PPD Company
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, North Carolina, United States CEO: David Simmons Number of employees: 20,000 (2017) Founder: Fredric N Eshelman Subsidiaries: Acurian, Inc., EVIDERA, PPD Japan K.K., Parent organization: Jaguar Holding Company I
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PPD Employees
PPD April 2015 - Present
PPD February 2014 - March 2015
PPD April 2013 - January 2014
PPD April 2012 - March 2013
PPD December 2006 - March 2012
PPD January 2005 - November 2006
PPD June 2003 - December 2004
SCIREX Corporation April 1999 - May 2003
SCIREX Corporation May 1998 - March 1999
SCIREX Corporation October 1997 - April 1998
Skills
GCP, Directed Audits, Process Improvement, Investigator Site Audit, Database Audit, Vendor Audit, Study File Audit, Clinical Study Report..., Inspection Preparation, QA Consulting, Clinical Research, CRO, SOP, Quality Assurance, EDC, Clinical Trial..., Clinical Monitoring, Clinical Trials, Pharmaceuticals, Databases, Pharmaceutical Industry, Auditing, Inspection, Sop, Protocol, ICH-GCP, 21 CFR Part 11, CTMS, Software Documentation, Regulatory Submissions, Clinical Data Management, GxP, FDA
Education
Texas State University-San Marcos
Bachelor of Arts
PPD September 2014 - Present
HEB June 2014 - September 2014
Gold's Gym December 2012 - April 2014
ID.CREATIVE November 2013 - January 2014
Fitness Institute of Texas January 2013 - August 2013
Kona Grill February 2010 - December 2012
Mama Fu's Asian House February 2007 - February 2010
Skills
Fitness Training, Human Nutrition, Food & Beverage, Food Safety, Food Safety Management..., Food Industry, Food Science, Food Preparation, Sports Nutrition, Nutritional Counseling, Nutrition Education, Weight Management, Nutrition, Exercise Physiology, Wellness Coaching, Weight, Health Promotion, Health Education, Corrective Exercise, Dietetics, Microsoft Office, Social Media, Public Speaking, Customer Service, Research, Microsoft Word, Marketing
Education
Texas State University 2015 — 2017
Master's degree, Business Administration and Management, General
The University of Texas at Austin 2010 — 2014
Bachelor of Science (B.S.), Dietetics/Dietitian
University of Washington September 2014 - Present
PATH June 2014 - August 2014
University of Washington March 2011 - August 2014
University of Washington September 2012 - June 2013
University of Washington March 2011 - August 2012
University of Washington September 2010 - March 2011
University of Wisconsin April 2009 - August 2010
Johns Hopkins Bloomberg School of Public Health February 2008 - June 2008
PPD January 2005 - August 2007
Skills
Epidemiology, Stata, Public Health, Infectious Diseases, Research, Biostatistics, PCR, Teaching, Global Health, Vaccines, Data Analysis, Statistics, Life Sciences, Clinical Research, Program Evaluation
Education
University of Washington 2010 — 2014
PhD, Epidemiology
The Johns Hopkins University 2007 — 2009
MHS, Global Disease Epidemiology and Control
University of Wisconsin-Madison 2001 — 2005
BS, Molecular Biology
DSHS - Central Office July 2012 - January 2014
ProPath Pathology Services August 2009 - November 2011
Austin Regional Clinic March 2007 - August 2008
PPD May 2005 - March 2007
Skills
Testing, Phlebotomy, Laboratory, Quality Assurance, Direct Patient Care, Time Management, Research, Histology, Software Documentation
Education
Texas State University 2001 — 2005
Aptiv Solutions November 2011 - Present
PPD May 2010 - October 2011
Advanced Liver Therapies February 2007 - May 2010
Skills
GCP, CRO, Clinical Research, Protocol, Sop, Clinical Monitoring, CTMS, EDC, ICH-GCP, Clinical Trials, Clinical Development, Oncology, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry, Infectious Diseases, Cardiology, Endocrinology
Education
Texas Woman's University 2008 — 2009
MBA, Business
BioReliance August 2015 - Present
BioReliance March 2014 - August 2015
BioReliance January 2011 - March 2014
Genetic and Molecular Toxicology, Covance July 2007 - January 2011
PPD October 2006 - June 2007
Skills
GLP, GMP, Cell Culture, Mammalian Cell Culture, Bacterial Cell Culture
Education
The Johns Hopkins University 2011 — 2014
Master of Science (M.S.), Biotechnology
The Johns Hopkins University - Carey Business School 2011 — 2014
Master of Business Administration (M.B.A.)
University of Florida 2002 — 2006
B.S., Chemistry
Ocean Lakes High School
PPD June 2014 - Present
PPD April 2011 - June 2014
PPD June 2010 - April 2011
PPD August 2008 - June 2010
Midnight Rodeo January 2007 - August 2008
Skills
GCP, CRO, Clinical Research, Clinical Trials, ICH-GCP, Microsoft Excel, Microsoft Office, Validation, CTMS, Pharmaceutical Industry, Customer Service, SOP, Management, Clinical Development, PowerPoint, Research, EDC, Leadership
Education
Texas State University 2002 — 2006
Bachelor of Science (B.S.), Psychology
Aransas Pass High School 1998 — 2002
PPD June 2015 - Present
PPD September 2014 - May 2015
US Air Force June 2014 - August 2014
Pentagon, United States Air Force June 2012 - May 2014
Senior Leader, 2400 employees, 218 aircraft, aerospace September 2011 - June 2012
US Army Graduate Master's Education Program - Army Command & General Staff College August 2009 - September 2011
US Army War College 2008 - 2009
335th Fighter Squadron 2006 - 2008
336th Fighter Squadron 2003 - 2006
Air Command and Staff College 2002 - 2003
Skills
Weapons, Military Experience, Strategic Planning, Integration, Program Management, Aircraft Maintenance, Defence Sector, Aviation, Policy, Defense, C4ISR, Aerospace, Flight Safety, Training, Operations Management, Organizational..., Government, Piloting, Tactics, Government Contracting, Strategy, Process Improvement, Leadership, Systems Engineering, Logistics, Military Aviation, Aircraft, Foreign Military Sales, Joint Military..., Information Assurance, Flight Training, Electronic Warfare, Combat, NATO, Afghanistan, SIGINT, Force Protection, Contingency Planning, Reconnaissance, Readiness, UAV, Military Training, Military Logistics, Homeland Security, DoD Top Secret Clearance, Counterterrorism, Army, Radar
Education
The George Washington University 1996 — 1998
MA, Organizational Management
United States Air Force Academy 1986 — 1990
BS, Geography
Indivior, PLC December 2014 - Present
Reckitt Benckiser Pharmaceutical, Inc January 2014 - December 2014
Reckitt Benckiser Pharmaceutical, Inc February 2013 - January 2014
Reckitt Benckiser Pharmaceutical, Inc March 2012 - February 2013
PPD 2009 - March 2012
Pharmion July 2007 - March 2009
PRA International July 2004 - July 2007
Skills
Clinical Pharmacology, Pharmacokinetics, Clinical Trials, Pharmacodynamics, Translational Medicine, Modeling and simulation, Drug Development, Pharmaceutical Industry, Oncology, Pharmacology, CRO, Clinical Development, ICH-GCP, IND, GCP, Protocol, CTMS, PK/PD, Pharmaceutics, Medical Affairs, Regulatory Submissions, Medical Writing, Clinical Research, Therapeutic Areas, Toxicology, Infectious Diseases, Drug Discovery, Regulatory Affairs, GLP, Pharmacovigilance, Drug Metabolism, Drug Delivery, Drug Safety, Pharmaceutical Research, Immunology, Biomarkers, Biopharmaceuticals, Sop, Bioanalysis, FDA, Clinical Study Design, Hematology, DMPK, Biotechnology, ADME, WinNonlin, Lifesciences, NONMEM, Life Sciences
