PAREXEL Company
Industry: Pharmaceutical company
DescriptionPAREXEL International is a global provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. Headquarters: Waltham, Massachusetts, United States CEO: Jamie Macdonald (15 Mar 2018–) Number of employees: 19,000 Founder: Josef H. von Rickenbach Founded: 1982 Subsidiaries: ClinPhone Inc, ClinPhone Ltd,
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PAREXEL Employees
PAREXEL April 2013 - Present
Orthodontia May 2012 - April 2013
YMCA of the Foothills September 2006 - May 2012
Kaiser Permanente August 2011 - December 2011
Skills
Public Health, Data Entry, Administration, Customer Service, Program Facilitation, Community Outreach, Marketing, Project Management, Research, Clinical Trials, Leadership
Education
California State University-Northridge 2006 — 2011
BS, Public Health
NW Life Care May 2007 - Present
Kannact May 2014 - January 2015
Pharmaceutical Research Associates February 2013 - January 2014
PAREXEL June 2012 - February 2013
Welch Allyn December 2003 - March 2011
OHSU July 1999 - January 2004
Skills
Clinical Trials, FDA, Medical Devices, Research, Customer Service, Microsoft Office, Regulatory Affairs, Windows, Clinical Research, Clinical Monitoring, English, GCP, Product Development, EDC, Product Launch, Capital Equipment, CTMS, ICH-GCP, CRO, 21 CFR Part 11, Healthcare, Software Documentation, Cardiology, Quality Assurance, Hospitals, Regulatory Submissions, Cpr Certified, Sop, Process Improvement, CAPA, Data Analysis, ISO 13485, Regulatory Requirements, Clinical Development, Biotechnology, Validation, Pharmaceutical Industry, Quality Auditing, Oracle Clinical, Therapeutic Areas, Access, Lifesciences, Lotus Notes, Training, Data Entry, Project Management, SharePoint
Education
Oregon Health and Science University 1996 — 1999
Bachelor of Science (BS), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
Chemeketa Community College 1992 — 1996
Associate's degree, Licensed Practical/Vocational Nurse Training
SOLUTIONS STAFFING 2013 - Present
Wells Fargo June 2012 - June 2013
PAREXEL June 2008 - November 2011
Quintiles 1998 - 2001
Skills
Sales Management, Clinical Data Management, Banking, Government Loans, Customer Service, Customer Retention, Data Analysis, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft SQL Server, PowerPoint, GCP, ICH-GCP, Adverse Event Reporting, Data Cleaning, Data Validation, Quality Control, Loan Modifications, Construction, Restaurant Management, Experience Working with..., Sports Coaching, User Acceptance Testing, Quality Auditing, Project Coordination, Research, Lotus Notes, MICROSOFT OUTLOOK, Query Writing, Clinical Trials, FDA, ServSafe, Oracle Clinical, Electronic Data Capture, Oncology Clinical..., Safety Surveillance and..., HUD Foreclosures, Investigator Brochures, Dashboard Metrics, CRF design, Edit Checks, Document Management, Clinical Protocol..., Lab, IVRS, SAE..., Teleconferencing, SAS programming, Painting, Angel Street LLC and..., Biochemistry
Education
Catawba College 1993 — 1997
Bachelor of Arts (BA), BIOLOGY/CHEMISTRY
LEXINGTON SENIOR HIGH SCHOOL 1989 — 1993
GED, HIGH SCHOOL EDUCATION
10-4 Systems February 2015 - Present
LifePics Inc September 2014 - February 2015
NTN Buzztime May 2014 - September 2014
NTN Buzztime January 2012 - September 2014
Oakstone Services, LLC October 2010 - January 2014
PAREXEL June 2006 - April 2012
GameStop October 2003 - February 2006
Skills
Testing, Quality Assurance, Agile Methodologies, Software Quality..., SDLC, Test Automation, Manual Testing, .NET, Microsoft SQL Server, Software Documentation, Team Leadership, Business Analysis, Waterfall, Information Technology..., Software Project..., Entrepreneurship, Business Strategy, Business Process..., Product Management, Tablets, Game Development, Mobile Technology, Mobile Applications, Vendor Management, Computer Hardware, Scrum
Education
California State University-Long Beach - College of Business Administration 2003 — 2006
B.S, Management Information Systems
Saddleback College 2001 — 2003
Associate of Arts (A.A.), Business
PAREXEL June 2013 - Present
Olivet International April 2012 - 2013
NYPD Pizza Dellcatessan November 2010 - October 2011
SweeT's: Funnel Cakes and Fried Delights November 2009 - March 2011
Skills
Microsoft Office, Customer Service
Education
California State University-Los Angeles 2011 — 2013
Master of Science (M.S.), Criminalistics
University of California, Riverside 2006 — 2011
Bachelor of Science (B.S.), Biochemistry with an emphasis in Chemistry
Longwood Management Corporation January 2011 - Present
PAREXEL January 2010 - January 2011
Royal Health Homecare Agency, Inc January 2006 - January 2010
Soliant Health, Inc. September 2005 - January 2006
Burbank Audio Video Service, CA January 2001 - August 2004
Wells Fargo Bank August 1999 - February 2001
Skills
Customer Service, Management, Marketing, Microsoft Excel, Microsoft Office, Public Speaking, Recruiting, Sales, Sales Operations, Account Management, Leadership, Marketing Strategy, Microsoft Word, Negotiation, Strategic Planning, Team Building
Education
Concorde Career College 2009 — 2010
Licensed Vocational Nurse, Nursing
California State University-Northridge 1999 — 2007
BA, Biology
INC Research September 2013 - Present
INC Research June 2013 - September 2013
INC Research December 2012 - June 2013
PRA International December 2011 - December 2012
PAREXEL June 2010 - December 2011
MedFocus February 2010 - June 2010
Greene Resources February 2009 - July 2009
Cato Research August 2008 - December 2008
Kelly Services March 2008 - July 2008
PharmaLinkFHI September 2007 - December 2007
Skills
Data Management, Clinical Research, Clinical Data Management, CRO, ICH-GCP, EDC, Oncology, Pharmaceutical Industry, GCP, Clinical Development, Biotechnology, FDA, 21 CFR Part 11, Data Analysis, SAE Reconciliation, Local Lab Reconciliation, Central Lab..., Data Management Plan, Quality Control Plan, Paper Study, Vendor Reconciliation, Query Resolution, Data Review, Case Report Forms, Listings, Hands-on Training, training, project specific..., Protocol, Data Entry, Electronic Filing, Documentation, Testing, User Acceptance Testing, screen testing, Edit Check Specification, Edit Check Testing, InForm, DataLabs, Software Documentation, Inform, CRF design, Oracle Clinical
Education
Campbell University 2005 — 2007
BS in Clinical Research, Clinical Research
Fayetteville Technical Community College 2003 — 2005
General Associate in Arts, Liberal Arts and Sciences, General Studies and Humanities
PAREXEL June 2015 - Present
ProEd Communications May 2008 - May 2015
Case Western Reserve University School of Medicine November 2007 - May 2008
Skills
Scientific..., Publication Planning, Medical Communications, Scientific Writing, Oncology, Strategy, Pharmacology, Medical Writing, Neuroscience, Clinical Trials, Biotechnology, Medical Education, Therapeutic Areas, Immunology, Life Sciences, Molecular Biology, Infectious Diseases, Clinical Development, Cell Culture, Clinical Research, Biochemistry
Education
Case Western Reserve University School of Medicine 2001 — 2007
PhD, Pharmacology
Case Western University College of Arts and Sciences 1997 — 2001
Bachelor of Arts, Biology and Psychology
SynteractHCR August 2015 - Present
PAREXEL January 2015 - August 2015
UC San Diego Health System September 2011 - January 2015
UC San Diego Health System August 2009 - February 2012
Meritage Pharma, Inc. July 2008 - April 2009
Affiliated Research Institute March 2003 - July 2008
Henry Jackson Foundation March 2002 - March 2003
Henry Jackson Foundation September 1999 - March 2002
AIDS Prevention Studies, University of California, San Francisco March 1999 - September 2001
Skills
Data Analysis, FDA, Clinical Development, Biotechnology, Clinical Trials, GCP, Clinical Research, EDC, CRO, Protocol, Pharmaceutical Industry, ICH-GCP
Education
California State University-San Bernardino
Bachelors of Arts, Psychology
California State University-San Bernardino
Masters of Arts, in General/Experimental Psychology
PAREXEL December 2014 - Present
PAREXEL January 2013 - December 2014
F1F9 October 2013 - July 2014
PAREXEL June 2011 - January 2013
Liberty International Underwriters March 2011 - May 2011
Timberland October 2010 - March 2011
Intergen October 2008 - October 2010
InterGen January 2008 - September 2008
StockerYale May 2007 - December 2007
Windmill International, Inc. November 2004 - May 2007
Skills
Excel, TM1, Essbase, Database Administration, Database Development, Financial Analysis, Financial Reporting, Financial Modeling, Business Intelligence, Forecasting, Budgeting, Business Planning, DCF, Allocations, FX, Finance, Management, Budgets, Leadership, Program Management, CRM, Business Development
Education
Carnegie Mellon University - Tepper School of Business 2001 — 2003
MBA, Finance, Organizational Behavior
Cornell University 1995 — 1996
MEng, Civil Engineering
Princeton University 1991 — 1995
BSE, Civil Engineering & Operations Research
E. L. Crossley 1987 — 1991
O.S.S.D.
