, Project Management, Strategy, Training, Clinical Research, CRM, Clinical Development, Budgets, Leadership, Marketing
Education
University of Cincinnati 1992 — 2000
BA, AA, Geography, General Studies
Pioneer Technologies Corporation April 2008 - Present
Computer Troubleshooters February 2006 - April 2008
Computer Sciences Corporation / ATD August 2004 - March 2006
Quietboom LLC May 2003 - August 2004
SCIREX Corporation March 1999 - May 2003
Kendle International July 1998 - March 1999
ViaSat April 1995 - July 1998
USMC April 1989 - April 1995
Skills
Information Technology, Windows Server, Database Administration, Windows, Microsoft SQL Server, IT Management, Program Management, Team Leadership, Team Building, Business Analysis, ITIL, VoIP, Active Directory, Security, Troubleshooting, SharePoint, Disaster Recovery, Software Documentation, VMware, Enterprise Architecture, Management
Education
The National University 1994 — 1998
B.S, Information Technology
Cincinnati Education and Research for Veterans Foundation, Inc. October 2014 - Present
University of Cincinnati September 2011 - Present
Hill Top Research September 2009 - June 2010
Kendle International January 2008 - May 2009
LBR Regulatory and Clinical Consulting Services January 2007 - August 2007
Cincinnati Children's Hospital Medical Center December 2003 - December 2006
Kennedy Health System June 1999 - December 2002
Skills
Management, Software Documentation, Microsoft Excel, Research, Leadership, Strategic Planning, Data Analysis, Microsoft Office, Project Management, Team Building, Customer Service, Sales, Marketing, Public Speaking, Project Planning, Team Leadership, Social Media, Market Research, Clinical Research, Recruiting, Healthcare, Clinical Trials, Sop, IRB
Education
University of Cincinnati 2003 — 2007
Theorem Clinical Research October 2014 - Present
PPD September 2012 - September 2014
PharmaNet/i3 January 2009 - September 2012
Hewlett-Packard February 2008 - January 2009
Kendle International November 2004 - February 2008
GKNobloch February 2004 - November 2004
ACNielsen June 2001 - December 2002
Education
Universidad Nacional Autónoma de México 1997 — 2001
2002Bachelor, on Applied Mathematics and Computers
INC Research July 2011 - Present
Kendle International March 2010 - July 2011
Kendle International October 2008 - March 2010
Kendle International March 2008 - October 2008
Kendle International March 2007 - March 2008
Kendle International January 2007 - March 2007
Kendle International June 2006 - January 2007
Kendle International July 2005 - June 2006
Kendle International June 2003 - June 2005
Kendle International August 2001 - May 2003
Skills
Clinical Data Management, Clinical Research...
Education
University of Cincinnati 1993 — 1997
BS, Biology
inVentiv Health Clinical July 2015 - Present
PRA Health Sciences April 2013 - Present
Bazaarvoice November 2011 - April 2013
Genetic Research Affiliates LLC September 2010 - April 2013
Starwood Hotels & Resorts Worldwide, Inc. July 2010 - August 2010
PPD November 2009 - July 2010
Kendle International September 2008 - February 2009
Quintiles October 2006 - July 2008
Solução Supernova 2006 - 2007
Arquest Scientific Consulting May 2006 - October 2006
Skills
System Monitoring, GCP, Sop, Clinical Research, Clinical Trials, Protocol, Regulatory Requirements, Diabetes, IRB, Clinical Monitoring, Medical Devices, CRO, CTMS, ICH-GCP, Oncology, EDC, Therapeutic Areas, Clinical Development, Ophthalmology, Biotechnology, Regulatory Affairs, Regulatory Submissions, Pharmacovigilance, Rheumatoid Arthritis, Medical Writing, Pharmaceutical Industry, FDA, Clinical Data Management, Oncology Clinical..., Clinical Operations, Lifesciences, Immunology, Cardiology, CRF design, Pharmaceutics, Infectious Diseases, Drug Development, Drug Discovery, Vaccines, Data Management, Neuroscience, Neurology, Dermatology, Endocrinology, Inform, Pharmacology, Clinical Research..., Clinical Study Design, Clinical Pharmacology, Rheumatology
Education
Universidade de São Paulo 2003 — 2005
Masters, Cancer Chemoprevention- Experimental Nutrition
Universidade de São Paulo 1998 — 2002
Bachelor, Pharmaceutical Sciences and Biochemistry
Cincinnati Children's Hospital Medical Center May 2014 - Present
INC Research July 2012 - May 2014
INC Research November 2010 - May 2012
Kendle International April 2008 - November 2010
Kendle International November 2006 - April 2008
Skills
Clinical Trials, Clinical Data Management, EDC, CRO, Clinical Research, Data Management, ICH-GCP, Oracle Clinical, Clinical Monitoring, GCP, Clinical Development, Microsoft Excel, Process Improvement, Inform, CRF design, Therapeutic Areas, Informatics, Microsoft CRM, Instructional Manuals, Data Cleaning, Data Analysis, 21 CFR Part 11, OC RDC, Survey Design, Service Desk, Employee Training, Training, Databases, Microsoft Office, Outlook Express, Microsoft Word, Access, Visio, PowerPoint, Lotus Notes, InfoPath
Education
The Ohio State University 2001 — 2006
Communication, Interactive Communication Processes
Ursuline Academy 1997 — 2001
Logicalis June 2013 - Present
Paycor October 2010 - June 2013
Kendle International July 2008 - October 2010
PlaneTechs LLC 2006 - 2007
Convergys 1998 - 2004
Ryland Homes 1996 - 1998
Skills
Process Improvement, Quality Assurance, Software Documentation, Leadership, Business Analysis, SDLC, SharePoint, Requirements Analysis, Project Management, Team Building, Software Project..., Training, PMP, Agile Methodologies, Program Management, Visio, Requirements Gathering, Analysis, Business Process..., Vendor Management, Management, Cross-functional Team...