Education
Virginia Commonwealth University 2000 — 2004
Ph.D, PK/PD
The Hebrew University 1980 — 1984
Bachelor of Science (BS), pharmacy
BioReliance June 2013 - Present
BioReliance March 2008 - June 2013
Cellphire August 2005 - March 2008
BioReliance June 2004 - August 2005
PPD August 2003 - May 2004
Skills
Immunoassays, ELISA, Flow Cytometry, Western Blotting, Protein Purification, Assay Development, Antigen, Antibodies, Cell Culture, Immunology, Virology, In Vitro, In Vivo, GLP, Biotechnology, Lifesciences, Pharmaceutical Industry, Inventory Management, Product Development, SOP development, Molecular Biology, LIMS, Laboratory, Sop, Validation, Baculovirus, CHO, Mouse Lymphoma, Mammalian Cell Gene..., Fluorescence
Education
The Johns Hopkins University 2006 — 2008
Coursework towards MS, Bioscience Regulatory Affairs
Mary Washington College 1999 — 2003
BS, Biology
Magruder HS 1995 — 1999
High School Diploma
PPD April 2011 - Present
PPD October 2004 - March 2011
PPD February 2002 - September 2004
Womble Carlyle Sandridge & Rice, LLP September 1999 - January 2002
Skills
CTMS
Education
The George Washington University 2013 — 2016
MSHS, Clinical Research Administration
The George Washington University School of Medicine and Health Sciences 2013 — 2016
Masters of Science in Health Science, Clinical Research Administration
University of North Carolina at Chapel Hill 1997 — 1999
Bachelor of Arts, Political Science, Chemistry, Biology
inVentiv Health Clinical June 2015 - Present
Quintiles April 2014 - June 2015
Quintiles February 2008 - March 2014
INC Research July 2007 - February 2008
PPD January 2005 - August 2007
PPD April 2003 - December 2004
PPD September 2000 - April 2003
PPD September 1999 - September 2000
Skills
Clinical Development, CRO, Clinical Trials, Project Management, CTMS, EDC, GCP, Clinical Monitoring, ICH-GCP, Team Leadership, Pharmaceutical Industry, Risk Management, Regulatory Submissions, Budgets, Infectious Diseases, Inform, Problem Solving, Vaccines, Clinical Research, Biotechnology, Drug Development, Rheumatology, Financial Reporting, Cross-functional Team..., Protocol, Clinical Data Management, Data Management, Oncology
Education
The College of New Jersey 1987 — 1992
Bachelor of Science, Marketing/International Business
Georgia Regents University - Center of Operational Medicine January 2013 - Present
Lucky Dog Upcycle/luckydogupcycle.com July 2014 - Present
Nicely Creative - Communications, Marketing, Graphic Design, PR June 2009 - Present
Granite Services March 2013 - April 2013
Granite Services September 2012 - December 2012
The Coalition for Tactical Medicine "Saving Lives Under Fire" September 2009 - September 2012
PPD December 2007 - May 2009
Wilmington Regional Association of REALTORS February 2006 - December 2007
Skills
Public Relations, Training, Leadership, Newsletters, Event Management, Press Releases, Emergency Management, Social Networking, Project Management, Social Media, Fundraising, Marketing Communications, Editing, Public Speaking, Nonprofits, Disaster Response, Customer Service, Government, Publications, Problem Solving, Volunteer Management, Management, Event Planning, Creative Writing, Marketing, Budgets, Research, Analysis, Web Content, Creativity, Policy, Crisis Management, Community Outreach, Strategic Communications, Strategic Planning, Publishing, Start-ups, Proposal Writing, Media Relations, Coordinator, Creative Thinking, Brand Development, Community Development, Researcher, Outstanding Customer..., Leadership Development, Proofreading, Recruiting, Copy Editing, Technical Writing
Education
The George Washington University
BA, Communications
University of North Carolina at Wilmington 2002 — 2004
Arts
PPD July 2014 - Present
inVentiv Health March 2013 - July 2014
PharmaNet/i3 Strategic Resourcing January 2008 - March 2013
Children's National Medical Center March 2003 - January 2008
Quintiles May 2001 - March 2003
Children's National Medical Center July 1999 - May 2001
Skills
Clinical Trials, CRO, Oncology, Pharmaceutical Industry, Clinical Development, Biostatistics, Clinical Data Management, SAS, Clinical Research, SAS programming, Therapeutic Areas, Clinical Study Design, Lifesciences, Protocol, Survival Analysis, Medical Writing, SAS Programming, Life Sciences
Education
The George Washington University 1997 — 1999
Master of Public Health (M.P.H.), Epidemiology and Biostatistics
PPD June 2000 - Present
PPD 2006 - 2008
Skills
Microsoft Word, Microsoft Office, Clinical Trials, Pharmaceutical Industry, CRO, GCP, Employee Training, Microsoft Excel, Adobe Acrobat, Regulatory Requirements, FDA, Healthcare, Social Media, PowerPoint
Education
Texas Tech University
Bachelor's Degree, Social Work
Texas Tech University
Bachelor of Arts (B.A.), Social Work
Quintiles April 2008 - Present
PPD April 2007 - April 2008
US Navy July 1992 - July 1997
Skills
Clinical Research, CTMS, ICH-GCP, CRO, Clinical Trials, Exercise Physiology, GCP, Siebel, Government, Military, Emergency Medical, SharePoint, Biotechnology, Clinical Development, Pharmaceutical Industry, Oncology, Neurology, Medicine, Infectious Diseases, Healthcare, EDC, Clinical Monitoring
Education
The Ohio State University 1997 — 2001
BSc, Exercise Science
Field Medical Service School 1994 — 1994
Field Medicine
Hospital Corps School, US Navy 1992 — 1992
HealthPartners October 2011 - January 2015
FindLaw, a Thomson Reuters business April 2011 - August 2011
Best Buy Mobile October 2010 - December 2010
Best Buy Mobile March 2010 - October 2010
Express Scripts April 2008 - December 2009
PPD January 2001 - April 2008
SingleSourceIT September 1999 - December 2000
Education
The Ohio State University 1993 — 1999
B.S., Computer Science and Engineering
PPD February 2013 - Present
Wegmans Food Markets July 2006 - May 2012
GlobalEpi Research May 2012 - February 2013
Pneumonia Etiology Research for Child Health (PERCH) Project February 2012 - May 2012
Johns Hopkins Bloomberg School of Public Health June 2011 - May 2012
Bangladesh January 2012 - January 2012
Rochester, NY August 2005 - May 2006
Skills
Global Health, Epidemiology, Biostatistics, Stata, Public Health, Literature Reviews, Reproductive Health, Healthcare, Program Evaluation, Data Analysis, Pharmacokinetics, Pharmacovigilance, Pharmacology, Maternal-Child Health, Food Safety, Environmental Health, GIS, Infectious Diseases
Education
The Johns Hopkins University 2011 — 2012
MPH, Masters in Public Health
University at Buffalo 2000 — 2006
PharmD, Doctorate in Pharmacy
GlaxoSmithKline April 2012 - Present
Stiefel, a GSK company January 2011 - April 2012
Stiefel, a GSK company August 2009 - January 2011
Stiefel Laboratories January 2009 - August 2009
Stiefel Laboratories August 2007 - December 2008
PPD 2005 - 2007
McKesson 2002 - 2005
Skills
FDA, Regulatory Submissions, Dermatology, Advertising, Promotions, Regulatory Affairs, Clinical Trials, Regulatory Requirements, Drug Development, Validation, 21 CFR Part 11, GMP, R&D, Sop, IND, Pharmaceutical Industry, Clinical Development, Clinical Research, Medical Affairs, Infectious Diseases, eCTD, Biologics
Education
