PAREXEL International
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 International Employees
PAREXEL International January 2011 - July 2013
PAREXEL International/California Clinical Trials March 2003 - January 2011
California Clinical Trials February 2002 - February 2003
California Clinical Trials February 2000 - January 2002
California Clinical Trials August 1998 - January 2000
Skills
Clinical Development, Clinical Research, Pharmaceutical Industry, CRO, Clinical Trials, FDA, CTMS, GCP, Sop, ICH-GCP, Quality Assurance, EDC, Protocol, Clinical Monitoring, SOP, Regulatory Affairs
Education
University of California, Los Angeles
Bachelor of Arts (BA), Psychology
ROLEX November 2014 - Present
Christopher Fan Photography January 2012 - Present
Volcom May 2014 - November 2014
Blinnk Photography May 2014 - August 2014
Beckman Coulter October 2013 - February 2014
Robert Benson July 2012 - October 2013
PAREXEL International August 2011 - August 2012
University of California June 2011 - December 2011
University of California San Diego September 2010 - June 2011
Skills
Sales, Luxury Goods, Retail, Customer Service, Sales Management, Mandarin, Japanese, Photography, Analysis, Budgets, Economics, Research, Forecasting, Microsoft Excel, Finance, Financial Accounting, Teaching, Data Analysis, Invoicing, Market Research
Education
University of California, San Diego 2008 — 2012
Bachelor of Arts, Economics
University of California, San Diego 2008 — 2012
Economics
Patara Pharma, LLC July 2015 - Present
Auspex Pharmaceuticals, Inc. April 2015 - July 2015
Auspex Pharmaceuticals, Inc. March 2014 - April 2015
Santarus, Inc. August 2011 - March 2014
NexBio July 2010 - August 2011
Proacta November 2008 - May 2010
Vical May 2007 - November 2008
PAREXEL International April 2005 - May 2007
Pfizer 2004 - 2005
Skills
Clinical Trials, Clinical Research, Clinical Development, CRO, GCP, Oncology, CTMS, Biotechnology, Clinical Monitoring, EDC, Drug Development, Pharmaceutical Industry, Regulatory Submissions, Lifesciences, Therapeutic Areas, Clinical Data Management, Life Sciences
Education
The University of Southern Mississippi 1999 — 2006
MA, PhD
Truman State University 1995 — 1999
Bachelor of Science
Pfizer February 2014 - Present
Proacta, Inc. January 2008 - October 2013
Proacta, Inc. July 2006 - January 2008
Pfizer, Inc. January 2006 - June 2006
Pfizer 2004 - 2005
Parexel International 1999 - 2005
Parexel International 1999 - 2000
Skills
Clinical Trials, Clinical Monitoring, Oncology, Clinical Operations, Clinical Development, GCP, CTMS, Therapeutic Areas, CRO, Pharmaceutical Industry, Biotechnology, EDC, Clinical Research, ICH-GCP, Drug Development, Clinical Data Management, Regulatory Affairs, Regulatory Submissions, Lifesciences, FDA, Infectious Diseases, Sop, Hematology, IND, Protocol
Education
University of Arizona 1993 — 1997
Bachelor of Science (BS), Exercise Physiology
PAREXEL February 2013 - Present
PAREXEL International December 2011 - Present
Duke Clinical Research Institute April 2011 - December 2011
PAREXEL International April 2010 - April 2011
PAREXEL International June 2008 - April 2010
PAREXEL International October 2006 - June 2008
PharmaNet June 2006 - October 2006
Family Health International June 2004 - June 2006
Family Health International June 2002 - June 2006
Family Health International January 2001 - July 2002
Skills
Clinical Research, Proposal Writing, RFP, Strategic Partnerships, Contract Negotiation, Contract Management, Proposal Review, Training Personnel, Personnel Training, Personnel Supervision, Pharmaceutical Industry, Clinical Trials, CRO, Management, Project Management
Education
University of North Carolina at Chapel Hill 2007 — 2009
MPH, Health Policy and Management
University of North Carolina at Chapel Hill 1995 — 1999
BSPH, Health Administration
San Diego Unified School District July 2013 - June 2015
San Diego Blood Bank July 2013 - June 2015
Kohl's Department Stores August 2013 - April 2015
Volunteering at The Medical Examiners office in San Diego April 2013 - November 2013
Kohl's Department Stores October 2012 - December 2012
MMD INC/ Inventiv Health Clinical June 1998 - December 1998
Parexel International August 1997 - November 1997
Dependable Nurses Inc August 1995 - December 1996
Skills