Education
The George Washington University - School of Business 1999 — 2001
Masters Certificate, Project Management
Parks College
University of Central Oklahoma
Bachelor's degree
University of Cincinnati
Master's degree
SIGA Technologies December 2014 - Present
Artcraft Health Clinical Trials June 2013 - December 2014
LabCorp Clinical Trials November 2011 - November 2012
Eurofins Global Central Laboratory March 2010 - December 2011
LabConnect LLC September 2006 - March 2010
NovoNordisk May 2004 - July 2006
Advanced Biologics (acquired by INC Research) 2002 - 2004
Advanced Biologics (acquired by INC Research) 2001 - 2002
Kendle International 2000 - 2001
Skills
Account Management, Vendor Management, CRM, Pharmaceutical Sales, CRO, Clinical Trials, Clinical Development, Pharmaceutical Industry, Oncology, Biotechnology, CTMS, Clinical Research, GCP, Infectious Diseases, EDC, Data Management, Cardiology, Cross-functional Team..., Project Management, Drug Development, Diabetes, Clinical Data Management, 21 CFR Part 11, Laboratory, Clinical Monitoring, ICH-GCP, Strategic Partnerships, Contract Negotiation, Management, Business Development, Lifesciences, Therapeutic Areas, Sop, Medical Devices, Neurology, Strategy, Biopharmaceuticals, FDA, Vaccines, Immunology, Medical Writing, Regulatory Submissions, Regulatory Affairs, GLP, Validation, Pharmaceutics, Life Sciences, SOP
Education
The George Washington University School of Medicine and Health Sciences 2004 — 2006
MSHS, Clinical Research
The College of New Jersey 1984 — 1985
BSN, Nursing
The E.W. Scripps Company April 2015 - Present
Omnicare June 2011 - April 2015
Kendle International October 2010 - June 2011
Kendle International April 2007 - October 2010
American Financial Group, Inc. June 2000 - March 2007
Education
Thomas More College 1995 — 1999
INC Research February 2012 - January 2014
Strategic Medical Associates April 2010 - January 2012
Meetings & Events March 2010 - January 2012
Kendle International August 2007 - February 2010
Kendle International September 2004 - August 2007
P&G Pharmaceuticals September 2000 - September 2004
P&G Pharmaceuticals August 1997 - September 2000
P&G Pharmaceuticals August 1991 - August 1997
Skills
Leadership, Strategy, Program Management, Meeting Planning, Clinical Development, Pharmaceutical Industry, Regulatory Affairs, Management, Project Management, Clinical Trials, Budgets, Training, Proposal Writing, Event Management, Business Development, Recruiting
Education
University of Cincinnati 1975 — 1976
Health Care Business Management Strategic Courses
University of Cincinnati 1969 — 1971
RT, Jewish Hospital School of Radiologic Technology
Cincinnati Children's Hospital Medical Center February 2006 - Present
Kendle International April 2005 - February 2006
University of Cincinnati July 1998 - July 2005
University of Cincinnati July 1996 - July 1998
University of Cincinnati January 1987 - July 1996
Skills
EDC, Clinical Trial..., Database Design, Mentoring Of Staff, Youth Mentoring, ICH-GCP, Regulatory Submissions, Regulatory Requirements, GCP, CCRP, Recruiting, Recruitment Advertising, CRF design, Medical Terminology, Database Administration, Data Entry, Team Leadership, Highly Detailed, Administrative..., Customer Service, Community Outreach, Coordination, CRP, Clinical Trials, Training, Protocol, FDA, Clinical Monitoring, Patient Recruitment, Clinical Data Management, Oracle Clinical, Inform, CTMS, CRO, Therapeutic Areas, IRB, Informed Consent, Leadership, Strategic Planning, Team Building, Clinical Research, Management, Public Speaking
Education
University of Phoenix 2007 — 2009
Masters, Health Administration
University of Cincinnati 1976 — 1982
BA, Psychology
2010SOCRA
CCRP
INC Research July 2011 - Present
Cincinnati Children's Hospital Medical Center February 2013 - September 2013
Kendle International April 2001 - July 2011
Whittman-Hart July 1996 - April 2001
Skills
Validation, Software Documentation, .NET, HTML, 21 CFR Part 11, CRO, Vendor Management, SharePoint, SDLC, GCP, Quality Assurance, FDA
Education
University of Cincinnati 1995 — 1996
BBA, Information Systems
The Ohio State University 1989 — 1993
BS, Economics
KPMG US August 2015 - Present
Prever Business Solutions July 2012 - Present
Honda of America Mfg., Inc. August 2014 - April 2015
BCBSNC September 2013 - August 2014
Apex Systems April 2013 - August 2013
Ajilon Australia September 2012 - March 2013
Eastman Kodak September 2011 - January 2013
Battelle 2012 - 2012
Kendle International June 2009 - July 2011
KPMG/BearingPoint April 1999 - September 2009
Skills
IT Strategy, Peoplesoft ESA, PeopleSoft Financial, Siebel 7.x, SAP FICO, SAP R/3, Business Process..., Project Management, Program Management, Enterprise Architecture, Technology Solutions, Project Planning, Change Management, Business Process..., Business Process..., Technology Integration, IT Outsourcing, Business Objects, Business Intelligence, PeopleSoft, CRM, Outsourcing, Strategy, Business Process, Integration, Consulting, Process Improvement, ERP, Enterprise Software, Cross-functional Team..., SDLC, Management, Leadership, Business Analysis
Education
Texas A&M University
MBA
inVentiv Health Clinical November 2013 - Present
PharmaNet/i3 September 2012 - November 2013
PharmaNet/i3 April 2009 - September 2012
Northstar Neuroscience September 2006 - April 2009
Northstar Neuroscience September 2006 - January 2008