The George Washington University School of Medicine and Health Sciences 1989 — 1993
PhD, Genetics
University of Vermont 1981 — 1985
B.S., Nutrition
Medpace November 2013 - Present
Excelsior Clinical Research, Inc. March 2013 - Present
DOCS March 2013 - October 2013
PPD March 2012 - March 2013
PPD February 2011 - March 2012
Washington University in St. Louis January 2009 - February 2011
Barnes-Jewish Hospital 2007 - 2009
American Italian Pasta Company 1999 - 2006
Skills
Clinical Trials, CTMS, Clinical Research, GCP, Clinical Research..., ICH-GCP, IRB, CRO, EDC, Clinical Monitoring, Nursing, Surgery, CRA, Infectious Diseases, Biotechnology, Inform, Cardiovascular, risk-based monitoring, Kidney Transplant, Liver Transplant, Medidata, Oracle E-Business Suite, Stroke, neurosurgery, neurology, diabetes, cardiology, interventional..., Oncology, Lymphoma
Education
The George Washington University 2009 — 2010
MSN, Clinical Research Administration
University of Missouri-Saint Louis 2005 — 2007
BSN, Nursing
Aeras August 2010 - Present
GenVec September 2009 - June 2010
GenVec May 2007 - September 2009
PPD 2006 - 2007
Ascend Therapeutics 2005 - 2006
Westat 1999 - 2005
The EMMES Corporation 1995 - 1997
DynCorp International 1992 - 1995
Skills
Clinical Trials, Infectious Diseases, CRO, Clinical Development, CTMS, Vaccines, Biotechnology, Clinical Monitoring, Clinical Operations, Drug Development, EDC, GCP, ICH-GCP, Immunology, Oncology, Therapeutic Areas
Education
The Johns Hopkins University 1998 — 2001
MPH, Epidemiology
University of Arizona 1988 — 1992
BS, Microbiology and Immunology
AstraZeneca September 2015 - Present
AstraZeneca March 2014 - September 2015
PPD December 2010 - February 2014
PPD February 2006 - December 2010
Sheppard Pratt Health System December 2002 - February 2006
Skills
Clinical Research, CTMS, Clinical Trials, Neurology, Therapeutic Areas, Clinical Monitoring, ICH-GCP, GCP, EDC, Protocol, CRO, CNS disorders, Budgets, Clinical Trial..., Research Project..., Budget Management, Psychiatry, Financial Forecasting, Mentoring, Type 2 Diabetes
Education
The George Washington University 2003 — 2005
M.S., Clinical Research Administration
Mary Washington College 1998 — 2002
B.S., Psychology
HTM Research July 2013 - Present
SynteractHCR October 2010 - July 2013
Takeda Pharmaceuticals March 2009 - July 2010
Sanofi February 2008 - March 2009
PPD September 2006 - February 2008
J&J, AstraZeneca, PPD January 2001 - September 2006
Glaxo Smith Kline June 1998 - January 2001
Skills
Microsoft Excel, Management, Microsoft Office, Clinical Trials, Leadership, Pharmaceutical Industry, Research, Biotechnology, CRO, CTMS, Clinical Development, Clinical Research, Customer Service, EDC, ICH-GCP, Oncology, PowerPoint, Project Management, Sales, Microsoft Word
Education
The George Washington University 2004 — 2006
Master's Degree, Clinical Research Administration
University of Hartford 1995 — 1998
Bachelor's Degree, Health Science
BAE Systems Inc. July 2011 - Present
PPD September 2009 - July 2011
General Dynamics 2006 - 2009
U.S. House of Representatives Committee on Education and the Workforce 1996 - 1998
Skills
Systems Engineering, DoD, Government Contracting, Contract Management, Earned Value Management, Program Management, Licensing, Security Clearance, Proposal Writing, Government, Government Procurement, Leadership, Military, Defense, Logistics, Aerospace
Education
The Catholic University of America, Columbus School of Law
J.D.
The George Washington University Law School
LL.M. Candidate in Goverment Contracts
Quintiles December 2010 - Present
PPD July 2005 - December 2010
Skills
Clinical Monitoring, CTMS, GCP, CRO, ICH-GCP, Clinical Trials, EDC, Clinical Development, Oncology, Therapeutic Areas, Clinical Data Management, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Sop
Education
Texas State University-San Marcos 2000 — 2003
BFA, Communication Design
Mallinckrodt Pharmaceuticals February 2013 - Present
ICON plc August 2011 - January 2013
SAIC August 2010 - August 2011
Caliper Life Sciences June 2005 - August 2010
PPD August 2003 - April 2005
Medical College of Virginia March 2002 - August 2003
U.S. Army Public Health Command May 1997 - August 1999
Skills
IND, Drug Development, FDA, Drug Discovery, Enzyme Assays, Regulatory Affairs, Pharmaceuticals, Biopharmaceuticals, PMP, Regulatory Requirements, CRO, Lifesciences, Regulatory Submissions, Project Management, Project Planning, Regulatory Guidelines, Pharmaceutical Industry, EPA, Biochemistry, GLP, High Throughput..., Validation, Assay Development, ELISA, Biotechnology, Laboratory, Toxicology, Infectious Diseases, Protein Chemistry, In Vitro
Education
The Johns Hopkins University 2010 — 2013
MS
Virginia Polytechnic Institute and State University 1999 — 2002
University of Richmond 1994 — 1998
BS
DNAtrix, Inc. February 2015 - Present
M.C. Clinical Research LLC January 2012 - July 2015
University of Miami Research Services and Quality April 2012 - September 2012
Schering Plough Research Institute/Merck Research Laboratories December 2007 - March 2012
ReSearch Pharmaceutical Services July 2007 - December 2007
PPD March 2006 - July 2007
Nova Rx. January 2006 - March 2006
Radiant Research March 2005 - March 2006
US Oncology June 2004 - January 2005
University of Miami Sylvester Cancer Center July 2001 - July 2003
Skills
Clinical Trials, CTMS, GCP, Clinical Data Management, Clinical Monitoring, Clinical Research, IRB, ICH-GCP, Medical Writing, Clinical Development, Oncology, CRO, Infectious Diseases, Patient Recruitment, Pharmacovigilance, Regulatory Submissions, Regulatory Affairs, Protocol, EDC, Biotechnology, CRF design, Clinical Study Design
Education
Texas Tech University 1999 — 2001
Cell and Molecular Biology, Cell Biology of Cancer
Texas Tech University 1999 — 2001
Bachelors Cell and Molecular Biology
Texas Tech University 1999 — 2001
Cell and Molecular Biology, Emphasis in Oncology
University of Miami Medical School
GlaxoSmithKline May 2004 - Present
PPD May 2002 - January 2004
Cancer Therapy Research Center November 2000 - May 2003
Skills
CRO, CTMS, Clinical Trials, GCP, Protocol, Biotechnology, Clinical Research, Clinical Data Management, Healthcare, Therapeutic Areas, Neuroscience, Sop, Patient Recruitment, Pharmaceutical Industry, Oncology, Lifesciences, Clinical Monitoring, Infectious Diseases, EDC, ICH-GCP, Clinical Development
Education
Texas State University-San Marcos 1996 — 2000
Bachelor of Science, Health Information Management
PPD March 2015 - Present
PPD February 2013 - February 2015
Westat October 2011 - October 2012
Skills
Statistics, SAS programming, SAS
Education
The George Washington University 2009 — 2011
Master of Science (MS), Statistics
Salesforce December 2013 - Present
Dell October 2012 - December 2013
Dell February 2012 - October 2012
Dell February 2011 - February 2012
Dell September 2009 - February 2011
Emergent Technologies 2007 - 2008
Emergent Technologies February 2007 - July 2007
PPD 2006 - 2007
Dell 2003 - 2006
Premier Research 2000 - 2003
Skills
Strategic Planning, Business Development, Business Strategy, Program Management, Cross-functional Team..., Strategy, Sales Operations, Customer Experience, Change Management, Salesforce.com, Leading Change, Call Centers, CRM, Business Analysis, Process Improvement, Competitive Analysis, Enterprise Software, Management, Product Management, Project Management
