PPD Inc.
Industry: Pharmaceutical company
DescriptionThe Pharmaceutical Product Development, LLC is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. The company’s clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. Headquarters: Wilmington, NC CEO: David Simmons Number of employees: 20,000 (2017) Founder: Fredric N Eshelman Subsidiaries: EVIDERA, Acurian, Inc., PPD Japan K.K., Parent organization: Jaguar Holding Company I
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PPD Inc. Employees
PPD, Inc. September 2013 - Present
Duke University Medical Center September 2011 - Present
VANG 1991 - 2012
Quintiles July 2006 - June 2010
BioKinetic Clinical Applications October 2005 - February 2006
BIOKINETIC CLINICAL APPLICATIONS October 2005 - February 2006
Aderis Pharmaceuticals February 1999 - April 2005
ADERIS PHARMACEUTICALS January 1999 - January 2005
PRA International October 1992 - January 1999
PRA International January 1992 - January 1999
Skills
Clinical Trials, Clinical Development, CRO, Drug Development, Strategic Planning
Education
Furman University 1971 — 1975
Bachelor of Science (BS), Biology, General
Medical College of Virginia / Virginia Commonwealth University
PPD November 2013 - Present
PPD April 2011 - November 2013
PPD October 2010 - April 2011
PPD, Inc. October 2009 - October 2010
InterContinental Hotels 2008 - November 2009
Concepts Worldwide January 2007 - March 2008
Education
University of Arizona 2001 — 2006
University High School 1997 — 2001
PPD, Inc. April 2014 - Present
PPD October 2011 - March 2014
PPD October 2009 - October 2011
PPD July 2006 - September 2009
BioNumerik Pharmaceuticals 2004 - 2006
PPD March 1999 - July 2004
Skills
CRO, CTMS, EDC, Sop, Clinical Monitoring, GCP, Clinical Data Management, Therapeutic Areas, Quality Assurance, Pharmacovigilance, Clinical Research, ICH-GCP, Pharmaceutical Industry, Clinical Development, Risk Based Audits, Auditing, Quality Management, Risk Based Inspection, 21 CFR Part 11, Clinical Trials, FDA, Protocol, Regulatory Affairs
Education
Texas A&M University 1995 — 1998
BS, Biomedical Science
Premier Research October 2013 - Present
PPD, Inc. July 2008 - October 2013
Fox Valley Clinical Research Center, LLC. December 2004 - June 2008
Radiant Research, Inc. September 1996 - December 2004
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, CTMS, Clinical Development, Oncology, ICH-GCP, Clinical Monitoring, EDC, Sop, Clinical Research, Regulatory Affairs, Regulatory Submissions, Biotechnology, Therapeutic Areas, Clinical Data Management, Pharmacovigilance, FDA, Infectious Diseases
Education
Northwood University 2005 — 2008
Bachelor of Business Administration (BBA), Business Administration, Management and Operations
College of DuPage 2002 — 2005
Associate of Arts (AA), Business Administration and Management, General
STATPH Associates, Inc. February 1999 - Present
Pfizer April 2000 - February 2006
PPD, Inc. July 1996 - April 1997
Skills
Statistics, Clinical Trials, Pharmaceuticals, Pharmacokinetics, SAS, Pharmaceutical Industry, Biostatistics, Clinical Development, SAS programming, Respiratory Therapy, Oncology, Central Nervous System, HIV, Infectious Diseases, Gastrointestinal..., Diabetes, CRO, SAS Macros, QC, Statistical Modeling, In Vivo, Quality Control, Lifesciences, Predictive Modeling, R, Statistical Programming, Survival Analysis, Predictive Analytics, CDISC, FDA, Clinical Data Management, Outcomes Research, Biotechnology, EDC, Protocol, S-Plus
Education
University of North Carolina at Chapel Hill 1989 — 1991
Master, Biostatistics
Fu Jen Catholic University 1982 — 1986
Bachelor's degree, Statistics and Information Science
PPD March 2014 - Present
PPD January 2010 - March 2014
PPD, Inc. March 2005 - December 2009
PPD, Inc. October 2002 - March 2004
PPD, Inc. December 2001 - October 2002
PPD, Inc. January 1998 - December 2001
Skills
Miller Heiman Large..., Clinical Trials, Management, Contract Management, CRO, Six Sigma, Business Development, Training, CTMS, SAS, Pharmaceutical Industry, Clinical Development, Cross-functional Team..., Global Alliance..., Leadership, Negotiation, Strategic Partnerships, Strategy, Drug Development, Analysis, Oncology, EDC, Outsourcing, GCP, Proposal Writing, Project Management
Education
University of North Carolina at Wilmington 1998 — 2000
MBA, Finance
University of Mississippi 1992 — 1996
B.A., English, Chemistry
Westat April 2014 - Present
PRA International May 2013 - March 2014
Comprehensive Clinical Development April 2012 - May 2013
INC Research February 2009 - March 2012
INC Research July 2007 - February 2009
PPD, Inc. August 2004 - July 2007
Duke University January 2003 - July 2004
Skills
SAS, Statistics, Clinical Trials, Data Analysis, SAS/SQL, Statistical Programming, Biostatistics, Validation, CDISC, CRO, SAS programming, Clinical Data Management, Macro, Data Management, SDTM, GCP
Education
North Carolina State University 2000 — 2005
MS, Bioinformatics
North Carolina State University 1998 — 2000
MS, Statistics
University of Missouri-Rolla 1994 — 1998
BS, Applied Mathematics
Parkway West HS 1990 — 1994
Pharmatech April 2015 - Present
Metis Clinical Consulting, LLC January 2012 - Present
Biodesix, Inc. January 2013 - April 2015
Execupharm January 2011 - November 2012
Gilead Sciences, Inc. (Gilead Colorado office closed 12/31/09) November 2006 - December 2009
Myogen, Inc. (acquired by Gilead Sciences, Inc. in 11/06) November 2004 - November 2006
PPD, Inc. January 2000 - October 2004
Skills
CRO, Sponsor, Contractor, Clinical Development, Clinical Trial..., Clinical Trials, Phase 1 studies, GCP, CTMS, ICH-GCP, Clinical Research, EDC, Clinical Monitoring, Oncology, Drug Development, Clinical Operations, Clinical Data Management, Therapeutic Areas, Regulatory Submissions
Education
State University of New York College at Cortland 1990 — 1994
BSE, Health Education
PRA Health Sciences March 2013 - Present
Hartwick Research Consulting, LLC May 2012 - March 2013
ReSearch Pharmaceutical Services January 2011 - May 2012
Takeda Pharmaceuticals July 2008 - January 2011
TAP Pharmaceuticals 2003 - 2008
PPD, Inc. December 2001 - January 2003
BD Technologies 1998 - 2001
Skills
Disease, Clinical Monitoring, Diabetes, Neurology, CTMS, EDC, Clinical Research, GLP, Therapeutic Areas, ICH-GCP, GCP, CRO, Clinical Development, Clinical Research..., Clinical Trials, Ophthalmology
Education
Ohio University 1992 — 1996
BS, Biological Sciences
Quintiles October 2014 - Present
PPD October 2013 - October 2014
PPD November 2010 - September 2013
PPD, Inc. June 2005 - November 2010
CEDRA Corporation 2000 - 2005
CEDRA Corporation 2000 - 2005
Skills
GCP, Clinical Research, Science, CRO, Clinical Trials, SOP, Protocol, Sop, Pharmaceutical Industry
Education
Texas A&M University 1997 — 2000
BS, Biomedical Science
Westwood High School 1993 — 1997
General, General
Covance June 2013 - Present
Aerotek October 2012 - June 2013
Execupharm June 2012 - October 2012
PPD, Inc. October 2004 - June 2012
PAREXEL International March 2001 - October 2004
Duke University Medical Center June 1998 - March 2001
Alpha Therapeutic 1997 - 1998
Skills