PRA Health Sciences September 2014 - Present
PAREXEL October 2011 - August 2014
Richard Wern Lawyers July 2010 - June 2011
Kahn Law Firm, LLP August 2009 - December 2009
U.S. District Court for the District of South Carolina May 2009 - August 2009
Skills
CRO, Contract Negotiation, Clinical Trials, Training, Clinical Research, Contract Management, Pharmaceutical Industry, Management Contracts, Contract Managers, Civil Litigation, Litigation, Mediation, GCP, Leadership, Legal Writing, Management, Negotiation
Education
Charleston School of Law 2006 — 2009
Doctor of Law (JD), Cum Laude
Wofford College 2002 — 2006
Bachelor of Arts (B.A.), English and Sociology, Magna Cum Laude
PAREXEL September 2014 - Present
Covance July 2012 - September 2014
Covance January 2010 - July 2012
Covance September 2008 - December 2010
Walgreens 2005 - 2008
Skills
Pharmaceutical Industry, Qvidian, Pharmacokinetics, Microsoft Word, Microsoft Excel, Chemistry, CRO, Salesforce.com, Analytical Chemistry, GCP, Oncology
Education
Cardinal Stritch University 2011 — 2014
Master of Business Administration (M.B.A.), Health/Health Care Administration/Management
University of Wisconsin-Eau Claire 2004 — 2008
Bachelor of Science (BS), Chemistry with a business emphasis
PAREXEL September 2014 - Present
Team Beachbody September 2012 - Present
Quintiles November 2012 - August 2014
Quintiles September 2011 - October 2012
Quintiles July 2009 - September 2011
CTMG Inc. January 2008 - July 2009
Skills
CRO, Clinical Trials, Clinical Research, GCP, ICH-GCP, Clinical Development, Clinical Monitoring, CTMS
Education
Campbell University 2004 — 2008
Bachelor of Science (BS), Clinical Research
ICON plc September 2014 - Present
PAREXEL July 2010 - 2014
PAREXEL July 2008 - July 2010
Quintiles 2007 - 2008
Skills
Highly detail oriented, Organization, Timely Decision Making, Flexibility, Customer Satisfaction, Proficient Typing Skills, Microsoft Office, Multi Tasking, Dependable Team Player, Clinical Operations, Clinical Monitoring, Protocol Analysis, Team Leadership, Experienced Trainer, Type 2 Diabetes, Site Identification, CTMS, Highly motivated..., Clinical Research, Clinical Trials, CRO, Pharmaceutical Industry, Clinical Data Management, GCP, Global Cross-Functional..., International Relations, Patient Recruitment, SOP development, Feasibility Studies
Education
Campbell University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
Central Carolina Community College 2003 — 2003
Certified Nursing Assistant
Westside Aesthetics January 2014 - Present
PAREXEL January 2013 - August 2013
Medicus Research August 2012 - January 2013
Skills
Clinical Research, Clinical Trials, GCP, ICH-GCP, Clinical Monitoring, CTMS, Lifesciences, Medicine, Public Health, CRO, Immunology, Molecular Biology, Neuroscience, EDC, Healthcare, Epidemiology
Education
Glendale Community College 2010 — 2011
California State University-Northridge 2008 — 2009
Bachelor of Arts, Psychology
Naurex INC August 2013 - Present
PAREXEL October 2007 - July 2013
Medifacts International (Global Research Services) September 2003 - October 2007
Various CRO/Pharma companies August 1998 - October 2007
Skills
GCP, Clinical Trials, CTMS, Oncology, Cardiology, Pharmaceutical Industry, FDA, Clinical Research, Infectious Diseases, Protocol, Medical Devices, Clinical Operations, Clinical Study Design, Pediatrics, Data Management
Education
Castleton State College
RN Associate Degree, Registered Nursing/Registered Nurse
Castleton State College
Registered Nurse
PAREXEL July 2015 - Present
AllOne Health Resources September 2012 - July 2015
AllOne Health Resources August 2008 - September 2012
RimPro Inc May 2004 - August 2008
Skills
Healthcare, Clinical Research, Healthcare Management, Hospitals, Process Improvement, Customer Service, Strategic Planning, Microsoft Office
Education
Champlain College
Salem State College
Starbucks Coffee Company September 2011 - Present
BJ's Wholesale Club August 2010 - September 2011
PAREXEL October 2007 - September 2010
CB Richard Ellis October 2005 - October 2007
Symantec March 2001 - June 2005
Skills
Facilities Management, Vendor Management, Contract Negotiation, Operations Management, Budgets, Construction Management, Procurement, Inventory Management, Property Management, Contract Management, Facilities Operations, Construction, Team Building, Project Planning, Process Scheduler, Contractors, Purchasing, Supervisory Skills, Management, Negotiation
Education
Cambridge College
Bachelor, Management
Dean College
Associate's degree, Social Sciences
PAREXEL October 2012 - March 2015
Roche KForce Alliance-Acquired by Pharmanet/i3 September 2004 - August 2012
MDS 1997 - 2004
Skills
CTMS, Oncology, Cardiology, Diabetes, Clinical Trials, Infectious Diseases, Clinical Research, Pharmaceutical Industry, Clinical Monitoring, EDC, Healthcare, Endocrinology, Remote Monitoring, Fit for Purpose..., Written & Oral..., Inflamation, Vaccines, Line Management, CRA Manager, ICH-GCP, Clinical Research..., CRO, Pediatric Trials, Clinical Development, GCP
Education
California State University-Northridge
B.S., Health Science
Pierce College
A.A., Registered Nurse
inVentiv Health November 2014 - Present
PAREXEL October 2012 - November 2014
UNC Department of Psychiatry School of Med February 2010 - October 2012
Psych Support Incorporated March 2008 - June 2012
Healthcore Resources Incorporated March 2007 - December 2008
Skills
Clinical Research, Treatment, ICH-GCP, Patient Recruitment, EDC, Clinical Monitoring, Clinical Trials, Informed Consent, CRO, CRF design, Research Ethics, Clinical Study Design, Oracle Clinical, Human Subjects Research, Protocol, Neuroscience, Therapeutic Areas, Social Services, CTMS, Clinical Development, GCP, IRB
Education
Capella University 2008 — 2010
Master of Science (M.S.), Psychology
North Carolina Central University 2002 — 2006
Bachelor of Arts (B.A.), Psychology
Duke Health Technology Solutions (DUHS) April 2010 - Present
Parexel International July 2008 - November 2009
PAREXEL July 2008 - October 2009
Quintiles September 2006 - July 2008
Duke University Health System June 2006 - September 2006
myConsulting Self-employed January 2005 - May 2006
Heritage Custom Homes February 2002 - January 2005
Sapiens August 1999 - January 2002
Enza and Usko Pty Ltd September 1996 - July 1999
Persetel and Supported Software October 1987 - September 1996
Skills
Oracle, Databases, Microsoft SQL Server, SQL, Active Directory, Software Documentation, Windows Server, Servers, IIS, Software Development, XML, Operating Systems, MS Project, Project Management, Data Analysis, Visual Basic, Analysis, Testing, Access, Enterprise Software, Microsoft Exchange, Troubleshooting, Integration, Security, Process Improvement, Disaster Recovery, System Administration
Education
Cape Peninsula University of Technology 1980 — 1980
MIS, Information Systems
PAREXEL July 2010 - Present
Bed Bath August 2008 - November 2012
TW Design January 2008 - October 2009
Saddleback Christian Academy January 1999 - January 2007
Saddleback Christian Academy January 1993 - January 2007
Saddleback Christian Academy January 1995 - January 2002
Christian Blue January 1989 - January 2002
Skills
Editing, Adobe Acrobat, Newsletters, Adobe Creative Suite, Dreamweaver, Photoshop, Illustrator, InDesign, Mac, Copywriting, Microsoft Office, Content Management, Technical Writing, QuarkXPress, Customer Service, Training, Research, Madcap Flare Certified, Layout, Copy Editing, Advertising, Windows, Teaching, Interviews, DITA
Education
UCI 2012 — 2013
eLearning Instructional Design
California State University-Long Beach 2007 — 2009
BA, English, Technical Writing Certificate
Fashion Institute of Technology, SUNY 1982 — 1984
AA, Advertising
University of California, Irvine
Certificate in progress, Business Analyst
Quintiles June 2014 - Present
Quintiles June 2012 - June 2014
Quintiles January 2008 - June 2012
Quintiles March 2006 - January 2008
PAREXEL July 2005 - February 2006
Skills
Microsoft Office, Clinical Trial..., EDC, Clinical Trials, Excel, MS Project, CTMS, Project Management, ICH-GCP, CRO, Patient Recruitment, Clinical Monitoring, GCP, Clinical Development, Microsoft Excel, Clinical Operations, Clinical Data Management
Education
Campbell University 2004 — 2012
Master's degree, Clinical Research
North Carolina State University 1997 — 2001
Bachelor of Science (B.S.), Biological Sciences
PRA Health Sciences June 2015 - Present
PAREXEL February 2014 - May 2015
INC Research September 2011 - February 2014
PAREXEL February 2010 - September 2011
AAIPharma, INC. May 2008 - August 2009
Wyeth Vaccines January 2006 - April 2008
PPD August 2005 - January 2006
WakeMed February 2004 - July 2005
Skills
GCP, GMP, Quality Assurance, Quality Auditing, Quality Control, Clinical Monitoring, Environmental Monitoring, EDC, ICH-GCP, IRB Auditing, Pharmaceutical Industry, Clinical Trials, Clinical Research, CAPA, FDA, 21 CFR Part 11, Phase 1, SOP
Education
Campbell University 2008 — 2011
Master of Science (MS), Clinical Research
North Carolina State University 1999 — 2003
Bachelor of Science (B.S.), Biologicial Sciences
McCormick LifeScience Consultants, LLC October 2011 - Present
Allen Fleishman Biostatistics September 2000 - Present
Barrington James Pharmaceutical recuitment 2015 - 2015
Boston Biostatistics (Averion) October 1998 - September 2000
CIBA Vision March 1995 - March 1996
