Kendle Company
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Kendle Employees
Gilead Sciences June 2014 - Present
Biotie Therapies, Inc. November 2011 - June 2014
FibroGen September 2010 - November 2011
i3 Research November 2009 - September 2010
Kendle November 2007 - November 2009
CV Therapeutics August 2006 - November 2007
CV Therapeutics for ASG February 2006 - August 2006
Nextrials July 2005 - January 2006
Biogen Idec March 2003 - December 2004
Skills
Clinical Trial..., Clinical Operations, Clinical Trials, CRA Management, Subject Recruitment, GCP, CRO, EDC, Clinical Research, Clinical Data Management, Clinical Development, FDA, CTMS, ICH-GCP, Protocol, Regulatory Submissions, Clinical Site Monitoring, Clinical Monitoring, Clinical Study Design, Drug Development, CRF design, Data Management, Clinical Site Management, Site Initiation, Medidata, Phase I, Phase II, Phase III, Clinical Trial Analysis, Microsoft Excel, Therapeutic Areas, Cardiovascular Disease, CNS disorders, Hematology, Infectious Diseases, Oncology, Pulmonary Diseases
Education
North Carolina State University 1998 — 2002
BS, Business Management, Market Research
University of California, Santa Cruz
CRA I & CRA II
Advanced Clinical Research Consulting Group 2011 - Present
Advanced Clinical Research Consulting Group May 2013 - Present
PAREXEL July 2012 - March 2013
Advanced Clinical Research Consulting Group August 2007 - March 2012
Advanced Clinical Research Consulting Group January 2009 - 2011
Amgen September 2008 - June 2009
INC Research September 2008 - October 2008
MedFocus September 2007 - September 2008
Kendle 2006 - June 2008
Skills
Medical Writing, Clinical Monitoring, Clinical Research, ICH-GCP, Oncology, Gastroenterology, Hematology, Pediatrics, Obesity, Infectious Diseases, Endocrinology, Asthma, Urology, Clinical Trials, GCP, EDC, Vaccines, CTMS, Medical Devices, Therapeutic Areas, CRO, Dermatology, FDA, Sop, Biotechnology, Protocol, Clinical Development, Clinical Data Management, Neurology, Clinical Study Design, Pharmaceutical Industry, Pharmacovigilance, Regulatory Affairs, IND, Medical Affairs, Clinical Operations, Diabetes, Cardiology, Drug Development, Rheumatology, Phase I, Ophthalmology, Validation, Oracle Clinical, CRF design, Inform, 21 CFR Part 11, Cancer, Central Nervous System, Regulatory Submissions
Education
Robert Gordon University 2014 — 2016
Master of Business Administration (M.B.A.), Business Administration, Management and Operations, Master
Université de Montréal 2006 — 2009
D.E.S.S, Drug Development
The Open University 1997 — 2000
Dipl. Mgmt., Management
Universitatea de Medicină și Farmacie „Iuliu Hațieganu” din Cluj-Napoca 1990 — 1996
MD, General Medicine
Liceul Industial Iacob Mureasianu 1983 — 1987
BS, Mathematics & Physics
Université de Montréal
M.Sc, Biomedical Sciences
Novant Health July 2015 - Present
Premier, Inc March 2015 - July 2015
Wellmont Health System December 2014 - February 2015
TEKsystems September 2012 - October 2014
Virtelligence May 2012 - November 2012
TEKsystems September 2011 - May 2012
Catholic Healthcare Partners October 2009 - September 2011
Elsevier February 2006 - October 2009
Catholic Healthcare Partners August 2004 - February 2006
Kendle August 2002 - August 2004
Skills
Databases, Access, Business Objects, Healthcare Information..., Epic Systems, Informatics, EHR, EMR, HL7, HIPAA, Crystal Reports, Software Implementation, Systems Analysis, CPOE, Visio, Software Documentation, SharePoint, Data Warehousing, SQL, Requirements Analysis, Information Technology, SDLC, Software Project...
Education
University of Phoenix - Online 1997 — 1999
MBA, Technology Management
University of Central Oklahoma 1984 — 1986
BBA, Computer Science
84.51˚ April 2015 - Present
AIM Young Professionals of Dearborn County October 2012 - Present
dunnhumby July 2012 - April 2015
dunnhumby 2014 - February 2015
dunnhumby May 2011 - February 2015
Kendle 2007 - May 2011
Sanford Rose Associates 2003 - 2007
Skills
Full-cycle Recruiting, Strategic Sourcing, Interviewing, Sourcing, Hiring, Contract Negotiation, Candidate Screening, Talent Acquisition, Screening Resumes
Education
Indiana University - Kelley School of Business
BS, Marketing
Quintiles February 2012 - Present
Quintiles April 2009 - February 2012
Kendle 2007 - 2009
Covance 2004 - 2006
Skills
Clinical Research, Clinical Data Management, Clinical Monitoring, Clinical Development, Clinical Research..., Clinical Project..., Infectious Diseases, Vaccines, Budget Monitoring, Team Leadership
Education
Auburn University
BSN, Nursing
Cincinnati Works, Inc. July 2007 - April 2014
Medpace 2004 - 2006
Kendle International Inc 1998 - 2004
Kendle 1998 - 2004
The Loewen Group 1995 - 1998
Hook-SupeRx, Inc. 1990 - 1994
Skills
Coaching, Leadership, Budgets, Accounting, Management Consulting, Nonprofits, Change Management, Pharmaceutical Industry, Fundraising, Customer Service, Strategic Planning, Public Speaking, Leadership Development, Project Management, Management, Training, Community Outreach, Building Relationships, Team Building, Process Improvement, Employee Relations, Mergers, Microsoft Office, Microsoft Excel