Clinical Trial..., Clinical Monitoring, EDC, Medidata, DataTrak, Cascade Server, CTMS, Seibel, Clinical Trials, CRO, Clinical, FDA, IRB, Data Collection, GCP, Clinical Development, Clinical Research, Pharmaceuticals, ICH-GCP, Ophthalmology, SOP, Microsoft Office 2007, Plateau, Clinical Operations, Neurology, Pharmaceutical Industry, Sop, Medical Devices, Clinical Research..., Regulatory Submissions, Data Management, Pharmacovigilance, Protocol, Oracle Clinical, Therapeutic Areas, Infectious Diseases, Rheumatoid Arthritis, Trial Management
Education
Drexel University College of Medicine 2011 — 2013
MS, Clinical Research Organization and Management
North Carolina Central University 1995 — 1997
BS, Biology
University of North Carolina at Greensboro
FujiFilm Diosynth Biotechnologies USA July 2012 - November 2012
Novartis 2009 - 2011
Novartis V&D July 2009 - November 2009
PPD, Inc. 2008 - 2009
GlaxoSmithKline March 2007 - June 2008
Garments, Etc. 2005 - 2008
LabCorp 2006 - 2007
GSK 2000 - 2004
Burroughs Wellcome, Glaxo Wellcome, GlaxoSmithKline 1993 - 2000
DuPont 1990 - 1993
Skills
Validations, Methods Development and..., Quality Assurance, IT Integration, V&V, FDA, Transfer, Statistics, USP, GMP, Analytical Chemistry, GLP, Information Technology, Validation, Pharmaceutical Industry, Biotechnology, Sop, Change Control, Quality Control, Chromatography, HPLC, 21 CFR Part 11, Technology Transfer, Chemistry, CAPA
Education
Virginia Commonwealth University 1989 — 1990
BS, Chemistry
Old Dominion University 1986 — 1989
None, Biochemistry, minor in Computer Science
John Tyler Community College 1983 — 1986
AS, Science
The Select Group January 2013 - Present
The Select Group May 2012 - January 2013
Pi Sigma Epsilon Professional Sales Fraternity - Delta Tau Chapter February 2011 - May 2012
PPD, Inc. November 2010 - May 2012
Cameron School of Business August 2008 - May 2012
Euromed Management, Marseille June 2011 - August 2011
Education
University of North Carolina at Wilmington 2008 — 2012
BS
Ecole de Management de Marseille / Euromed Marseille 2011 — 2011
BS, Business Administration
Little River Pharmaceutical Consultants 2011 - Present
PPD, Inc. 2011 - Present
Cardiokine, Inc. 2009 - 2011
Otsuka Pharmaceuticals 2006 - 2009
Targacept, Inc. 2002 - 2006
Carter Wallace, Inc. 1985 - 2002
Sterling Drug, Inc. 1980 - 1985
Skills
Regulatory Affairs, Clinical Trials, FDA, IND, Biotechnology, Drug Development, GCP, Oncology, Regulatory Submissions, CRO
Education
Miami University 1974 — 1976
PhD, Immunology and Microbiology
Rutgers University
BA/MS, Microbiology
Caterpillar Inc. June 2013 - Present
Caterpillar Inc. – Building Construction Products (BCP) July 2010 - May 2013
North Carolina Department of Labor February 2010 - July 2010
PPD, Inc. October 1999 - July 2009
VFL Technology June 1997 - August 1999
Resource Applications Inc. 1990 - 1997
Skills
Ergonomics, Emergency Management, Environmental, Radiation Safety, Bloodborne Pathogens, Environmental Awareness, Industrial Hygiene
Education
Penn State University 1984 — 1988
B.S., Chemistry
Dover Area High School 1980 — 1984
Academic
Wake Technical Community College
inVentiv Health Clinical October 2014 - Present
Premier Research July 2014 - Present
Premier Research October 2012 - Present
PAREXEL International March 2010 - September 2012
PPD, Inc. August 2007 - March 2010
Hills Fitness Center May 2001 - April 2009
PPD, Inc September 2005 - August 2007
3M Corporation December 2006 - May 2007
St. Edward's University May 2004 - May 2007
Self-employed February 2004 - July 2006
Skills
Recruiting, Project Management, Data Analysis, Process Improvement, Strategic Planning, Leadership, Clinical Research, Training, Change Management, Human Resources, Clinical Trials, Healthcare, Public Speaking, Management, ICH-GCP, EDC, INFORM 4.6, INFORM 5.5
Education
St. Edward's University 2004 — 2007
MBA, Global Business/Finance
Webster University 1995 — 1997
MA, Human Resource Management
University of Louisville 1985 — 1991
BA, Biology
PPD February 2014 - Present
Eurofins Global Central Laboratory May 2013 - February 2014
InterMune March 2010 - March 2013
PPD, Inc. September 2007 - March 2010
Jazz pharmaceuticals April 2006 - September 2007
MDS Pharma Services April 2004 - April 2006
MDS Pharma Services February 2003 - April 2004
MDS Pharma Services April 2001 - February 2003
Oriental Trading Company March 1998 - April 2001
University of Nebraska Medical Center February 1995 - March 1998
Skills
Medical Affairs, Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Drug Development, Clinical Research, Drug Discovery, Bioanalysis, GCP, Clinical Pharmacology, GLP, Pharmacokinetics, Biopharmaceuticals, Biotechnology, Pharmaceutics, Pharmacology, Biomarkers, Sop, Neurology, EDC, Cardiology, CTMS, IND, Validation, Global Central Lab, Immunology, SOP, Oncology
Education
University of Nebraska Medical Center 1995 — 1998
Postdoctoral Fellowship, Pharmacology and Developmental Toxicology
University of Florida College of Medicine 1988 — 1995
Ph.D., Pharmacology
Clark University 1984 — 1988
B.A., Chemistry
PPD, Inc. May 2004 - October 2012
PPD, Inc October 2003 - May 2004
PPD, Inc March 2001 - October 2003
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, Protocol, FDA, Hospital Admitting..., Hospital Ward Secretary, Hospital Insurance..., Bank Teller, Building Supply..., Human Resources..., Accounts Receivable, Accounts Payable, Executive..., Medical Terminology, Accurate Data Entry, Ten Key, Microsoft Office, Computer Literate, Copying, Calculator, Multi-line Phone, Document Scanning
Education
Mount Olive College 2007 — 2007
Business Administration and Management, General
University of North Carolina at Wilmington 2001 — 2001
Computer Science
Rockingham Community College 1989 — 1991
transfer courses
Wentworth High School 1967 — 1971
VentiRx Pharmaceuticals April 2013 - Present
Seattle Genetics October 2011 - April 2013
PPD, Inc. November 2000 - October 2011
Skills
Oncology, Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, CTMS, Medical Affairs, Therapeutic Areas, Clinical Monitoring, Drug Development, Clinical Data Management, Infectious Diseases, GCP, Lifesciences, Medical Devices, ICH-GCP, FDA, Biotechnology, Clinical Research, Regulatory Submissions, Medical Writing
Education
Louisiana State University School of Medicine in New Orleans 1982 — 1986
Doctor of Medicine (MD)
Louisiana State University 1979 — 1982
Bachelor of Science (BS), Biochemistry
INC Research September 2011 - Present
PPD, Inc. October 1999 - September 2011
American Diabetes Association February 1995 - June 1999
Skills
Regulatory Submissions, Publishing, Medical Writing, Manuscript, Pharmaceutical Industry, ICH-GCP, Regulatory Requirements, Creative Writing, Theatre, Copy Editing, Editing, CRO, FDA, Playwriting, Books, Content Development, Literature, Copywriting, Board of Directors, Technical Writing, eCTD, Pharmacology, Press Releases, Social Networking, 21 CFR Part 11, Drug Development, Storytelling, Stage Direction, Acting, Report Writing, Community Theatre, Performing Arts, Social Media, Management, Public Speaking
Education
Wilkes University 2009 — 2011