Johnson & Johnson Pharmaceutical Research Institute March 1993 - March 1995
Johnson & Johnson Ethicon February 1992 - 1993
Sandoz 1989 - January 1992
Lederle Laboratories 1980 - 1989
PAREXEL June 1966 - October 1968
Skills
Biostatistics, Statistical Programming, Statistical Consulting, Data Analysis, SAP, Protocol Design, ISS, Power Analysis, ISE, Statistical Analysis..., Team Management, Clinical Trials, CRO, Analysis, FDA, Diabetes, Therapeutic Areas, Biotechnology, Clinical Development, Life Sciences
Education
University of Illinois at Urbana-Champaign 1972 — 1978
PhD
City University of New York 1971 — 1972
BS
Amgen July 2015 - Present
Knowledge Tree Tutoring January 2011 - Present
PAREXEL August 2010 - January 2011
PAREXEL March 2010 - August 2010
California State University, Northridge January 2008 - January 2010
California State University, Northridge 2008 - 2010
California State University, Northridge January 2008 - December 2009
New Heights Preparatory High School March 2009 - June 2009
California Cryobank August 2006 - July 2007
UCLA January 2006 - April 2006
Skills
Laboratory, Biology, Gel Electrophoresis, Molecular Genetics, ELISA, Microbiology, Molecular Biology, Biotechnology, PCR, Immunology, Western Blotting, Cell Culture, Lifesciences, Chemistry, Tissue Culture, HPLC, CGTP, cGMP practices
Education
California State University-Northridge 2004 — 2010
B.S, Biology; Biotechnology 2006
California State University-Northridge
M.S, Molecular Biology2010
Los Angeles County Department of Public Health November 2012 - Present
PAREXEL February 2012 - November 2012
Jazan University January 2010 - October 2012
The Place August 2011 - February 2012
My Friend's Place 2008 - February 2012
U.S. Naval Medical Research Unit 3 (NAMRU-3), Centers for Disease Control and Prevention, GDDRP June 2010 - July 2010
Dr. Jill Razani Neuropsychology Lab April 2007 - December 2009
University of Iowa Hospitals and Clinics June 2008 - August 2008
What Kids Want! August 2006 - February 2007
Icon Media Direct Advertising 2007 - 2007
Skills
Clinical Trials, Research, Psychology, Neuroscience, Neuropsychology, Clinical Research, Epidemiology, Data Analysis, Statistics, Public Health, SPSS, Public Health Education, SAS, Healthcare
Education
San Diego State University-California State University 2009 — 2011
MPH, Epidemiology
California State University-Northridge 2004 — 2009
BA, Psychology
ICON plc May 2015 - Present
INC Research July 2014 - May 2015
INC Research September 2013 - July 2014
INC Research September 2012 - September 2013
PAREXEL July 2010 - August 2012
PAREXEL May 2008 - July 2010
PAREXEL October 2009 - January 2010
Duke University Medical Center August 2007 - May 2008
Duke University Medical Center (CALGB) November 2005 - August 2007
East Cooper Regional Medical Center 2003 - 2005
Skills
Clinical Data Management, Clinical Trials, Clinical Research, Data Management, FDA, OmniComm TrialMaster, Medidate RAVE, InForm, 21 CFR Part 11, Biotechnology, CRF design, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Study Design, EDC, GCP, ICH-GCP, Infectious Diseases, Inform, Oncology, Oracle Clinical, Pharmaceutical Industry, Pharmacovigilance, Protocol, Regulatory Affairs, Regulatory Submissions, SOP, Software Documentation, Sop, Therapeutic Areas, Validation
Education
Campbell University 2005 — 2007
MS, Clinical Research
College of Charleston 2000 — 2004
BS, Biochemistry
Ocean Above Productions September 2009 - Present
PAREXEL August 2010 - November 2010
Boston Harbor Hotel 2005 - 2006
Harvard Medical School June 2005 - August 2005
Education
The George Washington University 2003 — 2007
BA, Psychology
New York University
Certificate, Entertainment Media Management
New York University
Certificate, Producing
University of California, Los Angeles
Certificate, Business and Management of Entertainment
Carnegie Mellon University
Master's, Entertainment Industry Management
PAREXEL December 2012 - Present
Advanced Clinical June 2011 - November 2012
Halozyme Therapeutics, Inc. April 2008 - October 2010
Biosite June 2007 - April 2008
Ligand Pharmaceuticals June 2003 - January 2007
Maxim Pharmaceuticals 2000 - 2002
Quintiles 1998 - 2000
Scientific Atlanta 1989 - 1997
Skills
Clinical Trials, GCP, FDA, Regulatory Affairs, Clinical Development, Regulatory Submissions, Clinical Research, Sop, CRO, Pharmaceutical Industry, Documentum, Software Documentation
Education
California State University-Long Beach
Radio/TV
Palomar College
Associate of Arts Degree, General Education
Verizon Business March 2009 - Present
Blue Cross and Blue Shield January 2009 - June 2009
GPI Technologies November 2006 - December 2008
AT&T 1999 - 2006
Tecstar Incorporated 1998 - 1999
PAREXEL 1997 - 1998
AT&T 1997 - 1997
I-Net 1995 - 1997
Wright-Patterson Air Force Base 1987 - 1995
Skills
Project Management, Project Planning, CRM, Contract Management, Process Scheduler, Information Technology, Logistics Management, Vendor Management, Program Management, PMP, Process Improvement, SDLC, Telecommunications, Cross-functional Team..., Business Analysis, Management, Software Project..., Business Process..., Requirements Analysis, MS Project, Integration, Leadership, Team Building, Outsourcing, Budgets, Project Portfolio..., Business Process, IT Strategy, PMO, Visio, Resource Management, IT Management, ITIL, Consulting, Data Center, Software Documentation, Professional Services, Service Delivery, Disaster Recovery, Business Intelligence, Cloud Computing, Enterprise Architecture, SharePoint, SaaS, ERP, Managed Services, Enterprise Software, Security, IT Service Management, System Deployment
Education
Central Michigan University 1991 — 1993
Masters, Business Administration
Wright State University 1981 — 1986
Bachelors, Business
Villanova University
PAREXEL May 2014 - Present
Accenture November 2010 - April 2014
Accenture @ Pfizer/Wyeth Pharmaceuticals January 2000 - November 2010
Mercy Suburban Hospital January 1990 - January 2000
Skills
Clinical Data Management, Clinical Research, Oracle Clinical, Microsoft Office
Education
California University of Pennsylvania
B.S.M.T., Medical Technology
Montgomery County Community College
HNTB June 2015 - Present
PAREXEL May 2013 - June 2015
SunTrust Bank January 2011 - May 2013
Hendrick Automotive Group March 2008 - January 2011
Skills
Customer Satisfaction, Customer Service, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Strategic Planning, Retail, Sales, Financial Analysis, Banking, Project Management, Forecasting, Finance, Data Analysis, Analysis, Lines Of Credit, Credit, CRM, Account Management, Relationship Management, Risk Management, Customer Retention, Financial Reporting, Strategic Financial..., Variance Analysis, Leadership, Management, Budgets
Education
Campbell University, Lundy-Fetterman School of Business 2007 — 2011
BBA, Business Administration, Economics
Intrinsic Imaging LLC December 2009 - Present
PAREXEL 2005 - 2008
TissueInformatics\Icoria 2002 - 2005
Bibliomondo 1997 - 2002
Phoenix International Life Sciences 1989 - 1997
Skills
FDA, Medical Imaging, Start-ups, EDC, 21 CFR Part 11, ISO 9001:2008, GAMP 5, Clinical Trials, GAMP, CTMS, Medical Devices, Strategy, Biotechnology, Clinical Development, Management, Cross-functional Team..., Pharmaceutical Industry, Oncology, Quality Management, Radiology, Product Development, Product Management, Lifesciences, CRO, Drug Development, Life Sciences, Business Development, Competitive Analysis, Leadership
Education
Concordia University 1989 — 1993
BSc., Chemistry
Concordia University
BSc., Biology
CEGEP - John Abbott College 1984 — 1987
DEC, Health Science
Concordia University
MBA, Entrepreneurship
PAREXEL February 2012 - Present
Aerie Pharmaceuticals June 2011 - November 2011
LMS Logistics January 2011 - May 2011
Aerotek Scientific November 2010 - February 2011
Novartis June 2009 - October 2010
OraSure Technologies April 2007 - June 2009
Novartis Consumer Health March 2006 - January 2007
NPS Pharmaceuticals August 2004 - March 2006
Medarex 2004 - 2004
sanofi-aventis July 2000 - April 2003
Skills
ICH-GCP, Clinical Trials, CRO, GCP, CTMS, Validation, Clinical Research, Regulatory Affairs, Sop, FDA, Lifesciences, Biotechnology, Cross-functional Team..., Drug Development, EDC, Protocol, Quality Assurance, Pharmaceutical Industry, Clinical Development, Clinical Monitoring, Regulatory Submissions, Clinical Data Management, Clinical Operations, Oncology, Data Management, Regulatory Requirements, Infectious Diseases, Therapeutic Areas, Pharmacovigilance
Education
Cedar Crest College 2005 — 2015
BSN, RN, Nursing
Community College 1992 — 1998
Associates, Liberal Arts
PAREXEL January 2015 - Present
Carolina Meadows, Inc. October 2005 - July 2015
PPD May 2014 - January 2015
Sequenom February 2014 - May 2014
UNC Health Care April 2008 - April 2010
Skills
First Aid, Cpr Certified, Data Entry, Customer Service, Document Review, HIPAA, StarLIMS, AOD, Committed to..., Healthcare, Clinical Research, Clinical Trials, Leadership, Management, Microsoft Excel, Microsoft Office, Microsoft Word, Outlook, PowerPoint, Public Speaking, Research
Education
North Carolina Central University 2010 — 2013
Bachelor of Science (B.S.), Environmental Science, 3.0
Central Carolina Community College 2007 — 2009
Associate of Arts and Sciences (A.A.S.)
Central Carolina Community College 2005 — 2007
Associate of Arts (A.A.)