Coordinating Events, Maintaining Strong..., investigate and direct..., Explain or educate..., Interview patients to..., Provide consultation or..., develop education..., Perpare and devlope..., documented actives and..., worked in hopital..., Organizational..., Collaberated with sales..., Collaborate with health..., Design and conduct..., Customer Retention, Customer Experience, Public Health, Health Insurance, Geriatric Nursing, Stroke Rehabilitation, Smoking Cessation, Creative Problem Solving, problem sensitivity, oral expression, speech clarity, deuctive reasoning, Teamwork, Social Networking, Social Skills, Social Media, Budgets, Strategic Planning, Listening to customers, Long-term Care, Child Advocacy, Women's Health, Write I.E.P. goals and..., Pharmaceutical Sales, Neuroscience, Osteoporosis
Education
University of Arizona 1993 — 1996
Bachelor’s Degree, Public Health
PAREXEL International September 2015 - Present
SunGard Financial Systems July 2013 - September 2015
AdapTech Corp January 2011 - February 2013
Project Resources Inc March 2010 - January 2011
LPL Financial December 2007 - January 2009
Skills
Strategic Financial..., Project Management, Contract Management, Contract Negotiation, Management, Budgets, Procurement, Team Building, Microsoft Excel, Risk Management, Financial Modeling, Project Finance, Financial Analysis, Financial Forecasting, Economics
Education
University of California, San Diego
BA, Economics
Celgene November 2011 - Present
PAREXEL July 2010 - September 2011
AstraZeneca/RPS September 2007 - September 2009
AstraZeneca May 2004 - September 2007
PAREXEL International February 2002 - May 2004
PRA International May 2000 - February 2002
Skills
Clinical Monitoring, CTMS, ICH-GCP, GCP, EDC, Therapeutic Areas, CRO, Clinical Trials, Oncology, Clinical Development, Clinical Operations, Clinical Research, Hematology
Education
University of Missouri-Columbia 1996 — 1999
BS, Nursing
IGNYTA, Inc. October 2015 - Present
Kauffman Fellows December 2014 - Present
AbbVie December 2014 - August 2015
Hyde Park Angels November 2012 - January 2015
Parexel International August 2011 - December 2014
Synteract, Inc. November 2008 - August 2011
Cedars-Sinai Medical Center January 2006 - May 2007
Skills
Clinical Trials, Oncology, Clinical Research, Biotechnology, Venture Capital, Clinical Development, CTMS, FDA, Regulatory Affairs, Medical Devices
Education
The University of Chicago - Booth School of Business 2012 — 2015
Master of Business Administration (MBA), Concentration in Finance and Entrepreneurship
University of California, Los Angeles 2004 — 2008
BS, Microbiology, Immunology, and Molecular Genetics
Premier Research October 2013 - Present
Parexel International January 2013 - October 2013
Cato Research August 2011 - November 2012
CROfessionals LLC August 2009 - May 2011
ICON Clinical Research October 2007 - August 2009
Vernalis 2005 - 2006
sanofi-aventis February 1997 - December 2005
GlaxoWellcome June 1987 - February 1997
Skills
Clinical Monitoring, Clinical Trials, Infectious Diseases, Life Sciences, Clinical, Oncology, Pain Management, Clinical Research, Neurology, GCP, Surgery
Education
University of Colorado Boulder
BA, Biology
University of Denver - Daniels College of Business
MBA, Business
PAREXEL International May 2015 - Present
PAREXEL International February 2013 - May 2015
PAREXEL International November 2011 - February 2013
PAREXEL International April 2010 - November 2011
PAREXEL International June 2007 - April 2010
PAREXEL, International June 2006 - June 2007
PAREXEL, International November 2004 - June 2006
PAREXEL, International December 1999 - November 2004
PAREXEL, International January 1999 - December 1999
Duke Cancer Prevention, Detection and Control Center January 1996 - January 1999
Skills
Leadership, Management, Data Management, Databases, Research, Proposal Writing, Clinical Trials, Pharmaceutical Industry, Oncology, CRO, Clinical Research, Biotechnology, Clinical Development
Education
St. Edward's University 1989 — 1991
MBA, Finance
The University of Texas at Austin 1981 — 1985
Bachelor of Arts (B.A.), Sociology
PPD April 2015 - Present
PAREXEL International January 2011 - March 2015
PAREXEL International May 2010 - January 2011
Pfizer/Wyeth Pharmaceuticals October 2008 - May 2010
Tufts Medical Center May 2006 - October 2008
Brown Medical School January 2003 - September 2005
University of Michigan September 1999 - May 2001
University of Michigan January 1997 - May 2001
Skills