MFA, Creative Writing
Radford University 1980 — 1981
Theatre/Theater
Lantech Communications, LLC. December 2000 - Present
PPD, Inc. November 1994 - December 2000
Merisel Inc September 1993 - October 1994
IBM, Inc December 1978 - September 1993
Skills
Telecommunications, Wireless, VoIP, Networking, Technical Support, Start-ups, Project Management, Call Center, Business Development, Telephony, Management, Operations Management, Product Development, Network Administration, Servers, New Business Development
Education
Mount Olive College
Bachelor of Science Degree
Durham Technical Community College
Mallinckrodt Pharmaceuticals, St. Louis, MO July 2013 - Present
PPD, Inc. December 2011 - June 2013
Bausch + Lomb June 2009 - November 2011
Clinical Documentation 2004 - June 2009
Novartis Ophthalmics 1999 - 2004
Ferndale Laboratories 1997 - 1999
Tampa Bay Clinical Research 1995 - 1997
Warner Chilcott 1990 - 1995
Skills
FDA-related..., Drug Metabolism, Toxicology, Pharmacokinetics
Education
The George Washington University School of Medicine and Health Sciences
Ph.D., Pharmacology
University of Virginia
B.A., Chemistry, Psychology
PPD, Inc. January 2014 - Present
Three Ships Digital Marketing Agency October 2014 - December 2014
Novo Nordisk January 2014 - July 2014
BCBSNC April 2013 - September 2013
RBC November 2012 - June 2013
CSC 2011 - 2012
Odum Institute for Research in Social Science 2009 - 2011
Skills
Social Media, Research, Editing, Project Management, Management, HTML, Event Planning, Writing, Blogging, Marketing
Education
UNC
PPD December 2014 - Present
PRA International April 2014 - December 2014
PRA International October 2010 - April 2014
PRA International October 2010 - October 2011
PPD January 2003 - October 2010
PPD, Inc. September 2005 - April 2007
PPD Inc. October 2004 - September 2005
PPD, Inc. March 2004 - October 2004
PPD Inc. January 2003 - March 2004
Skills
Clinical Monitoring, Clinical Research, Infectious Diseases, Sop, Protocol, CTMS, Regulatory Affairs, Neurology, Oncology, ICH-GCP, Clinical Trials, Pharmacovigilance, EDC, Clinical Operations, CRO, GCP, Therapeutic Areas, Clinical Data Management, Clinical Development, Drug Development, Regulatory Requirements, Regulatory Submissions, Biotechnology, Management
Education
East Carolina University 1998 — 2002
Bachelors of Science Degree, Nutrition and Dietetics
PPD, Inc. May 2008 - Present
PPD March 2003 - April 2008
Chiltern International 2001 - 2003
XOMA 2000 - 2001
Elan Pharmaceuticals 1998 - 2000
Elan 1997 - 1999
Chiron Corporation 1996 - 1998
Amersham Pharmacia Biotech 1994 - 1996
Chiron Corporation 1992 - 1994
Education
University of California, Berkeley 1988 — 1992
The University of Texas at Austin 1982 — 1986
BA, Microbiology
PPD August 2005 - Present
PPD 1991 - 2009
PPD, Inc. July 1999 - August 2005
Various January 1995 - July 1999
Skills
Clinical Trials, CRO, Clinical Development, Clinical Data Management, Leadership, Diabetes, Pharmacovigilance, Clinical Research, SAS programming, Programming, GCP, Oncology, Regulatory Submissions, SDTM, CDISC, ICH-GCP, FDA, Biostatistics, Data Management, Pharmaceutical Industry, CTMS, EDC, Statistical Programming, Data Analysis, SAS, Infectious Diseases, Management, 21 CFR Part 11, Validation, Biotechnology, Healthcare, Sop
Education
Bluefield State College 1979 — 2009
BS in BA, Majored in Computer Science and Management
Strayer University 2003 — 2007
MBA, Management
PPD, Inc. September 2006 - Present
MGI Pharma 1999 - 2006
Skills
CTMS, Clinical Development, Clinical Trials, GCP, EDC, Clinical Research, CRO, Oncology, Clinical Monitoring
Education
Northwestern University 1988 — 1989
MA, Audiology and Hearing Science
St. Olaf College 1983 — 1987
BA, Science, French, Education
University of Minnesota-Twin Cities
Decision Driver Analytics January 2006 - Present
PPD, Inc. 2002 - 2005
PPD, Inc January 2000 - January 2002
RTI International January 1999 - January 2000
National Institute of Environmental Health Sciences (NIEHS) January 1998 - January 1999
Southwestern University January 1996 - January 1998
Duke University January 1991 - January 1996
Skills
Data Analysis, Business Development, Leadership, Data Mining, Pricing, Budgets, Proposal Writing, Research, Negotiation, Consulting, Marketing, Management, Strategy, Market Development, Sales, Recruiting, Economics, Clinical Development, Clinical Trials, CRO, Clinical Research, Oncology, Market Research, Analysis, Healthcare, Analytics, Pharmaceutical Industry, CTMS, Health Economics
Education
Duke University 1991 — 1996
Ph.D., Mathematics
Stetson University 1987 — 1991
B.S, Mathematics/Computer Science
SHI International Corp. July 2015 - Present
Progression Technologies, Inc. April 2011 - July 2012
Oracle January 2010 - March 2011
Sorriso Technologies 2009 - 2010
PPD, Inc. 2007 - 2009
Pitney Bowes July 2005 - December 2007
Endeavor Recruitment August 2001 - March 2003
Kforce February 1997 - May 2001
Management Alliance Group January 1995 - January 1997
Skills
SPHR Certification, Recruiting, SPHR, Applicant Tracking..., CRM, Policy, Human Resources, Process Improvement, Technical Recruiting, Project Management, Sales Operations, Temporary Placement, Interviews, Hiring, Management, Talent Acquisition, Onboarding, Sales, Cold Calling, Enterprise Software, Account Management, SaaS, Start-ups, Business Intelligence, Networking, Internet Recruiting, Awesomeness
Education
Sam Houston State University 1990 — 1993
Bachelor's, Communications
KemPharm, Inc. June 2014 - Present
INC Research May 2013 - June 2014
Contract October 2011 - May 2013
Covidien October 2010 - April 2011
Covidien Positive Results for Life December 2009 - April 2011
Genentech September 2007 - March 2010
Inclinix, Inc. 2007 - July 2007
PPD, Inc. 2005 - February 2007
Kforce Technology Staffing 2001 - 2005
Barton and Polansky Associates 1999 - 2001
Skills
Research Project..., Clinical Monitoring, Remote Monitoring, Remote Management, Clinical Trial..., Project Management, CTMS, Clinical Trials, CRO, 21 CFR Part 11, Clinical Data Management, Clinical Research, Oracle Clinical, Pharmaceutical Industry, Protocol, Software Documentation, Sop, Clinical Operations, FDA, Neurology, Remote Infrastructure..., SOP
Education
Universidad de Puerto Rico 1981 — 1986
BS, Natural Sciences, Biology, Chemistry & Pre-Med
University of Puerto Rico 1981 — 1986
Bachelor in Sciences, Biology/Chemistry
Wild Dunes Resort September 2013 - Present
Chipton Ross November 2012 - September 2013
PPD, Inc. November 2009 - October 2012
Excalibur Hotel & Casino October 2005 - October 2009
MGM Grand June 2004 - October 2005
Skills
Recruiting, Onboarding, Employee Engagement, Applicant Tracking..., Training, New Hire Orientations, Talent Acquisition, Human Resources, Talent Management, Coaching, Employee Benefits, Leadership Development, Customer Service, Succession Planning, Team Building, Performance Management, Leadership, Employee Relations, Temporary Placement, Time Management, Staffing Services, Management, Taleo, Internet Recruiting, Interviews
Education
Cleveland State University
Bachelor of Business Administration (B.B.A.)