Duke Clinical Research Institute November 2014 - Present
PAREXEL March 2013 - November 2014
RTI International July 2011 - February 2013
GlaxoSmithKline 1996 - 2010
Skills
Clinical Development, Clinical Trials, CRO, Clinical Research, GCP, Pharmaceutical Industry, EDC, ICH-GCP, Clinical Monitoring, Infectious Diseases, Therapeutic Areas, Clinical Data Management, Oncology, Regulatory Submissions, CTMS
Education
Campbell University
Masters, Clinical Research
WVU
Bachelor of Science (B.S.), Medical Technology
PAREXEL April 2015 - Present
Skills
Apple OS, Stress Testing, REDCap, EEG, Pulmonary Rehabilitation, Hospitals, PowerPoint, CRO, Neurology, Sop, Clinical Data Management, Therapeutic Areas, Protocol, Clinical Operations, ICH-GCP, Healthcare, Clinical Trials, Medicine, SOP, Oncology, Clinical Study Design, Infectious Diseases
Education
Campbell University 2015 — 2016
Bachelor of Science (BS), Psychology
Durham Technical Community College 1978 — 1980
A.A.S, Respiratory Therapy
Campbell University 1974 — 1977
BS, Allied Health
PAREXEL Regulatory Affairs OfficerQuintiles2007 - 2010
Skills
Regulatory Submissions, Clinical Trials, GCP, ICH-GCP, Pharmaceutical Industry, Clinical Development, CRO, Clinical Research, Regulatory Affairs, CTMS, Sop, Clinical Monitoring
Education
NC State University 2000 — 2004
Bachelor of Science (BS), Microbiology, Biological Sciences, Genetics
Campbell University
Master of Science (MS), Clinical Research
PAREXEL December 2012 - Present
Coty June 2011 - December 2012
NNE Pharmaplan May 2010 - August 2010
RTI International October 2008 - May 2010
Wyeth Pharmaceuticals September 2004 - October 2008
Wyeth Pharmaceuticals July 2002 - September 2004
Wyeth Pharmaceuticals September 2000 - July 2002
Wyeth Pharmaceuticals July 1999 - September 2000
Gold Kist, Inc April 1995 - July 1999
Skills
Project Finance, Financial Analysis, Budgeting, Budgets, Financial Reporting, SAP, Accounting, Forecasting, Project Planning, Auditing, Project Management, Managerial Finance, Hyperion Enterprise, MS Project, Management, Outlook
Education
Strayer University 2007 — 2009
MBA, Masters of Business Administration - Management
Campbell University 2000 — 2004
BA, Bachelors in Business Administration
Partners HealthCare June 2015 - Present
Northern Area Multi-Service Center May 2014 - June 2014
PAREXEL August 2012 - February 2013
Skills
SAS, Microsoft Excel, Access, Microsoft Office, Database Administration, R, Business Analysis, Microsoft SQL Server, Project Management, Stata, Oracle Database
Education
Carnegie Mellon University 2013 — 2015
Master's Degree, Health Care Policy and Management
National Taiwan University 2008 — 2012
Bachelor's Degree, Business Administration and Management, General
PAREXEL October 2014 - Present
PAREXEL International 2013 - 2014
PAREXEL International April 2010 - January 2013
PAYCHEX Inc. October 2006 - January 2010
Skills
Clinical Trials, TMF, Medical Records, Naming Conventions, GCP, Microsoft Excel, Microsoft Word, PowerPoint, Interpersonal Skill, Leadership, Energetic team player
Education
Cambridge College 2008 — 2014
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Cambridge College 2006 — 2013
Bachelor of Science in Management Studies, Management Studies
PAREXEL June 2012 - October 2013
Avrio Biopharmaceuticals July 2011 - September 2011
Teva Pharmaceuticals July 2003 - June 2011
Abbott Vascular 1986 - 2002
Berhing Diagnostics, Div. American Hoechst Corp., San Diego, CA 1984 - 1986
Baxter Healthcare January 1983 - January 1984
Syva Co., Div. of Syntex Corp. January 1979 - January 1983
Bio Rad 1976 - 1978
Skills
Aseptic Processing, Injection Molding, Lyophilization, Medical Devices, Pharmaceuticals, Manufacturing, Auditing, Inspection, Validations, CAPA, Process Validation, cGMP, FDA, Validation, SOP, 21 CFR Part 11, Change Control, ISO 13485, Contract Manufacturing, Quality Systems, Quality Auditing
Education
California State University-Long Beach 1973 — 1975
BS, Medical Microbiology
Rio Hondo College 1970 — 1972
AS, Medical Microbiology
Sierra High School, Whittier, CA 1967 — 1970
Grad, General
Growth Ministries House Church Network April 1997 - Present
Walk Away Obesity Ministry July 2015 - Present
Health Decisions March 2015 - Present
PAREXEL November 2014 - March 2015
Health Decisions July 2013 - November 2014
PPD April 2012 - June 2013
Copernicus Group IRB June 2011 - July 2011
Education
Capella University
Doctor of Public Health (DrPH), Health Advocacy & Leadership
Walden University
Master of Science (MS), Clinical Research Administration
The North American Reformed Seminary
Master of Theological Studies (MTS)
Johns Hopkins Bloomberg School of Public Health
Independent Study (Coursera), Design & Interpretation of Clinical Trials
Stanford University
Independent Study (Coursera), Practical Tips to Improve Asian American Participation in Cancer Clinical Trials
PAREXEL August 2012 - Present
Quintiles Transnational August 2011 - August 2012
Quintiles November 2007 - August 2011
Diabetes and Endocrinology Associates May 2003 - November 2007
Skills
IRB, GCP, Excellect Communication..., Multitasker, Proficient computer..., Results Oriented, Strong Organizational..., Informed Consent, GCPs, Drug Accountability, Query Resolution, Oracle RDC, Clinical Research..., Therapeutic areas of..., Regulatory Documentation, Diabetic Neuropathy, Neuropathy, Clinical Informatics, Intralink, Clinical Monitoring
Education
University of Phoenix 2009 — 2012
Bachelors Science
Carteret Community College 1987 — 1988
Associates, Medical Assistant
PAREXEL July 2015 - Present
PAREXEL November 2012 - July 2015
PAREXEL January 2011 - November 2012
PAREXEL June 2008 - January 2011
Skills
Microsoft Office, Microsoft Excel, Customer Service, PowerPoint, Microsoft Word, Leadership
Education
California State University-Long Beach 2002 — 2004
Bachelor's degree, Finance, General
MC2 Events Exhibits Environments September 2015 - Present
Bank of America November 2014 - June 2015
Virtual, Inc. September 2013 - September 2014
Kantar Retail October 2012 - August 2013
Dassault Systemes, ENOVIA Corp December 2007 - October 2012
Dassault Systemes November 2007 - May 2010
Sonus Networks April 2006 - April 2007
Event Management Group July 2003 - August 2006
PAREXEL 2004 - 2004
PRRI March 2002 - July 2003
Skills
Event Planning, Project Management, Negotiation, Sales Enablement, Customer Experience, Community Development, Event Management, Trade Shows, Marketing Strategy, Marketing Communications, Product Marketing, Strategic Partnerships, Integrated Marketing, Strategic Planning, Social Media, Marketing Management, Leadership, Marketing, Management, Cross-functional Team..., Sales, Training, Contract Negotiation, Budgets, Team Building, Lead Generation, Project Planning, Corporate Events, CRM, Competitive Analysis, Business Development, Salesforce.com, Strategy, Public Relations, Team Leadership
Education
Central Michigan University 1979 — 1982
Bachelor of Science (B.S.), Food Service & Hospitality Services Admin
Lahser High School 1975 — 1978
PRA Health Sciences September 2014 - Present
PAREXEL March 2010 - September 2014
PAREXEL October 2007 - March 2010
Biogen Idec August 2004 - October 2007
Skills
Clinical Monitoring, GCP, Clinical Research, Clinical Trials, Regulatory Documentation, IRB, Therapeutic areas, ICH-GCP, Pharmaceuticals, Clinical Trial..., Regulatory Requirements, CRO, EDC, Diabetes, CTMS, SOP, Regulatory Submissions, Data Collection, Patient Recruitment, GMP
Education
Campbell University 2005 — 2011
M.S., Clinical Research
North Carolina State University 1998 — 2002
B.S., Biological Sciences
Collaborative Neuroscience Network, LLC. August 2015 - Present
PAREXEL December 2014 - August 2015
PAREXEL Int. March 2012 - December 2014
American Heart Association American Stroke Association September 2010 - September 2011
Skills
English: Fluent;..., Proficiency in..., Time Management, Efficiency, Strategic Planning, Preventive Maintenance, Collaborative Problem..., Clinical Research, Laboratory, Pharmaceutical Industry, Quality Assurance, Hospitals, Microsoft Office
Education
California State University-Northridge 2007 — 2010
Bachelor of Science (BS), Health Sciences, Public Health
PAREXEL August 2014 - Present
Labinal February 2013 - February 2014
Regeneron Pharmaceuticals July 2012 - October 2012
Quintiles June 2010 - May 2011
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking, Strategic Planning, Clinical Research, Data Analysis, Biotechnology, ICH-GCP, Clinical Trials, Life Sciences, Biochemistry, GCP, Clinical Development, Pharmaceutical Industry, EDC, SOP, Metrics Reporting, CRO, CTMS, Regulatory Affairs, Oncology, Clinical Data Management, FDA
Education
Gujarat University 2011 — 2012
Bachelor of Science (BS), Biochemistry
California State University-Los Angeles 2006 — 2009
Biology, General
PAREXEL January 2012 - Present
Research Pharmaceutical Services May 2011 - 2013
UnitedHealth Group May 2009 - May 2011
Charles River Laboratories August 2004 - July 2008
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, English, Outlook, Windows, Teaching, HTML, C++, Budgets, C, Java, Public Speaking, Editing, Strategic Planning, Negotiation, Infectious Diseases, Oncology
Education
Centennial College 1999 — 2001
3 years Diploma, Industrial Microbiology
University of Southern Mississippi 1994 — 1997
Master of Science (MSc), Medical Technology
National University of CI 1990 — 1993
Master of Science (MSc), Biotechnology
University of Cote d'Ivoire 1987 — 1991
Bachelor's degree, Biochemistry
PAREXEL January 2014 - Present
Upstate Medical University May 2012 - January 2014
Crouse Hospital May 2009 - January 2014
American Red Cross June 2010 - May 2012
Skills
Clinical Research, Clinical Trials, Clinical Site Management, Healthcare, Research, GCP, Phlebotomy, ICH-GCP, Microsoft Office, CTMS, PowerPoint, Program Development, Hospitals, Neurology, Rheumatology, Protocol, Dermatology, Gastroenterology, Clinical Monitoring, SOP, FDA, Microsoft Excel, Clinical Study Design
Education
Calvin College 2007 — 2010
Bachelor of Science (B.S.), Biology, General
PAREXEL June 2012 - Present
U.S. Army Reserves July 2002 - April 2015
Sanofi Pasteur October 2003 - June 2012
Independent Contractor May 2002 - October 2003
St. Luke's University Health Network September 1997 - May 2002
Emergency Medical Services April 1991 - September 2000
Blue Mountain Health System September 1995 - September 1997
Skills
