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
Techdemocracy LLC November 2010 - Present
Facebook March 2011 - June 2011
PPD 2011 - 2011
American Home Mortgage Servicing 2010 - 2011
CPSG Partners 2009 - 2010
Skills
Oracle Identity Manager, Oracle Internet..., Oracle Virtual Directory, Active Directory, Java, Weblogic, Red Hat Linux, Unix, SDLC, Oracle, SOA, SQL, Enterprise Architecture, Consulting, Java Enterprise Edition, Integration, Data Migration, Identity Management, IAM, IDM, WebLogic, Oracle Fusion Middleware, LDAP, Oracle Access Manager, Siteminder, OID, SSO
Education
Jawaharlal Nehru Technological University
BTech, Electronics and Communications
PPD August 2015 - Present
Allergan January 2015 - August 2015
Forest Laboratories May 2013 - January 2015
The Buonopane Group April 2011 - April 2013
Newport Capital Group, LLC December 2010 - April 2011
UNCW February 2010 - May 2010
Merrill Lynch September 2008 - December 2008
Mid Atlantic Vegetable Shortening 2008 - 2008
Skills
Market Research, Analysis
Education
KEDGE Business School 2009 — 2010
Masters of Science in International Business, Business
University of North Carolina at Wilmington 2009 — 2010
IMBA, International Finance
University of North Carolina at Wilmington 2005 — 2009
Finance
PAREXEL July 2013 - Present
Aerotek on assignment to Exact Sciences July 2012 - June 2013
Pfizer September 2007 - July 2012
Pfizer December 2001 - September 2007
PPD June 1999 - November 2001
MIMC August 1997 - May 1999
Westat January 1992 - August 1997
Northwestern University July 1989 - December 1991
Mayo Clinic 1983 - 1989
Skills
CTMS, Clinical Development, CRO, EDC, GCP, Pharmaceutical Industry, Clinical Trials, FDA, Oncology, Biotechnology, Regulatory Affairs, GMP, Drug Development, ICH-GCP, Clinical Research, Clinical Monitoring
Education
Keller Graduate School of Management of DeVry University
Courses in Project Management
Viterbo University
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Altria December 2013 - Present
PPD September 2010 - December 2013
James Madison University Biology Department August 2008 - May 2010
Skills
Cell Culture, Vaccines, Immunoassays, LIMS, Bioanalysis, Data Analysis, Quality Assurance, GLP, Assay Development, Immunology, High Throughput..., Pharmaceutical Industry, CRO
Education
James Madison University 2006 — 2010
Bachelor of Science (B.S.), Biology
INC Research December 2014 - Present
CASA of Travis County May 2014 - Present
Premier Research October 2013 - November 2014
PPD June 2012 - October 2013
Seton Family of Hospitals- Specially for Children August 2010 - June 2012
PPD January 2010 - July 2010
Skills
Clinical Research, CTMS, Regulatory Affairs, IRB, Protocol, Public Health, Data Collection, Clinical Monitoring, Biostatistics, Lifesciences, Data Entry, Healthcare, PowerPoint, Excel, Word, Outlook, Appointment Scheduling, Minute Taking, Life Sciences, Epidemiology, Statistics, SPSS, Invoice Verification, Payments, Epi Info, Laboratory Skills, Fingerprinting, Medical Records, Cpr Certified, Biology, Informed Consent, MS Project, Prior Authorization, Budget Process, Communication, GCP, Clinical Trials, CRO, Research, EDC, ICH-GCP, Microsoft Excel, Microsoft Office, Microsoft Project, Public Speaking, Report Writing
Education
Kaplan University 2010 — 2012
Master of Public Health, Epidemiology
University of Southern Mississippi 2003 — 2009
Bachelor of Science; Degree, Biological Science
Premier Research September 2013 - Present
Premier Research Group April 2012 - Present
PPD January 2010 - May 2012
PPD January 2007 - October 2010
Signature Science, LLC October 1997 - January 2007
JJT 1995 - 1997
Skills
SAS, Biostatistics, Clinical Trials, Regression, Survival Analysis, CDISC, Data Analysis, Clinical Data Management, Pharmaceutical Industry, Statistics, CRO, Clinical Research, EDC, Regression Testing, Clinical Development, Statistical Modeling, Data Management, Statistical Programming, SDTM
Education
New Mexico State University 1992 — 1994
M.S., Biostatistics
Kansas State University 1987 — 1992
B.A., Statistics
PPD December 2010 - Present
Skills
GLP, Vaccines, CRO, Clinical Development, Drug Development, Sop, Assay Development, GCP, Pharmaceutical Industry, GMP
Education
James Madison University 2004 — 2008
Bachelor's degree, Biology, General
PPD March 2015 - Present
PPD 2013 - Present
UCB Biosciences 2010 - 2012
Schwarz Biosciences (A member of UCB group of companies) June 2009 - October 2010
Eisai Medical Research November 2008 - March 2009
UCB Pharma February 2004 - October 2008
Makro tech 2001 - 2004
Skills
CDISC, SAS programming, Data Management, Data Mining, Clinical Research, Clinical Trials, NDA submissions, Project Management, Team Management, Multi-cultural..., Leadership, Process Control, OC RDC, CRF design, Protocol Review, CRF annotations, SDTM, SAS, CTMS, Clinical Development, CRO, Clinical Data Management, Oracle Clinical, FDA, GCP, 21 CFR Part 11, SAS Programming
Education
University of Missouri-Rolla 2001 — 2003
MS in Comp Sci, Research Thesis in Data Mining
Jawaharlal Nehru Technological University 1997 — 2001
BTech, Computer Science & IT
PPD April 2015 - Present
Clinipace Worldwide January 2013 - April 2015
Clinipace Worldwide February 2010 - January 2013
Carla Radke Clinical Research Solutions, LLC January 2008 - January 2010
PPD 2005 - 2008
Quintiles 2002 - 2005
Quintiles 1999 - 2002
Quintiles 1998 - 1999
Hoechst Marion Roussel 1995 - 1997
Skills
EDC, Clinical Data Management, Clinical Training, Clinical Monitoring, Clinical Research, Clinical Trials, GCP, Oncology, ICH-GCP, Clinical Development, IRB, Therapeutic Areas, Pharmaceutical Industry, CRF design, Phase I, 21 CFR Part 11, Biotechnology, CRO, CTMS, Clinical Operations, Clinical Research..., Clinical Study Design, Diabetes, Drug Development, Endocrinology, FDA, Hypertension, Immunology, Inform, Lifesciences, Patient Recruitment, Pharmacovigilance, Regulatory Requirements, Protocol, Regulatory Submissions, Sop, Training, Trial Management, Vaccines
Education
University of Kansas
Bachelor of Science (B.S.), Medical Record Administration
Johnson County Community College
AS, Nursing
PremierTox Laboratory July 2011 - November 2013
Cargill September 2008 - April 2009
3M October 2007 - July 2008
Medtox Laboratories September 2005 - October 2007
Viromed Laboratories June 2005 - September 2005
Amerilab Technologies January 2005 - June 2005
PPD January 2004 - August 2004
Skills
Quality Control, LC-MS, Analysis, Bioanalysis, Chromatography, FTIR, GLP, Chemistry, Assay Development, Sop, Method Development, Software Documentation, Testing, Validation, Toxicology, V&V, LIMS, Data Analysis, GMP, Troubleshooting, HPLC, PCR, Gas Chromatography, Analytical Chemistry, Mass Spectrometry, Purification, Laboratory, Pharmaceutical Industry, Biotechnology, Life Sciences, Microsoft Office
Education
James Madison University 1999 — 2003
BS
Ingevity September 2014 - Present
Boehringer Ingelheim March 2011 - July 2014
Boehringer Ingelheim December 2009 - March 2011
PPD September 2008 - December 2009
GlaxoSmithKline April 2007 - September 2008
Skills
GMP, HPLC, Validation, Chemistry, Technology Transfer, Sop, Pharmaceutical Industry, Analytical Chemistry, Quality Control, GLP, Chromatography, Change Control, LIMS, CAPA, V&V, Purification, FDA, Gas Chromatography, UV/Vis, Organic Synthesis, 21 CFR Part 11, Drug Development, Organic Chemistry, LC-MS, Drug Discovery, Cleaning Validation, IR, Mass Spectrometry, GxP, Trackwise, Biopharmaceuticals, Regulatory Affairs, Biotechnology, Medicinal Chemistry, CRO, Computer System..., FDA GMP, Regulatory Submissions, NMR, Pharmaceutics, R&D, UV, USP, Quality by Design, Regulatory Requirements, Lifesciences, Quality System, Spectroscopy, Process Optimization, SOP
Education
Virginia Commonwealth University 2013 — 2014
Master's degree, Chemistry
Penn State University 2005 — 2007
Work towards PhD, Organic Chemistry
James Madison University 2001 — 2005
Bachelor of Science (BS), Chemistry
PPD June 2015 - Present
Brandermill Country Club April 2014 - Present
Health Diagnostic Laboratory, Inc. April 2013 - September 2013
Brandermill Country Club March 2011 - August 2012
Douglas Aquatics, Inc. May 2009 - September 2009
Skills
Computers, Communication, Problem Solving, Teamwork, Determination, Responsiveness, Organization, Windows & Mac operating...