Quintiles April 2013 - Present
Quintiles January 2011 - March 2013
INC Research March 2010 - January 2011
INC Research October 2009 - March 2010
PAREXEL International November 2007 - October 2009
etrials Worldwide, Inc November 2006 - October 2007
PPD, Inc. January 2006 - November 2006
Tekelec June 2004 - July 2005
Tekelec August 1999 - September 2002
University of North Carolina at Chapel Hill August 1994 - February 1998
Skills
EDC, Clinical Data Management, Clinical Trials, CTMS, Clinical Research, CRO, Inform, GCP, Validation, ICH-GCP, Software Documentation, Project Management, Oracle Clinical, Therapeutic Areas, Medidata, Public Speaking, Program Management, 21 CFR Part 11, Clinical Study Design, Clinical Development, Pastoral Care, Pharmaceutical Industry, Clinical Monitoring, CRF design, Process Improvement, Medidata RAVE, Process Management, Staff Development, IVR, Research Project..., Christian Counseling, Spanish-speaking, InForm GTM, Leadership, Leadership Development, Training
Education
New Covenant International (NCI) Bible College 2009 — 2014
Doctor of Philosophy (Ph.D.), Christian Ministry
New Covenant International (NCI) Bible College 2009 — 2014
Master (M.B.S., en passant), Biblical Studies
University of North Carolina at Chapel Hill 1994 — 1997
Bachelor of Arts (B.A.), Foreign Language
OMNETRIC Group March 2015 - Present
Siemens Energy, Inc January 2010 - Present
Learning by experience 2013 - 2015
Siemens Energy, Inc. March 2008 - January 2010
Siemens Power Transmission & Distribution October 2005 - March 2008
PPD, Inc. October 2002 - October 2005
Plurimus 2001 - 2001
SAIC 1991 - 1993
Skills
Social Media, SEM, Online Marketing, Corporate Communications, Blogging, Content Management, Team Leadership, Business Strategy, Management, Marketing Strategy, Marketing Communications, Internal Communications, Budgets, Project Management, Social Media Marketing, Strategic Communications, SEO, Strategic Planning, Digital Marketing, Online Advertising, Public Relations, Web Analytics, Integrated Marketing, FMCG, Trade Marketing, P&L Management, International Marketing, Marketing Budget..., Channel Partners, Business Alliances, P&L, Shopper Marketing, Sales Effectiveness, Market Development
Education
Seton Hall University 1997 — 1999
MA, Corporate and Public Communications
University of Massachusetts Dartmouth 1987 — 1991
Bachelor’s Degree, English/Writing
OvaBio, Inc. October 2013 - May 2015
Stablebody Technologies, LLC September 2012 - April 2013
Epic May 2012 - August 2012
Aova Technologies, Inc. December 2006 - March 2012
SCCD, Inc. March 2002 - January 2007
PPD, Inc. August 2003 - December 2006
Nanosphere, Inc. March 2001 - July 2003
Ophidian Pharmaceuticals November 1996 - May 2000
University of Wisconsin-Madison 1990 - 1996
Merck June 1992 - September 1992
Skills
Biotechnology, Technology Transfer, Assay Development, Research, Product Development, Antibodies, Data Analysis, Quality Assurance, Start-ups, Grant Writing, Continuous Improvement, Vaccines, Poultry, Technical Presentations, Baking, cGMP, Problem Solving, R&D
Education
University of Wisconsin-Madison 1990 — 1996
Ph.D., Chemical Engineering (Immunology/Statistics/Virology/Biochemistry)
University of California, Davis 1985 — 1990
B.S., Chemical Engineering (Biotechnology), with Honors
Vanguard Clinical Consulting January 2013 - Present
Isis Pharmaceuticals June 2012 - Present
Histogenics Corporation April 2014 - Present
Millennium Pharmaceuticals October 2011 - October 2013
Advanced BioHealing February 2009 - October 2011
Tissue Repair Company April 2008 - February 2009
Cardium Therapeutics April 2008 - February 2009
PPD, Inc. July 2007 - April 2008
Covance, Inc. December 2006 - June 2007
University of California, San Diego February 2006 - December 2006
Skills
Clinical Trials, Clinical Development, Biotechnology, Oncology, CTMS, CRO, GCP, Pharmaceutical Industry, Clinical Research, EDC, Sop, Clinical Monitoring, FDA, Medical Devices, Clinical Data Management, Protocol Design, Operations Management, Cross-functional Team..., ICH-GCP, Clinical Study Design, Clinical Operations, Diabetes, Regulatory Requirements, Data Management, Vendor Management, SOP
Education
University of California, San Diego 2000 — 2005
Bachelor of Science/Bachelor of Arts, Biology/English Literature
YOUTHDIGITAL May 2015 - Present
Down Level Seven June 2014 - May 2015
Therasim, Inc. 2011 - March 2014
PPD, Inc. 2004 - 2011
JDS Software, Inc. August 2002 - August 2004
Skills
AJAX, jQuery, CSS, PHP, Web Development, Product Development, Product Management, Business Analysis, User Experience Design, Scrum, Integration, Business Intelligence, Web Applications, Software Development, Agile Methodologies, Software Engineering, Training, Management, SDLC, SaaS, Entrepreneurship, Business Development, User Stories, Cloud Computing, Software Project..., Leadership, Databases, General Awesomeness, Web Services, User Experience, Strategy, Testing, Quality Assurance, Enterprise Software
Education
University of South Florida 1996 — 1998
St. Petersburg College 1985 — 1989
AA, Liberal Arts
PPD, Inc. July 2015 - Present
PPD April 2012 - Present
PPD March 2007 - Present
PPD March 2007 - Present
First Citizens Bank July 2001 - March 2007
RBC Centura Bank July 1998 - July 2001
Skills
Instructional Design, Web-based Training, MS Office Suite, Captivate (formerly..., Audacity, Articulate, Project Management, Problem Solving, Collaboration with..., Captivate, Client, E-Learning, Collaboration, Cross-functional Team..., Microsoft Office, Multimedia, Training, Training Delivery, Lectora, Learning Management, Instructional Technology, SnagIt, Curriculum Design, Needs Analysis, Leadership, Staff Development, Distance Learning, Technical Training, Instructor-led Training, ADDIE, Performance Consulting, Software Documentation, Content Development, Moodle, Program Management, Blended Learning, Technical Writing, Camtasia, SCORM, Learning Management..., Hands-on Training, Adult Education, Business Process..., Educational Technology, Dreamweaver, Analysis, WebEx, Articulate Studio, Job Aids, Virtual Training
Education
University of North Carolina at Wilmington 1998 — 2001
MS, Instructional Technology, Education
University of North Carolina at Wilmington 1989 — 1997
BA, Elementary Education with an academic concentration in History
Sarepta Therapeutics September 2013 - Present
TESARO January 2012 - August 2013
FoldRx Pharmaceuticals January 2009 - August 2011
CombinatoRx Inc 2006 - 2008
Synta Pharmaceuticals 2005 - 2006
PPD, Inc. 2001 - 2005
Janssen Research Foundation 1996 - 1998
Squibb Diagnostics/Bracco 1992 - 1996
Education
Gettysburg College
BS, Political Science/Spanish
The Janssen Pharmaceutical Companies of Johnson & Johnson March 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson August 2012 - March 2015
PPD, Inc. August 2011 - July 2012
Janssen Pharmaceutcial Companies of Johnson & Johnson June 2009 - July 2011
Skills
cIEF, Empower, SDS-PAGE, HPLC, UV/Vis, Methods Development, LIMS (Labware and..., Caliper, cGMP, Microfluidic Chip..., NGHC, Gel Electrophoresis, UV-Vis, Ion Exchange, IEF, Microsoft Office, Calibration, QC, R&D, Documentation, Analytical Chemistry, Aseptic Technique, Bioanalysis, Characterization, GMP, Quality Control, GLP
Education
Villanova University 2012 — 2014
MS, Chemistry
Lafayette College 2005 — 2009
BS, Biochemistry
PPD, Inc. July 2015 - Present
DrugDev, Inc. January 2013 - July 2015
ICON Clinical Research November 2011 - January 2013
ICON plc April 2008 - September 2011
ICON plc April 2006 - April 2008
ICON plc August 1999 - April 2006
Skills
CRO, Strategy, Business Development, New Business Development, Pharmaceutical Industry, Clinical Trials, Clinical Development, Account Management, Cross-functional Team..., Contract Management, Strategic Communications, Sales Operations, Coaching, Therapeutic Areas, Biotechnology, EDC, Oncology, Management, CTMS
Education
West Chester University of Pennsylvania
Master of Science, Health Services Administration
Kutztown University of Pennsylvania
Bachelor of Arts, Psychology, Cum Laude
PPD, Inc. December 2006 - Present
State of Ohio September 2003 - November 2006
American Red Cross First Capital District 2001 - 2005
InfoSight Corporation 1990 - 2000
Wearever-ProctorSilex 1983 - 1987
Skills