Clinical Trials, Healthcare, Clinical Trial..., Therapeutic areas, Clinical Research, Clinical Development, Vaccines, EDC, CTMS, Infectious Diseases, Neurology, Pharmaceuticals, Protocol Development, Pediatrics, Immunology, Clinical Monitoring, Process Improvement, ICH-GCP, GCP, Cardiology, Clinical, Protocol, Pharmaceutical Industry, Therapeutic Areas, CRO, Internal Medicine, Medicine, Regulatory Affairs
Education
Drexel University 2002 — 2006
Master's, Nursing
Cedar Crest College 1999 — 2001
Bachelor's, Nursing
Lehigh Valley - Emergency Medicine Institute 1995 — 1996
PHRN, Pre Hospital Emergency Care
St. Lukes School of Nursing 1993 — 1995
ADN/Diploma, Nursing
LBR Regulatory and Clinical Consulting Services August 2014 - Present
PAREXEL November 2012 - August 2014
PAREXEL April 2012 - December 2012
Skills
MS Office Suite, Organizing, Data Entry, Customer Service, Problem Solving, Medical Terminology, Email Marketing, Microsoft Office, CRO, Clinical Research, Regulatory Affairs, Project Management, Biostatistics, Clinical Monitoring, Microsoft Excel, Operating Systems, Clinical Trials, Start-ups, Cell Biology, Molecular Biology, Managerial Finance
Education
Campbell University 2011 — 2013
MS, Clinical Research
Meredith College 2007 — 2011
BS, Biology
Delozier Consulting, Inc. June 2006 - Present
Medpace 2014 - 2015
Medpace 2014 - 2015
PAREXEL February 2005 - June 2006
Inveresk Research May 2003 - February 2005
PharmaResearch Corporation 2003 - 2004
GlaxoSmithKline June 1999 - May 2003
Skills
Microsoft Office, Clinical Research, Clinical Trials, FDA, Protocol, EDC, Validation, Clinical Monitoring, CTMS, Clinical Data Management, ICH-GCP, Oncology, GCP, Clinical Development
Education
Campbell University 2001 — 2004
MS, Clinical Research
North Carolina State University 1991 — 1996
BS, BA, Biochemistry, Chemistry
PAREXEL November 2012 - Present
PAREXEL November 2012 - Present
PAREXEL April 2010 - October 2012
PAREXEL April 2006 - April 2010
PAREXEL September 2004 - April 2006
Skills
GCP, Clinical Trials, CRO, Clinical Monitoring, Oncology, Clinical Development, Clinical Data Management, Pharmaceutical Industry, Clinical Research, Sop, FDA, Microsoft Office
Education
Cheonggang Academy
High School Diploma
Celgene Pharmaceuticals August 2014 - Present
ONO Pharmaceuticals June 2013 - February 2014
Cephalon May 2007 - May 2013
Teva Pharmaceuticals May 2007 - May 2013
PAREXEL March 2005 - May 2007
Eximias November 2004 - March 2005
ICON June 2002 - November 2004
Skills
Clinical Trials, CTMS, Oncology, Clinical Development, CRO, GCP, Cardiology, Clinical Monitoring, Clinical Research, Endocrinology, Immunology, Infectious Diseases, Pharmaceutical Industry, Therapeutic Areas, FDA
Education
Chestnut Hill College 1998 — 2002
B.S., Biology/Biochemistry
PAREXEL March 2015 - Present
GSK March 1995 - March 2015
Skills
Project Management, Drug Development, Clinical Development, ICH-GCP, Drug Discovery, GLP, Pharmaceutical Industry, Infectious Diseases, Quality Assurance, FDA, Life Sciences
Education
Campbell University
Bachelor's degree, Health Sciences
Central Carolina Community College
Associate of Arts and Sciences (A.A.S.), Veterinary/Animal Health Technology/Technician and Veterinary Assistant
North Carolina State University
Animal Sciences
PAREXEL International, CA, USA April 2014 - Present
PAREXEL November 2012 - April 2014
Lotus Clinical Research, LLC July 2012 - November 2012
PAREXEL October 2010 - July 2012
PAREXEL January 2010 - October 2010
PAREXEL March 2008 - January 2010
Skills
Clinical Trials, Sop, Pharmaceutical Industry, CRO, MS Project, Project Management, GCP, SOP development, Clinical Research, Biotechnology, Protocol, FDA, EDC, SOP
Education
California State University-Northridge 2002 — 2005
B.A, Sociology
Grifols July 2013 - Present
PAREXEL November 2010 - February 2013
PAREXEL January 2007 - November 2010
United States Marine Corps July 1998 - July 2003
Skills
Procurement, Sourcing, Vendor Management, Contract Management, Customer-focused Service, Thinking Outside The Box, Analytical Reasoning, Supply Chain Operations, Instructional Skills, Verbal & Written..., Solid Presentation..., Supply Management, Quality Assurance, Strategic Sourcing, Budgets, Cross-functional Team..., Logistics, Supply Chain, Sop, Six Sigma
Education
California State University-Los Angeles 2006 — 2010
Bachelor of Science (B.S.), Business Administration, Management and Operations, 3.8 GPA
Pasadena City College 2003 — 2006
Associate of Science (A.S.), Associate of Arts (A.A.), Business Administration and Management, 4.0 GPA
PAREXEL International March 2015 - Present
Biogen Idec July 2013 - Present
PAREXEL November 2011 - August 2013
Ockham Development Group February 2011 - October 2011
UPS 2010 - 2011
Skills
Clinical Trials, Pharmaceutical Industry, CRO, GCP, Biotechnology, Clinical Development, Oncology, EDC, CTMS, Clinical Research
Education
Campbell University 2005 — 2009
B.A., History
Athens Drive High School
West Lake
Western Carolina University
Novella Clinical, Inc. March 2014 - Present
PAREXEL November 2011 - September 2013
PPD April 2005 - October 2011
Skills
Contract Negotiation, Study Start-Up, Clinical Trial..., Budget Management, ICH-GCP, GCP, Clinical Trials, CTMS, Clinical Development, Software Documentation, Clinical Research, Regulatory Submissions, Budgets, Oncology, Validation, FDA, CRO, Oracle Clinical, IRB, Regulatory Affairs, Protocol, Sop, Clinical Operations, Clinical Data Management, Clinical Monitoring, SOP, Pharmaceutical Industry, Infectious Diseases
Education
Cape Fear Community College 2009 — 2011
Associate of Science (AS), Nursing
Cape Fear Community College 1992 — 1994
Associate of Arts and Sciences (A.A.S.), Business Administration and Management, General
University of Phoenix
Bachelor of Science (BS), Health/Health Care Administration/Management
Quintiles September 2011 - Present
PPD 2011 - October 2011
Access Care May 2009 - April 2011
Pinehurst Medical Clinic July 2008 - March 2009
PAREXEL July 2007 - August 2008
Wake Research Associates LLC March 2005 - July 2007
Dr. Mary Richards, M.D May 2000 - March 2005
Clinical Investigation Specialists June 1999 - May 2000
Duke UniversityGraduate School of Nursing September 1998 - June 1999
Education
Campbell University 1993 — 1997
Bachelor of Arts, Religion
PRA Health Sciences August 2011 - Present
PAREXEL March 2007 - August 2011
Prologue Research April 2005 - March 2007
PRA International November 2002 - April 2005
PRA International January 2002 - October 2002
Hematology and Oncology Associates of Va. (Virginia Cancer Institute) July 1997 - December 2001
Medical College of Virginia/Massey Cancer Center November 1990 - July 1997
Skills
Oncology, Clinical Research, Clinical Trials, Clinical Monitoring, EDC, GCP, CRO, Data Management, ICH-GCP, Regulatory Affairs, CTMS, Clinical Development, Sop, FDA, Protocol, Clinical Data Management, Medical Writing, Regulatory Requirements, Clinical Operations, Neurology, Pharmaceutical Industry, Biotechnology, Therapeutic Areas, Oncology Clinical..., SOP, Regulatory Submissions
Education
Central Michigan University 1988 — 1990
MS, Health Administration
Virginia Commonwealth University 1979 — 1984
BA, History/Education
Thomas Jefferson High School
United BioSource Corporation April 2012 - Present
SCDM 2014 - 2015
PAREXEL 2010 - 2012
Gilead Sciences January 2006 - July 2010
Gilead Sciences January 2002 - January 2006
Quintiles May 1999 - January 2002
Skills
Clinical Data Management, Clinical Operations, EDC, Data Management, CRF design, Validation, Clinical Trials, IND, Clinical Research, Phase I, Oracle Clinical, CTMS, Clinical Study Design, FDA, CDISC, Sop, Protocol, Clinical Development, CRO, GCP, ICH-GCP, SAS, MedDRA, SDTM, Clinical Pharmacology, Data Validation, SOP development, Pharmacology, Regulatory Requirements, Pharmacokinetics, Clinical Monitoring, Therapeutic Areas, 21 CFR Part 11, Infectious Diseases, Inform, Medidata, Pharmaceutical Industry, SAS programming, Software Documentation, Clinical Research..., Trial Management, NDA, Medical Devices, Laboratory, Outcomes Research, Databases, Regulatory Submissions, Medical Writing, Oncology, Pharmacovigilance
Education
Campbell University 2007 — 2010
Bachelors of Applied Science Degree Program, Clinical Trials Research
Durham Technical Community College 1998 — 2002
Diplomas: Associate of Applied Science, Clinical Trials Research; A.A.S in General Ed., Clinical Trials Research; General Education
North Carolina State University 1997 — 1998
Biological Sciences
Wake Technical Community College 1996 — 1997
Associates of Applied Science Nursing Program; Diploma: AAS, General Occupational Technology, Nursing
Methodist Hospital School of Nursing 1992 — 1994
Non-Diplomacy Program, Nursing
Galmed Pharmaceuticals Ltd. March 2015 - Present
Forest Laboratories November 2010 - Present
Halloran Consulting Group, Inc. October 2010 - Present
Shawna H. Evans, LLC June 2000 - Present
PAREXEL 2011 - 2011
PAREXEL 2011 - 2011
MVG Consulting December 2009 - September 2010
CPEX Pharmaceuticals April 2009 - March 2010
Bright Pharmaceuticals April 2009 - September 2009
MannKind Corporation 2003 - 2009
Skills
Oncology, Clinical Development, Clinical Trials, Medical Writing, Clinical Research, Cardiology, Endocrinology, Hematology, Psychiatry, Medicine, CTMS, GCP, CRO, EDC, Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Submissions, FDA, Regulatory Affairs, Sop, Lifesciences, Clinical Data Management
Education
Castleton University 1994 — 1996
BS, Exercise Physiology
Newbury College 1990 — 1992
Associate of Applied Science, Business Management
BioClinica February 2014 - Present
CCBR-Synarc August 2010 - February 2014
PAREXEL October 2007 - July 2010
Vesticon December 2006 - May 2007
Vesticon September 2006 - November 2006
Synarc, Inc. January 2006 - June 2006
Synarc September 1999 - December 2005
Oregon Osteoporosis Center July 1992 - September 1999
US Marine Corps April 1988 - April 1992
Skills
GCP, Clinical Trials, Clinical Development, Change Management, Project Management, Quality Assurance, Business Analysis, Sop, FDA, Medical Devices, Management, 21 CFR Part 11, Biomarkers, Clinical Research, Healthcare, Integration, Start-ups, Strategy
Education
Capella University 2006 — 2009
MS, Organizational Management, Leadership
Portland State University 1983 — 1987
BS, Physics & General Science
Bright Horizons July 2012 - Present
PAREXEL January 2010 - July 2012
Genzyme Corporation January 2008 - January 2010