Education
Texas State University-San Marcos
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology, summa cum laude
The University of Texas School of Law
Certified Mediator, State of Texas
PPD May 2007 - Present
Astute Technology 2006 - 2007
American Institutes for Research 2000 - 2006
Cystic Fibrosis Foundation 1994 - 1995
Johns Hopkins Hospital 1983 - 1990
Skills
Clinical Trials, Public Health, CTMS, Infectious Diseases, CRO, GCP, Clinical Monitoring, ICH-GCP, Therapeutic Areas, Data Collection, Clinical Development, SAS, Clinical Data Management, EDC, Clinical Operations, Regulatory Submissions, Protocol, Pharmacovigilance, Clinical Research, Pharmaceutical Industry
Education
The George Washington University
MPH, Health Promotion and Disease Prevention
The University of Southern Mississippi 1977 — 1982
BSN, Nursing
East Carolina University August 2009 - Present
Debra Kosko Health Consulting February 1998 - Present
INC Research 2006 - 2007
PPD 2005 - 2007
Duke University 2004 - 2005
University of North Carolina 2004 - 2005
United States Agency for International Development 2001 - 2002
Johns Hopkins University 1997 - 2002
Skills
International Level, Healthcare, Clinical Research, proposal development,..., Public Health, Policy, Nonprofits, Medicine, Nursing, Program Management, Pediatrics, Infectious Diseases, Training, Health Policy, Management, Global Health, Proposal Writing, Hospitals, Healthcare Management, Epidemiology, Program Development
Education
The George Washington University 2013 — 2015
Doctor of Nursing Practice, Global health, health policy
The University of Texas at Austin
BSN
University of California, Los Angeles
MSN, family nurse practitioner, public health, law
Old Dominion EMS Alliance June 2014 - Present
Tuckahoe Volunteer Rescue Squad November 2006 - Present
KidMed July 2012 - June 2015
Parham Doctor's Hospital April 2012 - March 2013
PPD July 2009 - April 2012
Skills
Clinical, Emergency Management, Healthcare, Cardiac, Hospitals, Research, Sales Support, Microsoft Office, Mac OS, Photography, Bartending, Pet care, Problem Solving, Health, Excel, Teaching, Public Speaking, Supervisory Skills, PowerPoint, Word, Strategic Planning, Clinical Research, Hazardous Materials, Leadership, Pets, Emergency Medicine
Education
The George Washington University 2015 — 2017
MSHS, EMS Leadership
University of Richmond 2005 — 2009
BS, Biochemistry and Molecular Biology
J. Sargeant Reynolds 2008 — 2010
Paramedic
Bronto Software July 2014 - Present
Atlantic BT May 2012 - July 2014
PPD July 2011 - May 2012
Beckman Coulter June 2008 - July 2011
BLD Science/PGC Scientifics May 2007 - January 2008
VWR International March 2004 - May 2007
The Philadelphia Inquirer June 1999 - March 2004
Library Video Company February 1995 - June 1999
Skills
Business Development, Salesforce.com, Web Marketing, Marketing Strategy, New Business Development, SEO, Advertising, Direct Marketing, Product Development, Strategic Partnerships, Product Marketing, Marketing, Email Marketing, CRM, Sales Operations, Creative Direction, Leadership, Cross-functional Team..., E-commerce, Online Advertising, Marketing Communications, Lead Generation, Strategy, Online Marketing
Education
The George Washington University 1989 — 1993
Bachelor of Arts (B.A.), Political Science and Government
PRA Health Sciences September 2014 - Present
Pfizer Pharmaceuticals June 2012 - September 2014
Pfizer Pharmaceuticals March 2011 - June 2012
Kforce Clinical Research, Inc./Pfizer October 2007 - March 2011
PPD October 2006 - October 2007
Liza Burns and Associates (CRO) June 2005 - October 2006
Thermage September 2004 - June 2005
Skills
Project Management, Clinical Monitoring, Data Management, GCP, Medical Devices, Database Administration, Access, Contract Management, Research, Budgets, Leadership, Team Management, Oracle, Marketing, SAP, Windows 2000, Medical Terminology, Windows NT, Clinical Trials, FDA, Protocol, Clinical Research, Clinical Development, EDC, CTMS, ICH-GCP, Pharmaceutical Industry
Education
The George Washington University 2010 — 2013
MSHS in process, Clinical Research Administration
University of Phoenix 2000 — 2003
BS, Business Management
West Valley College
AS, Business Administration
PPD October 2012 - Present
PharmaNet/i3 April 2004 - September 2012
CDER, US Food and Drug Administration October 2001 - March 2004
CDER, US Food and Drug Administration May 1996 - September 2001
CDER, US Food and Drug Administration April 1991 - April 1996
Skills
Clinical Trials, Clinical, Regulatory Strategy, IND, FDA, Biosimilar development
Education
The Johns Hopkins University School of Medicine 1986 — 1991
Post-Doctoral, Molecular Biology and Genetics
University of Maryland School of Medicine 1980 — 1985
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
GSK October 2013 - Present
GlaxoSmithKline April 2007 - Present
PPD 2001 - 2007
Skills
Neurology, CTMS, Oncology, Clinical Research, GCP, Clinical Monitoring, Breast Cancer
Education
Texas Tech University Health Sciences Center 1995 — 1999
Bachelor's Degree
inVentiv Health September 2012 - Present
i3 Research October 2010 - August 2012
ResearchPoint April 2008 - October 2010
PPD 1998 - 2000
Westat 1994 - 1998
Skills
EDC, Clinical Data Management, CRO, GCP, Oracle Clinical, Data Management, Clinical Monitoring, Oncology, 21 CFR Part 11, Therapeutic Areas, CRF design, CDISC, Infectious Diseases, Data Analysis, Cardiology, Neurology, Microsoft Office, SAS programming, Vendor Management, Cross-functional Team..., Project Management, Databases, SAS, CTMS, Clinical Development, Clinical Trials, ICH-GCP
Education
Texas Tech University 1982 — 1986
BA, Psychology/Chemistry
PPD October 2014 - Present
PPD April 2013 - October 2014
PPD December 2010 - March 2013
PPD March 2005 - November 2010
PPD March 2004 - February 2005
Skills
Oracle Clinical, Remote Data Capture, Phase Forward InForm, Project Management, SQL*Plus, Clinical Data Management, Budget Management, 21 CFR Part 11, Medidata, CRO, ICH-GCP, CTMS, Inform, CDISC, CRF design, Budgets, Clinical Trials, GCP, Management, EDC, Data Management
Education
Southwest Texas State University
Bachelor’s Degree, Psychology
PRA Health Sciences August 2008 - Present
PPD 2004 - 2008
UnitedHealth Group 2002 - 2004
Skills
Leadership, Management
Education
The College of New Jersey 1998 — 2002
Bachelor’s Degree, Finance, General
Watson Research, LLC July 2007 - Present
KCI/Medfocus (through Watson Research, LLC) May 2009 - December 2009
Aerotek/Parexel (through Watson Research, LLC) July 2007 - April 2009
ResearchPoint July 2006 - July 2007
PPD 2005 - 2006
PPD April 2004 - February 2005
PPD June 2003 - April 2004
NSABP Foundation Inc. April 2001 - June 2003
University of Pittsburgh Medical Center February 1997 - April 2001
Skills
Clinical Trials, CTMS, Clinical Research, CRO, Pharmaceutical Industry, Clinical Development, GCP, ICH-GCP, Clinical Monitoring, Protocol
Education
Texas State University 2004 — 2006
MS, Clinical Research Services
University of Pittsburgh 1997 — 2002
Bachelor of Arts (B.A.)