Education
Virginia Commonwealth University 2012 — 2015
Bachelor of Science in Biology Candidate, Biology, General
John Tyler Community College 2011 — 2012
Associate of Science (A.S.), Chemistry
Quintiles October 2012 - Present
PPD July 2004 - October 2012
Education
James Madison University 2002 — 2004
Masters of Science, Concentration in Kinesiology
Gilead Sciences August 2014 - Present
inVentiv Health February 2014 - August 2014
Amgen March 2008 - December 2013
Quintiles April 2007 - February 2008
Boston Scientific February 2005 - April 2007
PPD December 1999 - January 2005
Skills
SAS, SQL, Visual Basic, Clinical Data Management, CDISC, Clinical Trials, SAS programming, 21 CFR Part 11, Oracle Clinical, Data Management, Validation, EDC, FDA, Protocol, CRO, R, Octave, SDTM, Biostatistics, Statistical Programming, SAS Programming
Education
Johns Hopkins University Advanced Academic Programs 2014 — 2018
Master's Degree, Bioinformatics
North Carolina State University 1993 — 1999
Bachelor of Science, Biological Sciences/Minor in Genetics
University of California, Irvine 1998 — 1999
None, Neuroscience
DuPont February 2013 - Present
HCA November 2011 - Present
DuPont May 2003 - Present
DuPont October 1999 - May 2003
PPD January 1999 - October 1999
BioEhance May 1998 - December 1998
Skills
Certified Green Belt, Root Cause Analysis, Lean Manufacturing, Cpr Certified, Quality Assurance, Microsoft Office, PowerPoint, Minitab, Continuous Improvement, Manufacturing, Process Improvement, Six Sigma, Validation, Process Simulation
Education
John Tyler Community College 2009 — 2011
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Virginia Union University 1992 — 1996
Bachelor of Science (B.S.), Biology/Biological Sciences, General
The Select Group July 2015 - Present
The Select Group December 2013 - July 2015
The Select Group August 2012 - December 2013
The Select Group January 2012 - August 2012
PPD November 2010 - December 2011
Calix September 2011 - November 2011
COVERBIND September 2010 - December 2010
Skills
Project Management, Temporary Placement, Human Resources, Recruiting, Networking, Interviews, Screening, Employee Training, Testing, Marketing, SQL, Databases, Management, Cold Calling, Leadership, Technical Recruiting, Sales, Web Development, Quality Assurance, Business Analysis, Internet Recruiting, Staffing Services
Education
Ecole de Management de Marseille / Euromed Marseille 2011 — 2011
Business Law, French
University of North Carolina at Wilmington 2007 — 2011
Business, Marketing, Math
PPD December 2014 - Present
Commonwealth of Virginia Division of Consolidated Laboratory Services April 2013 - September 2014
Richmond Residential Services September 2010 - September 2014
Commonwealth of Virginia Division of Consolidated Laboratory Services March 2012 - April 2013
Capital Area Health Network October 2009 - March 2012
Skills
Public Health, Healthcare, SPSS, Research, Non-profits, Public Speaking, Teaching, PowerPoint, Health Promotion, Health Education, Training, Event Planning, Microsoft Word, Microsoft Excel, Community Health, Nonprofits, Health Communication, Mental Health, Program Development, Program Evaluation, Clinical Research, Community Outreach
Education
Liberty University 2013 — 2015
Master's degree, Public Health
James Madison University 2005 — 2009
Bachelor's degree, Public Health Education and Promotion
PPD March 2015 - Present
PPD March 2014 - Present
James Madison University August 2012 - January 2014
James Madison University May 2011 - August 2012
James Madison University May 2011 - January 2012
Skills
OPA, Serum Bactericidal..., ELISA, Cellular Assays, Research, Data Analysis, Spectrophotometry, PCR, Customer Service, Troubleshooting, IT Solutions, DNA extraction, Micropipette, IT Operations, Customer Communication, Windows, Microsoft Office, Data Entry, Mac OS, Leadership, Teamwork
Education
James Madison University 2009 — 2013
Bachelor of Science (BS), Biotechnology, Graduated
PPD September 2013 - Present
Unilever September 2011 - August 2013
PPD February 2006 - September 2011
Skills
Analytical Chemistry, Materials Science, Characterization, Science, UV/Vis, HPLC, Quality System, Chemistry, Chromatography, R&D, Laboratory, Rheology, Materials, Problem Solving, Method Development, DSC, TGA, Particle Size Analysis, DVS, KF, Thermodynamics, Microscopy, Ring Shear tester, Surface Tension, Spectroscopy, Powder X-ray Diffraction, Differential Scanning..., SOP
Education
University of Wisconsin-Madison 2006 — 2009
Masters, Materials Science-Rheology
University of Karachi 2001 — 2005
Masters, Applied Chemistry-Thermodynamics
Dana Laymon Photography October 2009 - Present
PPD April 2010 - July 2013
PPD October 2009 - April 2010
Cherry Productions January 2007 - December 2009
PPD May 2008 - October 2009
Wilmington Regional Association of REALTORS May 2007 - May 2008
Skills
Microsoft Excel, PowerPoint, Microsoft Office, Microsoft Word, Photoshop, Lawson HRIS, SuccessFactors, SkillPort, Human Resources, Employee Benefits, Consulting, HRIS, Training, Personnel Management, Customer Service, Software Documentation, Data Entry, Portrait Photography
Education
University of North Carolina at Wilmington 2003 — 2007
BS, Human Resource Management
Ecole de Management de Marseille 2006 — 2006
International Business
Intarcia Therapeutics, Inc. April 2015 - Present
PPD 2014 - 2015
PPD 2011 - 2014
PPD 2009 - 2011
PPD 2007 - 2009
PPD 2006 - 2007
PPD 2005 - 2006
Amylin Pharmaceuticals 2004 - 2005
Eli Lilly 1999 - 2004
Skills
Clinical Research, Pharmaceuticals, Clinical, Clinical Trial..., EDC, CRO, Clinical Study..., Vendor management, Project Planning, Project Delivery
Education
University of California, San Diego 2004 — 2005
Certificate, Business Management
Karachi University 1998 — 1999
Masters of Science, Biochemistry
Karachi University 1995 — 1997
Bachelors of Science (Honors), Biochemistry
PPD July 2014 - Present
Carolina East Quinn Hospice Center May 2013 - July 2014
Lower Cape Fear Hospice and Life Care Center August 2006 - December 2012
hospice care center August 2006 - December 2012
Hanover Medical Specialists May 2005 - June 2006
New Hanover Regional Medical Center August 2004 - June 2005
Precision Heating and Air January 1989 - January 2001
NationsBank January 1981 - January 1989
Skills
Nursing, Hospitals, Healthcare, BLS, Microsoft Office, Inpatient, EMR, Wound Care, Pain Management, Palliative Care, Telemetry, Home Care, Symptom Management, Home Infusion, Nursing Education
Education
James Sprunt Community College 2001 — 2004
Associate Degree, Nursing
Pender High 1977 — 1980
Cisco April 2015 - Present
NetApp August 2014 - May 2015
NetApp June 2013 - August 2014
PPD February 2013 - May 2013
PPD September 2012 - February 2013
Skills
Time Management, Microsoft Excel, NetApp, Salesforce.com, French, Customer Service, Market Research, Data Storage..., New Business Development, Sales, Business Development, Healthcare Information..., Sales Prospecting, Channel Partners, Solution Selling, Account Management, Lead Generation, Sales Process, Cold Calling, Storage, Networking
Education
University of North Carolina at Wilmington 2009 — 2013
Bachelor of Science, Business Administration, International Business, French
Ecole de Management de Marseille / Euromed Marseille 2011 — 2012
International Business; CESEMED Bachelor Program
East Chapel Hill High 2005 — 2009
PPD April 2015 - Present
Arista Laboratories February 2014 - April 2015
Open Arms September 2013 - February 2014
Chanco on the James April 2013 - August 2013
Domino's Pizza December 2012 - March 2013
Chanco on the James June 2010 - August 2012
Skills
Science, Cell Culture, ELISA, Microsoft Word, Microsoft Excel
Education
James Madison University 2008 — 2012
Bachelor of Science (BS), Biology, General
Ocean Lakes High School 2004 — 2008
American HR & Management Consulting Group and Training Academy April 2012 - Present
Roadmark Corporation February 2013 - January 2015
StaffMasters /AWNC- Toyota Transmissions (Japanese Company) February 2010 - April 2012
PPD January 2008 - September 2009
Fidelity Investments 2004 - 2007
Monarch Recruitment Ltd 1994 - 2001