Genzyme Corp October 2006 - January 2008
ECI Biotech, Inc October 2005 - September 2006
Warner Brothers (WB56) January 2006 - April 2006
Merrill Lynch March 2005 - May 2005
United Locating Services August 2003 - August 2004
Federal Probation May 2002 - August 2002
Skills
Forecasting, Variance Analysis, Analysis, Financial Analysis, Accounts Payable, Budgets, Internal Audit, Finance, Account Reconciliation, Accounting, Cost Accounting, Accounts Receivable, Financial Reporting, Sarbanes-Oxley Act, Process Improvement
Education
Clark University 2004 — 2006
MBA, Accounting and Finance
Carroll College 1999 — 2003
BA, double major in Business Management and Sociology
Sentinel
PAREXEL March 2015 - Present
GlaxoSmithKline January 2009 - Present
Pharsight Corp. September 2007 - December 2008
Entelos Inc. 1999 - 2007
Skills
Modeling, Simulation, Pharmacokinetics, Pharmacodynamics, Clinical Pharmacology, Systems Biology, Drug Metabolism, Clinical Trials, Biostatistics, Control Engineering, Pharmaceutical Industry, Pharmacometrics, Drug Discovery, Pharmacology, NONMEM, PK/PD, Biomarkers, Simulations, WinNonlin, Clinical Development, Drug Development
Education
Caltech 1997 — 1999
Postdoc, Systems & Control Theory
University of Maryland College Park 1993 — 1997
Phd., Electrical Engineering (Systems & Control Theory)
Technische Universität Berlin
Diplom Ingenieur, Electrical Engineering (Systems & Control Theory) 1993
PAREXEL November 2014 - Present
PAREXEL December 2012 - October 2014
Keller Willams Realty August 2013 - August 2013
Best In Show Realty August 2008 - July 2013
PharmaNet/i3 Strategic Resourcing November 2011 - November 2012
i3 Statprobe November 2008 - September 2011
Eli Lilly February 2002 - October 2008
IMN Companies 2006 - 2008
Skills
Clinical Data Management, Data Management, Statistical Programming, CRO, CDISC, EDC, Clinical Trials, Pharmaceutical Industry, 21 CFR Part 11, SAS programming, GCP, Biotechnology, SAS, FDA, Clinical Development, Clinical Research, Biostatistics, Oncology, CTMS, Validation, Protocol
Education
Central Michigan University 1997 — 2001
Bachelor of Science in Business Administration, Management Information Systems, General, Magna cum Laude
Covidien February 2011 - December 2014
Covidien April 2009 - February 2011
PAREXEL International January 2007 - April 2008
PAREXEL September 2003 - January 2007
Skills
Medical Devices, Clinical Research, FDA, Healthcare, Clinical Trials, Operations Managment,..., Protocol, Software Documentation, Biotechnology, GCP, Management, CTMS, Strategy, Quality Assurance, Project Management, Medical Imaging, Strategic Planning, Design Control, R&D, MS Project, Cross-functional Team..., Pharmaceutical Industry, Biomedical Engineering, Clinical Development, Sop, CRO, Product Launch, Process Improvement
Education
Cambridge College 2005 — 2006
Masters of Management, Health Care Management, 3.8
University of Massachusetts Dartmouth 1993 — 1997
Bachelors in Fine Arts, Electronic Imaging
Dekkun Corporation April 2012 - Present
Genzyme Corporation July 2005 - April 2012
PAREXEL 2003 - 2005
Beth Israel Deaconess Medical Center 1996 - 2002
Skills
Drug Development, Clinical Trials, Clinical Research, Clinical Development, Oncology, Pharmacovigilance, Hematology, Therapeutic Areas, Transplant, Medical Writing, CTMS, GCP, Immunology, Infectious Diseases, Pharmaceutical Industry, Regulatory Affairs, CRO, Medical Affairs, Regulatory Submissions, Biotechnology, FDA, Medicine
Education
Chicago Medical School at Rosalind Franklin U-Med & Science 1992 — 1996
M.D., Physician
University of Massachusetts, Amherst 1987 — 1991
B.S., Zoology, Exercise Science
Shire June 2015 - Present
Vertex Pharmaceuticals June 2012 - May 2015
Genzyme January 2005 - June 2012
Genzyme 1999 - 2005
Genzyme 1998 - 1999
Genzyme 1997 - 1999
PAREXEL 1996 - 1997
Massachusetts General Hospital 1995 - 1996
Massachusetts Institute of Technology 1992 - 1995
Metpath 1991 - 1992
Skills
FDA, Program Management, PMP, ITIL, IT Strategy, Biotechnology, Pharmaceuticals, Process Development, Compliance, Cross-functional Team..., Process Improvement, Change Management, Strategic Planning, Vendor Management, Product Development, Documentation, Life Sciences, Business Analysis, Budgeting, Team Building, Risk Management, Outsourcing, R&D, Customer Relations, Project Portfolio..., Software Documentation, Pharmaceutical Industry, Lifesciences, SDLC, Drug Development, 21 CFR Part 11, Management, Validation, Project Planning, Clinical Trials, CTMS, Requirements Analysis, Leadership, Quality Assurance, Testing, Change Control, Sop, GMP, Computer System..., CRO, EDC, Biopharmaceuticals, Oncology, Regulatory Submissions, Analysis
Education
Northeastern University 1999 — 2000
Certificate, Computer Programming
Cambridge College 1993 — 1994
MM, Finance
University of Massachusetts Boston 1987 — 1991
BS, Biology
PAREXEL October 2007 - Present
PAREXEL September 2006 - October 2007
PAREXEL August 2005 - September 2006
PharmaNet August 2004 - July 2005
Rho, Inc. July 2003 - July 2004
Education
Campbell University 1998 — 2002
PAREXEL June 2013 - Present
Robert Half International Inc July 2000 - June 2013
Randstad 1997 - 2000
Skills
Accounts Receivable, Account Reconciliation, Invoicing, PeopleSoft, Accounting, Temporary Placement, Finance, General Ledger, Forecasting, Recruiting, Human Resources, Customer Service, Call Center, Budgets, Coaching, Training, Credit, Talent Acquisition, Microsoft Excel, Leadership, Management, Process Improvement, Call Centers
Education
Capella University 2006 — 2011
Bachelors, Business Administration
OmniComm Systems, Inc. December 2014 - Present
PAREXEL June 2014 - November 2014
Onyx Pharmaceuticals (Subsidiary of Amgen) May 2013 - May 2014
INC Research July 2011 - April 2013
Kendle International May 2010 - July 2011
Kendle International January 2008 - May 2010
Kendle July 2007 - January 2008
Client Associated Businesses, Inc. June 2002 - June 2007
Keane 2000 - 2002
Skills
CRF design, EDC, Programming, Oracle Clinical, Editing, Inform, Data Management, Operating Systems, Training, Project Management, Associate Development, Medidata, Team Leadership, Clinical Data Management, Sop, OC RDC, CRO, Clinical Trials, SAS, SDTM, Databases, Management, Clinical Study Design, GCP, Pharmaceutical Industry
Education
Villanova University 2011 — 2011
Black Belt Certification, Six Sigma Black Belt Certification Program
Central Connecticut State University 1996 — 2000
Bachelor Science, Computer Science, Criminal Justice
PAREXEL July 2014 - Present
Marsh & McLennan Companies, Mercer November 2013 - June 2014
Philips July 2012 - July 2013
Procter & Gamble/Gillette 2005 - 2007
The Gillette Company 2003 - 2005
The Gillette Company 2001 - 2003
The Gillette Company 1999 - 2001
Skills
Employee Engagement, Coaching, HR Policies, Sourcing, Workforce Planning, Organizational..., Strategic Planning, Orientation &..., Performance Management, Staff Recruitment &..., Organization Change..., Work Life & Diversity &..., Recruiting, Leadership, Talent Management, Benefits Administration, Career Development, Employee Training, Employment Law, Executive Coaching, HR Consulting, Management, Onboarding, Performance Management, Personnel Management, Policy, Program Management, Strategy, Process Improvement, Training
Education
Cambridge College
Bachelor of Science (BS), Business Management
PAREXEL March 2015 - Present
GlaxoSmithKline 1998 - 2015
GSK 1998 - 2008
Case Western Reserve University 1995 - 1997
Skills
Drug Discovery, Biomarkers, Drug Development, Clinical Trials, Clinical Development, Pharmaceutical Industry, Biotechnology, Lifesciences, Genetics, Oncology, Molecular Biology, Pharmacology, Statistical Data..., Pharmacogenetics, Pharmacogenomics, Biostatistics, Management
Education
Case Western Reserve University 1995 — 1997
Post-doc, Genetic Epidemiology
University of Pittsburgh 1987 — 1994
Doctor of Philosophy (Ph.D.), Human Genetics
PAREXEL June 2015 - October 2015
Clinical Research July 2012 - June 2015
Amgen November 2007 - May 2008
Amgen August 2006 - November 2007
PPD April 2004 - 2006
PAREXEL 2001 - 2003
PAREXEL 1998 - 2001
Skills
Clinical Development, Rheumatology, EDC, Dermatology, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Gastroenterology, Drug Development, FDA, Protocol, Clinical Data Management, Life Sciences, Medical Devices, Pharmacovigilance, SOP, Oncology, Clinical Monitoring, GCP, CRO, CTMS, Clinical Research
Education
Central Michigan University 1995 — 1998
MSA, Health Services Administration
Colorado State University 1989 — 1993
BS, Consumer Science
Xellia Pharmaceuticals March 2015 - Present
Alliance Behavioral Healthcare April 2014 - November 2014
Eisai February 2013 - January 2014
Merck May 2011 - November 2012
Emerson Process Management March 2008 - November 2010
Self Employed Consultant June 2001 - March 2008
PAREXEL June 1999 - July 2001
Procter & Gamble October 1988 - June 1999
Skills
Validation, Process Improvement, SDLC, Software Documentation, Business Process..., Computer System..., Change Management, Technical Writing, Project Management, Sop, Quality Management, Continuous Improvement, Testing, Business Analysis, 21 CFR Part 11, Quality Auditing, Six Sigma, Microsoft Office, SharePoint, MS Project, 5S, FMEA, Lean Manufacturing, Implementer, cGMP practices, Documentation, Lean, Business Process..., Business Process Design, Business Process Mapping, Microsoft Project, SOP
Education
Champlain College 2008 — 2010
MS, Managing Innovation and IT
Capella University 2004 — 2007
BSIT, Computer and Information Systems Security/Information Assurance
Rochester Institute of Technology 2001 — 2006
AAS, Quality Management
Villanova University 2001 — 2002
Certificate, Project Management
Shire Pharmaceuticals September 2011 - Present
Shire Pharmaceuticals March 2005 - September 2011
PA Consulting Group July 2000 - March 2005
Quintiles July 1999 - July 2000
Quintiles April 1998 - July 1999
PAREXEL June 1996 - May 1998
Sandoz November 1993 - June 1996
Ciba-Geigy June 1992 - December 1993
Skills
Due Diligence, Cross-functional Team..., Strategic Planning, Product Development, Program Management, Geographic Expansion, Business Process..., Globalization, Acquisition Integration, Business Development, Risk Assessment, Life Cycle Planning, Strategic Alliances, Project Finance, Decision Support, Pharmaceutical Industry, Lifesciences, Management, Oncology, Biotechnology, Clinical Development, CRO, Life Sciences, Strategy, Clinical Trials, Leadership, Regulatory Affairs, Drug Development, Biopharmaceuticals