Project Management, Cross-functional Team..., Communication Skills, Project Finance, Supply Chain Management, Critical Thinking, Training Delivery, Third Party Vendor..., IVR, Creative Solutions, Analytical Skills, Clinical Study Design, GCP, Pharmaceutical Industry, CRO, CTMS, EDC, Clinical Development, Clinical Research, Clinical Trials, Data Management, FDA, Oncology, SOP, Logistics Management, Team Leadership, Biotechnology, Peer Mentoring
Education
University of Michigan 1995 — 1997
M.P.H., Public Health
Brown University 2005 — 2006
Medical Coursework
Bryn Mawr College 2001 — 2002
Post-Baccalaureate Pre-Medical Certificate
University of Michigan
B.A., Anthropology and African Studies
PAREXEL International November 2014 - Present
PAREXEL International May 2012 - Present
PAREXEL Consulting January 2011 - April 2012
Science and Compliance LLC April 2008 - April 2012
Rondaxe Pharma April 2008 - April 2012
Bristol-Myers Squibb December 2001 - December 2007
Bristol-Myers Squibb November 1999 - December 2001
Bristol-Myers Squibb September 1997 - November 1999
Skills
Technology Transfer, Quality Assurance, Manufacturing, Project Management, CAPA, Quality System, Management, FDA, Pharmaceutical Industry, Product Development, Biotechnology, Analytical Chemistry, Regulatory Affairs, Process Engineering, Quality Control, Process Simulation, Chemistry, Strategy, Validation, GMP, Leadership, SOP, V&V
Education
TCU 1979 — 1981
National Science Foundation Postdoctoral Fellow, Synthesis and Study of Unique Organic Molecules with P. D. Bartlett
The Ohio State University 1973 — 1978
Ph.D., Organic Chemistry - Synthesis of Nucleoside Antibiotics
State University of New York College at Potsdam 1969 — 1973
Bachelors, Chemistry and Biology - Double Major with Honors
CrunchTime! June 2015 - Present
Copyright Clearance Center March 2014 - June 2015
Copyright Clearance Center September 2011 - March 2014
Copyright Clearance Center August 2007 - September 2011
Copyright Clearance Center October 2002 - August 2007
Parexel International July 2001 - October 2002
Inforonics May 1997 - July 2001
Copyright Clearance Center March 1996 - May 1997
The Analytic Sciences Corp. (TASC) June 1993 - March 1996
Skills
Software Development, Architecture, Agile Methodologies, Database Design, XML, Java Enterprise Edition, SQL, Java, Web Services, Scrum, Databases, Requirements Analysis, Software Project..., Unix, PL/SQL, Architectures, Perl, Web Applications, Oracle, Software Requirements, JavaScript, Integration, Enterprise Software, SDLC
Education
University of Massachusetts Lowell 1990 — 1993
BS
PAREXEL August 2013 - Present
PAREXEL International October 2010 - July 2013
Paragon Biomedical June 2008 - October 2010
Metagenics, Inc July 2002 - June 2008
FHS Research Center December 1999 - July 2002
Skills
Inform, Datalabs, Medidata, CIMS, CTMS, Impact Harmony, My Sites
Education
Tacoma Community College
Associates, Arts and Sciences
Liberty Mutual Insurance February 2014 - Present
PAREXEL International July 2012 - February 2014
University at Buffalo School of Management August 2010 - May 2012
University at Buffalo September 2011 - December 2011
National Fuel Gas Distribution Corporation May 2011 - August 2011
Wegmans Food Markets October 2004 - August 2011
St. Joseph's Villa June 2009 - July 2009
Skills
Data Modeling, Hypothesis Testing, Pivot Tables, Reconciliations, Linear Regression, Solver, Offset, Data Validation, Excel, Microsoft Office, Data Analysis, PowerPoint, Financial Analysis, Word, Public Speaking, Mentoring, Microsoft Excel, Microsoft Word, Analysis, Spreadsheets, Teamwork, Leadership, Human Resources, Statistics, Research, Finance, Employee Benefits, Account Reconciliation, Access, Inventory Management, Time Management, SPSS, Recruiting, Offset Printing, Management, Deferred Compensation, Outlook, PeopleSoft, Market Research
Education
University at Buffalo 2010 — 2012
MBA, Consulting and Workforce Management
State University of New York College at Brockport 2006 — 2010
BS, Business Management, Finance
Penfield High School 2002 — 2006
PAREXEL International February 2012 - Present
Synthon Pharmaceuticals, Inc. January 2012 - February 2012
Synthon Pharmaceuticals, Inc. February 2008 - January 2012
Stiefel, a GSK company June 2006 - February 2008
Stiefel Research Institute, Inc. January 2005 - June 2006
Stiefel Research Institute, Inc. June 2001 - January 2005
Skills
Regulatory Affairs..., Regulatory Affairs, Analytical Chemistry, Regulatory Strategy, Regulatory Submissions, GMP, ANDA, HPLC, Pharmaceuticals, Sop, Pharmaceutical Industry, V&V, FDA, 21 CFR Part 11