Education
University of Cincinnati College of Business 1965 — 1970
Quintiles March 2010 - Present
Worldwide Clinical Trials September 2009 - February 2010
Kendle August 2004 - September 2009
PPD February 1999 - August 2004
Skills
CRO, EDC, CTMS, Clinical Monitoring, Clinical Development, GCP, Pharmaceutical Industry, Clinical Trials, Clinical Data Management, ICH-GCP, Oncology, Vaccines, Clinical Research, Data Management, Medical Writing, Regulatory Affairs, Neurology, Pharmacovigilance, Biotechnology, Lifesciences, Medical Devices, Therapeutic Areas, 21 CFR Part 11, Quality Assurance
Education
Central Michigan University 1987 — 1990
MSA, General Administration
Lake Superior State University 1975 — 1979
BS, Medical Technology
ExecuPharm November 2014 - Present
Otsuka Pharmaceutical Companies (U.S.) September 2013 - November 2014
JBB Research Management May 2012 - September 2013
ExecuPharm September 2007 - May 2012
Pfizer Inc 2003 - September 2007
Pfizer 1999 - 2003
Kendle 1995 - February 1999
UCLA DRUG ABUSE RESEARCH CENTER, 1994 - 1996
Cal Poly Pomona 1991 - 1992
Skills
Clinical Trials, Oncology, Infectious Diseases, Protocol Writing, Research Project..., Diabetes, Urology, Clinical Data Management, Global Study Management, Chemical Dependency, Grant Writing, Statistics, Neonatology, Women's Health, Project Management, Management, Health, Clinical Study Design, CRO, Pharmacovigilance, Pharmaceutical Industry, GCP, Recruiting, Risk Assessment, Budgets, Budget Forecasts, Patient Safety, Patient Outcomes, Presenter, Presentation Development, Therapeutic Areas, ICH-GCP, EDC, Regulatory Submissions, Clinical Research, Clinical Development, Team Management, Team Building, Cross-functional Team..., Multi-Cultural Team..., Neurology, CTMS, Global Sourcing, Large Global Clinical..., Biotechnology, CRF design, Medical Affairs, Trial Management, Medical Writing, Vaccines
Education
Claremont Graduate University - Peter F. Drucker and Masatoshi Ito Graduate School of Management 1988 — 1992
MA
California State University-Northridge 1985 — 1988
BA
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
inVentiv Health Clinical May 2007 - Present
Kendle 1996 - 2007
Skills
Clinical Trials, CDISC, CRO, Statistical Programming, Oncology, Validation
Education
University of Cincinnati 1994 — 1996
Master of Science (MS), Mathematics
Atman International January 1997 - January 2003
Kendle June 2000 - December 2000
Health Net Wellness Department January 1993 - January 1996
Johnson & Johnson Health Management January 1986 - January 1993
UCLA School of Public Health January 1983 - January 1986
Education
University of California, Los Angeles
Bachelor of Arts, Anthropology
University of California, Los Angeles - Fielding School of Public Health
Courses in Biostatistics & Database Management
Foresight Group LLC May 2007 - Present
Foresight Group International, AG May 2007 - Present
IKARIA, Inc. 2012 - 2012
Abbott Laboratories 2011 - 2011
Elan Pharmaceuticals April 2010 - 2010
Novo Nordisk April 2009 - July 2009
Kendle February 2009 - April 2009
Sentrx 2008 - 2008
onProject 2000 - May 2007
Hoffmann-La Roche 2007 - 2007
Skills
Databases, Requirements Analysis, Microsoft SQL Server, 21 CFR Part 11, Computer System..., SDLC, Oracle, Pharmacovigilance, Testing, Validation, Java, PL/SQL, Integration, JavaScript, Pharmaceutical Industry, PMP, GxP
Education
Georgia State University 1993 — 1997
MS
Emory University 1986 — 1991
BA
TissueGene, Inc. July 2014 - Present
CRA-Solutions, Inc. September 2013 - June 2014
Lanx, Inc. February 2012 - July 2013
SpinalMotion, Inc. October 2008 - February 2012
Silverwind research 2005 - 2007
Urology Associates of Denver 2002 - 2005
Kendle 2002 - 2003
Skills
FDA, Clinical Research, Medical Devices, GCP, CTMS, Clinical Trials, ICH-GCP, Clinical Monitoring, Regulatory Affairs, Clinical Development, Regulatory Submissions, Infectious Diseases, CRO, EDC, Therapeutic Areas
Education
The University of Memphis 1992 — 1996
Bachelor of Science (B.S.), Microbiology, General, Physical Sciences
Strategic Solutions Division of PRA Health Sciences March 2013 - Present
Proventus Group, LLC July 2010 - March 2013
Medicor Clinical Services September 2009 - July 2010
Medicor Clinical Services February 2009 - September 2009
KForce 2006 - 2008
SRG Wolf Group 2004 - 2005
Schering Plough 2002 - 2004
Kendle 2001 - 2002
Quintiles 2000 - 2001
Aberdeen Royal Infirmary 1998 - 2000
Skills
Clinical Development, Clinical Research, Clinical Trials, Protocol, Sop, Medical Devices, Research, SOP, Clinical Monitoring
Education
Johnson University 2015 — 2017
MBA
University of Kentucky 1982 — 1986
Bachelor of Arts (B.A.), Creative Writing
University of Kentucky 1982 — 1986
Bachelor of Arts (BA), Creative Writing
PAREXEL August 2014 - Present
PAREXEL September 2013 - July 2014
Novo Nordisk A/S November 2012 - July 2013
Quintiles April 2008 - November 2012
Quintiles April 2008 - December 2008