Kendle International March 2006 - September 2006
Kendle International July 2004 - March 2006
Kendle International March 2002 - July 2004
Kendle International September 2000 - March 2002
Kendle International March 1999 - September 2000
Skills
SAS programming, ICH-GCP, Validation, Sop, Medical Devices, SAS, EDC, Clinical Data Management, Clinical Trials, Statistical Programming, Statistics, Regulatory Submissions, CRO, Clinical Study Design, Data Analysis, Therapeutic Areas, Protocol, SOP, Regulatory Affairs, Neurology
Education
University of Cincinnati 1983 — 1986
MBA - Finance
Wittenberg University 1976 — 1980
BA, Biology, Chemistry
Ad Spice Promotional Marketing August 2012 - Present
A Better Image Printing October 2010 - Present
Councilor, Buchanan & Mitchell, PC January 2006 - June 2008
Legg Mason April 2004 - December 2005
Kendle International 2003 - 2004
Kendle International 2001 - 2003
AAC Consulting Group, Inc. 1997 - 2001
Skills
Advertising, Digital Printing, Leadership, Public Speaking, Online Advertising, Direct Mail, Strategic Planning, Offset Printing, Corporate Gifts, Marketing, Customer Service, Marketing Strategy, Small Business, Microsoft Office, Account Management, InDesign, Start-ups, Screen Printing, Budgets, New Business Development
Education
The George Washington University - School of Business 1994 — 1999
MBA
University of Maryland College Park 1982 — 1986
BA, Eonomics
Roche October 2014 - Present
Boehringer Ingelheim 2011 - Present
Kendle International 2011 - 2011
Hospital Affiliated Research Centre 2008 - 2010
Stanley Academy 2007 - 2008
Providence Institute for Health Research 2006 - 2008
CHS 2003 - 2006
Skills
GCP, CTMS, Clinical Trials, Clinical Research, Sop, ICH-GCP, Clinical Monitoring, CRO, Clinical Data Management, Clinical Development, Project Management, Project Planning, Respiratory Disease, Anticoagulation, Cardiovascular Disease, Atrial Fibrillation, COPD, Exercise Physiology, SOP, Biotechnology, FDA, Pharmaceutical Industry, Protocol
Education
University of Medicine and Pharmacy Cluj Napoca 1995 — 2001
Doctor of Medicine (MD), Medicine
The University of British Columbia
Master of Public Health, Public Health, Research Methodology, Global Health
Kendle International 2008 - Present
Lenovo 2014 - 2015
Lenovo 2014 - 2015
Lenovo 2014 - 2015
Credit Suisse 2006 - 2007
GSK 2005 - 2006
Education
University of North Texas 1984 — 1986
Computer Science
The University of Texas at Austin 1981 — 1983
Computer Science
PPD July 2012 - Present
INC Research (Kendle International) May 2009 - July 2012
Kendle International May 2006 - May 2009
Kendle International, Inc April 2007 - August 2008
Skills
Clinical Research, Clinical, Clinical Trials, CRF design, Validation, Team Leadership, EDC
Education
The University of Texas Health Science Center at Houston 1990 — 1996
Ph.D, Cancer Biology
University of Madras 1987 — 1990
M.Sc, Medical Microbiology
Fatima Matriculation Higher Secondary School, Madras
Mercy Health (formerly Mercy Health Partners) August 2013 - Present
ZF Friedrichshafen contract job May 2013 - July 2013
Executive Jet Management January 2013 - May 2013
UC Health 2003 - December 2012
Griffin Industries 1999 - 2002
Kendle International 1998 - 1999
Griffin Industries 1997 - 1998
MATRIXX Marketing 1994 - 1997
Mercantile Stores Company 1992 - 1994
Skills
Access, Lawson, Accounts Payable, Account Reconciliation, Journal Entries, Cash Management, 10 Key, Excel, Word, Outlook, Fixed Assets, Tax, Wire, Crystal Reports, Use Tax, Property Tax, OnBase, Lawson General Ledger, Financial Statements, Invoicing
Education
Thomas More College 1987 — 1991
Bachelor's degree, Accounting
Thomas More College
BS, Accounting
Pacific Research Solutions, LLC April 2006 - Present
Kendle International April 2003 - March 2005
Baxter Healthcare, Inc. 1998 - 2003
Education
University of California, San Diego 1984 — 1988
INC Reseach December 2013 - Present
INC Research February 2013 - December 2013
INC Research (Previously Kendle International) September 2011 - February 2013
Kendle International November 2010 - September 2011
Kendle International April 2008 - November 2010
Kendle International September 2007 - April 2008
New Hanover Regional Medical Center January 2006 - October 2007
Good Samaritan Hospital 1998 - 2005
Skills
Epidemiology, Infectious Diseases, Clinical Research, GCP, Clinical Trials, Biostatistics, CTMS, Clinical Development, Vaccines, Oncology, Research, Clinical Study Design, Data Management, CRO, Pharmaceutical Industry, Clinical Data Management, Biotechnology
Education
University of North Carolina at Chapel Hill 2007 — 2010
Masters Public Health Leadership
Thomas More College 1994 — 1998
BSN
PAREXEL International November 2014 - Present
PAREXEL 2010 - Present
PAREXEL International April 2010 - November 2014
Kendle International July 2001 - July 2003
Skills
EDC, Clinical Trials, GCP, CTMS, Clinical Development, Team Building, CRO, Clinical Monitoring, Clinical Data Management, Therapeutic Areas, ICH-GCP, Oncology, Pharmaceutical Industry, SOP
Education
University of California, Irvine 1993 — 1995
Bachelor of Science (BS), Biological Sciences
University of California, Los Angeles 1988 — 1991
Bachelor of Arts (BA), Psychology
Novartis December 2013 - Present
INC Research May 2011 - November 2013
Kendle International February 2008 - May 2011
Reata Pharmaceuticals December 2007 - February 2008