Skills
Staffing Services, Applicant Tracking..., Temporary Staffing, Behavioral Interviewing, Technical Recruiting, Talent Acquisition, Temporary Placement, I-9 Compliance, Recruiting, Background Checks, Sourcing, E-Verify, Managment Consulting, Account Management, Business Relationship..., Training, Employee Relations, Program Management, Project Management
Education
Kaplan University 2009 — 2011
MBA, Business
Topstone Research August 2014 - Present
Topstone Research August 2014 - Present
MD Clinical Research LLC 2012 - Present
PPD January 2012 - August 2014
AB Science 2011 - 2012
Asclepius Solutions Inc. September 2010 - 2011
Medpace March 2008 - August 2010
Vanderbilt University Medical Center November 2005 - March 2008
West Virginia University January 2005 - November 2005
Skills
Clinical Trials, Clinical Research, Oncology, PCR, FDA, Sop, GCP, CTMS, EDC, Clinical Development, Protocol, Endocrinology, SOP, Clinical Study Design, Western Blotting, Laboratory, Clinical Monitoring, In Vivo, ICH-GCP, CRO, Infectious Diseases, Pharmaceutical Industry, Genetics
Education
Karachi University 1994 — 1999
MBBS, Medicine
Health Decisions January 2014 - Present
Health Decisions August 2012 - January 2014
Health Decisions March 2012 - August 2012
Copernicus Group IRB June 2011 - March 2012
Copernicus Group IRB June 2010 - June 2011
Duke University Medical Center July 2008 - June 2010
PPD July 2007 - July 2008
Encysive Pharmaceuticals July 2004 - June 2007
i3 Research 2003 - 2004
Eisai Medical Research May 2002 - December 2003
Skills
Continuous Improvement, Quality Management, Auditing, ISO, Quality Systems, Six Sigma, Kaizen, Process Improvement, Risk Management, Lean Sigma, Compliance Management, Regulatory Affairs, Regulatory Submissions, Quality System, FDA, GCP, Sop, ISO 13485, Clinical Research, Validation, Quality Assurance, Pharmaceutical Industry, GLP, Clinical Trials, EDC, 21 CFR Part 11, CRO, Software Documentation, CAPA, Cross-functional Team..., GMP, GxP, Quality Control, Clinical Development, CTMS, Biotechnology, Change Control, Quality Auditing, Medical Devices, Regulatory Requirements
Education
Temple Graduate School of Pharmacy 2003 — 2006
MS
Kean University 1992 — 2002
BS
PRA Health Sciences August 2014 - Present
PPD October 2012 - August 2014
Aerotek June 2011 - October 2012
Skills
Public Speaking, Market Planning, Research, Time Management, Segmentation, Organizational Structure, Account Management, Marketing Communications, Management, Integrated Marketing, Team Building, Social Media, Customer Service, PowerPoint, Coaching, Recruiting, Leadership, Sales, Team Leadership, Outlook, Strategic Planning, CRM, Training, Talent Acquisition, Contract Negotiation, Employee Training, Microsoft Office, Cold Calling, Salesforce.com, Employee Relations, Social Networking, Event Planning, Networking, Marketing, Human Resources, Budgets, Interviews, Microsoft Word, Technical Recruiting, Sourcing, Applicant Tracking..., College Recruiting, Clinical Trials, CRO, Biotechnology Industry, Pharmaceutical Industry, Scheduling
Education
Kent State University 2007 — 2011
Bachelor, Managerial Marketing, Cum Laude
PPD April 2015 - Present
PPD July 2009 - March 2015
PPD July 2007 - July 2009
PPD March 2005 - July 2007
Skills
Learning Management..., Plateau LMS, Software Documentation, Microsoft Office 365, Access, Microsoft Visio, SuccessFactors, SkillSoft software, SharePoint, Ascent Capture, Microsoft Office 2010, Microsoft Office 2007, Microsoft Office 2003, Databases, ProtoSphere
Education
North Carolina State University 2002 — 2005
B.S, Business Management; Information Systems, 3.62 GPA
Johnston Community College 2000 — 2002
Business Administration and Management, General
BurroughsNet, LLC June 2014 - Present
INC Research July 2014 - June 2015
ICON plc February 2013 - June 2014
inVentiv Health Clinical April 2009 - January 2013
PPD April 2007 - October 2008
Comair July 2004 - April 2007
Dentsply September 2002 - March 2003
Hitachi-Aloka Medical, Ltd. January 2001 - March 2002
Bausch & Lomb July 2000 - December 2000
Hologic September 1997 - July 2000
Skills
Regulatory Affairs, Clinical Research, Project Management, Clinical Trials, GCP, FDA, Pharmaceutical Industry, CRO, CTMS, Regulatory Submissions, Clinical Development, FDA GMP, PERT, TQM, Quality Auditing, Earned Value Management, Business Process..., Medical Device Directive, Quality Assurance, Medical Devices, GMP, Clinical Monitoring, EDC, ICH-GCP, Therapeutic Areas, Clinical Data Management, Protocol, Sop, Oracle Clinical, 21 CFR Part 11, Infectious Diseases, Clinical Operations, Regulatory Requirements, Patient Recruitment, CAPA, IND, IRB, Trial Management, Rheumatology, ICH guidelines, Training, Inform, Quality System, R, ISO 13485, Drug Development, Pharmacovigilance, SOP, CRF design
Education
University of Phoenix 2011 — 2015
Doctoral Student, Health Administration
Keller Graduate School of Management of DeVry University
Master of Project Management (MPM), Project Management
University of Phoenix
Bachelor of Science in Business (BSB/A), Business Administration
Pace University
Biology/Medical Technology
Engility Corporation May 2014 - Present
Engility Corporation March 2014 - Present
Engility Corporation August 2013 - Present
Pennsylvania Army National Guard September 2010 - March 2015
Engility Corporation February 2012 - July 2013
PPD April 2011 - July 2011
Sanofi Pasteur April 2003 - December 2010
Pennsylvania Army National Guard September 2008 - September 2010
Pennsylvania Army National Guard February 2004 - September 2008
Skills
Military, Security Clearance, Army, Weapons, Tactics, Command, Organizational..., Intelligence, Defense, Military Operations, Military Training, Security, Leadership Development, Operational Planning, DoD, Special Operations, Military Experience, Intelligence Analysis, Employee Training, Military Logistics, Interagency Coordination, Exercises, Counterinsurgency, Analysis, Team Leadership, Leadership, Reconnaissance, Supervisory Skills, Project Planning, Force Protection, Counterterrorism, Information Assurance, National Security, Quality Assurance, Research, Combat, Program Management, Training, Instructor-led Training, Training Management, Personnel Management, Training & Development, Military Leadership, Operations, Foreign Military..., Problem Solving, Operations Management, Tactical Operations, Weapons Training, Small Unit Tactics
Education
King's College 1999 — 2002
B.S., Biology
Wyoming Area HS 1989 — 1993
Merck March 2015 - Present
Zimmer September 2014 - February 2015
Genzyme May 2013 - September 2014
Sunovion Pharmaceuticals Inc. January 2012 - July 2012
SeraCare Life Sciences August 2011 - December 2011
Lonza: A Global Leader In Life Sciences May 2009 - May 2011
PPD November 2008 - April 2009
Sanofi Pasteur MSD January 2002 - August 2007
Laboratory Corporation of America January 1998 - December 2001
Skills
GMP, Validation, Sop, FDA, LIMS, Microbiology, CAPA, Biopharmaceuticals, 21 CFR Part 11, Assay Development, Cell, Immunology, Quality Assurance, Vaccines, Chemistry, Laboratory, Statistics, Regulatory Submissions, Biotechnology, Reviews, Quality Control, GLP, CRO, Chromatography, SOP
Education
University of Scranton 2004 — 2007
Master Degree, Clinical Chemistry, 3.0
King's College 1991 — 1995
B.S, Biology, 3.5
Care Management Technology, Inc. via RHT Contract March 2014 - Present
Quintiles Transnational September 2007 - January 2011
Quintiles Transnational September 2004 - September 2007
Quintiles Transnational October 2003 - September 2004
nTouch Research March 2000 - October 2003
PPD January 1999 - March 2000
PPD January 1996 - January 1999
Glaxo February 1992 - July 1995
Skills
Clinical Trials, Software Documentation, Requirements Gathering, Process Improvement, Cross-functional Team..., SDLC, Analysis, Requirements Analysis, Business Analysis, Leadership, Management, Program Management, Team Leadership, Testing, Training
Education
Jamestown Community College 1984 — 1986
AAS, Programming and Systems
PPD April 2015 - Present
PPD March 2013 - March 2015
Whitsell Innovations, Inc. May 2012 - March 2013