Contract Management, Project Management, Proposal Writing, Analysis, Vendor Management, Strategic Communications, Training, Cross-functional Team..., Program Management, Management, Pharmaceutical Industry, Clinical Trials, Leadership, Software Documentation, Contract Negotiation, Strategic Planning, Process Improvement, Customer Service, Strategy
Education
CHS 1964 — 1968
Ohio University
Integra Research, LLC June 2011 - Present
Genitech, LLC March 2012 - December 2012
Celgene Corporation November 2005 - March 2012
PPD, Inc. May 2001 - October 2005
Innovex a division of Quintiles January 2001 - May 2001
Florida Hospital Tampa August 1998 - May 2001
Moffitt Cancer Center October 2000 - January 2001
Clinical Pharmacology Services January 1999 - October 2000
Gulf Coast Recycling, Inc August 1996 - August 1998
Moffitt Cancer Center January 1996 - May 1996
Skills
Oncology, Clinical Research, CRO, Clinical, ARO, EDC, Electronic Medical..., Phase I-IV, PK/First-in-humans, Pivitol Trials, Aggressive timelines, GCP, Lead CRA, CTMS superuser, Mentoring, Trials, Clinical Trials, Regulatory Submissions, Clinical Monitoring, EMR, Clinical Development, ICH-GCP, CTMS, Protocol, Timelines, Healthcare, Therapeutic Areas, Patient Recruitment, Neurology, Pharmacovigilance, Clinical Operations, Oracle Clinical, Inform, Medical Writing, Clinical Study Design, Hematology, Clinical Data Management, Medical Devices, Drug Development, Infectious Diseases, Sop, SOP
Education
University of South Florida 1994 — 1996
Bachelor of Science in Nursing, Registered Nurse
University of Central Florida 1993 — 1994
Undergraduate studies, Science
Hillsborough Community College 1990 — 1993
AS, Business, Science
Accenture November 2012 - Present
Aris Global August 2011 - November 2012
Drug Safety Alliance December 2010 - June 2011
Copernicus Group IRB July 2007 - December 2010
PPD, Inc. December 2005 - June 2007
PharmaLinkFHI 1999 - 2005
Skills
Staff Development, Negotiation, Staff Management, Budgeting, Customer Relations, Forecasting, Contract Management, Strategic Planning, Planning, Team Building, Business Planning, Customer Service, Problem Solving, Mentoring, Budgets, Project Planning, Clinical Trials, CRO, Pharmacovigilance, CTMS, Risk Management, Leadership, Project Management, Human Resources, Quality Assurance, GCP, Management, Pharmaceutical Industry
Education
Southern Illinois University, Carbondale 1978 — 1981
BSIE, Industrial Engineering
Community College of the Air Force 1977 — 1978
AAS, Aeronautical Engineering
Jefferson College 1974 — 1976
AFA, Instrumental Music, Elementary Education
Independent Clinical Research Associate 2006 - Present
PPD, Inc. March 2001 - May 2006
Unifour Medical Research Assoc April 2000 - March 2001
Carolinas Research Associates April 1996 - April 2000
Skills
Clinical Trials, Clinical Research, Oncology, CTMS, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, GCP, EDC, CRO, Clinical Development, Clinical Data Management, Therapeutic Areas, Infectious Diseases, Oracle Clinical, Inform, Regulatory Affairs, Pharmacovigilance, Biotechnology, Drug Development, SOP, Regulatory Submissions, Protocol, Clinical Operations, Cardiology, FDA, Neurology, Diabetes, Medical Devices, Life Sciences, Pharmaceutics, Clinical Research..., Clinical Study Design, Vaccines, Immunology, Endocrinology, Data Management, Quality Assurance, 21 CFR Part 11, Management, Rheumatology, CRF design, Regulatory Requirements, Healthcare
Education
University of North Carolina at Charlotte 1995 — 1999
BS, Biology
Virginia Department of Taxation May 2014 - Present
Virginia Department of Social Services August 2011 - April 2014
PPD, Inc. July 2007 - August 2011
Northrop Grumman Corporation May 2000 - July 2007
Skills
JavaScript, Information Assurance, Testing, Requirements Analysis, SQL, Security, Databases, Integration, PL/SQL, Oracle, Software Development, XML, Unix
Education
Old Dominion University 1998 — 2000
BS, Computer Science
Virginia Polytechnic Institute and State University
CARA Therapeutics, Inc. June 2015 - Present
Amgen April 2013 - June 2015
Amgen, Inc. March 2008 - February 2015
Amgen, Inc. January 2005 - March 2008
Eible Research Consulting, LLC May 2002 - December 2004
Target Research Associates December 2000 - May 2002
Medical University of South Carolina at Charleston June 2000 - December 2000
Clinimetrics August 1999 - June 2000
New Hanover Regional Medical Center May 1998 - April 2000
PPD, Inc. February 1999 - August 1999
Skills
Clinical Trial..., Oncology, Clinical Trials, Clinical Research, Infectious Diseases, EDC, Clinical, GCP, Psychiatry, Pain, CRO, Pediatrics, Clinical Development, Hematology, CTMS, Cardiology, Rheumatology, Dermatology, FDA, Pharmaceuticals, Biotechnology, Urology, Cancer, Clinical Monitoring, Healthcare, Ophthalmology, Gastroenterology, Patient Recruitment, SOP, IND, Osteoporosis, Research, Treatment, Health, Therapeutic areas, Change Management, Pharmaceutical Industry, Drug Development, Therapeutic Areas, Protocol, Clinical Data Management, Medical Writing, Sop
Education
Hartwick College 1994 — 1997
BSN, Nursing
Utica College 1992 — 1994
ICON plc May 2013 - Present
Novella Clinical, Inc. 2008 - May 2013
PPD, Inc. 2005 - 2008
PPD January 2003 - August 2004
PPD April 2002 - January 2003
PPD January 2001 - April 2002
Skills
Forecasting, Budgets, Analysis, Management, Project Management, Risk Management, Finance, Accounts Payable, Time Management, Variance Analysis, Research, Clinical Trials
Education
North Carolina State University
B.A., Sociology
ABC Laboratories January 2010 - Present
ABC Laboratories September 2009 - January 2010
PPD, Inc November 2007 - January 2009
PPD, Inc. October 2004 - November 2007
PPD, Inc. April 2003 - October 2004
PPD, Inc. January 2002 - April 2003
PPD, Inc. February 2001 - January 2002
PPD, Inc. August 2000 - February 2001
Covance Laboratories September 1999 - August 2000
Skills
Sop, Analytical Chemistry, Clinical Trials, Cross-functional Team..., Formulation, GLP
Education
University of Minnesota-Twin Cities
B.S., Chemistry
Managed Healthcare Associates, Inc. 2002 - Present
PPD, Inc. 1992 - 2002
Skills
Pharmaceutical Industry, Managed Care, Healthcare, Medical Devices, Hospitals, Pharmaceutical Sales, Biotechnology, Healthcare Management, Healthcare Information..., Medicare, Strategic Planning, Account Management, Sales Operations
Education
Radford University 1988 — 1992
PRA Health Sciences April 2014 - Present
PRA International August 2011 - March 2014
PPD, Inc. August 2002 - June 2011
Southeast Interactive Technology Funds 1999 - 2002
Skills
Financial Analysis, Sarbanes-Oxley Act, US GAAP, Forecasting, Financial Reporting, Financial Modeling, Managerial Finance, Internal Controls, GAAP, Auditing, Accounting, Financial Accounting, SEC filings, Mergers & Acquisitions, Variance Analysis, Strategic Financial..., Finance, Cost Accounting, Financial Planning
Education
North Carolina State University
PPD, Inc. November 2014 - Present
PPD, Inc. September 2006 - November 2014
Skills
CRO, EDC, Clinical Trials, Clinical Development, CDISC, GCP, Therapeutic Areas, Regulatory Submissions, Clinical Data Management, CTMS, Oncology, Clinical Study Design, Biostatistics, SDTM, ICH-GCP, CRF design, Oracle Clinical, Statistical Programming
Education
University of North Carolina at Chapel Hill 1995 — 1997
M.S., Biostatistics
Western Michigan University 1990 — 1995
BS, Mathematics and Statistics
Amgen June 2012 - Present
inVentiv Health October 2010 - June 2012
PPD October 2008 - October 2010
PPD, Inc. June 2007 - October 2008
Skills
SAS, Statistical Programming, CDISC, CRO, SAS programming, Clinical Data Management, EDC, Biostatistics, GCP, Clinical Research, Drug Development, SDTM, SAS/SQL, 21 CFR Part 11, CRFs, Project Documentation, SAS Base, SAS/STAT, SAS Enterprise Guide, Team Management, Phase I, Phase II, Phase III, Phase IV, Program specifications, Data Quality Control, Project Lead, Integrated Databases, Clinical Development, Clinical Trials, Pharmaceutical Industry, SAS Programming
Education
North Carolina State University 2005 — 2007
BS, Mathematics
Covance, Inc. March 2013 - Present
Covance February 2012 - Present
PPD, Inc. May 2006 - February 2012
Clinsys Clinical Research 2003 - 2006
Bassett Healthcare 1993 - 1999
Skills