Amgen April 2006 - April 2008
Clinimetrics July 2003 - April 2006
PPD April 2002 - July 2003
Kendle 1999 - 2002
Skills
CRO, Biotechnology, Pharmaceuticals, Change Management, People Management, Cross-functional Team..., Cost Reduction..., Pharmaceutical Industry, Job Coaching, Project Management, Collaborative Leadership, Strategic Leadership, GCP, ICH-GCP, Management, Hematology, Phase I, Clinical Research, FDA, Oncology, Clinical Trials, Clinical Operations, Biopharmaceuticals, CTMS, Protocol, Clinical Development, Therapeutic Areas, EDC, Clinical Monitoring, SOP
Education
Thomas Edison State College 2007 — 2012
M.S. Applied Science/Trial Management, Clinical Trial Management
Drexel University College of Medicine 2010 — 2010
Graduate Course, Clinical Research Operations and Management
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1999
BS, Public Health
NBTHS 1990 — 1994
PPD August 2011 - Present
Kendle January 2006 - August 2011
Charles River Laboratories 2004 - 2006
PharmaResearch 2001 - 2006
Inveresk Research 2003 - 2004
PharmaResearch Corporation 1998 - 2001
Creative Choice Homes 1997 - 1998
Skills
Quality Assurance
Education
University of North Carolina at Wilmington 1987 — 1991
BA, Philosophy, Eastern Religion
Hendersonville
not listed 2010 - Present
Kendle February 2008 - June 2010
Inspire Pharmaceuticals 2005 - 2008
GSK 1988 - 2003
Skills
Clinical Research, Clinical Development, CRO, Pharmaceutical Industry, Oncology, CTMS, GCP, Biotechnology, Regulatory Affairs, Infectious Diseases, Program Management, Lifesciences, FDA, Project Management, Neurology, Cardiology, Diabetes, Medical Devices, Sop, Strategy, Leadership, Medical Writing, Biopharmaceuticals, 21 CFR Part 11, Clinical Operations, Drug Development, Pharmacovigilance, Dermatology, Vaccines, SOP, Clinical Trials, Life Sciences, EDC
Education
Nova Southeastern University 2000 — 2003
Doctorate, Health Sciences
St. Francis University 2000 — 2002
MSc, Master of Science
Pace University
BSc, Pre-Med
Stony Brook University
BSc, Physician Assistant
PharmaNet/i3 2001 - 2011
Kendle 1999 - 2001
Covance 1995 - 1999
Skills
Clinical Research, CRO, Clinical Trials, GCP, Clinical Operations, Oncology, Pharmaceutical Industry, Clinical Study Design, Cross-functional Team..., Clinical Development, Infectious Diseases, Hematology, ICH-GCP, EDC, Clinical Monitoring, Regulatory Submissions, Protocol, Clinical Data Management, Regulatory Affairs, Phase I, Strategic Planning, Vendor Management, Immunology, Drug Development, Therapeutic Areas, Pharmacovigilance, Vaccines, Team Building, Cardiology, Medical Writing, Inform, Hypertension, Clinical drugs and..., Clinical Development..., Study Design, Global Project..., DSMB/DMC Oversight, Steering Committees, R&D, Senior Director..., Contract Negotiations, Problem Solving, Asthma, Cancer, Cardiovascular Disease, Strategic Partnerships, Asset Management, Risk Management, Business Development
Education
University of Pennsylvania
BS, BA, Cell Molecular Biology, South Asia Regional Studies
Eli Lilly and Company March 2015 - Present
Quintiles October 2012 - October 2014
St. Vincent Hospital December 2011 - September 2012
Indiana University School of Medicine June 2007 - December 2011
Cincinnati Childrens Hospital Medical Center 2005 - 2007
Kendle 2005 - 2006
Indiana University School of Medicine, Dept. of Psychiatry 2002 - 2005
Skills
Clinical Trials, Clinical Research, GCP, Data Management, Clinical Data Management, Clinical Development, Pharmaceutical Industry, CRO, Healthcare, IRB
Education
University of Indianapolis 1990 — 1993
B.S., Social Work
Fifth Third Bank July 2015 - Present
Fifth Third Bank May 2014 - July 2015
Fifth Third Bank May 2010 - May 2014
Kendle June 2008 - May 2010
Kendle International June 2006 - June 2008
Kendle International November 2005 - June 2006
Kendle International June 2005 - November 2005
Skills
Talent Management, Human Resources, Employee Relations, Performance Management, Recruiting, Talent Acquisition, Training, Leadership Development, Applicant Tracking..., Interviews
Education
Xavier University - Williams College of Business 2007 — 2009
Masters of Business Administration, International Business
Miami University 2001 — 2005
Bachelor of Science, Business Administration / Human Resources
Messer Construction Co. March 2012 - Present
LCA Vision June 2011 - March 2012
Kendle July 2007 - June 2011
Skills
Interviewing, Onboarding, Hiring, Applicant Tracking..., Full-cycle Recruiting, Employee Relations, Sourcing, College Recruiting, Talent Acquisition, Technical Recruiting, Recruitment/Retention, Employee Engagement, PeopleSoft, HR Policies, Coaching, Mentoring, Recruitment Advertising, Team Building, Process Improvement, Strategic Sourcing, Customer Service, Customer Relations, Cold Calling, Employer Branding, Healthcare, Building Relationships, Resume Writing, Employment Law, Executive Search, Diversity & Inclusion, Recruiting, Interviews
Education
Xavier University 2004 — 2006
Master's, Human Resource Development