University of North Carolina September 2008 - March 2013
University of North Carolina at Chapel Hill September 2008 - March 2013
University of North Carolina at Chapel Hill September 2008 - March 2013
University of North Carolina September 2008 - June 2010
Temple University School of Medicine August 2002 - August 2008
Centers for Disease Control and Prevention August 2001 - June 2002
Skills
Molecular Biology, Regulatory Affairs, Medical Writing, Immunology, Clinical Trials, Infectious Diseases, Oncology, Clinical Development, Clinical Research, GCP, Biochemistry, Drug Development, In Vitro, Microbiology, Sop, Medical Devices, Clinical Study Design, Therapeutic Areas, Protocol, Lifesciences, Assay Development, Biotechnology, Diabetes, In Vivo, Cancer, Cell Culture, Life Sciences
Education
Temple University School of Medicine 2002 — 2008
Ph.D., Microbiology and Immunology
Kennesaw State University 1997 — 2001
B.S., Biology
Rohto-Mentholatum Research Labs May 2014 - Present
PPD January 2013 - May 2014
Intertek May 2011 - December 2012
Skills
HPLC, GC-FID, Dissolution, Karl Fisher, Wet Chemistry, Analytical Chemistry, Analytical Instruments, GC-MS, Organic Synthesis, Analytical Method..., Analytical Methods..., Method Transfer, Organic Chemistry, UV/Vis, Chemistry, NMR
Education
Lehigh University 2009 — 2011
Master's degree, Chemistry
King's College 2006 — 2009
Bachelor of Science (B.S.), Chemistry
PPD April 2014 - Present
PPD August 2012 - March 2014
University of Virginia November 2008 - August 2012
The Pennsylvania State University College of Medicine August 2003 - November 2008
Fisher Diagnostics September 2002 - May 2003
Bechtel May 2002 - September 2002
James Madison University January 2002 - May 2002
Lyotropic Therapeutics, Inc. May 2001 - August 2001
Skills
Immunology, In Vivo, Data Analysis, Research, Molecular Biology, Cell Culture, Flow Cytometry, Microscopy, Biotechnology, Cell Based Assays, Confocal Microscopy, Immunohistochemistry, Tissue Culture, In Vitro, Immunofluorescence, Fluorescence Microscopy, Transfection, Microbiology, Cell Therapy, Viruses, Monoclonal Antibodies, Animal Handling, PCR, Animal Husbandry, Proliferation, ELISA, Cell Biology, Cell, Laboratory
Education
Pennsylvania State University College of Medicine 2004 — 2008
Ph.D, Immunology and Infectious Diseases
James Madison University 1998 — 2002
B.S., Integrated Science and Technology
PPD September 2014 - Present
PPD November 2013 - September 2014
JMU Net Impact August 2011 - May 2012
James Madison University September 2011 - December 2011
Ruby Tuesday May 2008 - December 2010
Virginia Department of Education June 2010 - July 2010
Skills
Mass Spectrometry, Reagents, Pipetting, Laboratory Safety, Laboratory Equipment, Technical Writing, Science Literacy, Spanish, Public Speaking, Microsoft Word, PCR, PowerPoint, Customer Service, Travel, Spanish translation, write Spanish, Russian, Brazilian Portuguese, French, Excel, Word, Bass, Singing, Acoustic Guitar, Piano
Education
James Madison University 2007 — 2012
James Madison University
B.S, Integrated Science and Technology; Applied Sciences
Medical University of South Carolina July 2015 - Present
PPD August 2012 - October 2014
Absorption Systems, LP October 2009 - October 2012
Skills
Cell Culture, Data Analysis, Cell Based Assays, ADME, Bacterial Culture, Laboratory Automation, Cell, Vaccines, SOP, Pharmaceutical Industry, GLP, Assay Development
Education
Kent State University 2004 — 2006
B.S, Biology
PPD April 2015 - Present
PPD March 2013 - Present
PPD July 2005 - March 2013
Skills
Clinical Monitoring, CRO, CTMS, Clinical Trials, ICH-GCP, EDC, Therapeutic Areas, Clinical Data Management, GCP, Clinical Development, Trial Management, Clinical Operations, Regulatory Submissions, IRB, Therapeutic Area, Oracle Clinical, CRF design, Inform, Budget, Forecasting, Team Management
Education
James Madison University 2001 — 2005
Bachelor of Science (B.S.), Integrated Science and Technology
PPD June 2013 - Present
PAREXEL May 2012 - May 2013
PAREXEL July 2009 - May 2012
PAREXEL International December 2006 - June 2009
clinivation, Inc. June 2005 - November 2006
Biocatalytics, Inc. August 2004 - May 2005
Beckman Coulter, Inc. May 2004 - July 2004
Skills
Clinical Research, Project Management, Clinical Trials, Biotechnology, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, CRO, Lifesciences, Sop, Clinical Study Design, ICH-GCP, Clinical Monitoring, CTMS, Data Management, Therapeutic Areas, GCP, Commercialization, Infectious Diseases, Protocol, Clinical Operations, Clinical Data Management, Cancer, Vaccines, EDC, Dermatology, GMP, Drug Discovery, Validation, Diabetes, Cross-functional Team..., Endocrinology, Drug Development, 21 CFR Part 11, SOP
Education
Keck Graduate Institute 2003 — 2005
Masters of Biological Sciences, Healthcare Management, Clinical & Regulatory Affairs
National Institute of Technology Karnataka 1999 — 2003
Bachelor of Engineering (B.E.), Chemical Engineering
kaleo January 2015 - Present
kaléo June 2010 - December 2014
PPD December 2009 - June 2010
Skills
Microsoft Office, Microsoft Excel, Sop, Pharmaceutical Industry, FDA, Quality Assurance, PowerPoint, Document Control, Project Management, CRO
Education
University of Virginia 2012 — 2013
Graduate Certificate in Project Management
James Madison University 2005 — 2009
BS, Integrated Science and Technology (Biotechnology)
Stiefel, a GSK company June 2009 - Present
Stiefel, a GSK company November 2007 - May 2009
PPD March 2005 - November 2007
Pfizer Pharmaceuticals December 2003 - March 2005
Skills
Oncology, Dermatology, Cardiology, Endocrinology, Central Nervous System, Team Leadership, Training, Teaching, Vendor Management, Media Analysis, GI, Medical Writing, Clinical Trials, Protocol, Clinical Development, Clinical Study Design, GCP, Regulatory Submissions, Clinical Research, Sop, CRO
Education
James Madison University
MS, Biology
James Madison University
BS, Biology
JW Robinson
PRA International March 2011 - Present
ICON Clinical Research January 2007 - February 2011
ICON Clinical Research November 2004 - March 2009
PPD 1999 - 2004
Trial Masters 1997 - 1999
XII Policlinic Krakow September 1994 - October 1995
Skills
Clinical Research, CRO, Clinical Monitoring, Infectious Diseases, Clinical Management, ICH-GCP, Diabetes, Oncology, Regulatory Requirements, Rheumatoid Arthritis, IRB, Immunology, Cardiology, Site Selection, Clinical Development, Phase I, Clinical Trials, GCP, Pharmaceuticals, Line Management, Cross-functional Team..., Clinical Trial..., EDC, Regulatory Submissions, Rheumatology, Inform, Nephrology, Protocol Development, Dermatology, Endocrinology, Psychiatry, Urology, Clinical Pharmacology, Hypertension, Pediatrics, Ophthalmology, Breast Cancer, FDA, Asthma, CTMS, Pharmaceutical Industry, Management, Therapeutic Areas, Pharmacovigilance, Patient Recruitment, Vaccines, Clinical Data Management, Hematology, Drug Development, Medical Writing
Education
Uniwersytet Jagielloński w Krakowie 1989 — 1994
MD, Medical
ACRP 2003 — 2003
Certified CRA, (ICH GCP, Site Management)
Chiltern June 2015 - Present
inVentiv Health Clinical August 2014 - May 2015
PRA International November 2010 - August 2014
LWB 2011 - 2012
Cmed August 2009 - November 2010
PharmaLinkFHI October 2007 - August 2009
PPD 2004 - 2007
PPD 2002 - 2004
PPD 2001 - 2002
PPD 2000 - 2001
Skills
CRM, Business Development, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, Clinical Trials, Cross-functional Team..., Drug Development, EDC, GCP, ICH-GCP, Management, Oncology, Process Improvement, Product Development, Program Management, Project Management, Proposal Writing, Regulatory Submissions, Training, Therapeutic Areas, Sop, Budgets
Education
James Madison University 1988 — 1992
BS, Medical Technology
James Madison University 1988 — 1992
PPD April 2015 - Present
PPD July 2005 - April 2015
PPD January 2004 - July 2005
PPD July 2003 - January 2004
Skills
Regulatory Submissions, eCTD, Pharmaceutical Industry, Regulatory Affairs, IND, Clinical Trials, FDA, CRO, ICH-GCP, Drug Development, CTMS, Pharmacovigilance, GCP, 21 CFR Part 11, Clinical Development, Sop, Clinical Data Management, Medical Writing, Extedo eCTD manager, Insight Publisher..., Adobe Acrobat, ISI Tool Box, Open Text Livelink, SOP