Oncology, Phase I, Medical Devices, Customer Relations, Financial Management, Clinical Research, Therapeutic areas, Clinical, Clinical Monitoring, Clinical Trial..., CRO, GCP, Clinical Trials, Infectious Diseases, CTMS, Diabetes, EDC, Endocrinology, Dermatology, Pharmaceuticals, Vaccines, Neurology, Clinical Development, SOP, Ophthalmology, Hematology, ICH-GCP, Cardiology, Gastroenterology, Clinical Pharmacology, Pain, Nephrology, Asthma, Line Management, Mentoring, Research, Drug Development, Therapeutic Areas, Protocol, Pain Management, Sop, Pharmaceutical Industry, Regulatory Submissions, Pharmacovigilance, Clinical Operations
Education
RSCS
SUNY Polytechnic Institute
Bordman Household 2009 - Present
PPD, Inc. 2002 - 2009
Education
University of North Carolina at Charlotte 1991 — 1995
Brevard High School 1987 — 1991
SynteractHCR July 2013 - Present
PharmaNet/i3 Strategic Resourcing July 2012 - July 2013
PRA International April 2012 - July 2012
Takeda Pharmaceuticals February 2010 - March 2012
Paragon Biomedical, Inc. October 2006 - February 2010
PPD, Inc. July 2006 - October 2006
Paragon Biomedical, Inc. April 2006 - July 2006
Paragon Biomedical, Inc. November 2003 - April 2006
Paragon Biomedical Inc. January 2003 - November 2003
Paragon Biomedical, Inc. January 2002 - January 2003
Skills
Clinical Research, CRF design, Budget, Management, EDC, Pharmaceutical Industry, CRO, Clinical Trials, Clinical Monitoring, Budgets, CTMS, GCP, Biotechnology, Infectious Diseases, Vaccines, ICH-GCP, Immunology, Clinical Operations, Rheumatology, Clinical Data Management, Clinical Development
Education
University of North Carolina at Chapel Hill 1998 — 2000
MPH, Health Policy and Administration
University of North Carolina at Chapel Hill 1988 — 1992
BA, Industrial Relations & Sociology
Independent Contractor January 2003 - Present
Sanofi-Synthelabo 2002 - 2003
PPD, Inc. September 1999 - November 2001
Education
University of Maryland College Park 2002 — 2002
Exercise Physiology
The University of Texas at Austin 1997 — 1999
MA, Exercise Physiology
Furman University 1993 — 1997
MedSource February 2014 - Present
Media Partners, Inc. 2012 - Present
Raleigh Little Theatre 2010 - Present
Aerotek April 2012 - January 2014
Camargo Pharmaceutical Services August 2011 - February 2012
i3 Research September 2009 - August 2011
i3 Research 2009 - 2010
PPD, Inc. 2008 - 2009
PPD (North America) 2004 - 2008
GSK 1989 - 2004
Skills
Clinical Trials, Risk Management, Strategic Thinking, Clinical Development, Industrial Sector, CRO, Project Management, Project Planning, Training Delivery, Biotechnology, eCRF, Clinical Monitoring, EDC, Analytical Skills, GCP, Time Line Management, Clinical Research, Therapeutic Areas, IND, Lifesciences, Drug Development, CTMS, Medical Devices, ICH-GCP, Medical Writing, Clinical Data Management, Oncology, Clinical Operations, Regulatory Submissions, Clinical Study Design
Education
Carmi High School
University of Alabama
Masters
University of West Florida
BA
PPD, Inc. August 1999 - Present
Education
North Carolina State University
BS, Economics
UNC-Chape Hill
BS, Clinical Laboratory Science
Chiltern July 2015 - Present
PPD, Inc. April 2010 - June 2015
PPD December 2001 - March 2010
PPD April 1997 - November 2001
Quintiles, Inc. 1994 - 1997
Skills
Clinical Development, Clinical Trials, Biologics, Diabetes, Oncology, Drug Development, Pharmaceutical Industry, CRO, Medical Devices, Biostatistics, GCP, Therapeutic Areas, Regulatory Submissions, EDC, CTMS
Education
Virginia Commonwealth University School of Medicine 1983 — 1989
PhD, Biostatistics
University of North Carolina at Chapel Hill 1975 — 1979
BA, Zoology
PPD Inc. April 2007 - Present
PPD, Inc. April 2007 - Present
Sweeney May 2005 - April 2007
Education
University of North Carolina at Wilmington 2001 — 2005
INC Research November 2014 - Present
Duke University Medical Center/Duke Clinical Research September 2012 - May 2014
Duke University Medical Center 2012 - 2013
Novella Clinical, Inc. 2012 - August 2012
Adecco at Cisco November 2011 - April 2012
Consonus Technologies June 2011 - October 2011
PPD, Inc. March 2010 - December 2010
GlaxoSmithKline January 2000 - February 2008
Northrop Grumman 2008 - 2008
GSK January 1997 - January 2000
Skills
Process Improvement, Cross-functional Team..., Program Management, Project Management, Management, Strategy, Integration, Contract Negotiation, Leadership, Training, Vendor Management, CRM, Analysis, Six Sigma, Business Process, Business Intelligence, Performance Management, Strategic Planning, SDLC, Budgets, PMP, Recruiting, Human Resources, Operations Management, Pharmaceutical Industry, Business Analysis
Education
North Carolina Wesleyan College
BSBA, Bachelor of Science Business Administration
North Carolina Wesleyan College
Pharmaceutical Product Development February 2011 - Present
PPD, Inc. 2011 - Present
Lantheus Medical Imaging March 2009 - February 2011
Education
University of Pennsylvania 1983 — 1987
Neuroanatomy
Universite de Montpellier, France 1968 — 1969
Licence es lettres, French and Comparative Literature
Massachusetts Institute of Technology 1963 — 1967
B.S., Humanities and Chemistry
PPD, Inc. July 2005 - Present
Cell Therapeutics, Inc. 2000 - 2005
Skills
Clinical Development, CRO, Cross-functional Team..., Clinical Trials, Lifesciences, GCP, CTMS, EDC, Clinical Research, Clinical Data Management, Oncology, Regulatory Submissions, Therapeutic Areas, Clinical Monitoring, Life Sciences, Pharmaceutical Industry
Education
Pacific Lutheran University - School of Business 2002 — 2004
MBA, Technology & Information Management
University of California, Davis 1988 — 1990
MS, Animal Science, Quantitative Genetics & Animal Breeding
Portland State University 1987 — 1988
BS, Biology
PPD, Inc. February 2010 - July 2011
PPD, Inc. April 2007 - February 2010
Education
Pontifical College Josephinum 2013 — 2017
Master of Arts (MA), Theology
St. Charles Borromeo Seminary 2011 — 2013
Pre-Theology
University of Dayton School of Law 1995 — 1998
JD, Law
Western Carolina University 1991 — 1993
MPA, Public Affairs & Finance
Western Carolina University 1985 — 1990
BSBA, Marketing
PPD, Inc. 2001 - Present
PharmComm / Cetan Technologies 1999 - 2001
Oxford Laboratories 1999 - 1999
Corning Incorporated 1997 - 1998
Quintiles / BRI 1996 - 1997
Skills
21 CFR Part 11, CRO, GCP, FDA, Validation, Software Documentation, Sop, Computer System..., Change Control, Quality Assurance, Trackwise
Education
University of North Carolina at Wilmington 1992 — 1996
B.S., Biology / Chemistry
PPD, Inc. September 2013 - Present
PPD April 2013 - Present
PPD, Inc. 2008 - January 2010
PVA, Inc. February 1996 - April 2008
Martin Marietta May 1981 - June 1994
Skills
Cross-functional Team..., 21 CFR Part 11, Document Management, Quality Assurance, Vendor Management, SDLC, Software Documentation, Data Management, Documentum, Computer System..., Process Improvement, FDA, SharePoint, Business Process, Visio, Change Control, Validation, Sop
Education
DeVry University 1975 — 1978
BSEET, Electronics
CoteClinical February 2013 - Present
Elan Pharmaceuticals February 2013 - December 2013
Janssen Pharmaceuticals a subsidiary of Johnson & Johnson February 2012 - December 2012
Johnson & Johnson (transitioned from Elan) December 2007 - February 2012
Elan Pharmaceuticals (AIP program transitioned to Janssen AI) December 2007 - September 2009
PPD, Inc. 2003 - 2007
Ivax Pharmaceuticals April 2000 - May 2003
Noven Pharmaceuticals February 1997 - April 2000
Quintiles February 1996 - March 2000
Mount Sinai Medical Center March 1991 - March 1996
Skills
FDA, CRO, Sop, Pharmaceutical Industry, Regulatory Submissions, GCP, Clinical Research, EDC, CTMS, Clinical Trials, Biotechnology, Clinical Development, Oncology, 21 CFR Part 11, SDLC, Regulatory Affairs, GxP, Clinical Data Management, Drug Development, Infectious Diseases, Clinical Operations, Pharmacovigilance, Lifesciences, IND, Medical Devices, Protocol, Validation, Clinical Monitoring, ICH-GCP, GLP, Therapeutic Areas, Vaccines, Neurology, Quality Assurance, CAPA, Oracle Clinical, Phase I, Cross-functional Team..., Biopharmaceuticals, Quality System, Healthcare, Clinical Study Design, Drug Safety, R&D, Quality Management, Neuroscience, Drug Discovery, Central Nervous System, Assurance and Compliance, Integrated Risk...