Princeton High School
The Ohio State University - The Max M. Fisher College of Business
Bachelor, Business-Human Resources
Pfizer November 2013 - Present
Pfizer November 2010 - Present
Pfizer October 2009 - Present
Law Office of Richard E Buckley, LLC 2005 - Present
Medical Solultions 2005 - July 2010
Bristol Myers Squibb 2002 - October 2009
Bayer 1999 - 2001
Mystic Marinelife Aquarium 1994 - 2001
Kendle 1996 - 1999
Skills
Intellectual Property, Outsourcing, Adaptation, Corporate Law, Medical Law, Strategic Sourcing, Offshore Outsourcing, Risk Management, Strategy, Pharmaceutical Industry, Clinical Development, Biotechnology, Oncology, Infectious Diseases, Hematology, CTMS, ICH-GCP, CRO, Clinical Trials, Therapeutic Areas, EDC, GCP, Protocol, Clinical Research, Clinical Monitoring, Pharmacovigilance, Regulatory Affairs, Drug Development
Education
University of Rhode Island - College of Business Administration 2011 — 2014
MBA
Quinnipiac University 2004 — 2006
MS
Quinnipiac University School of Law 2000 — 2004
JD
University of Connecticut 1994 — 1998
Wittenberg University 1986 — 1990
Bachelor of Science (BS)
Newtown High School 1982 — 1986
INC Research January 2012 - Present
INC Research October 2010 - December 2011
Kendle January 2006 - October 2009
Skills
CTMS, EDC
Education
North Carolina State University 1994 — 1998
Kendle Director, Clinical Operations - North AmericaINC ResearchJuly 2011 - Present
Kendle 2006 - Present
Kendle Int. 2006 - Present
Kendle Int 2006 - Present
Kendle International 2006 - Present
Kendle International 2006 - Present
Pfizer 2000 - 2006
Education
Eastern Michigan University 1992 — 1994
Medpace August 2013 - Present
Advanced Clinical September 2012 - July 2013
INC Research October 2011 - June 2012
INC Research January 2009 - September 2011
Kendle June 2004 - December 2008
INC Research June 2004 - September 2006
Skills
Oracle Clinical, Remote Data Capture, CRF Design, Personnel Management, Project Team Management, Database Design, Inform, Oracle Discoverer, User Acceptance Testing, Data Validation, Data Management Plan, Customer Service, Customer Satisfaction, Lotus Notes, Microsoft Excel, Clinical Research, Managing Project Budgets, Clinical Data Management, ICH-GCP, Outlook, Medical Terminology, Data Management, CRF design, Oncology, Medidata, CTMS, GCP, Clinical Trials
Education
University of Cincinnati 1996 — 2002
Master's degree, Public Health Promotion and Education
Thomas More College 1992 — 1997
Bachelor of Arts, Biology
Quintiles August 2015 - Present
UnitedHealth Group August 2007 - July 2015
Kendle March 2006 - July 2007
Pfizer 1989 - 2006
Pharmacia 1989 - 2002
Pharmacia & Upjohn 1996 - 2000
Upjohn 1989 - 1996
Skills
Clinical Trials, Clinical Development, CRO, Pharmaceutical Industry, Cross-functional Team..., Biopharmaceuticals, Medical Affairs, Clinical Research, Drug Development, Clinical Operations, Regulatory Affairs, Health Economics, Therapeutic Areas, Oncology, Regulatory Submissions, GCP, CTMS
Education
London School of Economics and Political Science 2010 — 2012
Master of Science (MSc), Health Economics, Policy and Management
Wayne State University 1978 — 1984
PharmD, Pharmacy
Quintiles October 2014 - Present
PRA International, Inc April 2007 - October 2014
Kendle International 1997 - 2007
Kendle 1997 - 2007
Skills
Endocrinology, CRO, EDC, CTMS, GCP, Epilepsy, Rheumatology
Education
Loyola University of Chicago 1990 — 1994
BS, Biology, General
St Xavier High School
St Xavier High School
PPD August 2008 - Present
PPD 2008 - Present
Kendle International March 2007 - August 2008
kendle 2006 - 2008
ICON 2006 - 2008
ICON plc 2004 - 2008
University of Illinois at Chicago 2002 - 2004
University of Illinois at Chicago 2002 - 2004
Education
University of Lagos 1983 — 1985
DA, Anesthesiology
University of Ibadan 1975 — 1980
University of Ibadan 1975 — 1980
MBBS, Medicine
PRA International November 2013 - Present
PRA International July 2011 - October 2013
Clinsys Clinical Research April 2011 - July 2011
Clinsys Clinical Research September 2009 - April 2011
PPD July 2004 - September 2009
PPD July 2001 - July 2004
kendle June 1999 - July 2001
Kendle International January 1998 - June 1999
Hebrew University 1992 - 1996
Hebrew University 1992 - 1996
Skills
CTMS, CRO, Clinical Development, Regulatory Affairs, Clinical Trials, Clinical Monitoring, Oncology, Pharmaceutical Industry, ICH-GCP, GCP, EDC, Clinical Data Management, Therapeutic Areas, Clinical Operations, Clinical Research, Infectious Diseases, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRF design, Cardiology, Clinical Study Design, Data Management, Dermatology, Diabetes, Drug Development, Drug Discovery, Endocrinology, FDA, Hematology, IND, Immunology, Lifesciences, Medical Affairs, Medical Devices, Medical Writing, Patient Recruitment, Oracle Clinical, Pharmacology, Neurology, Pharmacovigilance, Phase I, Project Management, Protocol, Quality Assurance, Sop, Regulatory Submissions, Team Leadership, Trial Management, Vaccines
Education
Loyola University Chicago 1997 — 2000