Sunrise IT Solutions Group September 2010 - Present
Flowserve Corporation March 2015 - May 2015
Fuzzy's Taco Shop May 2014 - June 2014
PPD June 2013 - July 2013
Carl William Printing June 2008 - January 2010
Skills
Management, Data Center, Software Installation, Servers, Storage, Infrastructure, Microsoft Office, Cabling, Printers, System Administration, IT Service Management, DHCP, Hardware, Wireless Networking, Web Design, OSI Model, Teamwork, Customer Service, PowerPoint, Time Management, Microsoft Excel, Microsoft Word, Marketing
Education
Texas State University-San Marcos 2011 — 2014
Bachelor's Degree, Computer/Information Technology Administration and Management
Team Beachbody May 2015 - Present
Heather's Custom Creations March 2015 - Present
PPD November 2011 - April 2013
Garretson Resolution Group March 2009 - November 2011
The Nielson Company May 2007 - March 2009
Skills
Outlook, Excel, PowerPoint, Word, Microsoft Office, Problem Solving, Microsoft Excel, Microsoft Word, Budgets, Process Scheduler, Project Management, Public Speaking, Strategic Planning, Training
Education
The Defiance College 2001 — 2005
Bachelor of Arts, Business Management
PPD January 2015 - Present
Westat November 1999 - January 2015
EMMES Corporation March 1994 - October 1999
Atlis Systems, Inc March 1992 - March 1994
Biospherics, Inc June 1988 - March 1992
Social and Scientific Systems, Inc. May 1985 - May 1988
Washington Hospital Center September 1983 - May 1985
ORI, Inc. August 1980 - May 1983
Skills
Protocol, Statistics, Public Health, Access, Treatment, Cancer, Data Analysis, Medicine, Databases, Oncology, FDA, Strategy, CRO, Infectious Diseases, Epidemiology, Qualitative Research, Informatics, Program Evaluation, Pharmaceutical Industry, Technical Writing, Clinical Trials
Education
The George Washington University 2003 — 2008
Masters in Health Science, Clinical Research Administration
University of Maryland College Park 1975 — 1979
Bachelor of Arts, English
PPD September 2014 - Present
DST Health Solutions April 2014 - September 2014
Novella Clinical, Inc. April 2013 - April 2014
Novella Clinical, Inc. March 2011 - April 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2010 - March 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" April 2009 - October 2010
RTI Health Solutions April 2007 - April 2009
Skills
Clinical Trials, CTMS, GCP, EDC, CRO, Clinical Development, Oncology, Clinical Research, ICH-GCP, Pharmaceutical Industry, Inform, Sop, Infectious Diseases, Regulatory Affairs, Pharmacovigilance, Cardiology, Diabetes, Biotechnology, Clinical Operations, Medical Devices, Vaccines, Drug Safety, 21 CFR Part 11, Drug Development, Regulatory Requirements, Gastroenterology, FDA, Protocol
Education
The George Washington University School of Medicine and Health Sciences 2009 — 2011
MSHS, Clinical Research
William & Mary 1998 — 2002
BA, Anthropology, History
PPD October 2012 - Present
PharmaNet/i3 April 2004 - October 2012
CDER, US Food and Drug Administration October 2001 - April 2004
CDER, US Food and Drug Administration April 1996 - September 2001
Skills
Clinical Trials, Regulatory Affairs, Clinical Development, FDA, Clinical Research, Drug Development, IND, Pharmaceutical Industry, Infectious Diseases, Biotechnology, Lifesciences, Oncology
Education
The Johns Hopkins University School of Medicine 1987 — 1991
Postdoctoral Fellow, Molecular Biology and Genetics
University of Maryland School of Medicine 1981 — 1986
Ph.D., Biochem and Mol. Bio.
National Taiwan University School of Medicine 1977 — 1979
Master of Science (M.S.), Biochemistry
PPD June 2011 - Present
George Washington University March 2009 - August 2009
BearingPoint September 2007 - March 2009
The Interfaith Alliance May 2003 - September 2007
Bill Bradbury for US Senate March 2002 - November 2002
Various Organizations February 2001 - March 2002
Holden for Governor August 2000 - January 2001
Missouri Democratic Party January 2000 - August 2000
NY City Councilman Noach Dear July 1999 - January 2000
Women's Center September 1998 - July 1999
Skills
Versatile Writer, Graphic Design, Corporate Communications, Proposal Writing, Public Relations, Public Policy, government relations, Political Communication, Event Management, Event Planning, Online Advocacy, Strategy, Editing, Policy, Leadership, Strategic Communications, Public Speaking, Press Releases, Management, Nonprofits, Strategic Planning
Education
The George Washington University 1994 — 1996
Master of Arts, Politics
University of North Carolina at Greensboro 1988 — 1992
Bachelor of Arts, Political Science
Inovio Pharmaceuticals Inc. March 2015 - Present
Inovio Pharmaceuticals Inc. September 2013 - March 2015
Inovio Pharmaceutials May 2011 - September 2013
PPD December 2010 - May 2011
University of Pennsylvania, School of Medicine - Vaccines and Gene Therapy June 2007 - January 2011
The George Washington University 2002 - 2007
Skills
Vaccines, ELISPOT, ELISA, Luminex, Immunology, Flow Cytometry, Virology, Lifesciences, DNA, Western Blotting, Cell Culture, Gene Therapy, Tissue Culture, Assay Development, Immunoassays, In Vivo, In Vitro, Protein Chemistry, Clinical Trials, Clinical Development, Life Sciences
Education
The George Washington University 2002 — 2007
Ph.D., Immunology
The George Washington University 2002 — 2004
M.Phil, Immunology
University of Maryland College Park 1998 — 2002
B.Sc., Microbiology
PPD June 2014 - Present
PPD October 2013 - June 2014
PPD June 2012 - September 2013
Texan Eye May 2007 - January 2010
Skills
Customer Service, Microsoft Office, Clinical Research, Clinical Trials, Medical Terminology, Healthcare, PowerPoint, Microsoft Excel
Education
Texas State University 2006 — 2010
Bachelor of Science, Biology, Biochemistry
Bristol-Myers Squibb January 2013 - Present
Roche Pharmaceuticals December 2008 - January 2013
PPD June 2002 - December 2008
Westat March 2001 - June 2002
DynCorp International / AdvanceMed August 1999 - March 2001
UTA July 1998 - August 1999
Sallie Mae June 1995 - June 1998
Information Management Services, Inc. September 1990 - June 1995
Skills
Management, Clinical Trials, SAS, Pharmaceutical Industry, Problem Solving, Coaching, Microsoft Office, SAS programming, Presentations, SDTM, CDISC, CRO, Clinical Development, Training, Validation, GCP, 21 CFR Part 11, FDA, Clinical Research, Oracle Clinical, Oncology, EDC, Statistical Programming, Sop, SAS Programming, Regulatory Submissions
Education
The Johns Hopkins University - Carey Business School 1998 — 2002
MS, Information and Telecommunications Systems
Virginia Polytechnic Institute and State University 1985 — 1990
BS, Computer Science
Triangle Vascular Associates July 2013 - Present
PPD January 2013 - July 2013
Healthways October 2011 - January 2013
Wake Med February 2009 - October 2011
WakeMed May 2001 - February 2009
TGS Healthcare Solutions, LLC August 2001 - April 2003
Raleigh Community hospital March 1998 - August 2001
Bard Medical Division October 1995 - March 1998
Riverside Regional medical Center June 1989 - June 1995
Skills
Disease Management, Utilization Management, Case Managment, Hospitals, Patient Safety, Clinical Research, PALS, Patient Education, EMR, Healthcare, Healthcare Management, ACLS, Medical/Surgical, Telemetry, Geriatric Nursing, Nursing, IV
Education
New School University 1986 — 1990
Master's degree, Health/Health Care Administration/Management
New School University 1985 — 1990
Bachelor's degree, Health/Health Care Administration/Management
Boston City Hospital School of Nursing
diploma, Registered Nursing/Registered Nurse
PPD January 2011 - August 2012
TechLab January 2009 - August 2010
Sake House November 2008 - April 2009
Ruby Tuesday 2006 - 2008
C & F Marketing May 2005 - August 2005
Skills
HPLC with AKTA System, Flow Cytometry, Cell Culture, Protein Expression,..., Immunoassays, Aseptic Technique, Bacterial Identification, Gel Electrophoresis, MS Word, Excel, Outlook..., JMP Statistical Software, Lifesciences, Biotechnology, HPLC
Education
The George Washington University 2012 — 2014
Master's degree, Biochemistry and Molecular Biology, GPA 4.0/4.0
Virginia Tech 2004 — 2008
Bachelor's degree, Biology/Biological Sciences, General, GPA: 3.5/4.0
Texas Commission on Environmental Quality 2007 - Present
PPD July 1996 - October 1999
Education
Texas State University-San Marcos
BS, Environmental Science
The University of Texas at Austin
MSE, Engineering Management
Gilead Sciences January 2014 - Present
Gilead Sciences February 2012 - Present
Gilead Sciences November 2009 - February 2012
PPD April 2007 - November 2009
J&J October 2006 - February 2007
Skills
CDISC, Biostatistics, Clinical Trials, CRO, SAS, SAS programming, Statistical Programming, Pharmacovigilance, Oracle Clinical, Data Analysis, Oncology, Pharmaceutical Industry, Clinical Research, Clinical Data Management, EDC, GCP, 21 CFR Part 11, SDTM, Clinical Study Design, SAS Programming
Education
Texas Tech University
MS, Mathematics