Orthofix INC July 2007 - December 2007
Kendle International November 2004 - July 2007
Benaroya Research Institute April 2002 - March 2004
Skills
GCP, Clinical Trials, Clinical Data Management, CRO, EDC, Oracle Clinical
Education
University of Calicut
The Windsor Leigh Group LLC 2004 - Present
Sanofi-Synthelabo 2002 - 2004
ALZA Corporation 2000 - 2002
Kendle International 1998 - 2000
Skills
New Business Development, Product Development, Direct Sales, Pharmaceutical Sales, Neurology, Managed Care, Sales Management, Psychiatry, Entrepreneurship
Education
University of Cincinnati 1981 — 1984
BA, Economics and Business
INC Research September 2013 - Present
INC Research August 2011 - September 2013
Kendle International May 2001 - August 2011
Kendle International August 1996 - May 2001
Catholic Health Initiatives July 1988 - August 1996
Skills
Contract Negotiation, Team Building, Negotiation, Budgets, Management, New Business Development, Microsoft Excel, Business Development, Leadership, Account Management, Training
Education
Thomas More College 2007 — 2009
MBA, Business Administration
INC Research May 2012 - Present
Kendle International 1996 - Present
INC Research August 1996 - May 2012
Skills
EDC, CRO, GCP, Clinical Trials, CTMS
Education
Thomas More College 1983 — 1987
INC Research July 2011 - Present
Kendle International January 2011 - July 2011
New England IRB June 2007 - January 2011
CenterWatch 2002 - 2010
New England IRB June 2005 - June 2007
Skills
Clinical Development, Pharmaceutical Industry, New Business Development, Biotechnology, CRO, Oncology, Clinical Trials, Clinical Research, Lifesciences, Infectious Diseases, Cardiology, Medical Devices
Education
The Ohio State University
BA, Journalism, Business, French
Tyco October 2014 - Present
Tyco Security Products May 2012 - September 2014
Vantiv March 2011 - March 2012
Kendle International April 2008 - March 2011
C-Change Young Professional Leadership Development Program January 2010 - December 2010
Cintas June 2004 - April 2008
Naval Historical Founation December 2002 - February 2003
International Monetary Fund December 2001 - February 2002
Skills
Mergers, Market Research, Financial Planning, Competitive Analysis, Financial Modeling, Mergers & Acquisitions, Valuation, Corporate Finance, Accounting, Process Improvement, Financial Analysis, Strategic Financial..., Strategy, Strategic Partnerships, Cash Flow, Forecasting, Portfolio Management, Budgets, Strategic Planning, Internal Controls, Management, Sarbanes-Oxley Act, Cross-functional Team..., Analysis, Due Diligence, Management Consulting, Acquisition Integration, Financial Reporting, Finance, Business Analysis
Education
The University of Chicago - Booth School of Business 2012 — 2015
Master of Business Administration (MBA), Economics and Entrepreneurship
University of Maryland College Park 2003 — 2005
Bachelor of Science, Finance and Accounting
Procter & Gamble September 2011 - Present
The David J. Joseph Co. July 2011 - August 2011
Kendle International August 2009 - July 2011
Various Clients May 2007 - July 2009
Marvin F. Poer and Company April 2002 - April 2007
Grant Thornton LLP May 1998 - March 2002
GE May 1994 - May 1998
GE August 1988 - May 1994
Skills
Property Tax, Tax Accounting, CPA, Sarbanes-Oxley Act, Fixed Assets, Internal Controls, General Ledger, Accounting, PeopleSoft, Budget, Financial Analysis, Business Planning, Financial Modeling, Budgets, Cash Flow, Access
Education
The University of North Dakota
Bachelor's degree, Accounting
Medpace June 2004 - Present
Medical Research Laboratories March 2001 - June 2004
Kendle International March 1999 - March 2001
Skills
Clinical Development
Education
University of Cincinnati College of Pharmacy 2005 — 2007
MS, Pharmaceutical Sciences (Drug Development)
Thomas More College 1994 — 1998
BA, Biology
Nektar Therapeutics August 2015 - Present
Nektar Therapeutics June 2014 - August 2015
Nektar Therapeutics December 2013 - June 2014
Nektar Therapeutics October 2012 - December 2013
Nektar Therapeutics February 2012 - October 2012
Gilead Sciences December 2010 - June 2011
Amgen November 2005 - December 2010
Kendle International March 2005 - November 2005
American Medical Response May 2000 - March 2005
Skills
Biotechnology, Clinical Data, Clinical Trials, FDA, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Research, GCP, EDC, 21 CFR Part 11, Drug Development, SOP, Clinical Data Management, Data Management
Education
University of California, Irvine 1999 — 2003
B.Sc., Biological Sciences
Valley Forge Military Academy & College 1993 — 1999
PPD Quality Assurance ManagerNavidea BiopharmaceuticalFebruary 2010 - June 2014
Kendle International January 2008 - April 2009
PharmaFORCE November 2006 - December 2007
Alkermes March 2006 - November 2006
Boehringer Ingelheim March 2005 - March 2006
Skills
FDA GMP/GCP, EMA, Quality Auditing, Quality Management, Analytical Method..., Training, Supply Chain Management, Aseptic Technique, Batch Release, CAPA, Deviation Management, OOS, Global Regulatory..., eCTD, Pharmacovigilance, SOP development, Clinical Trials, Clinical Monitoring, Radiopharmaceuticals, Medical Devices, Biologics, Positron Emission..., FDA, Quality System
Education
The Johns Hopkins University 2006 — 2009
Master of Science
University of Toledo 1999 — 2004
BS
Agility Clinical, Inc. March 2015 - Present
SynteractHCR September 2013 - February 2015