Education
James Madison University 1998 — 2001
BS, Integrated Science and Technology - Biotechnology
PPD November 2014 - Present
Brown Mackie College January 2014 - Present
PPD June 2009 - December 2014
Cleveland Clinic July 1997 - June 2009
Helena Laboratories February 2007 - August 2008
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking, HTML, Strategic Planning, Budgets
Education
Kent State University 1993 — 1997
Bachelor of Science (BS), Medical Technology/ Chemistry
PPD February 2001 - Present
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Research, Oncology, CRO, Clinical Development, GCP, SOP, CTMS, ICH-GCP
Education
Kalamazoo Valley Community College
Associate's degree -RN, Registered Nursing/Registered Nurse
Apex Systems March 2015 - Present
PPD June 2014 - January 2015
Image Designers INC. July 2012 - June 2014
Mackenzie Grace June 2013 - January 2014
Mark Obenshain Campaign September 2013 - November 2013
SouthernCare, Inc. November 2011 - May 2013
Image Designers Inc. April 2006 - June 2012
Skills
Pharmacy Technicians, Medical Terminology, Customer Service, Prezi, Social Media, Human Anatomy, Healthcare, Microsoft Word, Microsoft Excel, Public Speaking, Microsoft Office, Sales, Social Media Marketing, PowerPoint, Teamwork, Social Networking, Time Management, Event Planning, Research, Leadership, Facebook
Education
James Madison University 2010 — 2014
Bachelor of Science (B.S.), Health Services/Allied Health/Health Sciences, General
John Randolph Tucker High School 2006 — 2010
High school
PPD June 2015 - Present
PetEx Rescue 'n Transport April 2011 - Present
UBC - An Express Scripts Company March 2015 - June 2015
UBC - An Express Scripts Company December 2013 - March 2015
Quintiles October 2008 - December 2013
Adecco Staffing, USA December 2007 - October 2008
Quintiles November 2004 - November 2005
Skills
EDC, Oracle Clinical, Clinical Data Management, CRO, CRF design, GCP, ICH-GCP, Clinical Trials, CTMS, Clinical Development, Data Management, CDISC, Pharmaceutical Industry, 21 CFR Part 11, Oncology, Pharmacovigilance, SAS, Validation, Protocol, FDA, Sop, Clinical Research, Computer System..., Software Documentation, Regulatory Affairs, Regulatory Submissions, Data Validation, Lifesciences, Database Design, Inform, Biotechnology, SDTM, MedDRA, Life Sciences, SOP
Education
Conseva 2001 — 2001
IT FastTrak Certificate of Completion, Oracle Database Administration
Washington High School 1984 — 1987
Johnson County Community College
Computer Science
PPD April 2015 - Present
Verizon Enterprise Solutions May 2013 - March 2015
Credit Suisse February 2012 - September 2012
IBM December 2011 - February 2012
HCL America June 2011 - December 2011
Lenovo January 2005 - September 2009
Skills
Technical Support, Troubleshooting, VPN, ITIL, Help Desk Support, Software Documentation, Information Technology, Active Directory, Vendor Management, Customer Service, Networking, Call Centers, Network Security, Cisco Technologies, Windows XP, Data Center, IT Service Management, IT Operations, Oracle Database, Oracle SQL Developer, Access, Database Queries
Education
Strayer University 2015 — 2017
Master of Business Administration (MBA), Project Management
Johnson C. Smith University - JCSU 2000 — 2004
Bachelor of Science (B.S.), Computer Science Information System
PPD July 2015 - Present
National Institutes of Health August 2014 - July 2015
James Madison University January 2014 - June 2014
James Madison University January 2014 - May 2014
Rasmus Asset Advisors August 2011 - January 2014
James Madison University 2009 - 2013
Skills
Molecular Biology, PCR, Biotechnology, DNA Extraction, PBMC isolation, Gene Cloning, Flow Cytometry, Immunophenotyping, Cell Culture, ELISA, Immunofluorescence, Genome Annotation, Immunocytochemistry, PCR Primer Design, Plasmid Design, Protein Purification, Bioinformatics, RNA Isolation, Gene Knock Out, Genotyping, Western Blotting, Gene Overexpression, Microbiology
Education
James Madison University 2009 — 2013
Bachelor of Applied Science (BASc), Biotechnology, 3.375
Bishop Ireton
PPDI, Inc December 2009 - Present
Lowe's Companies, Inc. October 2014 - January 2015
Consultant January 2009 - March 2010
Triumph Consultancy Services November 2006 - December 2008
Hoffmann-La Roche 2006 - 2008
PPD February 2002 - November 2006
Bassett Furniture Industries 1998 - 2000
Skills
SDLC, Business Analysis, Business Process, Siebel, Visio, Integration, CTMS, Requirements Analysis, Requirements Gathering, Business Intelligence, Regression Testing, 21 CFR Part 11, Agile Methodologies, Software Documentation, SharePoint, XML, Web Services, Testing, CRO, Data Management, Pharmaceutical Industry, Microsoft Project, Business Process..., Data Warehousing, Business Requirements, SOA, Business Process Design, System Testing, Functional Analysis, Functional Requirements, MS Project, Clinical Trials, Quality Center, ODS, Data Integration, Functional Design, UML, Use Case Diagrams, Process Modeling, Regulatory Requirements, Mobile Design, Systems Analysis, Business Strategy, HP Quality Center
Education
Kaplan University 2012 — 2014
Bachelor of Science (B.S.), Information Technology
inVentiv Health Clinical (PharmaNet / i3) April 2009 - Present
PPD June 1999 - January 2005
Pharmacia & Upjohn December 1998 - May 1999
Quintiles (Biodesign / Clinical Research Foundation / Innovex) March 1989 - November 1998
Skills
Clinical Trials, Regulatory Affairs, CRO, Clinical Monitoring, GCP, Clinical Development, Pharmaceutical Industry, Analysis, Cross-functional Team..., Creative Solutions, Quality Improvement, Process Improvement, Contingency Planning, Open Mind, Supporting Others, CTMS, Oncology, EDC, Regulatory Submissions, Therapeutic Areas, Drug Development, Clinical Research, Protocol, Quality Assurance, IRB, Pharmacovigilance, Infectious Diseases, Clinical Data Management, Oracle Clinical, FDA, Medical Writing, Vaccines, CRF design, Clinical Study Design
Education
Justus-Liebig-Universität Giessen
BS, Medical Documentation
PPD June 2013 - Present
PPD September 2005 - June 2013
Skills
Clinical Monitoring, CRO, ICH-GCP, EDC, CTMS, Therapeutic Areas, GCP, Clinical Trials, Clinical Development, Oncology, Regulatory Submissions, Pharmaceutical Industry, Clinical Data Management, Infectious Diseases, Clinical Research
Education
James Sprunt Community College
RN, Registered Nursing/Registered Nurse
University of North Carolina at Wilmington
Nursing, Pre-Nursing Studies
PPD January 2011 - January 2014
Skills
SOP, GLP, Confidential Documents, Technical Documentation, HIPAA, Laboratory Skills, Laboratory Safety, ELISA, Pipetting, Reagents, Infectious Diseases, Disease Control, Vaccines, Global Health, Public Health Emergency..., Microsoft Office, ArcGIS, SAS
Education
Johns Hopkins Bloomberg School of Public Health 2014 — 2015
Master of Public Health (MPH), Infectious Diseases, 3.51 GPA
James Madison University 2007 — 2010
Bachelor of Science (BSc), Biology, General
PPD May 2014 - Present
Winegardner & Hammons (Cleveland Marriott East) March 2013 - May 2014
John Carroll University (University Advancement/Office of Alumni Relations) September 2011 - May 2014
Good Karma Broadcasting (ESPN Cleveland) January 2013 - May 2013
Allegheny College - Alumni Affairs May 2012 - August 2012
Skills
Event Planning, Teamwork, Community Outreach, Detailed Organization, Marketing, Time Management, Leadership, Clinical Trials, CRO, Organization, Editing, Social Media Marketing
Education
John Carroll University 2010 — 2014
Marketing
UST Mfg LLC March 2015 - Present
University of Phoenix July 2009 - Present
Oso BioPharmaceuticals Manufacturing, LLC March 2014 - September 2014
Hospira June 2012 - October 2013
Scientific Protein Labortories LLC 2008 - 2012
Covance 2007 - 2007
Thermo Fisher Scientific 2003 - 2007
PSI Pharma Support Intl October 2002 - March 2003
PPD January 2001 - April 2001
Baxter Healthcare August 1999 - January 2001
Skills