PPD August 2012 - Present
ICON Clinical Research July 1996 - August 2012
The Liposome Company 1993 - 1996
Education
The Johns Hopkins University 1987 — 1991
Bachelor of Science (BS), Biomedical/Medical Engineering
PRA Health Sciences August 2013 - Present
PRA Health Sciences November 2012 - Present
PRA Health Sciences September 2009 - November 2012
PRA Health Sciences September 2007 - September 2009
Averion International January 2007 - September 2007
Averion International August 2006 - January 2007
Millennix December 2005 - August 2006
PPD October 2003 - October 2005
Omnicare Clinical Research (Contractor) January 2003 - August 2003
Skills
Clinical Data Management, EDC, CDISC, CRO, Medidata, Oracle Clinical, Oncology, SDTM, Project Management, Vendor Management, Databases, Data Management, CRF design, Sop, ICH-GCP, GCP
Education
The College of Saint Rose
BA, Biology
PPD September 2014 - Present
ICON plc April 2011 - September 2014
MedImmune April 2010 - March 2011
MedImmune March 2009 - April 2010
MedImmune November 2007 - March 2009
Wyeth Research June 2007 - November 2007
sanofi pasteur June 2005 - June 2007
The Johns Hopkins University November 1999 - June 2005
Skills
Clinical Trials, Oncology, Vaccines, Sop, EDC, Therapeutic Areas, Clinical Development, Clinical Monitoring, Regulatory Submissions, CRO, Biotechnology, Pharmaceutical Industry, GCP, FDA, CTMS, Infectious Diseases, Regulatory Affairs, Protocol, Clinical Research, ICH-GCP, IND, Data Management, Drug Development, Hematology, Clinical Data Management, 21 CFR Part 11, Project Management, SOP
Education
The George Washington University School of Medicine and Health Sciences 2003 — 2005
MSHS, Clinical Research Administration
Towson University 1992 — 1995
BS, Mass Communications
Bel Air High School
Abraxis BioScience September 2008 - Present
PPD August 2007 - September 2008
Amgen 2003 - 2007
Education
The Johns Hopkins University
FDA September 2012 - Present
FDA April 2010 - September 2012
PPD August 2006 - March 2010
University of Oklahoma 2005 - 2006
University of Oklahoma October 2001 - June 2005
Skills
Clinical Trials, GCP, CRO, Healthcare, Clinical Development, Hospitals, Oncology, Research, Clinical Research, Software Documentation, Data Analysis, Regulatory Affairs
Education
The George Washington University School of Medicine and Health Sciences 2003 — 2005
Master of Science in Health Sciences
University of Tulsa 1992 — 1996
BSN, Nursing
PPD Quality Assurance ManagerNavidea BiopharmaceuticalFebruary 2010 - June 2014
Kendle International January 2008 - April 2009
PharmaFORCE November 2006 - December 2007
Alkermes March 2006 - November 2006
Boehringer Ingelheim March 2005 - March 2006
Skills
FDA GMP/GCP, EMA, Quality Auditing, Quality Management, Analytical Method..., Training, Supply Chain Management, Aseptic Technique, Batch Release, CAPA, Deviation Management, OOS, Global Regulatory..., eCTD, Pharmacovigilance, SOP development, Clinical Trials, Clinical Monitoring, Radiopharmaceuticals, Medical Devices, Biologics, Positron Emission..., FDA, Quality System
Education
The Johns Hopkins University 2006 — 2009
Master of Science
University of Toledo 1999 — 2004
BS
PAREXEL November 2012 - Present
INC Research January 2012 - November 2012
PPD 2011 - January 2012
PPD 2009 - 2011
Momentum Group September 2008 - December 2009
Skills
Clinical Trials, RFP, Pharmaceutical Industry, Proposal Writing, CRO
Education
University of North Carolina at Wilmington 2006 — 2008
MBA
The Catholic University of America 1993 — 1998
Bachelor of Architecture (BArch)
QlikTech June 2012 - Present
QlikTech March 2009 - Present
QlikTech, Inc. May 2005 - March 2009
PPD 2000 - 2005
GlaxoWellcome 1998 - 2000
Aeronaut Industries Pty. Ltd. 1997 - 1998
The BridgBuilder Company 1996 - 1997
American Airlines 1989 - 1994
Skills
Business Intelligence, Analytics, Data Modeling, SaaS, Requirements Gathering, Integration, SQL, SSO, Enterprise Software, Data Warehousing, QlikView, Business Analysis, Dashboard, Product Specification, Cloud Computing, Software Project..., Enterprise Architecture, Solution Architecture, Master Data Management, Business Alliances, ETL, Databases, Professional Services, Pre-sales, Sales Enablement, Business Analytics, Requirements Analysis, OLAP, Go-to-market Strategy, Business Objects, Architecture, Partner Management, Business Intelligence..., Big Data, Agile Methodologies, Data Integration, Strategic Alliances, Product Management, Data Quality, Agile Project Management, Business Process, Predictive Analytics, Solution Selling, Software Development, Scrum, ERP, Software Industry, Salesforce.com, Microsoft SQL Server, CRM
Education
University of North Carolina at Chapel Hill 1986 — 1994
BA, Anthropology
The Johns Hopkins University 1985 — 1986
N/A, Undergraduate
PPD 2015 - Present
PPD 2014 - 2015
United States Marine Corps 1990 - 2013
Skills
Military, Leadership, Marine Corps, Supervisory Skills, Military Training, Organizational..., Strategic Planning, Process Improvement, Program Management, Cross-functional Team..., Training, Team Building, Policy, Recruiting, Full Life Cycle..., College Recruiting, Interviews, Internal Audit, Sourcing, Strategic Leadership, Strategic Sourcing, Development & delivery..., Curriculum Development, Quality Management, Quality Control, Change Management, Organizational..., Organizational..., Communication Skills, Crisis Stabilization, Management, Employee Training, Military Logistics
Education
Webster University 2008 — 2010
MBA
The Citadel 1986 — 1990
BS, Education
Lean Six Sigma
Green Belt
PPD July 2014 - Present
PPD April 2013 - July 2014
PPD April 2010 - April 2013
PPD October 2008 - April 2010
PPD January 2007 - October 2008
PPD August 2005 - January 2007
University of Maryland School of Medicine January 2005 - August 2005
Social & Scientific Systems July 2004 - January 2005
Children's National Health System May 2002 - July 2004
Skills
Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, Proposal Writing, Project Management, Strategy, Contract Negotiation, Vendor Management, Legal Writing, Intellectual Property
Education
University of Maryland Francis King Carey School of Law 2004 — 2007
JD
The George Washington University 1999 — 2002
MPH
University of Maryland College Park 1990 — 1994
BS, Biology
Genentech July 2015 - Present
Genentech January 2013 - Present
Genentech September 2008 - December 2012
MedImmune May 2005 - September 2008
PPD 2002 - 2005
Skills
Clinical Development, Clinical Operations, Clinical Trials, CRO, GCP, Infectious Diseases, Clinical Research, Vaccines, Biotechnology, Clinical Study Design, Protocol, Immunology, Rheumatology, Clinical Data Management, Clinical Monitoring, EDC, Strategic Planning, CTMS, Team Leadership, ICH-GCP, Oncology, Drug Development, Biopharmaceuticals, Therapeutic Areas, Pharmaceutical Industry
Education
The George Washington University School of Medicine and Health Sciences
MS, Clinical Research Administration
University of Maryland Baltimore
BS, Physical Therapy
PPD October 2012 - Present
PPD August 2009 - October 2012
PPD October 2008 - August 2009
PPD July 2004 - October 2008
Radiant Research October 2002 - July 2004
Radiant Research June 2001 - October 2002
Skills
Clinical Research, CRO, Clinical Monitoring, GCP, CTMS, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Oncology, Infectious Diseases
Education
Texas Tech University
Bachelor's Degree, Biology
IKARIA, Inc. State Meat InspectorState of WisconsinJanuary 2013 - June 2013
Wysong / NFP August 2012 - January 2013
Algae Systems, LLC March 2012 - May 2012
Deibel Laboratories September 2007 - April 2011
Sexing Technologies, LLC. July 2006 - August 2007
PPD August 2005 - October 2005
Northwest Observers Inc. December 2003 - October 2004
Bank of Tokyo-Mitsubishi UFJ September 1999 - April 2003
Skills
Quality Assurance, Consultative Selling, Biotechnology Industry, Food Processing, Aseptic Processing, Laboratory Techniques, Entrepreneurship
Education
The Citadel 1992 — 1996
Bachelor of Science (B.S.), Biology/Biological Sciences, General
PPD May 2014 - Present
PPD April 2011 - April 2014
i3 statprobe July 2009 - April 2011
PPD August 2007 - June 2009
PPD June 2006 - July 2007
Texas State University August 2004 - May 2006
Skills
SAS programming, Clinical Trials, CRO, CDISC, SAS, Biostatistics, Statistical Programming, 21 CFR Part 11, Pharmaceutical Industry, Oncology, ICH-GCP, SQL, Data Management, EDC, GCP, Oracle Clinical, SAS Programming
Education
Texas State University 2004 — 2006
MS, Computer Science
University of Madras 2001 — 2004
BE, Computer Science
Advanced Auditing and Clinical Research September 2000 - Present
Independent Contractor 1995 - 2015
Vital Therapies,Inc August 2013 - December 2013
PPD June 2012 - August 2013
Advanced Auditing and Clinical Trial Research September 2000 - June 2012
Skills
Clinical Research, Monitoring and Auditing..., Experienced in..., Cardiology Devices, Oncology-Thyroid,..., Hepatitis C, HIV, Idiopathic...