SynteractHCR January 2013 - September 2013
Synteract, Inc. February 2009 - January 2013
Novartis January 2007 - January 2009
Kendle International April 2006 - January 2007
PharmaNet November 2004 - April 2006
Scripps Clinic November 2002 - November 2004
Pacific Sleep Medicine October 2000 - October 2002
The Scripps Research Institute August 1999 - November 2000
Skills
GCP, Clinical Monitoring, EDC, CRO, CTMS, ICH-GCP, Clinical Trials, Clinical Research, Clinical Data Management, Therapeutic Areas, Clinical Development, Infectious Diseases, Clinical Operations, Drug Development, Regulatory Submissions
Education
University of California, San Diego 1994 — 1999
Bachelor of Arts (BA)
Amgen April 2015 - Present
Baxter Healthcare July 2012 - Present
Baxter BioScience May 2009 - November 2012
Kendle International March 2008 - May 2009
Skills
Oracle Clinical, EDC, Clinical Data, GCP, 21 CFR Part 11, Clinical Data Management, Clinical Trials, Pharmaceutical Industry, SOP
Education
University of California, Berkeley
BA, Molecular and Cell Biology
Shamrock Reins February 2014 - Present
ReSearch Pharmaceutical Services, Inc 1999 - April 2013
Kendle International 1997 - 1999
Quintiles (Innovex) 1995 - 1997
Omnicare Clinical Research (IBAH) 1993 - 1995
Covance (PACT) 1991 - 1993
Thomas Jefferson University Hospital 1987 - 1991
Skills
Nonprofit Management, Executive Level..., Research Trials
Education
Thomas Jefferson University 1988 — 1989
BSN, Registered Nursing/Registered Nurse
PharmaNet Resource Solutions June 2010 - December 2010
Kendle International 2008 - 2010
The Ohio State University December 1997 - December 2008
Abbott Nutrition 1996 - 1997
Skills
Molecular Biology, PCR, Immunology, Infectious Diseases, Cell Culture, Scientific Writing, Sop, Life Sciences, ELISA, Pharmaceutical Industry, Laboratory, SOP, Clinical Trials, Clinical Research, HPLC, Clinical Development, Immunohistochemistry, CRO, Biotechnology
Education
The Ohio State University 2002 — 2007
Doctorate, Molecular Biology
JPL Clinical Research January 2008 - Present
Kendle International August 2006 - January 2008
Charles River Laboratories June 2005 - August 2006
Education
Université du Québec à Trois-Rivières 1989 — 1994
B.Sc., Medical Biology
Pfizer August 2005 - Present
Pfizer (formerly Wyeth) 2005 - Present
Wyeth Research 2005 - October 2009
Pfizer 2005 - 2009
Transkaryotic Therapies 2004 - 2005
PAREXEL March 1999 - November 2004
Kendle International May 1997 - March 1999
TheraTech Inc. 1993 - 1998
Theratech. Inc 1993 - 1998
Skills
Oncology, Clinical, R&D, Biotechnology, Clinical Trials, GCP, Therapeutic areas, Clinical Research, CRO, Clinical Development, Drug Development, Infectious Diseases, FDA, CTMS, Pharmaceutical Industry, Regulatory Affairs, Therapeutic Areas, Clinical Monitoring, EDC, Regulatory Submissions, Medical Writing, Pharmacovigilance, Vaccines, Immunology, Medical Affairs, Protocol, Lifesciences, Drug Discovery, ICH-GCP, Sop, Hematology, Pharmacology, Clinical Data Management, Clinical Study Design
Education
The University of Texas Health Science Center at Houston 1978 — 1980
Masters in Public Health, International Public Health/International Health
Université Denis Diderot (Paris VII) 1972 — 1973
PhD, Biological Anthropology
ENAH 1967 — 1972
MA, Physical Anthropology
INC Research April 2011 - Present
Kendle International 2006 - March 2011
Charles River Laboratories 2004 - 2006
Inveresk Research 2004 - 2006
Skills
Clinical Monitoring, EDC, GCP, Clinical Research, Clinical Trials, Clinical Trial..., ICH-GCP
Education
University of Sherbrooke 1993 — 1995
Liceul C. Negruzzi, Iasi
PCMS March 2008 - February 2013
Kendle International 2008 - 2008
Convergys 1996 - 2007
Skills
Quality Assurance, Quality Center, User Acceptance Testing, Test Planning, SDLC, Software Quality..., Regression Testing, Analysis, Test Automation, Testing, System Testing, Manual Testing, Defect Tracking, Performance Testing, Test Cases
Education
Tennessee State University 1991 — 1996
Bachelor of Science, Computer Science
Indiana Wesleyan University
Masters of Science, Management
Avanir Pharmaceuticals March 2015 - Present
Allergan Pharmaceuticals January 2005 - March 2015
Kendle International June 2003 - December 2004
LSU Health Sciences Center June 2002 - May 2003
Skills
Oracle Clinical, Clinical Data Management, Data Management, Biostatistics, EDC, Clinical Trials, GCP, CRO, Clinical Development, Pharmaceutical Industry, CTMS, 21 CFR Part 11, ICH-GCP, Clinical Research, Oncology
Education
Tulane University School of Medicine 2001 — 2002
Master of Science, Biostatistics
University of California, Riverside 1998 — 2000
Bachelor of Science, Statistics
bluebird bio 2015 - Present
Shionogi Inc. 2010 - 2014
Celgene 2003 - 2010
PPD 2002 - 2003
Kendle International 2001 - 2002
Sparta Systems, Inc. 2000 - 2001
Interlink Rehab Services 1998 - 1999
Prism Rehab Systems, Inc. 1994 - 1998
Skills
Clinical Data Management, ICH-GCP, Oracle Clinical, CRO, EDC, CDISC, Clinical Trials, Clinical Research, Oncology, Medidata, Inform, CRF design, MedDRA, Cross-functional Team..., Clinical Trial..., SDTM, SOP development, Data Validation, Sop, 21 CFR Part 11, CTMS, Clinical Development
Education
Union County College 1995 — 1997
Associate of Science (A.S.), Physical Therapist Assistant
Saint John's University 1984 — 1988
Bachelor of Business/Athletic Administration (B.B.A.)