Education
Dominican College of Blauvelt 1982 — 1984
PPD, Inc. July 2004 - Present
Education
Jackson State University 1998 — 2002
Optum January 2013 - Present
OptumInsight February 2011 - January 2013
i3 Global March 2006 - February 2011
PPD, Inc. July 2004 - March 2006
PAREXEL May 1999 - July 2002
Skills
Pharmaceutical Industry, Pricing, Outsourcing, Business Development, Contract Negotiation, Risk Management, CRO, Change Management, Clinical Research, Project Management, Mergers, Business Strategy, Budgets, Performance Management, Clinical Trials, Sales Management
Education
Florida Gulf Coast University 2002 — 2004
MBA, Marketing, Management
The University of Connecticut School of Business 1995 — 1999
Bachelor of Science (BS), Health Systems Management
PPD, inc. Adjunct FacultyMontana State University - Great Falls College of Technology2005 - 2006
Information Technology Center 2000 - 2006
montana state university 1999 - 2006
Education
University of Montana 1992 — 1997
Biology
PAREXEL December 2011 - Present
Intracoastal Realty July 2010 - July 2011
PPD, Inc. October 2005 - July 2009
SunTrust Bank March 2003 - October 2003
Skills
Microsoft Office, Data Management, Microsoft Excel, PowerPoint, Data Analysis
Education
University of North Carolina at Wilmington 1998 — 2003
Bachelor of Arts, Communication Studies/Creative Writing
Premier Research Group Limited January 2012 - Present
Premier Research Group May 2009 - January 2012
Premier Research Group September 2007 - May 2009
PPD, Inc. July 2005 - September 2007
Target Research Group 2002 - 2005
Education
Doane College 1992 — 1995
BA, Education
PPD April 2012 - Present
PPD, Inc. March 2012 - April 2012
PPD October 2008 - March 2012
PPD October 2005 - October 2008
The Princeton Review September 2000 - September 2005
Duke University August 1999 - August 2005
Skills
Feasibility/Start-up, Multiple EDC systems, Multiple IVRS, CTMS, Certified..., CTMS Mentor, Visit-Specific Training..., CRA Management Training
Education
Duke University 1999 — 2005
Chemistry
Bethesda-Chevy Chase High School 1995 — 1999
Dartmouth College 1995 — 1999
A.B., Chemistry
Retired October 2013 - Present
PPD April 2013 - October 2013
PPD. Inc. June 2010 - March 2013
PPD February 1996 - February 2011
Cape Fear Valley Health System September 1992 - February 1996
Johns Hopkins Hospital August 1990 - August 1992
Skills
Clinical Trials, EDC, Clinical Monitoring, CRO, CTMS, Hematology, Oncology, Immunology, Clinical Research, Protocol, Clinical Operations, Clinical Development, Therapeutic Areas, GCP, Pharmacovigilance, Clinical Data Management, Infectious Diseases, ICH-GCP, Drug Development, Regulatory Submissions, Oracle Clinical, Oncology Clinical...
Education
University of Delaware 1986 — 1990
BSMT, Medical Technology, Biology
Quintiles August 2011 - Present
Chiltern International Inc. November 2008 - August 2011
PPD, Inc. August 2006 - November 2008
Wright Medical Technology, Inc. August 2005 - August 2006
University Clinical Research January 2004 - August 2005
Skills
CRO, Clinical Trials, Clinical Monitoring, ICH-GCP, EDC, Clinical Development, Oncology, GCP, Clinical Research, Neurology, Clinical Data Management, Biotechnology
Education
The George Washington University 2004 — 2007
MSHS, Clinical Leadership
The George Washington University 1999 — 2002
BSHS, Clinical Research Administration
Gallatin County Detention Center June 2010 - Present
Montana State University, Student Health Services October 2009 - Present
PPD, Inc. July 1998 - June 2009
Craig Hospital December 1996 - December 1998
CPCRA at Denver Public Health February 1995 - May 1998
Swedish Medical Center, Denver, CO September 1989 - May 1996
Skills
Nursing, Patient Safety, BLS, Hospitals, Healthcare, Healthcare Management, Pediatrics, IV, Cpr Certified, ACLS, Neurology, Clinical Monitoring
Education
Seton Hall University 1983 — 1988
BSN, Nursing
Raritan Valley Community College 1981 — 1983
Biology
The Maryland Institute College of Art 1979 — 1980
Fine Arts
PAREXEL International May 2014 - Present
PAREXEL International November 2010 - Present
PAREXEL International January 2009 - October 2010
PPD, Inc. July 2007 - October 2008
Kendle International March 1998 - June 2007
Self Employed June 1991 - June 1998
USCI Division of C.R.Bard, Inc. January 1984 - August 1989
Framingham Board of Health October 1982 - December 1983
Lexington Board of Health April 1982 - September 1982
St. Joseph's Hospital May 1981 - September 1982
Skills
Clinical Trials, CTMS, CRO, GCP, EDC, Clinical Monitoring, Clinical Research, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Oncology, Clinical Development, FDA, Protocol, Regulatory Affairs
Education
University of Massachusetts Lowell 1978 — 1982
BS, Health Services Administration
West Pharmaceutical Services February 2015 - Present
West Pharmaceutical Services January 2011 - May 2013
PPD, Inc. March 2010 - November 2010
Wyeth Pharmaceuticals September 2005 - November 2008
Education
Delaware Valley College 2009 — 2011
M.B.A, General Business
Delaware Valley College 2003 — 2005
B.S., Animal Biotechnology & Conservation
Manor College 2001 — 2003
A.S., Veterinary Technology
AB SCIEX July 2012 - Present
PPD, Inc. March 2005 - July 2012
Skills
Ph. D. in Chemistry, Mass Spectrometry, HPLC, Research and Development, Validation, LC-MS, Chromatography, Biopharmaceuticals, CRO, Bioanalysis, Analytical Chemistry
Education
The University of Georgia 1999 — 2004
Ph. D., Chemistry, Inorganic Chemistry
Northern Illinois University 1996 — 1999
B. S., Chemistry, Biochemistry
SynteractHCR May 2014 - Present
PPD, Inc. May 2004 - May 2014
NextGen, Inc. April 2002 - February 2003
Intersys Southeast April 2001 - October 2001
CGS, Inc September 1999 - February 2001
Skills
Clinical Trials, Clinical Research, Clinical Development, MedDRA, EDC, Sop, GCP, CRO, Pharmacovigilance, Oncology, CTMS, Pharmaceutical Industry, Regulatory Submissions, Clinical Data Management
Education
Old Dominion University
Santen April 2015 - Present
Santen April 2013 - Present
Santen January 2010 - March 2013
Acucela Inc. March 2009 - December 2009
PPD, Inc. February 2008 - March 2009
AcuFocus October 2007 - February 2008
Santen Inc. January 2001 - October 2007
UC Davis March 1996 - January 2001
Skills
Ophthalmology, Clinical Research, Clinical, Clinical Trial..., EDC
Education
University of Central Missouri 1979 — 1981
BS, Data Processing
Indiana University of Pennsylvania 1973 — 1977
BS, Business Administration
PPD January 2011 - Present
i3 Statprobe August 2010 - January 2011
PPD April 2004 - August 2010
PPD, Inc. August 1999 - April 2004
PPD 1996 - 1998
Skills