Education
University of Pennsylvania - The Wharton School 2008 — 2012
Certificate of Professional Development, Strategy and Management
City University London 1991 — 1992
MSc, Medical Informatics
University of Southampton 1988 — 1991
BSc, Biochemistry & Physiology
KPMG Executive Leadership 2013 — 2014
ICON Clinical Research January 2008 - Present
PAREXEL February 2005 - October 2007
CHF Solutions March 2004 - February 2006
Arizant Healthcare October 1997 - March 2004
Skills
CTMS, Clinical Data Management, Medical Devices, Regulatory Submissions, Pharmaceutical Industry, Sop, Infectious Diseases, Pharmacovigilance, Oracle Clinical, Regulatory Affairs, Drug Development, Protocol, Clinical Operations, Vaccines, Biotechnology
Education
Capella University 2008 — 2011
MHCA, Masters in Health Care Administration
Walden University 2004 — 2005
Master of Public Health Course work
Concordia University-St. Paul 1998 — 2001
Organizational Leadership
PAREXEL April 2015 - Present
Newton-Wellesley Hospital March 2014 - Present
Coldwell Banker July 2013 - Present
Church of God (Cleveland, TN) October 2012 - Present
Tufts Medical Center August 2013 - March 2014
Dana-Farber Cancer Institute August 2007 - August 2013
Tufts Medical Center 2004 - 2007
Skills
Nonprofits, Clinical Research, Public Speaking, Community Outreach, Windows, Non-profits, Program Development, Volunteer Management, Microsoft Office, Editing, Program Management, Management, Teaching, Clinical Trials, Research, Healthcare, Training, Public Health, Hospitals, Customer Service, Budgets
Education
Cambridge College 2008 — 2009
MS, Healthcare Management
University of Massachusetts Boston 1997 — 2002
BA, Economics
PAREXEL August 2014 - Present
PAREXEL February 2014 - August 2014
OC Medical and Disc Institute June 2013 - February 2014
Family Health Centers of San Diego March 2012 - June 2012
Student Health Services September 2010 - June 2012
MCL Health Management August 2008 - November 2009
Skills
Wellness, Health Education, Software Documentation, Crisis Intervention, Public Health, Illustrator, Community Service, Program Evaluation, Research, Health Promotion, Fundraising, Program Development, Nonprofits, SPSS, Volunteer Management, Qualitative Research, Community Outreach, Case Managment, Healthcare, Grant Writing, Public Speaking, Grants, Community Health, Prevention, Epidemiology
Education
San Diego State University-California State University 2009 — 2015
Master of Public Health, Health Promotion and Behavioral Science
California State University-Long Beach 2003 — 2008
Bachelor of Arts, Medical Sociology
PRA Health Sciences September 2006 - Present
AstraZeneca March 2004 - August 2006
Parexel 2003 - 2004
Pharmaceutical Resource Corporation 2001 - 2003
Lee Memorial Health System, Southwest Florida Regional Medical Center 1996 - 2001
Skills
Clinical Monitoring, CTMS, GCP, EDC, ICH-GCP, CRO, Clinical Trials, Clinical Development, Oncology, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Pharmaceutical Industry, Clinical Research, Diabetes, Neurology, Regulatory Submissions, Cardiology, Clinical Operations, Protocol, Phase I, Sop
Education
Florida Gulf Coast University 1999 — 2001
BSN, Registered Nursing/Registered Nurse
City University of New York 1994 — 1996
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse
PRA Health Sciences November 2007 - Present
PAREXEL January 2006 - October 2007
Kendle International 1997 - 2005
Skills
Medical Devices, Clinical Trials, CTMS, FDA, Healthcare, Regulatory Affairs, Microsoft Office, Sop, Clinical Data Management, EDC, CRO, Clinical Development, Clinical Operations, Clinical Monitoring, Program Management, GCP, Pharmaceutical Industry
Education
California State University-Long Beach 1981 — 1988
Microbiology, Medical Microbiology and Chemistry
CRC Clinical Research Services, Inc (Study Start-up/Compliance/Reg Doc Creation and Review) April 2010 - Present
SRA International (previously Constella Group) 2008 - 2009
Constella Group 2006 - 2008
Constella Group 2004 - 2006
Parexel February 2003 - August 2004
PPD 2004 - 2004
UNC Lineberger Comprehensive Cancer Center-Protocol Office 2002 - 2003
Skills
Internal Audit, Clinical Trials, Clinical Research, CRO, CTMS, GCP, ICH-GCP, Pharmaceutical Industry, Protocol, Regulatory Affairs, SOP, Sop
Education
Campbell University
MS, Clinical Research
North Carolina State University
BS, Biology, minor in Genetics
ClinExpert Consultants Inc. January 2015 - Present
Harubin Consulting Inc. January 2001 - December 2014
Covance 2010 - 2012
Covance 2010 - 2012
Parexel November 1998 - December 2000
Quintiles May 1997 - November 1998
McGill University March 1996 - May 1997
McGill University January 1989 - March 1996
Skills
Clinical Monitoring, EDC, GCP, CTMS, CRO, Endocrinology, Oncology, Infectious Diseases, Neurology, Cardiology, Protocol, Clinical Trials, Clinical Research, Dermatology, Medicine, Ophthalmology, Diabetes, ICH-GCP, Clinical Data Management, Pediatrics, Therapeutic Areas
Education
Concordia University 1984 — 1988
Bachelor's, Psychology
CEGEP - John Abbott College 1981 — 1984
Degree, Health Sciences
Worldwide Clinical Trials May 2014 - Present
Parexel March 2012 - March 2014
ICON plc April 2011 - April 2012
WWCT April 2011 - March 2012
Paraxel June 2010 - October 2010
Chiltern International May 2005 - May 2010
Wyeth Pharmaceuticals November 1989 - April 2000
Skills
Vaccines, Immunology, Lupus, Infection, Pain Management, Arthritis, GERD, ICU, Clinical Operations, Clinical Trials, Clinical Research, oncology, Kidney Transplant, Cardiology, diabetes neuropathy, CNS disorders, ICH-GCP, Oncology, Biotechnology, CTMS, Sop
Education
Saint Joseph's University 1974 — 1979
Health Management
Cape Cod Community College 1969 — 1972
AD, Registered Nurse
PAREXEL November 2012 - Present
eClinical Solutions, a division of Eliassen Group July 2010 - Present
Skills
Clinical Research, Data Management, CDISC, Oracle Clinical, Clinical Data Management, FDA, EDC, 21 CFR Part 11, CRO, Clinical Trials, SAS, GCP, Biostatistics, SAS programming, Pharmaceutical Industry, Validation, Statistical Programming, Clinical Development, Oncology, Biotechnology
Education
Central Connecticut State University 2006 — 2007
Masters, Computer Science
Deloitte September 2012 - Present
Invesco US May 2013 - December 2013
McDonald's Corporation March 2013 - July 2013
Motorola Solutions March 2012 - March 2013
LG&E & KU February 2013 - February 2013
Deloitte Consulting August 2010 - August 2012
Gilead Sciences August 2010 - January 2012
PAREXEL August 2009 - May 2010
Dot Hill Systems 2008 - 2009
Beachbody April 2008 - August 2008
Skills
Oracle E-Business Suite, Oracle Applications, PL/SQL, ERP, Business Process, Business Intelligence, Requirements Analysis, SDLC, Business Analysis, Oracle, Business Process..., Consulting, Solution Architecture, Integration, IT Strategy, Oracle HR, Software Development..., Oracle Cloud Project..., Oracle Cloud Financial, Accounting operations, Financial Systems..., Project Management, ERP Financial Training, Business Process..., Financial Reporting, Leadership, Microsoft Project, User Acceptance Testing, Cloud Applications, Software Project..., Business Process Design, SQL, Enterprise Software, Requirements Gathering, Oracle Financials
Education
Wayne State University 2003 — 2006
Bechlor of Science, Electrical and Computer Engineering, 3.7
City Colleges of Chicago-Harry S Truman College 2001 — 2003
Associate of Science (A.S.), Associates, Honor Roll
Marc Garneau Collegiate Institute 1997 — 2000
High School Deploma - Honor Roll, High School/Secondary Diplomas and Certificates
Novella Clinical August 2015 - Present
PAREXEL March 2015 - Present
GlaxoSmithKline April 2003 - March 2015
GLAXOSMITHKLINE (CLINFORCE) MEDICAL AFFAIRS September 2002 - April 2003
PAREXEL INTERNATIONAL January 2001 - April 2002
CLINTRIALS RESEARCH September 1998 - September 2000
Skills
Clinical Research, Clinical Trials, CRO, Clinical, FDA, Sop, ICH-GCP, Clinical Development, Data Management, Drug Development, Pharmaceutical Industry, Protocol, Clinical Data Management, Clinical Study Design, CTMS, Therapeutic Areas, Validation, GCP, EDC, Clinical Operations, Regulatory Submissions, Infectious Diseases, Inform, Oncology
Education
University of Phoenix 2007 — 2012
Bachelor of Science (BS), Psychology-Behavioral Science
Campbell University 2005 — 2006
Clinical Research
PPD August 2010 - Present
PAREXEL August 2008 - August 2010
Skills
CTMS, Clinical Monitoring, GCP, Training, Clinical Research, CRO, Clinical Trials, Regulatory Submissions, Customer Service, Sales Management, Strategic Planning, Microsoft Word, Public Speaking, Pharmaceutical Industry, Research, EDC, Microsoft Office, Management, Microsoft Excel, Leadership, Marketing Strategy
Education
Capella University 2010 — 2013
Master of Education (MEd), Adult Education
Marshall University 2000 — 2005
Bachelor's degree, Psychology/Political Science
PAREXEL January 2015 - Present
Amgen November 2013 - January 2015
Amgen April 2006 - November 2013
Quest Diagnostics 2003 - April 2006
Quest Diagnostics 1996 - 2003
Skills
Clinical Trials, EDC, GCP, Sop, Clinical Data Management, Six Sigma, Pharmaceutical Industry, Clinical Development, Biotechnology, Data Management, CTMS, Oncology, CRO, 21 CFR Part 11, Protocol, FDA, Validation, Biopharmaceuticals, Change Control, Clinical Research, Computer System..., Databases, Drug Development, Drug Discovery, GLP, GMP, Lifesciences, ICH-GCP, Immunology, Infectious Diseases, Laboratory, Medical Devices, Microbiology, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Clinical Monitoring, Quality System, R, Life Sciences
Education
California State University-Northridge 1997 — 2001
BA, Art
University of California, Davis 1991 — 1995
BS, Animal Science
Automated Systems, Inc. May 2003 - Present
PAREXEL 1998 - 2002
Fischer and Porter - (ABB) 1988 - 2001
Advanced Automation Associates, inc. 1992 - 1997
Research Cottrell, Inc. 1981 - 1988
Skills
SDLC, 21 CFR Part 11, Quality Assurance, Validation, CAPA, Project Management, FDA, GMP, V&V, Program Management, Change Management, Pharmaceutical Industry, Business Analysis, Change Control, Testing, Computer System..., Biotechnology
Education
California State University-Northridge
Bachelor of Science in Electrical Engineering (BSEE), Automation Engineering.