MBA, Operations and International Business
The Hebrew University 1992 — 1996
B-Pharm, pharmacy
King David Linksfield 1987 — 1991
community day school
moshe sharet primary school
Medpace October 2003 - Present
Kendle 1998 - 2003
Skills
Pharmaceutical Industry, Clinical Trials, CRO, CTMS, Clinical Development, Clinical Research, Oncology
Education
Xavier University - Williams College of Business 2005 — 2007
MBA
University of Cincinnati College of Business 1995 — 1998
BBA, Finance
Kendle July 2006 - July 2011
Kendle International 2006 - July 2011
Pfizer 2001 - 2006
Pfizer Global Research & Development 2001 - 2004
Education
Oakland University 1984 — 1987
OmniComm Systems, Inc. December 2014 - Present
PAREXEL June 2014 - November 2014
Onyx Pharmaceuticals (Subsidiary of Amgen) May 2013 - May 2014
INC Research July 2011 - April 2013
Kendle International May 2010 - July 2011
Kendle International January 2008 - May 2010
Kendle July 2007 - January 2008
Client Associated Businesses, Inc. June 2002 - June 2007
Keane 2000 - 2002
Skills
CRF design, EDC, Programming, Oracle Clinical, Editing, Inform, Data Management, Operating Systems, Training, Project Management, Associate Development, Medidata, Team Leadership, Clinical Data Management, Sop, OC RDC, CRO, Clinical Trials, SAS, SDTM, Databases, Management, Clinical Study Design, GCP, Pharmaceutical Industry
Education
Villanova University 2011 — 2011
Black Belt Certification, Six Sigma Black Belt Certification Program
Central Connecticut State University 1996 — 2000
Bachelor Science, Computer Science, Criminal Justice
INC Research February 2013 - Present
INC Research September 2008 - February 2013
INC Research December 2006 - September 2008
Kendle October 2004 - December 2006
Skills
CRO, CTMS, Immunology, Inflammation, Clinical Data Management, Clinical Development, GCP, Pharmaceutical Industry, Clinical Trials, Ophthalmology, Oncology, Project Management, ICH-GCP, Women's Health, Clinical Monitoring, Clinical Research, EDC
Education
Northeastern University 1973 — 1977
PAREXEL March 2010 - Present
Integrium 2008 - September 2009
QualoPro Services March 2008 - May 2008
Kendle International August 2005 - March 2008
Kendle 2005 - 2008
Quintiles May 2003 - March 2005
Eisai March 2000 - June 2002
Forest Laboratories November 1996 - March 2000
Skills
Oncology, Clinical Development, CRO, Pharmaceutical Industry, Clinical Trials, Medical Writing, Drug Development, Regulatory Submissions, Clinical Monitoring, Clinical Research, Therapeutic Areas, Pharmacovigilance, Sop, Regulatory Affairs
Education
Binghamton University 1984 — 1987
cours rene descartes 1968 — 1980
terminal d
EKR Therapeutics, Inc. May 2011 - August 2012
EKR Therapeutics, Inc May 2008 - April 2011
Azur Pharma August 2007 - April 2008
Avanir Pharmaceuticals 2006 - 2007
Alamo Pharmaceuticals LLC 2004 - 2006
Alamo Pharma 2004 - 2006
Kendle International March 1994 - November 2002
Kendle 1994 - 2002
Skills
Cardiology, Clinical Research, Psychiatry, Medical Affairs, Project Management, Womens' Health, Neurology, Women's Health, Hospital Sales, Managed Care, Hematology, Gastroenterology, Rheumatology, GCP, Endocrinology, Therapeutic Areas, Medical Writing, Lifesciences, Pharmaceutical Sales, Clinical Monitoring, Clinical Development, CRO, Healthcare, Pain Management, Regulatory Affairs, Nephrology, Life Sciences, Pharmaceutical Industry
Education
Boston University
MS, Nursing
Columbia University in the City of New York
MPH, Health Policy and Administration
County College of Morris
Certificate, Project Management
Syracuse University
BS, Nursing
PAREXEL November 2012 - Present
PPD July 2005 - November 2012
UCLA Health System July 2004 - July 2005
Kendle September 2001 - April 2003
Kendle International, Inc. 2001 - 2003
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Clinical Research, Biotechnology, Regulatory Affairs, Sop, Clinical Monitoring, CRO, CTMS, EDC, GCP
Education
ESLSCA 2003 — 2004
MBA, Business
University of California, Santa Barbara 1997 — 2001
Bachelor of Arts (B.A.), Religion/Religious Studies
Genentech February 2011 - Present
Teikoku Pharma USA November 2007 - February 2010
NeurogesX, Inc. 2007 - 2007
Clinimetrics 2001 - 2007
Clingenix 2000 - 2001
Oculex 1998 - 2000
Celtrix 1997 - 1998
Kendle 1996 - 1997
Chemtrak 1993 - 1996
Skills
CTMS, Clinical Trials, Clinical Study Design, CRO, GCP, Clinical Monitoring, Oncology, Clinical Research, EDC, Clinical Development, Pharmaceutical Industry, Biotechnology, Clinical Data Management, Drug Development, Sop, FDA, ICH-GCP, Therapeutic Areas, Medical Devices
Education
California Polytechnic State University-San Luis Obispo 1989 — 1992
BS, Bio-Chemistry
The Medicines Company June 2004 - May 2015
Kendle International Inc 1991 - 2004
Kendle 1991 - 2004
Skills
Clinical Trials, Clinical Operations, Therapeutic Areas, Pharmacovigilance, CTMS, Clinical Development, CRO, GCP, Clinical Pharmacology, Clinical Data Management, EDC, Regulatory Affairs, Regulatory Submissions, Drug Development, ICH-GCP
Education