Data Management, Validation, Protocol, Oracle Clinical, GCP, EDC, Databases, Database Design, Clinical Trials, Clinical Research, Clinical Data Management, CTMS, CRO
Education
The University of Texas at Austin 1992 — 1996
B.S., Biology
PPD, Inc. August 2010 - Present
PPD, Inc. July 2005 - August 2010
Diosynth Biotechnology November 2001 - June 2005
UNC Wilmington December 1999 - November 2001
aaiPharma, Inc. July 1998 - November 1999
aaiPharma, Inc. June 1996 - July 1998
aaiPharma, Inc. October 1990 - June 1996
UNC Wilmington September 1982 - September 1989
Skills
Auditing, Quality Management, Process Improvement, Continuous Improvement, Cross-functional Team..., GMP, 21 CFR Part 11, Quality Assurance, Change Control, Sop, Analysis, Business Process
Education
University of North Carolina at Wilmington 1986 — 1987
Bachelor of Arts, Philosophy & Religion
University of North Carolina at Wilmington 1982 — 1986
Bachelor of Arts, Psychology
PPD, Inc. February 2011 - Present
PPD, Inc. January 2010 - February 2011
Well Care Home Health April 2007 - July 2009
Cape Craftsmen, Inc. January 2005 - December 2006
Skills
Analysis, Market Research, Cross-functional Team..., CRM, Management, Project Planning, Data Analysis, Project Management, Leadership, Training, Budgets, Negotiation, Strategy, Business Development, Marketing Strategy, Team Leadership, Sales, Outsourcing, Customer Service, Proposal Writing, Retail, Research, Competitive Analysis, Process Improvement, Forecasting, Business Intelligence, Strategy analytics
Education
Villanova University 2014 — 2014
Essentials of Business Intelligence Certificate, Business Intelligence
Villanova University 2014 — 2014
Mastering Data Management and Technologies Certificate, Business Intelligence
University of Phoenix 2004 — 2006
MBM, Master of Business Management
University of North Carolina at Wilmington 1999 — 2002
B.A., Communications Studies
Thermon Manufacturing Company September 2010 - Present
Forgent Networks, Inc May 2000 - August 2009
PPD, Inc. May 1996 - May 2000
PriceWaterhouse September 1993 - April 1996
Skills
Internal Controls, Auditing, Sarbanes-Oxley Act, Financial Reporting, Accounting, SOX 404, Finance
Education
The University of Texas at Austin - Red McCombs School of Business 1992 — 1993
MBA, Accounting
The University of Texas at Austin - Red McCombs School of Business 1989 — 1992
BBA, Business Honors & Management
Walgreens August 2013 - Present
CVS Caremark Corporation January 2012 - August 2013
The Johns Hopkins Hospital October 2011 - January 2012
PPD, Inc. June 2011 - September 2011
UNC Health Care May 1992 - December 2010
CVS Caremark Corporation May 2005 - April 2009
Duke University Medical Center December 1996 - July 2003
Skills
Clinical Trials, Clinical Research, Medical Writing, Pharmacology, Pharmacy, Medicine, Inpatient, CRO, Pharmaceutics, Pharmacy Practice, Pharmacists, Medication Therapy..., Clinical Pharmacy, Hospitals, Medicare Part D, Pediatrics, Diabetes, Pharmacy Automation, Healthcare
Education
University of North Carolina at Chapel Hill 2001 — 2005
Pharm.D, Pharmacy
University of North Carolina at Chapel Hill 1997 — 1999
Doctor of Medicine (MD), Medicine, Withdrew in good academic standing
University of North Carolina at Chapel Hill 1994 — 1996
PreMedical, Biology, Chemistry (Inorganic and Organic), Physics, 3.7 GPA
Wake Forest University 1986 — 1990
BA, English, Cum Laude, English and Interdisciplinary Honors Programs
Novella Clinical July 2015 - Present
Medical Research Network July 2014 - July 2015
Novella Clinical December 2012 - July 2014
Cari Kniola February 2011 - July 2014
PPD, Inc. November 2007 - December 2012
Bolton Medical July 2006 - November 2007
PPD June 2004 - July 2006
Skills
Clinical Research, Project Management, CRO, Clinical Monitoring, Clinical Trials, GCP, CTMS, EDC, eCRF, Global Management, Class III Medical..., Large Budget Management, Management, Project Team Management, Organization &..., Customer Service, Customer Support, Public Speaking, Clinical Management, Timeline Development, Timeline Management, Management of..., Media Planning, Marketing Plan Creation, Marketing Material..., Microsoft Office, Customer Oriented, Writing, Copy Editing
Education
Purdue University 1993 — 1996
BS, Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Worldwide Clinical Trials Drug Development Solutions June 2011 - Present
Seton Medical Center Hays October 2010 - March 2011
Clinical Pathology Laboratories February 2005 - May 2010
PPD, Inc. May 2004 - January 2005
Texas Department of Health and Human Services, Infectious Epidemiology Department January 2004 - May 2004
Texas State University at San Marcos, Texas January 2001 - May 2004
St. David's Medical Center December 2000 - December 2002
The Austin Diagnostic Clinic August 1998 - December 2000
Skills
Clinical Trials
Education
Walden University 2012 — 2015
Doctor of Philosophy (PhD), Public Health, PhD Student
Texas State Unversity 2001 — 2004
Master of Science, Health Services Research
Texas State University-San Marcos 2002 — 2003
Post Graduate Certificate, Biostatistics
Texas State University-San Marcos 2001 — 2002
Post Graduate Certificate, Epidemiology
Texas State University 1995 — 1999
Bachelor of Science, Microbiology
PPD May 2015 - Present
PPD, Inc. June 2010 - May 2015
Precision Therapeutics July 2009 - May 2010
Novum Pharmaceutical Research Services November 2007 - July 2009
Skills
GCP, Oncology, Clinical Monitoring, SOP, Clinical Research, Clinical Trials, ICH-GCP, CTMS, Clinical Development, CRO, EDC, Sop, Clinical Research..., Therapeutic Areas, Data Management, Protocol, Biotechnology
Education
University of Pittsburgh 2004 — 2007
BS, Clinical Dietetics and Nutrition
Washington and Jefferson College 1996 — 1998
UCB Biosciences, Inc. June 2014 - Present
UCB Biosciences, Inc. January 2009 - May 2014
SHKW Architects, Inc. October 2007 - November 2008
Surgical Review Corporation March 2007 - October 2007
Mylan Bertek Pharmaceuticals (Division closed in September, 2005) April 2001 - September 2005
Lipsinc October 2000 - March 2001
PPD, Inc. April 1999 - July 2000
Rex Healthcare July 1996 - January 1999
American Heart Association June 1991 - July 1996
Various Healthcare, Research and Pharmaceutical companies August 1980 - June 1991
Skills
Pharmaceutical Industry, Microsoft Office, Microsoft Excel, Outlook, PowerPoint, Microsoft Word, Project Management, Budgets, Management, Event Planning, Strategic Planning, Human Resources, Marketing, Office Management, Research, Process Improvement, Healthcare
Education
UNC at Pembroke 1976 — 1980
Bachelor of Science (B.S.), Biology
University of North Carolina at Pembroke 1976 — 1980
Bachelor of Science, Biology, Biology/Zoology