Ultragenyx Pharmaceutical Inc. August 2015 - Present
Amgen Inc. July 2004 - August 2015
Kendle International September 2003 - July 2004
MannKind Corporation June 2002 - September 2003
Skills
Medical Writing, Oncology, Clinical Development, Biotechnology, Immunology, HTA, Dossiers, Medical Communications, Publications, Value Propositions, Rheumatology, Metabolic Bone Disease, Healthcare Reimbursement, Clinical Trials, Regulatory Affairs, Medical Affairs, Pharmaceutical Industry, Drug Development
Education
University of California, Los Angeles
Doctor of Philosophy (PhD), Molecular Biology
University of California, Los Angeles
Bachelor of Science (BS), Biology, General
Genentech July 2015 - Present
Genentech December 2014 - July 2015
Takeda Oncology March 2013 - November 2014
Amgen April 2004 - January 2013
Kendle International 2001 - 2004
University of Cincinnati 1995 - 2001
Skills
Clinical Trials, GCP, 21 CFR Part 11, FDA, Sop, GLP, Regulatory Affairs, Oncology, Pharmacovigilance, Validation, Pharmaceutical Industry, Biotechnology, Quality Auditing, CRO, Clinical Development, Quality Assurance, Biopharmaceuticals, SOP
Education
The Johns Hopkins University 2012 — 2015
Master's degree, Regulatory Science
University of Pittsburgh
BSN, Nursing
PAREXEL July 2015 - Present
PAREXEL July 2008 - July 2015
JPL Clinical Research December 2007 - May 2008
Kendle International August 2006 - December 2007
Charles River Laboratories May 2006 - August 2006
Esbe Scientific 2000 - 2003
Skills
ICH-GCP, GCP, Therapeutic Areas, Clinical Trials, Oncology, Gastroenterology, Cardiology, Rheumatology, Leukemia, HIV, Hepatitis, Dermatology, CRO, Mentoring, Clinical Operations, Clinical Development, Inform, Clinical Data Management
Education
Université du Québec à Trois-Rivières 1989 — 1994
B.Sc., Medical Biology
Quintiles October 2012 - Present
Quintiles October 2010 - October 2012
Kendle International June 2008 - October 2010
AAIPharma Services Corp. January 2008 - June 2008
Duke University December 2006 - January 2008
PPD February 2004 - October 2006
Inveresk October 1999 - February 2004
Clintrials Reserch 1994 - 1999
Glaxo September 1992 - May 1994
American Cyanamid January 1990 - July 1992
Skills
Clinical Data Management, EDC, CRO, Oracle Clinical, Clinical Trials, GCP, CRF design, Inform, Data Management, ICH-GCP, Clinical Development, Oncology, Clinical Research
Education
The Ohio State University 1971 — 1975
BS, Microbiology
Neshaminy
Epsilon July 2014 - Present
Epsilon January 2011 - June 2014
Epsilon September 2008 - December 2010
Kendle International March 2008 - August 2008
PHILIP MORRIS USA August 2004 - December 2006
University of Cincinnati September 2001 - December 2004
University of Cincinnati September 2001 - December 2003
Skills
SAS, Programming, Database Marketing, Analytics, Segmentation, Statistics, Omni Channel Marketing, Analysis, Modeling, Optimization, Data Analysis, Strategy, Statistical Modeling, Databases, SAS programming, Data Mining, CRM
Education
University of Cincinnati 2007 — 2008
Master of Science & Business Administration, Quantitative Analysis
University of Cincinnati 2007 — 2008
Master's degree, Quantitative Analysis
University of Cincinnati College of Business 2007 — 2008
Masters, Quantitative Analysis
Smart Networks, LLC February 2014 - Present
Technology Associates January 2013 - February 2014
Technology Associates January 2012 - December 2012
Technology Associates January 2011 - December 2011
Technology Associates April 2010 - December 2010
Kendle International April 2006 - April 2010
United States Army Reserve December 1991 - July 2006
WorkSmart December 2004 - February 2006
NCDOT December 2000 - November 2004
Inacom Information Systems - Salisbury MD July 1999 - September 2000
Skills
Data Center, Network Administration, Software Documentation, Cisco Technologies, Operating Systems, System Administration, Project Management, Microsoft SQL Server, Windows Server, Citrix, Strategic Planning, Server Administration, IT Management, Disaster Recovery, VMware Infrastructure, Small Business Server, Customer Service, Enterprise Architecture, Process Improvement, Managed Services, IT Service Delivery, Small Business IT..., Project Team Management, Team Leadership, Project Planning, IT Operations Management, Network Security, Healthcare, Change Management, Business Analysis, Business Continuity, Customer-focused Service, IT Solutions
Education
University of Bridgeport
Gilead Sciences January 2015 - Present
Gilead Sciences January 2013 - December 2014
Bristol-Myers Squibb January 2011 - December 2012
Bristol-Myers Squibb, Princeton, New Jersey May 2001 - December 2010
Kendle International 1998 - 2001
Rhone-Poulenc Rorer 1994 - 1998
Bristol-Myers Squibb 1990 - 1994
Skills
Clinical Pharmacology, Anti-infectives, Clinical Development, Therapeutic areas, Outcomes Research, Medical Affairs, Clinical Research
Education
University of California, San Francisco 1981 — 1985
PharmD, Clinical Pharmacy
University of California, Irvine 1974 — 1979
Bachelor of Science (B.S.), Biological Sciences
University of California, Irvine 1974 — 1979
Bachelor of Arts (B.A.), Psychology
Cupido Designs February 2011 - December 2013
Kendle International July 2008 - January 2010