University of Cincinnati 1981 — 1983
PharmD, Clinical Pharmacy
University of Illinois at Chicago 1973 — 1978
BS Pharm, Pharmacy
Quintiles June 2014 - Present
Quintiles September 2012 - June 2014
Quintiles November 2010 - September 2012
Kendle August 2008 - November 2010
Merck Sharp & Dohme October 2007 - June 2008
Merck Sharp & Dohme October 2006 - June 2008
Merck Sharp & Dohme July 2003 - September 2006
Merck Sharp & Dohme July 2002 - June 2003
Elkis & Furlanetto Centro de Diagnósticos September 2001 - June 2002
Escola Paulista de Medicina November 2000 - July 2001
Skills
Oncology, Gastroenterology, Cardiology, Six Sigma, Project Management, Site Development, Clinical Trials, Pharmaceutical Industry, ICH-GCP, GCP, CTMS, CRO, Infectious Diseases, Vaccines, Regulatory Submissions, Clinical Operations, Clinical Monitoring, Therapeutic Areas, EDC, GMP, Phase I, Data Management, Regulatory Requirements, Patient Recruitment, Market Access, 21 CFR Part 11, GLP, Clinical Development, Immunology, Sop, Clinical Research, Management, Drug Development, Clinical Data Management, FDA, Pharmacovigilance
Education
Macquarie Graduate School of Management (MGSM) 2011 — 2013
Masters, Masters of Management - People and Development
Fundação Getulio Vargas 2009 — 2009
Certificate, People Management
Fundação Armando Álvares Penteado 2007 — 2008
Post Graduate, Businness Administration for Pharma Companies
Universidade de Mogi das Cruzes 1994 — 1998
Graduate, Biological Sciences (honours on Clinical Sciences)
Macquarie Graduate School of Management (MGSM)
Master of Business Administration (MBA)
My House! February 2011 - Present
Kendle August 2009 - February 2011
PRA October 2004 - August 2005
Overland Park Regional Medical Center August 2003 - July 2004
Skills
Clinical Monitoring, CTMS, ICH-GCP, GCP, CRO, EDC, Clinical Development, Clinical Trials, Oncology, Regulatory Submissions, Clinical Operations, Infectious Diseases
Education
Ball State University 2000 — 2004
Master of Science (MS), Dietetics/Dietitian
Ball State University 1984 — 1988
Bachelor of Science (BS), Business Administration and Management, General
Givaudan July 2011 - Present
Procter & Gamble October 2010 - June 2011
Kendle June 2008 - August 2010
Trane March 2003 - May 2008
Procter & Gamble 2008 - 2008
Skills
Oracle/SQL, SAP, CRM software, ERP/CRM, SCM, Cognos BI, PeopleSoft CRM, SAS/SQL, Microsoft Office, SharePoint Designer, Lotus Notes, Cognos, Adobe Creative Suite, WINDOWS OS, Unix, Windows Networking, Mac OS X, Database Design, Database Administration, Database Management, Database Analysis, Database Marketing, Financial Analysis, Financial Planning, Financial Reporting, Financial Management, Project Finance, Project Planning, Project Implementation, Project Coordination, Project Portfolio..., Project Execution, Supply Chain Management, Presentation Development, Group Presentations, Customer Presentations, Presentation Preparation, Presenter, Sourcing & Procurement, Logistical Planning, Logistics Analysis, RFP preparation, RFI, Contract Management, Contract Review, Contract Development, Contract Writing
Education
University of Cincinnati College of Business 1993 — 1998
Bachelors of Business Administration, Management and Marketing
Wyoming High School
Quintiles March 2010 - Present
Quintiles June 2008 - March 2010
Westat April 2007 - June 2008
Kendle January 2004 - April 2007
PRC 2001 - 2004
Skills
EDC, Data Management, Clinical Data Management, Oracle Clinical, User Acceptance Testing, Excel, Microsoft Office, GCP, Clinical Trials, CRF design, CRO, ICH-GCP, Data Validation, Oncology, Mentoring, Clinical Research, Clinical Trial..., Vendor Management, Customer Relations, Databases, MS Project, Clinical Development, CTMS
Education
UNC Chapel Hill
Quintiles May 2013 - Present
inVentiv Health Clinical October 2012 - May 2013
Takeda Global Research and Development March 2008 - March 2012
TAP Pharmaceuticals March 2005 - March 2008
Kendle 1998 - 2000
Education
DePaul University
Master of Business Administration (MBA)
Lafayette College 1991 — 1995
Bachelor of Arts (B.A.), Math & Economics
GlaxoSmithKline Pharmaceuticals September 2005 - Present
Data Sciences Lead - Neurosciences January 2009 - February 2011
GlaxoSmithKline, Lone Tree, CO September 2005 - December 2008
Myogen, Inc September 2001 - August 2005
PRA International September 1999 - September 2001
Kendle June 1998 - September 1999
Ross Products Division September 1994 - June 1998
Certified Tissue Bank November 1991 - September 1994
Skills
Clinical Research, Clinical Development, Infectious Diseases, Neuroscience, Clinical Trials, Pharmaceutical Industry, CTMS, CRO, Oncology, GCP, Biotechnology, Clinical Monitoring, Neurology, Personnel Management, Training Leadership, Project Management, Coaching, Mentoring, Drug Development, ICH-GCP, Therapeutic Areas, Regulatory Affairs, Clinical Data Management, Sop, Endocrinology, 21 CFR Part 11, FDA
Education
University of Colorado Denver 1999 — 2002
MBA, Business
University of Colorado at Boulder 1984 — 1989