Education
Texas Woman's University 1976 — 1981
Bachelor of Science in Nursing, Nursing
PPD August 2014 - Present
PPD April 2012 - August 2014
PPD October 2010 - April 2012
PPD October 2009 - October 2010
PPD May 2008 - October 2009
PPD January 2008 - May 2008
Biomat USA Inc. June 2004 - June 2006
Skills
Data Management, Oracle Clinical, EDC, Clinical Data Management, CRO, Data Validation, CDISC, Hematology, Oncology, Microsoft Office, Inform, Clinical Trials, ICH-GCP, Medidata, GCP, 21 CFR Part 11, Clinical Research, Pharmaceutical Industry
Education
Texas State University 2006 — 2007
MS, HEALTH SERVICE RESEARCH
The University of Texas at Austin 1999 — 2003
bs, Microbiology
ICON Clinical Research February 2007 - Present
PPD 2002 - 2007
Pharmaceutical Research Plus 1997 - 2002
Education
The Johns Hopkins University 2004 — 2006
MS, Biotechnology
University of California, Berkeley 1988 — 1992
BA, Political Economy of Industrial Societies
Santa Rosa High School 1984 — 1988
PPD May 2012 - Present
PPD October 2011 - April 2012
PPD April 2010 - October 2011
MedImmune March 2008 - April 2010
MedImmune April 2007 - February 2008
MedImmune December 2005 - March 2007
MedImmune March 2003 - November 2005
MedImmune June 2000 - February 2003
Skills
Cross-functional Team..., Biotechnology, Biopharmaceuticals, Strategy, Leadership, Management, Project Management
Education
The Johns Hopkins University - Carey Business School 2002 — 2007
MSF, Finance
Towson University 1991 — 1994
BS, Accounting
PPD February 2001 - Present
CL McIntosh & Associates July 1993 - February 2001
FDA, CDRH January 1977 - July 1993
Skills
Regulatory Affairs, FDA, Clinical Trials, CRO, GCP, Biotechnology, CTMS, Medical Devices, Pharmacovigilance, Validation, Clinical Research
Education
The Johns Hopkins University
Master of Publich Health, Public Health (epidemiology focus)
University of Maryland College Park
Bachelor of Science (BSc), Biology
Grifols October 2013 - Present
Griffols Inc. July 2011 - October 2013
Grifols Inc July 2008 - July 2011
PPD January 2006 - July 2008
Pfizer Pharmaceuticals 1993 - 2005
Skills
Clinical Trials, Regulatory Affairs, Data Management, MedDRA, Pharmaceutical Industry, Clinical Research, AES, Drug Safety, CRO, Quality Assurance, GCP, Team Leadership, Sop, Product Quality, Clinical Data Management, 21 CFR Part 11, Lifesciences, CTMS, Biotechnology, EDC, Regulatory Submissions
Education
The George Washington University School of Medicine and Health Sciences
BS, Clinical Research Administration
PPD October 2014 - Present
PPD January 2012 - Present
PPD April 2014 - September 2014
PPD 2010 - 2012
PPD 2004 - January 2010
PPD 2008 - 2009
Quintiles 2000 - 2003
Education
The George Washington University 1991 — 1995
BS, Biology
PRA Health Sciences December 2010 - Present
i3Research October 2009 - December 2010
PPD 2004 - 2009
PPD 2003 - 2004
PPD 1998 - 2003
Innovative Medical Research 1995 - 1998
Skills
Quality Assurance, Clinical Monitoring, EDC, CTMS, GCP, Training, Clinical Trials, CRO, Oncology, Clinical Site Management, ICH-GCP, Clinical Research, Infectious Diseases, Regulatory Submissions, Clinical Development, CNS disorders, Mental Health, Writing, Research, Team Management, Rheumatology, Clinical Operations, Protocol, Rheumatoid Arthritis, Vaccines, IRB, Inform, Therapeutic Areas, Urology, Clinical Data Management, Medidata, Cardiology, Patient Recruitment, CRF design, Oracle Clinical, Immunology
Education
The Johns Hopkins University
M.S., Counseling, Mental Health Concentration
University of Maryland Francis King Carey School of Law
JD
PPD September 2009 - Present
PPD January 2009 - September 2009
Merck January 2001 - December 2008
Merck March 1989 - December 2000
SMITH KLINE & BECKMAN LABORATORIES April 1986 - March 1989
SMITH KLINE & BECKMAN LABORATORIES September 1984 - April 1986
Skills
21 CFR Part 11, FDA, GMP, Regulatory Affairs, Sop, Clinical Research, Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, CRO, CAPA, Computer System..., GxP, Laboratory, Quality Assurance, Validation, V&V, Quality System, Change Control, Assay Development, LIMS, Vaccines, GCP, GLP
Education
The Hebrew University 1974 — 1978
M.Sc., Biochemistry
The Hebrew University 1972 — 1974
B.Sc, Biology, General
Ethicon, Inc. September 2014 - Present
PPD April 2014 - Present
PPD March 2012 - Present
Walgreens January 2009 - March 2012
Richmond Ambulance Authority August 2008 - January 2009
Virginia Commonwealth University August 2007 - August 2008
Skills
Microsoft Office, GLP, Clinical Trials, Sop, GMP, Regulatory Affairs, Quality Assurance, 21 CFR Part 11, Quality Auditing, GCP, Regulatory Requirements, LIMS, GxP, Chromatography, FDA, CAPA, Medical Devices
Education
The Johns Hopkins University 2010 — 2013
Master's Degree, Bioscience Regulatory Affairs
Virginia Union University 2004 — 2008
Bachelor's degree, Biology/Biological Sciences, General
GSTS
University of North Carolina at Chapel Hill July 2013 - Present
University of North Carolina at Chapel Hill January 2013 - July 2013
Quintiles September 2010 - September 2011
PPD January 2008 - June 2010
UNC Chapel Hill School of Medicine- UNC Nephropathology Laboratory June 2001 - January 2008
UNC Hospitals November 1998 - June 2001
Carolina Donor Services (previously Carolina Organ Procurement Agency) May 1998 - November 1998
UNC Hospitals April 1994 - May 1998
Skills
Clinical Research, Pharmacovigilance, Laboratory Medicine, Science, Infectious Diseases, CRO, Healthcare, Immunology, Clinical Trials, Pharmaceutical Industry, Clinical Laboratory..., EMT, MedDRA, University Teaching, Molecular Genetics, Molecular Diagnostics, Microbiology, Supervisory Experience, Medical Technology, Laboratory Safety, Environment, Health and...