Skills
Time Management, Customer Service, Microsoft Office, Leadership, Microsoft Excel, Team Leadership, Teamwork, PowerPoint, Social Media, Marketing, Sales, Event Planning, Financial Analysis, Data Analysis, Project Management, Social Networking
Education
Thomas M. Cooley Law School 2014 — 2017
Doctor of Law (J.D.), Law
University of Toronto at Scarborough 2007 — 2011
B.B.A., Management
Alcon Laboratories, Inc. 2009 - Present
Kendle International 2007 - April 2009
Retinal Consultants and MDS Pharma Services 2003 - 2007
Education
University of Arizona
BS, Molecular and Celluar Biology
University of Phoenix
MBA, Health Care Management
Kendle International March 2010 - February 2011
Center for Knee and Hip Surgery (Welcare Hospital) March 2008 - January 2010
Skills
GCP, EDC, Clinical Trials, Phase 2, Phase 3, IRB, Deep Vein Thrombosis, Rheumatoid Arthritis, Arthritis, Hip Fracture, ICH-GCP, CRO, Protocol, Regulatory Affairs, Clinical Monitoring, Clinical Research
Education
Northwestern University - School of Professional Studies 2012 — 2015
Master of Science (M.S.), Regulatory compliance, GPA 3.8
Sikkim Manipal University of Health, Medical and Technological Sciences 2008 — 2010
MSc, Clinical Research & Regulatory Affairs
IPCL
Vidya Vihar
The Maharaja Sayajirao University of Baroda
Bachelor's degree, Life Science -Botany, Zoology, Chemistry
Cincinnati Children's Hospital Medical Center January 2013 - Present
INC Research December 2007 - May 2012
Kendle International November 2005 - December 2007
Skills
CRO, Clinical Research, Regulatory Affairs, Pharmacovigilance, GCP, EDC, Clinical Trials, Clinical Data Management, Protocol, Inform, Hematology, CTMS, Oracle Clinical, ICH-GCP, Clinical Development, Oncology, Pharmaceutical Industry, Sop, Clinical Monitoring, Data Management, Therapeutic Areas, Regulatory Submissions, FDA, Adverse Event Reporting, Presentation Skills, Regulatory Filings, Team Leadership, CCRP, IND, Protocol Development, Informed Consent, Code of Federal..., Training, Bone Marrow..., Immune Disorders, Immunology, Pediatric..., Positive Work..., CRF design, TMF, IBC, IRB, Biotechnology, Gene Therapy
Education
The George Washington University School of Medicine and Health Sciences 2013 — 2016
Master of Science (M.S.), Health Services/Allied Health/Health Sciences, General
Xavier University 2008 — 2016
Master of Business Administration (M.B.A.), Business Administration and Management, General
Xavier University 2004 — 2007
Bachelor's degree, Liberal Arts and Sciences/Liberal Studies
Taft Stettinius & Hollister LLP October 2014 - Present
U.S. Bank July 2014 - October 2014
Kendle International June 2011 - October 2011
Kendle International July 2009 - September 2009
Fidelity Investments February 2007 - December 2008
Standard Parking September 2006 - December 2006
Skills
Microsoft Excel, Customer Service, Financial Analysis, Outlook, Microsoft Office, PowerPoint, Budgets, Access, Microsoft Word, Management, Data Analysis, Process Improvement, Accounts Payable, Leadership, Research
Education
University of Cincinnati College of Business 2011 — 2012
Master of Science (M.S.), Accounting
University of Cincinnati College of Business 2009 — 2010
Master of Business Administration (MBA), Business Administration and Management, General
The Ohio State University 2001 — 2006
Bachelor of Arts (B.A.), Psychology
lchisolm@lifespan.org October 2014 - Present
lizbeta_c@hotmail.com February 2013 - October 2014
INC Research September 1997 - August 2012
Kendle International September 1997 - July 2011
Skills
Clinical Data Management, EDC, Oracle Clinical, CRO, ICH-GCP, GCP, Clinical Trials, Data Management, Medidata, MedDRA, Sop, Clinical Research, Human Factors, Pharmaceutical Industry, Therapeutic Areas, Data Validation, Clinical Development, Clinical Monitoring, Oncology, Infectious Diseases, 21 CFR Part 11
Education
State University of New York at Buffalo 1975 — 1979
BSN, Nursing
POE Wellness Solutions & The Coaching Yogi January 2015 - Present
Patanjali's Place 2011 - Present
Neurocog Trials, Inc. January 2014 - December 2014
INC Research July 2011 - January 2014
Kendle International April 2008 - July 2011
Kendle International August 2006 - April 2008
Charles River Laboratories April 2006 - August 2006
Charles River Laboratories November 2004 - April 2006
Duke University Medical Center August 2001 - November 2004
Broadmead Continuing Care Retirement Community October 1998 - August 2001
Skills
Training, Leadership, Employee Training, Management, Instructional Design, Program Management, Program Development, Staff Development, E-Learning, Team Building, Change Management, Leveraging Training..., Training Requirements..., Learning Management..., Clinical Trials, Public Speaking, Program Design and..., Adult Learning Theory..., Process Design and..., Learning Systems..., Facilitation and..., Writing and Editing, Needs Analysis, Cross-functional Team..., Employee Wellness..., Wellness Coaching, Fitness Consulting, Health Education, Yoga, Pilates, Curriculum Design, Experiential Learning, Experiential Education, Performance Improvement, Curriculum Development, Health and Wellness..., Behavior Change
Education
Duke University Integrative Medicine 2015 — 2015