BA, Psychology, B
Smoky Hill High School 1980 — 1984
College Preparatory Studies
Medpace December 2011 - Present
Medpace December 2007 - December 2011
Kendle September 1997 - December 2007
Ethicon Endo-Surgery September 1993 - September 1997
Skills
Pharmaceutical Industry, Oncology, Clinical Trials, Clinical Research, CRO, Cardiology, Clinical Development, Biotechnology, CTMS, GCP, EDC, Business Development, Endocrinology, Medical Writing, Therapeutic Areas, Lifesciences, Medical Devices, Diabetes, Infectious Diseases
Education
The Ohio State University 1973 — 1975
Master of Science (MS), Education Administration
West Virginia University 1968 — 1972
BS Education, Elementary Ed
Genentech, Roche April 2006 - Present
Kendle March 2005 - April 2006
QIAGEN September 2003 - March 2005
Skills
Immunology, Biotechnology, Lifesciences, Pharmaceutical Industry, Publication Planning, Medical Writing, Oncology, Rheumatology, Clinical Development, Clinical Research, Dermatology, Clinical Trials, Biopharmaceuticals, Regulatory Submissions, Neuroscience, Medical Affairs, Therapeutic Areas
Education
University of Southern California 1999 — 2003
Post-Doctoral Studies, Neurobiology and Neurosciences
University of California, Los Angeles 1991 — 1999
PhD, MS, Biochemistry and Molecular Biology
UC Riverside 1984 — 1988
Bachelor of Science (BS), Chemistry
Quintiles October 2011 - Present
Kendle 2007 - September 2011
Kendle International 2004 - 2007
Kendle 2001 - 2004
Skills
Clinical Trial..., CRO, EDC, Clinical Monitoring, GCP
Education
Morehead State University
BS, Biology
Thomas More College
MBA, Business
Leading Edge Research 2009 - Present
Research Pharmaceutical Services March 2007 - September 2008
Kendle 2006 - 2007
Education
Brookhaven Community College 1986 — 1987
Social Science
Cincinnati Children's Hospital Medical Center February 2012 - Present
i3 Statprobe January 2011 - February 2012
i3 Statprobe January 2009 - December 2010
i3 Statprobe April 2007 - January 2009
Kendle International March 2006 - April 2007
Kendle 2001 - 2007
Kendle International March 2002 - March 2006
Kendle International June 2001 - March 2002
Skills
SAS, Clinical Trials, Programming, Validation, Analysis, CDISC, People Management, Statistical Programming, Management, Biostatistics, Regulatory Submissions, Scientific Programming, Protocol, CRO, EDC, Pharmaceutical Industry, GCP, Data Management, Clinical Data Management
Education
University of Cincinnati 2003 — 2010
MS, Biostatistics
Agnes Scott College 1995 — 1999
BA, Bio-Psychology
Bureau of Accounts Control 2011 - Present
Kendle 1997 - 1999
Education
Caldwell College 1989 — 1991
Lacordaire Academy 1985 — 1989
United Survey and Construction Services Inc. January 1995 - Present
New Age Spa Institute January 2012 - June 2012
McHenry County College August 2009 - January 2012
Kendle February 2006 - July 2008
Skills
Education, Biochemistry, Business Consultation
Education
Southern Illinois University, Carbondale 2003 — 2005
MS, Molecular Biology, Biochemistry and Microbiology
ICON Clinical Research January 2003 - Present
Kendle May 2001 - June 2003
Kendle September 1996 - May 2001
Skills
CRO, Clinical Development, Oncology, CTMS, EDC, Pharmaceutical Industry, Clinical Trials
Education
University of Cincinnati 1981 — 1986
Bachelor's degree, Pharmacist
INC Research March 2012 - Present
INC Research April 2014 - April 2015
PAREXEL 2008 - 2012
AstraZeneca May 2004 - December 2007
ReSearch Pharmaceutical Services 2002 - 2004
Kendle 1998 - 2001
Skills
Central Nervous System, Neurology, Dermatology, Osteoporosis, Diabetes, Protocol, Ophthalmology, Cardiology, Phase I, Pharmaceutical Industry, Hematology, Rheumatoid Arthritis, Psychiatry, Oncology, Clinical Research
Education
Rider University 1991 — 1993
MA, Counseling Psychology
Rider University 1986 — 1991
BA, Psychology
In House CRA March 2010 - Present
Kendle August 1999 - February 2010
Skills
CRO, CTMS, Clinical Monitoring, ICH-GCP, EDC, Clinical Trials, GCP, Clinical Development, Oracle Clinical, Infectious Diseases, Therapeutic Areas, Protocol, Medical Writing, Sop, Regulatory Affairs, SOP
Education
Notre Dame College of Ohio 1995 — 1998
Paralegal Certificate, Legal Assistant/Paralegal
The University of Akron 1991 — 1993
Master of Arts (M.A.), Political Science and Government
The University of Findlay 1988 — 1991
Bachelor of Arts (B.A.), Political Science and Government, Cum Laude
University of North Carolina at Chapel Hill 2015 - Present
PAREXEL 2012 - 2014
Kendle 2008 - 2009
Covance 2007 - 2008
PAREXEL 2006 - 2007
Research Point 2005 - 2006
Quintiles 2002 - 2004
GSK 1988 - 2001
Skills
EDC, Clinical Development, Clinical Monitoring, Protocol, FDA, Clinical Research, Validation, Cancer, Clinical Research..., Rheumatology, Phase I, Asthma, perform site contacts..., study database review, report writing, source document review, protocol training, Clinical Trials
Education
Ramapo College of New Jersey
BS, Business, co-major Life Sciences
Westchester Community College
A.A.S in Laboratory Technology