GMP, Quality Assurance, Chemistry, cGMP, R&D, Pharmaceuticals, Strategic Planning, Quality Systems, Change Management, Problem Solving, Budgeting, Mentoring, Customer Relations, Organizational..., Lean Manufacturing, Coaching, Analysis, Team Building, Teaching, Continuous Improvement, Microsoft Office, Supervisory Skills, Analytical Chemistry, Validation, Compliance, Auditing, Biotechnology, Pharmaceutical Industry, Quality System, HPLC, Chromatography, FDA, GLP, Technology Transfer, V&V, Sop, CAPA, 21 CFR Part 11, Biopharmaceuticals, SOP
Education
Keller Graduate School of Management of DeVry University 2002 — 2004
MBA, Business Administration and Management, General
University of Kentucky 1982 — 1989
PhD, Analytical Chemistry
University of Mumbai 1980 — 1982
M.Sc, Inorganic Chemistry
PPD October 2014 - Present
Covance March 2012 - October 2014
PRA International November 2011 - March 2012
PRA International June 2010 - November 2011
PRA International August 2006 - June 2010
PRA International August 2006 - June 2010
Skills
CTMS, ICH-GCP, FDA, Clinical Trial..., GCP, Clinical Trials, Clinical, Regulatory Requirements, Clinical Research, CRO, Clinical Development, Sop, Clinical Data Management, Clinical Operations, Regulatory Submissions, Therapeutic Areas
Education
James Madison University 2000 — 2004
Bachelor of Science, Kinesiology
Boatman Research Consulting, LLC 2005 - Present
Roche Pharmaceuticals August 2009 - 2013
PPD 2003 - March 2006
Skills
CTMS, Clinical Monitoring, EDC, ICH-GCP, Clinical Research..., GCP, CRO
Education
Jewish Hospital College of Nursing and Allied Health 1978 — 1981
RN
PPD October 2008 - Present
IKON Office Solutions October 2006 - April 2008
Alliance Abroad Group 2004 - 2006
Skills
Strategic Planning, Project Management, Management, Program Management, Recruiting, Customer Service, Event Planning, Training
Education
The University of Texas at Austin 2001 — 2004
Bachelor of Arts, Government
Kansas State University
Kansas City University July 2014 - Present
Epic January 2014 - May 2014
PPD July 2013 - December 2013
University of Wisconsin-Madison August 2011 - June 2013
University of Wisconsin-Madison September 2012 - May 2013
Forest Laboratories August 2010 - May 2011
University of Chicago Hospitals October 2008 - June 2010
The University of Chicago September 2006 - June 2010
University of Chicago, Department of Ecology & Evolution October 2008 - March 2009
Neighborhood Schools Program June 2008 - August 2008
Skills
Fluorescence Microscopy, Pharmaceutics, Laboratory, Teaching, CNS Drug Delivery, In Vivo, Biotechnology, Drug Delivery, Research
Education
University of Chicago 2006 — 2010
A.B. Honors, Biological Sciences, South Asian Languages & Civilizations
University of Wisconsin-Madison 2011 — 2013
M.S., Pharmaceutical Sciences: Drug Delivery
Kansas City University 2014 — 2018
D.O., Medicine
PPD July 2015 - Present
Kean University September 2010 - December 2014
UPS May 2013 - December 2013
Admit One June 2012 - August 2012
Skills
Java, SQL, PHP, HTML, Oracle SQL, Database Design, Oracle, CSS, MySQL, Android, JavaScript, C++, Objective-C, Linux
Education
Kean University 2010 — 2014
Bachelor’s Degree, Computer Science
Sunovion Pharmaceuticals Inc. August 2008 - Present
MannKind Corporation 2007 - 2008
Bristol-Myers Squibb October 2002 - April 2007
Hoffmann-La Roche July 2000 - May 2002
Forest Laboratories 2002 - 2002
PPD July 1998 - July 2000
Skills
Clinical Data Management
Education
Kean University 1992 — 1997
BS, Biology
PPD January 2013 - Present
Infosys November 2011 - January 2013
Infosys January 2008 - November 2011
Infosys August 2003 - November 2011
Bank of America 2007 - 2009
Palm, Inc May 2007 - December 2007
Schlumberger August 2006 - May 2007
British Telecom August 2005 - August 2006
DHLIndia November 2003 - August 2005
KVG InfoTech Ltd January 2003 - November 2003
Skills
Integration, PL/SQL, Web Services, Requirements Gathering, Oracle, Unix, .NET, EAI, Databases, JavaScript, User Acceptance Testing
Education
Jawaharlal Nehru Technological University 1999 — 2003
Bachelor of Technology (B.Tech.), Computer Science
Aprsg 1990 — 1995
Vignana Sudha
PPD August 2012 — Present
Johnson & Johnson April 2005 — August 2012
Kean University 2002 — 2008
Elusys Therapeutics, Inc. 2004 — 2005
Genta July 2002 — August 2004
Hoffmann-La Roche October 1996 — July 2002
Interferon Sciences October 1991 — October 1996
Skills
Management, Immunology, Genetics, Clinical Trials, Laboratory, Microsoft Office, Drug Development, ELISA, Regulatory Affairs, Project Management, Drug Discovery, Pharmaceutics, Quality Control, Chromatography, CAPA, Assay Development, Biochemistry, Protein Chemistry, Research, Cell, LIMS, Microbiology, Purification, Cell Culture, 21 CFR Part 11, CRO, GCP, V&V, LC-MS, Protein Purification, Change Control, Chemistry, Formulation, Regulatory Submissions, Oncology, Molecular Biology, CTMS, PCR, Regulatory Requirements, GxP, In Vitro, Immunoassays, Medical Devices, Monoclonal Antibodies, Quality System, Cell Biology, Biomarkers
Education
Kean University ... — 2002
Master of Science (MS), Biotechnology
Chiltern August 2015 - Present
PPD January 2014 - August 2015
PPD October 2010 - December 2013
PPD January 2008 - October 2010
PPD January 2007 - January 2008
PPD November 2005 - January 2007
Skills
CRO, CTMS, Clinical Trials, Clinical Research, GCP, Pharmaceutical Industry, Sop, Microsoft Excel, ICH-GCP, EDC, Protocol, Clinical Monitoring, Clinical Development, Software Documentation, Quality Assurance, Clinical Data Management, FDA, Oncology, SOP
Education
Kaplan University 2008 — 2010
MBA, Business
University of North Carolina at Wilmington 2001 — 2005
BA, Elementary Education K-6
PPD April 2013 - Present
PPD March 2010 - April 2013
PPD October 2004 - March 2010
Skills
21 CFR Part 11, GLP, Computer System..., Sop, LC-MS, Pharmaceutical Industry, SOP, FDA, Chromatography, LIMS
Education
James Madison University 1989 — 1993
BS, Biology (Major), Psychology (Minor)
PPD July 2007 - Present
PPD April 2002 - July 2007
PPD January 2000 - April 2002
New Hanover Regional Medical Center March 1991 - January 1999
Raleigh Community Hospital 1988 - 1991
Pitt Community Regional Hospital 1982 - 1988
Mercy Hospital of Watertown, NY 1981 - 1982
Skills
PowerPoint, Excel, Pharmacovigilance, Word, Clinical Trials, Nursing, Oncology, Therapeutic areas, Microsoft Word, Therapeutic Areas, Diabetes, Microsoft Excel, Hematology, EDC, Immunology, ICH-GCP, Sop, CTMS, Clinical Development, Clinical Monitoring, CRO
Education
St Regis University 2000 — 2003
PhD, Health Care Management
University of North Carolina at Wilmington 2000 — 2003
MA, Liberal Studies
Mount Olive University 1998 — 2000
BS, Business
Pitt Community College 1985 — 1988
Business and Comuputer Courses
Jefferson Community College 1978 — 1981
AAS, Registered Nurse
Gilead Sciences September 2012 - Present
Biogen Idec January 2011 - August 2012
Biogen Idec October 2009 - April 2011
PPD December 2007 - October 2009
Amgen June 2006 - December 2007
MedImmune 2004 - 2006
Johnson & Johnson CPPC 2002 - 2003
Skills
Oncology, Clinical Development, Clinical Trials, CTMS, Clinical Operations, GCP, CRO, Pharmaceutical Industry, Clinical Research, Biotechnology, FDA, EDC, Sop, 21 CFR Part 11, GxP, Drug Development, Lifesciences, Regulatory Submissions, Life Sciences
Education
Northeastern University 1992 — 1995
bsn, nursing
National University of Health Sciences 1979 — 1983
DC, Chiropractic
Kean University 1976 — 1979
BA, Biology
PPD June 2012 - Present
INC Research May 2010 - April 2012
Cetero - formerly DGD Research January 2009 - July 2009
AAIPharma February 2008 - October 2008
Summit Medical Research, LLC April 2007 - February 2008
PAREXEL International March 2005 - April 2007
MedImmune Inc. January 2004 - August 2004
Wyeth 2001 - 2003
ClinTrials Research 1996 - 1997
Skills
CRO, Clinical Trials, EDC, CTMS, Clinical Data Management, Protocol, Regulatory Affairs, Clinical Development, Clinical Research, Oncology, Therapeutic Areas, Diabetes, Sop, Biotechnology, FDA, GCP, Clinical Monitoring, Medical Affairs, Immunology, Infectious Diseases, Regulatory Submissions, Endocrinology, ICH-GCP, Drug Safety, Drug Development, Patient Recruitment, 21 CFR Part 11, Pharmacovigilance, Clinical Operations, Ophthalmology, Medical Writing, Lifesciences, Pharmaceutical Industry
