Kendle International (now INC Research)
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Kendle International (now INC Research) Employees
PPD August 2014 - Present
PPD October 2013 - August 2014
AstraZeneca May 2004 - October 2013
AstraZeneca April 2002 - May 2004
Premier Research 2001 - 2002
PMRS, Inc. 1998 - 2001
Kendle International (now INC Research) 1997 - 1998
Quality Biotech, Inc 1995 - 1997
Skills
GCP, FDA, Compliance, Quality Assurance, Clinical Research, Root Cause Analysis, Mentoring, Pharmacovigilance, Regulatory Submissions, Computer System..., Clinical Operations, CAPA, GMP, Auditing, Cross-functional Team..., Process Improvement, GxP, Drug Development, CRO, 21 CFR Part 11, ICH-GCP, Clinical Trials, Clinical Development, Validation, Pharmaceutical Industry, Clinical Monitoring, Neuroscience, Regulatory Affairs, EDC, Regulatory Requirements, Protocol, Therapeutic Areas, Change Control
Education
Wilmington University 2010 — 2012
Master of Business Administration (MBA), Health Care Administration
Temple University 2004 — 2010
Master of Science (MS), Quality Assurance/Regulatory Affairs
The Pennsylvania State University 1990 — 1995
Bachelor of Science (BS), Microbiology
GE Aviation April 2015 - Present
CVS Health Corporation February 2009 - April 2015
Kendle International (now INC Research) May 2008 - November 2008
Robert Half International January 2008 - May 2008
Alliant Credit Union March 2005 - September 2007
CIB Marine Bancshares, Inc. August 2004 - February 2005
Dade Behring, Inc. (now part of Siemens Healthcare) January 2004 - July 2004
CNG Financial August 2000 - November 2003
Skills
Auditing, Medicare Prescription..., Internal Audit, Medicare Part D, Financial Audits, Compliance, Legal Compliance, Compliance Testing, Standards Compliance, Sarbanes-Oxley, Risk Assessment, Enterprise Risk..., Operational Risk, Medicare, Medicare Advantage, Medicare/Medicaid..., Pharmaceutical Industry, Banking, Credit Unions, Regulatory Affairs, Regulations, Financial Regulation, Pharmaceutical Law, Pharmaceutical Research, Accounting, Finance, Leadership, Sarbanes-Oxley Act
Education
Northwestern University 1996 — 2000
Bachelor of Arts (B.A.), Economics
Reckitt Benckiser Pharmaceuticals (A subsidiary of Indivior PLC) March 2015 - Present
Reckitt Benckiser Pharmaceuticals (A subsidiary of Indivior PLC) June 2014 - March 2015
PRA International July 2007 - June 2014
PRA International September 2006 - July 2007
PRA International January 2006 - September 2006
GE Healthcare August 2005 - December 2005
GE Healthcare November 2004 - August 2005
GE Healthcare (formerly Amersham Health) November 2002 - November 2004
Kendle International (now INC Research) October 2001 - October 2002
Caesar Rodney High School August 1999 - August 2001
Skills
CRO, GCP, ICH-GCP, CTMS, Clinical Monitoring, EDC, Clinical Trials, Clinical Operations, Cardiology, Trial Management, Clinical Research..., Therapeutic Areas, Clinical Development, Regulatory Submissions
Education
University of Pittsburgh
Bachelor's Degree, Chemistry
INC Research November 2008 - Present
Kendle International (now INC Research) October 2005 - November 2008
St. Elizabeth Medical Center 2000 - 2006
Education
Beckfield College 2006 — 2007
Paralegal Studies
Northern Kentucky University 2000 — 2005
Business Management
Medpace August 2011 - Present
Kendle International (now INC Research) May 2005 - July 2011
University of Cincinnati May 2003 - May 2005
Children's Hospital August 1999 - May 2003
Loyola University Chicago August 1993 - August 1999
Skills
Clinical Trials, Oncology, CRO, Clinical Research, GCP, EDC, Clinical Data Management, CTMS, Clinical Development, Data Management, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Cancer, Infectious Diseases, Therapeutic Areas, CRF design, Immunology, Sop, Regulatory Submissions, Biotechnology, Protocol, Medical Writing
Education
University of Cincinnati 2008 — 2009
Certificate, Clinical Research
Loyola University Chicago 1993 — 1999
Doctor of Philosophy, Microbiology & Immunology
University of Cincinnati 1987 — 1992
Bachelor of Science, Biology
GlenOak High School 1987 — 1987
Pfizer WRD June 2004 - November 2012
Pfizer June 2004 - November 2012
Kendle International (now INC Research) 1996 - 2004
Analysis & Technology, Inc 1979 - 1996
US Navy Reserve 1978 - 1994
US Navy 1969 - 1978
Skills
Clinical Development, Pharmacodynamics, DMPK, ADME, Pharmaceutical Industry, Clinical Trials
Education
University of New Haven 1981 — 1984
Master of Science (MS), Industrial Engineering (Operations Research)
University of New Haven
Master of Business Administration (MBA), Operations Research
Rensselaer Polytechnic Institute 1964 — 1969
Bachelor of Science (BS), Chemical Engineering
Rensselaer Polytechnic Institute 1964 — 1968
Master of Engineering (M.Eng.), Chemical Engineering
iNDEPENDENT January 2015 - Present
INC Research September 2006 - July 2012
Kendle International (now INC Research) January 2000 - September 2011
Medpace 2005 - 2006
Universty of Cinicnnati May 1988 - January 2000
Skills
Therapeutic areas, Clinical Trials, Clinical drug..., Infectious Diseases, Clinical Nursing and..., Protocol design, strategic planning, creating and managing..., Professional..., Subject matter expert..., Experience in patient..., ALS, Leukemia, Hepatology, Study Design, Grant Application, Patient Advocacy, Oncology, CRO, CTMS, Pharmaceutical Industry, Clinical Development, Therapeutic Areas, Protocol Design, GCP, Clinical Study Design, Drug Development, Vaccines, Strategic Planning, Sop, Clinical Research, Grants, SOP
Education
University of Cincinnati College of Medicine 1987 — 1989
Medicine
University of Cincinnati 1978 — 1981
BSN, Nursing
PRA Health Sciences September 2014 - Present
PRA International August 2007 - September 2014
Kendle International (Now INC Research) January 2006 - August 2007
Kendle International (Now INC Research) August 2004 - January 2006
Skills
Clinical Trials, CRO, CTMS, Clinical Monitoring, SOP, GCP, Protocol, ICH-GCP, EDC, Pharmaceutical Industry, Clinical Data Management, Sop, Inform, Project Management, Clinical Operations, Clinical Research, Training, Strategy, Regulatory Requirements, Validation
Education
University of Dayton 2000 — 2004
Bachelor of Science in Business Administration, Marketing
Woolley Rieser LLC 2010 - Present
Kendle International (now INC Research) 2010 - 2011
Maxim Healthcare Services 2007 - 2010
Various Pharmaceutical Companies 1984 - 2006
Charles River Laboratories 2004 - 2005
GlaxoSmithKline 1998 - 2004
PPD 1995 - 2000
UNC Health Care 1982 - 1994
UNC Hospitals 1977 - 1981
Skills
Nia, Movement, Meditation, Clinical Research, CRO, Pharmacogenetics, Clinical Trials, Health, Healthcare, Endocrinology, Writing, Science Writing, Fitness, Healing, Wellness, Personal Coaching, Teaching, Holistic Health, Nursing
Education
Duke University 1973 — 1977
BSN, Nursing, Psychology
East Carolina University 1981 — 1982
Family Nurse Practitioner Certification, Advanced Practice Nursing