Baylor University
Medical Laboratory Technology
Clinical Research 2014 - Present
Covance April 2011 - April 2014
Kendle September 2007 - April 2011
Kendle International June 2006 - August 2007
Kendle International November 2004 - June 2006
PPD January 2002 - November 2004
PPD January 2001 - January 2003
PPD January 2001 - January 2002
PPD July 2000 - January 2002
PPD August 1998 - July 2000
Skills
Software Documentation, Training, Project Management, Leadership, Management, Budgets, Proposal Writing, Human Resources, Team Building, Clinical Research, Sop, Protocol, FDA, Access, CRO, New Business Development, CTMS, GCP, Clinical Trials, Clinical Development, Clinical Monitoring, EDC, ICH-GCP, Pharmaceutical Industry, Regulatory Affairs, SOP
Education
University of Phoenix 2005 — 2007
Masters, Business Admin/Health Care Management
North Carolina State University 1989 — 1994
BS, Zoology
PPD March 2014 - May 2015
Quintiles March 2010 - February 2014
Worldwide Clinical Trials September 2008 - February 2010
Kendle August 2004 - August 2009
PPD February 1999 - August 2004
Skills
Clinical Trials, CTMS, GCP, CRO, Therapeutic Areas, Oncology, Clinical Development, EDC, Clinical Monitoring
Education
Central Michigan University 1987 — 1990
Master of Science (MS), Administration
Lake Superior State University 1975 — 1979
Bachelor of Science (B.S.), Medical Technology
Sanofi Pasteur February 2013 - Present
sanofi-aventis March 2010 - January 2013
Sanofi May 2008 - March 2010
Sanofi September 2005 - May 2008
ICON plc November 2000 - September 2005
ICON plc August 2000 - November 2000
Kendle March 1998 - August 2000
Innovex, Inc October 1996 - March 1998
Thomas Jefferson University Hospitals February 1994 - October 1996
Frankford Hospital September 1992 - February 1994
Skills
Neurology, Regulatory Affairs, Pharmaceutical Industry, Clinical Monitoring, Clinical Development, Clinical Research, CRO, Clinical Trials, Oncology, GCP, Diabetes, Biotechnology, CTMS, Sop, Endocrinology, Management, EDC, Vaccines, Therapeutic Areas, Infectious Diseases, Lifesciences, FDA, Drug Development, Validation, Regulatory Submissions, 21 CFR Part 11, GMP, Clinical Data Management, ICH-GCP, Pharmacovigilance, Cardiology, Protocol, IND, Clinical Operations, Pharmaceutics, Oracle Clinical, Medical Affairs, Medical Writing, Biopharmaceuticals, Regulatory Requirements, Computer System..., Dermatology, Building Effective..., Pharmacology, Clinical Study Design, Hematology, Strategic Communications, Drug Safety, Gastroenterology, Clinical Pharmacology
Education
Chamberlain College of Nursing
Bachelor of Science in Nursing
Frankford Hospital School of Nursing
Diploma/Registered Nurse
Pennsylvania State University
Associate of Science in Nursing
PAREXEL August 2014 - Present
PPD February 2012 - July 2014
Kendle June 2005 - October 2011
Skills
Clinical Monitoring, CTMS, CRO, EDC, Clinical Trials, GCP, ICH-GCP, Oncology, Clinical Development, Therapeutic Areas, Infectious Diseases, Pharmaceutical Industry, Sop, Clinical Research, Oracle Clinical, Vaccines, Diabetes
Education
Johann Wolfgang Goethe-Universität Frankfurt am Main
Diploma, Biology
PRA International December 2011 - Present
Covance September 2008 - December 2011
Kendle August 2006 - September 2008
Skills
CTMS, ICH-GCP, Clinical Monitoring, CRO, GCP, Clinical Research, EDC
Education
University of Cincinnati 2001 — 2005
BS, Biological Sciences
Quintiles, GFR Performing Services on behalf Hoffmann-La Roche Limited June 2014 - Present
Quintiles, GFR Janssen Research & Development May 2012 - June 2014
Kforce Clinical Research, Inc. December 2011 - June 2012
PPD July 2011 - December 2011
INC Research May 2007 - July 2011
Kendle 2006 - 2007
Managed Clinical Solutions October 2005 - March 2006
PRA International 2004 - 2005
i3 Research 2001 - 2004
PPD 1999 - 2001
Skills
Oncology, Infectious Diseases, Ophthalmology, Nephrology, Musculoskeletal, GCP Certified, EDC, Clinical Monitoring, Environmental Monitoring, Healthcare Consulting, Team Management, Line Management, Clinical Site Management, GCP, Clinical Trials, CTMS, SOP, CRO, Pharmaceutical Industry, Protocol, ICH-GCP, Clinical Research
Education
Marymount University 2005 — 2008
M.S., Healthcare Management
Mississippi State University 1987 — 1993
B.S., Microbiology
Three Rivers Community College January 2012 - Present
Southeastern Employment Services January 2009 - November 2011
Kendle January 2000 - January 2007
Skills
Pottery
Education
Three Rivers Community College 2010 — 2013
Community College of Rhode Island 1997 — 2000
PPD April 2011 - Present
Kendle March 2007 - April 2011
Huntington Health Care and Rehab, INC. November 2001 - March 2007
Skills
Pharmacovigilance, Oracle Clinical, GMP, Lifesciences, Regulatory Submissions, Clinical Trials, CRO, EDC, GCP, Clinical Development, CTMS, Pharmaceutical Industry, Clinical Data Management, ICH-GCP, 21 CFR Part 11, CRF design, Therapeutic Areas, Medidata
Education
East Carolina University 1994 — 1998
Bachelor of Science (BS)
Louisburg College 1992 — 1993