West Coast University
Master of Science (M.S.) in Management Science, Finance and Project Management
INC Research February 2010 - Present
PAREXEL August 2005 - November 2009
PAREXEL September 2007 - February 2009
PAREXEL April 2007 - September 2007
PAREXEL August 2005 - April 2007
PharmaNet Development Group, Inc. August 2004 - July 2005
Rho, Inc. 2003 - 2004
Skills
Protocol, Lotus Notes, GCP, Clinical Trials, Clinical Research, Clinical Monitoring, Clinical Operations, Drug Development, Clinical Development, ICH-GCP
Education
Campbell University 1998 — 2002
BSCR, Clinical Research
DOCS September 2013 - Present
PAREXEL March 2010 - June 2012
PAREXEL February 2007 - March 2010
PAREXEL March 2004 - February 2007
PAREXEL March 2002 - March 2004
PAREXEL May 2001 - March 2002
Duke University Medical Center 1998 - 2001
Laboratory Corporation of America 1995 - 1998
Skills
Vendor Management, Quality Assurance, Clinical Trials, Pharmaceutical Industry, GCP, CTMS, EDC, Clinical Monitoring, Clinical Research, FDA, Data Management, ICH-GCP, Sop, Protocol, CRO, Clinical Development, SOP, Therapeutic Areas
Education
Campbell University
Master of Science (MS)
North Carolina Central University
Bachelor's degree
Baxalta July 2015 - Present
Baxter Healthcare January 2013 - Present
Apostle Clinical Trials, Inc. January 2012 - January 2013
Quest Diagnostics July 2011 - January 2012
PAREXEL December 2010 - June 2011
PAREXEL August 2010 - December 2010
PAREXEL November 2007 - October 2010
Skills
CAPA, SOP development, 21 CFR, ICH-GCP, FDA, Clinical Trials, Sop, GCP, Oncology, Management, CRO, Clinical Research, Quality Assurance, Protocol, Regulatory Requirements
Education
California State University-Northridge
Bachelor's degree, Biology, General
PAREXEL February 2015 - Present
PAREXEL June 2013 - January 2015
ICON collaborative partner of AMGEN November 2010 - June 2013
Pfizer Canada April 2006 - November 2010
PFIZER CANADA INC. December 2005 - April 2006
PFIZER CANADA INC. May 2004 - December 2005
MDS Pharma Services Inc. (Formerly LAB Pharmacological Research & MDS Harris Laboratories), September 2000 - July 2003
LAB PHARM. RESEARCH INTL. INC. June 1998 - September 2000
LAB PHARMACOLOGICAL RESEARCH INTL. INC. January 1998 - June 1998
PHOENIX INTL. LIFE SCIENCES INC., June 1995 - January 1998
Skills
CTMS, Clinical Trials, GCP, EDC, Clinical Research, Data Management, Regulatory Submissions, Oncology, Therapeutic Areas, Biotechnology, Rheumatology, Infectious Diseases, Vaccines, Endocrinology, Cardiology, Dermatology, Neuroscience, Clinical, Clinical Site Monitoring, Mentoring New Hires, Project Management, Customer Service
Education
Concordia University 1985 — 1989
Bachelor of Arts, Philosophy
CEGEP - John Abbott College 1983 — 1985
DEC, Social Sciences
Stony Brook University June 2014 - Present
Atlantic Research Group August 2013 - June 2014
University of Virginia October 2011 - August 2013
Alere, Inc. October 2010 - October 2011
PAREXEL March 2009 - October 2010
Nevada Cancer Institute November 2005 - March 2009
Southern Nevada Cancer Research Foundation May 2005 - November 2005
PRA International October 2003 - March 2005
Skills
Data Management, GCP, Research, Microsoft Office, Management, OnCore, Budget Development, Budget Reconciliation, Study Coordination, Clinical Development, Oncology, Clinical Monitoring, Clinical Research, Clinical Trials, CTMS, Protocol, Cancer, IRB, ICH-GCP, CRO, Infectious Diseases, EDC, Medical Devices
Education
Central Michigan University 2012 — 2013
MSA, Research Administration
University of Massachusetts, Amherst 2011 — 2012
Bachelor of Arts (BA), Healthcare Administration
PAREXEL April 2012 - Present
Novartis Pharmaceuticals Corporation July 2006 - February 2012
Novartis Pharmaceuticals September 2004 - October 2006
Skills
Contract Negotiation, Pharmaceutical Industry, Clinical Trials, Clinical Development, Biotechnology, Neuroscience, Clinical Research, CTMS, EDC, Healthcare, Contract Management
Education
Centenary College 2003 — 2006
BS, Business Administration and Management, General
PAREXEL March 2012 - Present
i3 Research May 2010 - January 2012
Clinsys Clinical Research October 2002 - March 2010
Schering-Plough Research Institute December 1991 - October 2002
Skills
CRO, Clinical Trial..., Protocol Development, GCP, Clinical Development, Clinical Research, EDC, Clinical Trials, Oncology, Infectious Diseases, Asthma, SOP, Pharmaceuticals, Neurology, Cardiology, Healthcare, Cross-functional Team..., Clinical Monitoring, Nursing
Education
University of Pittsburgh 1987 — 1991
MPH, Epidemiology
Carlow College 1973 — 1977
BSN, Nursing
PPD January 2014 - March 2015
NC Dept. Health and Human Services, Dept. of Medical Assistance October 2010 - January 2014
Wells Fargo July 2010 - September 2010
Rho, Inc. May 2007 - February 2009
Ockham Development Group (an ASG Company) December 2004 - May 2007
INC Research June 2004 - December 2004
PAREXEL March 1997 - February 2004
LOREX SYNTHELABO LIMITED June 1985 - March 1997
Skills
SAS, Oracle, Clinical Data Management, SAS programming, Data Analysis, Data Mining, Programming, Access, Oracle Clinical, Clinical Trials, Microsoft SQL Server, Sybase, Windows 7, CDISC, Database Design, PL/SQL, Unix, XML, Database Administration, SQL*Plus, CRO, SDTM, Databases, Data Management, SQL, Management, Data Warehousing, Consulting
Education
Chicago State University 1977 — 1982
B.S.
Kaiser Permanente May 2014 - Present
PAREXEL January 2013 - Present
Macy's November 2012 - January 2013
Skills
Neuroscience, Research, Matlab, Public Speaking, PowerPoint, Clinical Research, Microsoft Office, Molecular Biology, Teaching, Microsoft Word, Healthcare, Microsoft Excel, Data Analysis, Medical Education, Lifesciences, Cell Culture
Education
University of California, Los Angeles 2009 — 2012
Bachelor of Science (B.S.), Neuroscience
Mt. San Antonio College 2007 — 2009
None, Transfer (IGETC)
California Institute of Technology 2005 — 2007
None, Undeclared/Mechanical Engineering
PAREXEL March 2015 - Present
GSK April 2013 - February 2015
GlaxoSmithKline April 2012 - March 2013
GlaxoSmithKline February 1990 - July 2011
Skills
Case Report Forms, Clinical Data Management, Clinical Development, Clinical Research, Clinical Trials, GCP, Pharmaceutical Industry, Sop, Microsoft Office, PowerPoint, Microsoft Excel, Microsoft Word, Outlook, 21 CFR Part 11, SOP
Education
Campbell University
Gilead Sciences April 2013 - May 2015
Amgen 2008 - March 2013
Parexel October 2007 - May 2008
Skills
Inflammation, Neurology, Early Development, General Medicine, Liver Disease, Bone
Education
Woodbury University 2009 — 2010
MBA
California State University-Long Beach 2002 — 2005
Bachelor's degree, Biology, General
Holy Infant Home Care October 2011 - Present
PAREXEL March 2009 - Present
Education
Chaffey College
UCLA David Geffen School of Medicine (JCCC-Translational Research In Oncology–US) November 2014 - Present
PAREXEL August 2013 - November 2014
PAREXEL August 2012 - August 2013
AVG Medical Managment March 2010 - February 2012
Urban Outfitters August 2008 - August 2011
Skills
Clinical Research, Healthcare, Healthcare Management, Clinical Trials, HIPAA, Hospitals, Public Health, Medical Devices, Patient Safety, Medical Records, Cpr Certified, PowerPoint, Outlook, Research, Healthcare Consulting, Medicare, CRO, Early Phase Clinical..., Pharmaceutical Industry, Medical Terminology, CPR Certified, Clinical Development, Microsoft Office, Data Entry, Protocol, GCP, ICH-GCP
Education
California State University-Northridge 2008 — 2012
Bachelor of Science (B.S.), Health/Health Care Administration/Management
Verdugo Hills Senior High School 2004 — 2008
High School Diploma, General Studies
Northern Virginia July 2012 - Present
OptumInsight June 2007 - July 2012
PAREXEL January 2002 - March 2007
ActiveHealth Management July 2000 - January 2001
Skills
Clinical Research, Clinical Monitoring, Cross-functional Team..., Leadership, late phase research, Observational Studies, Interventional Studies, Personnel Management, Personnel Selection, Training Delivery, Learning Management..., Project Planning, Project Management, Health Promotion, Healthcare Management, Process Improvement, Process Management, Training, Resource Management, Coaching, Mentoring Of Staff, Organizational Learning, Healthcare Consulting, Employee Wellness...
Education
Central Michigan University 1993 — 1995
MS, Health Services Administration
George Mason University 1985 — 1990
BS, Health Education and Marketing
INC Research May 2015 - Present
Premier Research November 2012 - May 2015
PAREXEL January 2010 - November 2012
Premier Research April 2006 - October 2009
PPD February 2003 - April 2006
Skills
Clinical Development, Clinical Trials, GCP, CRO, Clinical Research, EDC, ICH-GCP, Clinical Monitoring, Therapeutic Areas
Education
Carson-Newman College 1995 — 1999
Bachelor's degree, Biology, General
PAREXEL 2015 - Present
PAREXEL 2013 - 2015
London Pain Consortium December 2008 - April 2013
GlaxoSmithKline September 2005 - September 2006
Skills
Clinical Trials, Clinical Research, Science, Statistics, Data Analysis, ICH-GCP, Research, Qualitative Research, Immunohistochemistry, Drug Discovery, Clinical Development, SPSS, Organisation of large..., Ethical application, HPLC-MS, Respiratory research, Neurology research
Education
King's College London 2009 — 2013
Doctor of Philosophy (PhD)
Imperial College London 2007 — 2008
Masters of Research (MRes) Bioimaging
Cardiff University / Prifysgol Caerdydd 2002 — 2007
BSc (Hons) including 2 years in Industry
Sussex Downs Tertiary College (part time evening course) 2001 — 2002
A level
Ryde High School, Isle of Wight, UK 1997 — 2001
A levels