Integrative Health Coach
Towson University 1998 — 2001
Master of Arts (MA), Research and Experimental Psychology
University of North Carolina at Chapel Hill 1991 — 1993
Master of Arts (MA), Exercise Physiology
University of North Carolina at Chapel Hill 1986 — 1990
Bachelor of Arts (BA), Psychology
University of North Carolina at Chapel Hill 1986 — 1990
Bachelor of Arts (BA), Health and Physical Education/Fitness
Quintiles September 2012 - Present
Advanced Clinical June 2012 - October 2012
Kendle International May 2007 - May 2012
Kendle International January 2008 - May 2009
Kos Pharmaceuticals November 1996 - September 1998
Skills
Oracle Clinical, Oracle Discoverer, J Review, ELARA, GCDS, ClinPhone, MS Excel Pivot Tables, MS Word, MS PowerPoint
Education
Thomas More College 2003 — 2005
MBA, business
Thomas More College 1999 — 2004
BBA, Business
Quintiles November 2013 - Present
Quintiles June 2011 - Present
i3 Innovus November 2009 - June 2011
i3 Innovus July 2007 - November 2009
Kendle International January 2003 - June 2007
Kendle International July 2001 - January 2003
Kendle International July 1999 - July 2001
Otology Associates May 1995 - May 1999
Skills
CRO, Clinical Research, Account Management
Education
University of Cincinnati 1992 — 1994
MA, Audiology
University of Cincinnati 1989 — 1991
Bachelors, Communication Disorders
The University of Georgia 1987 — 1989
Speech Pathology and Audiology
Independent Validation Consultat December 2014 - Present
Independent Contrator August 2012 - December 2014
Independent Consultant June 2006 - July 2012
Kendle International November 1999 - June 2006
Raytheon Engineers and Constructors 1996 - 1998
Skills
Computer System..., GxP, GAMP, 21 CFR Part 11, Validation, Sop, Software Documentation, Quality Auditing, V&V, FDA, Change Control, Aseptic Processing, Auditing, Biopharmaceuticals, Biotechnology, Equipment Qualification, Commissioning, Document Management, GMP, MES, Pharmaceutical Industry, Pharmaceutics, Project Management, Quality Assurance, Protocol, Quality Control, SOP development, GLP, GCP, CAPA, Manufacturing, Regulatory Requirements, Quality System, SOP, FDA GMP, Management Consulting, New Business..., Process Improvement
Education
Universidad Politécnica de Puerto Rico 1985 — 1991
Bachelor, Industrial Engineer
INC Research April 2014 - Present
INC Research October 2013 - April 2014
Kendle International June 2011 - September 2013
Kendle International August 2010 - June 2011
Pharma Medica Research Inc. August 2007 - May 2008
Skills
FDA, GCP, CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, EDC, ICH-GCP, Quality Assurance
Education
University of Toronto 2012 — 2013
Project Management Certificate
University of Toronto 2005 — 2010
HBsc, Co-op Psychology and its application
Università degli Studi di Siena 2009 — 2009
Psychology & Politics: Terror and Intolerance in Italy and the West
The University of Hong Kong 2006 — 2006
International Management
INC Research 2011 - March 2012
Kendle International 2009 - 2011
Kendle International 2006 - 2009
Kendle International 2003 - 2006
ECA 1998 - 2003
Miditel 1997 - 1998
Skills
Clinical Trials, Leadership, Pharmaceutical Industry, Human Resources, CRO, CTMS, GCP, Clinical Development, Deferred Compensation, Oncology, Change Management, Regulatory Submissions
Education
The University of Akron 2001 — 2005
MBA
Universidad Nacional Autónoma de México 1998 — 1999
Diploma, Clinical Pharmacology, Faculty of Medicine
ITESM 1992 — 1996
BA, Organizational Psychology
Cd3 September 2012 - Present
INC Research, LLC (through acquisition of Kendle International Inc) April 2006 - May 2012
Kendle International October 2002 - April 2006
Kendle International March 2001 - October 2002
Kendle International April 1999 - March 2001
Ortronics September 1998 - December 1998
Bailey Agencies, Inc May 1998 - August 1998
Kelsar Physical Therapy March 1996 - April 1998
Skills
Clinical Data Management, Oracle Clinical, Oracle Clinical RDC, Integrated..., Oracle Discoverer, Eclipse, Microsoft Excel, Microsoft Word, Lotus Notes, Outlook, Remote Data Capture
Education
Stonington High School
High school diploma
Three Rivers Community College
Associate's degree, Liberal Arts and Sciences/Liberal Studies
Client Associated Businesses Inc. January 2012 - Present
Client Associated Businesses Inc. September 2010 - January 2012
Client Associated Businesses Inc. January 2008 - September 2010
Client Associated Businesses Inc. January 2002 - January 2008
Kendle International June 1999 - January 2001
Education
Three Rivers Community College 2010 — 2015
Associate’s Degree, Science, 3.6
STATKING Clinical Services November 2013 - Present
STATKING Clinical Services November 2008 - Present
STATKING Consulting, Inc. November 2006 - November 2008
Shire Pharmaceuticals 2003 - 2006
INC Research 1998 - 2003
Kendle International 1998 - 2003
Kendle International 1998 - 2003
Skills
EDC, Clinical Data Management, Clinical Trials, FDA, Oracle Clinical, CTMS, Clinical Study Design, CDISC, Clinical Development, Regulatory Submissions, Inform, Quality Assurance
Education
Bethesda Hospital School of Nursing, Cincinnati 1980 — 1983
RN, Registered Nursing/Registered Nurse
The Ohio State University 1977 — 1979
Pre-Nursing Studies