Education
James Madison University 1981 — 1985
Bachelor of Science, Biology
Premier Research October 2013 - Present
PRA International June 2011 - October 2013
Social & Scientific Systems December 2008 - June 2011
PPD June 2004 - November 2008
Charles River/Inveresk/PharmaResearch September 1997 - March 2004
Skills
GCP, Clinical Monitoring, Clinical Trials, Project Management, CTMS, Clinical Development, Infectious Diseases, Clinical Data Management, Protocol, Clinical Operations, ICH-GCP, CRO, Clinical Research, Regulatory Affairs, FDA, Pharmaceutical Industry, Therapeutic Areas, Oncology, EDC, Vaccines, Regulatory Submissions, Pharmacovigilance, Oracle Clinical, Clinical Study Design, Inform, Drug Development, Medical Writing, Sop, IND, Phase I
Education
Jacksonville State University 1986 — 1989
BSN, Nursing
PPD April 2015 - Present
PPD July 2006 - March 2015
Merck & Co. July 2005 - June 2006
Merck & Co. Inc. May 1996 - June 2005
Skills
Clinical Trials, Data Management, Life Sciences, Clinical Data Management, Bilingual, EDC
Education
Kean University 2000 — 2004
BA, Biology
inVentiv Health Clinical November 2014 - Present
inVentiv Health Clinical September 2012 - November 2014
PharmaNet Development Group, Inc. August 2009 - September 2012
Centocor Orthobiotech Services LLC August 2008 - August 2009
Scala Avanti Clinical Consulting April 2008 - August 2009
Radpharm January 2008 - April 2008
Novartis February 2007 - January 2008
Novo Nordisk March 2004 - February 2007
PPD 2004 - 2004
ITC 1998 - 2002
Skills
Clinical Trials, ICH-GCP, Clinical Monitoring, Clinical Research, GCP, EDC, CRO, CTMS, Clinical Development, Oncology, Drug Development
Education
Kean University 1997 — 2001
B.S., Chemistry, ACS Certified
STS, Inc February 2011 - Present
Velocity Technology Solutions February 2010 - February 2011
Navisite August 2008 - February 2010
PPD 2004 - 2008
University of North Carolina Wilmington 2003 - 2004
netASPx 1998 - 2003
Skills
Business Analysis, Business Process, ERP, Finance, Integration, Leadership, MS Project, Payroll, Project Management, Requirements Analysis, SaaS, Vendor Management, Visio, Process Improvement, Software Documentation
Education
University of Delaware - Lerner College of Business and Economics 1985 — 1989
BS, Accounting Minor MIS/DSS
Keller Graduate School of Management of DeVry University
MPM, Project Management
eThos Electric Car Share, LLC January 2014 - Present
Planning Mediation, LLC March 2013 - January 2014
Tenant Resource Center August 2010 - January 2014
Capital Area Regional Planning Commission November 2008 - May 2013
SELP State Environmental Leadership Project January 2012 - December 2012
Dane County Planning and Development May 2007 - September 2007
PPD January 2006 - June 2006
Skills
Zoning, Public Participation, Land Use Planning, Urban Design, GIS, Adobe Creative Suite, Microsoft Office, Social Media, Mediation, Project Facilitation, SketchUp, ESRI
Education
Marquette University Law School 2011 — 2013
Certificate in Alternative Dispute Resoltion, ADR, Post Grad
University of Wisconsin-Madison 2006 — 2008
M.S., Urban and Regional Planning
Kent State University 1998 — 2005
Bachelor of Science (B.S.), Biology, General
PPD April 2014 - Present
PPD December 2009 - March 2014
PPD May 2006 - December 2009
PPD July 2005 - May 2006
Commonwealth Biotechnologies 2003 - 2005
Skills
GLP, Bioanalysis, CRO, Sop, Biotechnology, Validation, LIMS, Assay Development, ELISA, Immunochemistry, Pharmaceutical Industry, FDA, Clinical Trials, Immunology, Protein Chemistry, Protein Purification, Microsoft Office, Microsoft Excel, Microsoft Word, Laboratory, Life Sciences, Research, SOP, Drug Development
Education
James Madison University 1999 — 2003
B.S., Biotechnology
FibroGen, Inc. July 2014 - Present
FibroGen February 2013 - July 2014
PPD February 2012 - February 2013
Duke University July 1998 - July 2012
American Society of Nephrology 2000 - 2002
Skills
Clinical Research, Healthcare, Clinical Development, Clinical Trials, Medical Education, Oncology, Biotechnology, Diabetes, GCP, Immunology, Infectious Diseases, Internal Medicine
Education
Jefferson Medical College of Thomas Jefferson University 1987 — 1991
Doctor of Medicine (MD)
Penn State University
Bachelor of Science (B.S.)
PPD July 2015 - Present
The Dubin Group January 2014 - July 2015
The Dubin Group March 2012 - December 2013
Temple University June 2011 - August 2011
Kroger Pharmacy November 2009 - January 2011
Tech Bookstore May 2007 - January 2009
Promotores de Salud, Institute for Innovation in Health and Human Services August 2008 - December 2008
Skills
Training & Development, MS Office Suite, Quickbooks, Conflict Transformation, Organizational..., Payroll, Administrative Support, Client Billing, Reference Checking, New Hire Paperwork, New Hire Orientations, Unemployment Claims, Human Resources, Administrative..., Microsoft Office, Temporary Staffing, Deferred Compensation, Customer Service, Onboarding, Employee Relations, College Recruiting, Applicant Tracking..., Staffing Services, Interviews, Employee Training, QuickBooks, Training
Education
Temple University 2010 — 2012
Master of Education (M.Ed.), Adult and Organizational Development
James Madison University 2005 — 2009
Bachelor of Arts (B.A.), Communication, Sociology
American University Washington College of Law June 2009 - Present
PPD August 1998 - May 2008
Worden Brothers Inc April 1994 - June 1997
Education
James Madison University
B.A., Psychology / Sociology
PPD October 2014 - Present
Washington University School of Medicine November 2000 - October 2014
Washington University School of Medicine August 1997 - October 2014
Washington University School of Medicine August 1997 - November 2000
Skills
Research, Clinical Trials, Healthcare, Public Health, Life Sciences, Molecular Biology, Hospitals, Medicine, Oncology
Education
Jewish Hospital College of Nursing and Allied Health
BS
PPD July 2012 - Present
Kings Dominion May 2010 - October 2012
JMU Department of Integrated Science and Technology August 2011 - May 2012
SRI International May 2011 - August 2011
JMU Dept. of Biology August 2010 - May 2011
Skills
Laboratory, Pipetting, PCR, PCR primer design, Molecular Cloning, Molecular Biology, ELISA, Research, Cell Culture, Life Sciences
Education
James Madison University 2008 — 2012
B.S, Biotechnology; Pre-Forensic Studies
Research Point Global May 2013 - Present
Aerotek 2012 - 2013
PharmaNet/i3 Strategic Resourcing/InventivHealth Clinical August 2011 - October 2012
INC Research December 2009 - August 2011
Premier Research Group Limited June 2007 - October 2009
i3 Research August 2006 - May 2007
PPD March 2004 - July 2006
SCIREX Corporation April 2001 - March 2004
Capital Dialysis of Texas August 2000 - March 2001
Geary Community Hospital December 1999 - August 2000
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, GCP, CRO, Clinical Trials, Clinical Research
Education
Washburn University 1997 — 1999
B.S, Nursing
Kansas State University 1994 — 1995
B.S, Life Science
Hutchinson Community College 1992 — 1993
A.A, General Studies
inVentiv Health Clinical May 2014 - Present
inVentiv Health Clinical September 2012 - April 2014
PPD October 2010 - September 2012
PPD October 2008 - October 2010
York Clinical Research November 2007 - September 2008
Virginia Eye Consultants May 2007 - November 2007
Virginia Eye Consultants February 2006 - May 2007
Virginia Eye Consultants May 2005 - February 2006
Harvard University May 2002 - August 2002
Harvard University May 2001 - August 2001
Skills
CRO, Clinical Research, ICH-GCP, Study Start Up, ICF Review, Regulatory Document..., ICF Negotiation, GCP, Protocol, FDA, Sop, CTMS, IRB, Therapeutic Areas, Clinical Development, Regulatory Submissions, Clinical Data Management, Clinical Trials, Study Skills, Pharmaceutical Industry
Education
James Madison University 2000 — 2004
2nd Major
James Madison University - College of Business 2000 — 2004
Bachelor of Business Administration (B.B.A.)