Education
UNC Chapel Hill 2011 — 2012
MMDS, Masters in Molecular Diagnostic Science
University of North Carolina at Chapel Hill 2007 — 2008
Certificate, Core Public Health Concepts
Durham Technical Community College 2000 — 2002
Certificate, Environment, Health and Safety Technology
The College of St. Scholastica 1989 — 1993
BA, Clinical Laboratory Science
Novo Nordisk May 2014 - Present
inVentiv Health Clinical February 2014 - May 2014
ICON plc November 2012 - February 2014
PHARMANET February 2012 - October 2012
Takeda Pharmaceuticals November 2007 - February 2012
Kforce November 2007 - February 2012
KFORCE CLINICAL RESEARCH, INC November 2007 - February 2012
PharmaNet/i3 Strategic Resourcing 2007 - 2012
BLUEBONNET CLINICAL RESEARCH January 2007 - November 2007
PPD February 2006 - January 2007
Skills
Clinical Monitoring, EDC, Clinical Trial..., GCP, Therapeutic areas, Oncology, Phase I
Education
Texas Tech University 1987 — 1992
BS, Biochemistry, Cell Biology, Molecular Biology, Virology, Microbiology
PPD November 2009 - Present
PPD July 2008 - October 2009
PPD July 2007 - June 2008
Skills
Clinical Trials, Clinical Research, Pharmacists, Pharmacy, Healthcare, Public Health, Project Management, Quality Assurance, Data Analysis, Software Documentation, Microsoft Office, Process Improvement, Strategy, Training, Molecular Biology, Microsoft Excel, Research, Pharmaceutical Industry, Inpatient, Customer Service
Education
University of North Carolina at Chapel Hill 2002 — 2006
Doctor of Pharmacy (PharmD), Pharmacy
The Johns Hopkins University 1994 — 1998
Bachelor of Arts (BA), Biology / Music
Quintiles August 2014 - Present
Elevated Research, LLC July 2014 - Present
INC Research September 2012 - August 2014
PPD February 2007 - September 2012
Hematology Oncology Consultants, Inc 2004 - February 2007
Hematology Oncology Consultants, Inc 2002 - 2004
Skills
Oncology Clinical..., Clinical Research, Clinical Monitoring, Clinical Trials, EDC, CRO, Clinical Data Management, GCP, Clinical Development, Diabetes, Regulatory Affairs, Biotechnology, Data Management
Education
The College of Wooster 1998 — 2002
BA, Chemistry, Art History
Columbus Academy 1994 — 1998
Novella Clinical, Inc. July 2012 - Present
University of North Carolina at Wilmington May 2010 - May 2012
PPD January 2012 - April 2012
AAIPharma Services Corp. December 2006 - September 2007
University of North Carolina at Wilmington October 2005 - December 2006
Bayer HealthCare March 2000 - July 2005
UCSF October 1997 - December 1999
Chiron Corporation April 1997 - October 1997
Skills
Business Optimization, Global Strategy..., Strategic Planning, Market Research, Business Planning, Cross-functional Team..., PCR, Market Intelligence, Market Analysis, Global Drug Development, Data Analysis, Molecular Biology, Project Management, Statistics, Biotechnology, Cell Culture, Validation, Research, qPCR, Lifesciences, Infectious Diseases, Financial Analysis, FDA, Marketing, Life Sciences
Education
University of North Carolina Wilmington 2010 — 2012
MBA
Texas Woman's University 1994 — 1996
MS, Molecular Biology
University of Pune 1991 — 1993
MS, Microbiology
University of Pune 1988 — 1991
BS, Microbiology
TKL Research December 2013 - Present
TKL Research June 2012 - December 2013
PPD November 2010 - June 2012
Covance Inc June 2007 - November 2010
New Logic Educators 2007 - 2010
Skills
Clinical Monitoring, GCP, Oncology, Dermatology, Project Management, Clinical Research, CRO, CTMS, EDC, ICH-GCP, Clinical Operations, Drug Development, Pharmaceutical Industry, Clinical Trials, Therapeutic Areas, Clinical Development, Clinical Data Management
Education
The College of New Jersey 2003 — 2007
BS, Biology, Chemistry
PPD June 2013 - Present
Rose Garden China Bistro February 2009 - Present
Tanny Chatlosh Photography August 2005 - Present
Imperial Garden April 2007 - May 2013
DNC November 2010 - December 2010
Technology Team, LLC October 2005 - 2010
Skills
Restaurant Management, Customer Service, Bartending, Studio Photography, Restaurants, Phone Etiquette, Cooking, Cash Register, Hospitality, Food & Beverage, POS, Food
Education
Texas State University 2005 — 2009
BFA, Digital and Photographic Imaging
Texas State University-San Marcos 2005 — 2009
Bachelor of Fine Arts (BFA), Digital and Photgraphic Imaging
PPD June 2014 - Present
University of Maryland Medical System, Human Research Protections Office March 2004 - December 2007
University of Maryland Medical Systems, Head and Neck Oncology April 2000 - March 2006
Skills
Clinical Research, Oncology Clinical..., Data Analysis, Microsoft Office, Microsoft Excel, Teaching, CTMS, Clinical Data Management, Electronic Databases, Oncology Nursing, Surgical Oncology, Radiation Therapy, CTCAE, MedDRA, Data and Safety..., Pharmacovigilance, Quality Assurance, Pediatric Intensive Care, Solid Organ..., Head and Neck Oncology, Clinical Trials, EDC, CRO, Oncology, Pharmaceutical Industry, GCP
Education
The Community College of Baltimore County
Associate's Degree, Registered Nursing/Registered Nurse, Dean's List
University of Maryand, Baltimore County (UMBC)
Biology/Biological Sciences, General
PPD September 2015 - Present
PRA International October 2011 - September 2015
Accelovance January 2011 - October 2011
Quintiles January 2008 - January 2011
EMMES 2004 - 2008
The American Speech-Language-Hearing Association (ASHA) 1997 - 2004
The American Speech-Language-Hearing Association (ASHA) 1997 - 2004
Skills
CRO, EDC, Clinical Trials, GCP, Clinical Monitoring, CTMS, Clinical Research, ICH-GCP, Clinical Data Management
Education
The Johns Hopkins University 1992 — 1997
MS, Clinical Community Counseling
University of Mary Washington 1987 — 1991
BS, Psychology
PAREXEL April 2013 - Present
PPD March 2011 - April 2013
AAIPharma Services Corp. August 2006 - March 2011
Skills
CRO, Clinical Supplies, CTMS, Clinical Trials, GCP, Clinical Development, Sop, Pharmaceutical Industry, EDC, GMP, FDA, Drug Development, 21 CFR Part 11, Validation, Oncology, Regulatory Affairs, ICH-GCP, Clinical Monitoring, Biotechnology, Clinical Data Management, Technology Transfer, Therapeutic Areas
Education
The Ohio State University 1994 — 1999
B.S. Human Nutrition
Baxter Biosciences June 2012 - Present
ICON 2012 - 2014
sanofi-aventis June 2011 - May 2012
RPS Group 2012 - 2012
Urology Clinics of North Texas September 2005 - June 2011
PPD 2011 - 2011
Skills
CRO, ICH-GCP, Clinical Trials, Clinical Research, Sop, SOP, Protocol, Clinical Operations, GCP
Education
Texas Woman's University 1989 — 1992
B. S, Chemistry and Biology
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
PPD Director Project ManagementPPDApril 2015 - Present
PPD November 2011 - March 2015
PPD October 2010 - November 2011
Skills
EDC, GCP, CTMS, CRO, Clinical Trials, Clinical Development, ICH-GCP, Pharmaceutical Industry, Oncology, Clinical Monitoring, Clinical Data Management, Therapeutic Areas, SOP
Education
Texas Tech University
Bachelor of Science (B.S.), Animal Sciences
PharmaNet/i3 March 2012 - Present
Kforce Inc. April 2011 - March 2012
Kforce Inc. March 2008 - April 2011
INC Research January 2007 - March 2008
INC Research February 2006 - January 2007
PPD May 2005 - February 2006
Education
Texas State University-San Marcos 2002 — 2004
Bachelor of Science (BS), Biology, General
PPD July 2014 - Present
PPD January 2013 - July 2014
Kings Highway Animal Clinic July 2010 - December 2012
Texas State University August 2011 - May 2012
Skills
Chemistry, Research, Laboratory
Education
Texas State University-San Marcos 2010 — 2014
Bachelor of Applied Science (BASc), Microbiology, General
RPS/PRA June 2012 - Present
Teva Neuroscience February 2005 - May 2012
PPD April 2000 - January 2005
Skills
Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking
Education
The George Washington University 2004 — 2006
Master of Science (MS), Nursing