Woody's Sports Tavern March 2010 - Present
PPD October 2010 - December 2010
Classy Kids Cook July 2009 - July 2010
Outback Steakhouse March 2003 - July 2010
Structure House LLC May 2009 - May 2010
Daniel's Restaurant and Catering May 2006 - July 2007
Prestonwood Country Club May 2005 - July 2006
Ballantyne Country Club October 2005 - January 2006
Education
Johnson & Wales University 2005 — 2009
B.A., Culinary Arts, Culinary Nutrition
SPCA of Wake County April 2014 - Present
PPD 2003 - Present
Alliance Marketing Services 2001 - 2002
Unipath Diagnostics 1998 - 2001
Education
University of North Carolina at Chapel Hill
Master of Business Administration (MBA)
Kansas State University
Master of Science (MS)
University of Wyoming
Bachelor of Science (BS)
Gentris Corporation August 2012 - July 2013
Ockham Development Group (an ASG Company) January 2011 - May 2012
Celgene (formerly Abraxis BioScience) October 2010 - January 2011
Abraxis BioScience August 2010 - October 2010
PPD June 2006 - April 2010
Inveresk, Charles River Laboratories (merger) January 2004 - June 2006
PharmaResearch, Inveresk (merger) April 2001 - December 2003
Quintiles June 2000 - April 2001
University of North Carolina at Chapel Hill September 1997 - June 2000
Duke University September 1996 - May 1997
Skills
Clinical Data Management, Molecular Biology, EDC, Oracle Clinical, CRO, Clinical Trials, CRF design, Data Management, ICH-GCP, GCP, Oncology, Clinical Research, Clinical Development, Clinical Monitoring, Pharmaceutical Industry
Education
University of South Carolina-Columbia 1988 — 1996
Ph.D., Biology
Juniata College 1984 — 1988
B.S., Biology
PRA International December 2011 - Present
PPD March 2007 - December 2011
Corning Incorporated February 1999 - October 2001
Skills
Quality Assurance, Validation, 21 CFR Part 11, SDLC, Software Documentation, Testing, Software Quality..., Computer System..., Quality Center, User Acceptance Testing, Agile Methodologies, Pharmaceutical Industry, Process Improvement, CTMS, SQL, CRO, XML, MS Project, Software Development, Clinical Trials, Test Automation, Cross-functional Team..., Integration, Requirements Analysis, Siebel
Education
Kakatiya University 1995 — 1997
MBA
Lal Bahadur college 1992 — 1995
BS in Commerce
PPD March 2015 - Present
DuPont September 2012 - December 2014
Valley 25x25 May 2011 - August 2011
Skills
Chemistry, Data Analysis, Research, HPLC, Chromatography, Microsoft Office, Environmental Science, Cell Culture, Electrophoresis, PCR, Mass Spectrometry, Spectroscopy, JMP, Immunoblotting
Education
James Madison University 2007 — 2012
Bachelor of Science (B.S.), Biotechnology
Young Living Essential Oils July 2013 - Present
Mason Trendsetters July 2006 - July 2008
PPD October 2005 - April 2006
PPD July 2003 - August 2005
PPD January 2003 - July 2003
PPD September 2001 - July 2003
Tangram Enterprise Solutions June 2000 - July 2001
Tangram Enterprise Solutions January 1997 - June 2000
Tangram Enterprise Solutions June 1996 - January 1997
Skills
Clinical Data Management, Clinical Trials, Project Management, Requirements Analysis, Data Management, Clinical Research, Pharmaceutical Industry, Sop, Regulatory Affairs, Data Analysis, Quality Assurance, Validation, FDA, Budget Proposals, Software Development, Project Management Plan, Oracle Clinical, Information Technology, CRFs, PL/SQL, 21 CFR Part 11, Software Documentation, CRM, Training, Strategy, Management, Business Analysis, Enterprise Software, Leadership, Customer Service, Team Building, Cross-functional Team..., Program Management, Sales
Education
Keller Graduate School of Management of DeVry University 2008 — 2012
Master of Business Administration (MBA), Project Management
Radford University 1994 — 1996
Bachelor of Applied Science (B.A.Sc.), Computer Science
Patrick Henry Community College 1991 — 1993
Associate's degree, General Studies
Celgene Corporation Sr Therapeutic Radiation LiaisonGlaxoSmithKlineFebruary 2005 - March 2009
GSK 2004 - 2008
PPD January 2002 - June 2004
Education
James Madison University 1989 — 2003
BS, Biology
PPD April 2015 - Present
PPD November 2013 - Present
PPD March 2012 - November 2013
PPD May 2008 - March 2012
PPD March 2006 - May 2008
BASF Factory Karachi January 2005 - February 2005
Skills
HPLC, Analytical Chemistry, GLP, Chemistry, R&D, Science, Quality System, Chromatography, LC-MS, Sop, Biotechnology, Pharmaceutical Industry, Lifesciences, Mass Spectrometry, UV/Vis, FDA, GMP, Validation, 21 CFR Part 11, USP, UV, CAPA, Fluorescence, LIMS, Drug Development, CRO, Purification, Assay Development, Dissolution, Bioanalysis, IND, Biopharmaceuticals, Pharmacokinetics, Method Development, Analytical Method..., Regulatory Submissions, Formulation, Drug Delivery, Pharmaceutical Research, SOP
Education
University of Karachi 2003 — 2004
Master of Science (MSc), Applied Chemistry
University of Karachi 2001 — 2003
Bachelor of Science (BSc), Applied Chemistry
PPD February 2008 - Present
Education
James Madison University
Bachelor of Science (BS), Health Services/Allied Health/Health Sciences, General
Lake Braddock
Onyx Pharmaceuticals March 2015 - Present
PPD February 2008 - October 2012
PPD 2008 - 2012
aaiPharma December 2002 - December 2004
AAIPharma Services Corp. 2002 - 2004
New Hanover Regional Medical Center 1990 - 1996
Skills
CRO, CTMS, Clinical Monitoring, Clinical Trials, Clinical Research, Oncology, ICH-GCP, Pharmaceutical Industry, GCP, Clinical Development, Cardiology, Hematology, Therapeutic Areas, Pharmacovigilance, Pediatrics, EDC, Infectious Diseases, Pharmaceutical Sales, Medical Devices, Hospitals, Clinical Training, Post Approval, Medical Affairs, Oracle Clinical, Clinical Data Management, Drug Safety, Neurology, Diabetes, Regulatory Submissions, Protocol, Endocrinology
Education
Mount Olive College 1997 — 1999
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services, Graduated
James Sprunt Community College 1980 — 1982
AD Nursing, Registered Nursing/Registered Nurse, Graduated
PPD January 2015 - Present
QBE North America May 2003 - May 2008
QBE North America December 2001 - May 2003
Skills
Microsoft Certified..., ICCE Interaction Center..., IC Administrator 3.0, ICHD Interaction Center..., CIC Installation and..., VoIP Profesional, IC 4.0 Certification, WAN, Networking, Infrastructure, Hardware, Disaster Recovery, Change Management, Call Centers, Customer Service, Leadership, Software Documentation, Team Building
Education
Kansas Wesleyan University 1987 — 1989
Bachelor's degree, Computer Science
Kansas State University of Salina 1983 — 1985
Associate's degree, Computer Science
Covance August 2013 - Present
Covance June 2011 - April 2013
Covance August 2009 - June 2011
PPD June 2006 - August 2009
Skills
CRO, EDC, CTMS, ICH-GCP, Clinical Monitoring, Clinical Trials, Clinical Research, Drug Development, Pharmaceutics, Clinical Study Design, Therapeutic Areas
Education
James Madison University 1988 — 1992
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology/Technologist
PPD April 2012 - June 2014
Education
James Madison University
Bachelor of Science (BS), Biology
Lord Fairfax Community College
Associate of Arts and Sciences (AAS)
University of Nebraska–Lincoln August 2011 - Present
Tsinghua University December 2010 - June 2011
PPD October 2009 - September 2010
National Institute of Biological Sciences, Beijing February 2009 - October 2009
Skills
Organic synthesis, NMR spectroscopy, LC-MS, HPLC, UV/VIS spectroscopy, Fluorometry spectroscopy, PRC/Molecular biology..., Protein expression and..., Protein labeling
Education
University of Nebraska-Lincoln 2011 — 2016
Doctor of Philosophy (PhD), Chemistry
Jilin University 2005 — 2009
Bachelor's degree, Pharmaceutical Sciences
Veterans NW Construction January 2014 - Present
Duke Clinical Research Institute January 2006 - August 2008
PPD November 2000 - October 2003
Skills
Microsoft Office, InDesign, Photoshop, Design Documents, Notary Public, Adobe Acrobat, Social Media Marketing, Photography, Microsoft Word, Data Entry, Outlook
Education
James Cook University 2010 — 2013
Bachelor of Arts (B.A.), Creative Industries
Tidewater Community College 1995 — 1997
Associate of Arts and Sciences (A.A.S.), Design and Visual Communications, General