Education
The College of Saint Rose 1997 — 2001
Bachelor of Arts, Biology
Chatham High School 1992 — 1996
PAREXEL International October 2012 - Present
PAREXEL April 2012 - October 2012
PAREXEL International March 2010 - April 2012
PAREXEL International May 2007 - March 2010
PAREXEL International May 2006 - May 2007
Healthcare Research Division March 2006 - May 2006
Harris Interactive October 2005 - March 2006
Harris Interactive January 2004 - October 2005
Harris Interactive September 2002 - January 2004
University of Rochester June 1999 - July 2002
Skills
Clinical Research, Clinical Trials, CRO, CTMS, GCP, Clinical Development, EDC, Protocol, Regulatory Submissions, Clinical Data Management, Clinical Monitoring, Pharmaceutical Industry, ICH-GCP, Therapeutic Areas, Oncology, Drug Development, Diabetes, Neurology, Cross-functional Team..., Lifesciences, Sop, Biotechnology, Clinical Operations, Infectious Diseases, Medical Writing, Vaccines, Pharmacovigilance, Endocrinology, Inform, Clinical Study Design, SOP, Life Sciences
Education
State University of New York College at Brockport 1996 — 2001
Bachelors of Science, Psychology
Stoney Brook Veterinary Hospital April 2009 - Present
Brinbella Kennel October 2005 - Present
Mascoma Valley Regional High School March 2014 - May 2015
Hanover Veterinary Clinic September 2005 - December 2008
Dartmouth College February 2002 - April 2005
Animal Hospital of Nashua December 2000 - January 2002
Parexel International November 1999 - July 2000
Statprobe, Inc October 1998 - October 1999
Children's Hospital February 1997 - June 1998
CEISAR, Guatemala June 1997 - August 1997
Skills
Data Analysis, Project Coordination, Motivated self-starter, Databases, Time Management, Appointment Scheduling, Clinical Data Management, Communication Skills, GLP, Work Well Independently, Coordinating Events, Data Entry, Animal Behavior, Multitasking Skills, Database Design, Trial Management, Team-oriented, Process Improvement, Policy, Creativity, Kennel Management, Animal Husbandry, Close Attention to..., Reports, Timely Decision Making, Animal Work
Education
Bancroft School of Massage 2006 — 2007
Certification, Small Animal Massage Therapy
University of Alabama at Birmingham 1996 — 1998
Master of Public Health, International Health and Epidemiology
The College of Wooster 1991 — 1995
Bachelor of Arts, History, Technical Theater (minor)
PAREXEL International Senior Manager, Feasibility & Clinical InformaticsPAREXELFebruary 2013 - November 2013
PAREXEL International 2009 - February 2013
PAREXEL 2009 - 2010
Merck Research Laboratories 2002 - 2009
Merck 2002 - 2004
Skills
Clinical Research, Pharmacovigilance, Feasibility Studies, Line Management, Clinical Trials, Pharmaceutical Industry, CTMS, CRO, Clinical Development, EDC, GCP, Clinical Data Management, ICH-GCP, Biotechnology, Therapeutic Areas, Cardiology, Lifesciences
Education
Tulane University 1998 — 2002
BS, Neuroscience
Pearl Pathways February 2015 - Present
Pharm-Olam International March 2012 - September 2013
Pharm-Olam International May 2010 - July 2011
BRANDominance December 2008 - January 2009
SRG Woolf Group May 2007 - August 2007
Pharm-Olam International February 2006 - March 2007
Essex Pharma GmbH April 2001 - September 2003
Fujisawa GmbH April 1999 - March 2001
Parexel International April 1998 - March 1999
Education
Université Pierre et Marie Curie (Paris VI) 1996 — 1997
DU FARC
Université Paris Descartes 1994 — 1996
DEUG B
FRS Global Inc. February 2007 - October 2008
PAREXEL International December 2005 - February 2007
Skills
Data Warehousing, Microsoft SQL Server, T-SQL
Education
University of New Hampshire
BS, Math/Computer Science
Society for Clinical Research Sites October 2014 - Present
PAREXEL International 2008 - 2014
PAREXEL 2007 - 2008
AAI Pharma 2001 - 2007
Beansprout Networks Inc. 2001 - 2002
GSK 2001 - 2001
PAREXEL 1999 - 2001
Skills
Pharmaceutical Industry, Clinical Research, Clinical Trials, Cardiology, Clinical Development, CRO, Oncology
Education
University of Connecticut
Bachelor's Degree, Communications
HERON - A PAREXEL COMPANY April 2015 - Present
Bristol-Myers Squibb June 2012 - March 2015
Bridgehead International 2011 - June 2012
Heron Evidence Development 2010 - 2011
ConvaTec 2009 - 2010
ConvaTec 2006 - 2009
Accenture 2005 - 2006
PAREXEL International 2003 - 2005
American Red Cross - Biomedical Services 2002 - 2003
The Advisory Board Company 1999 - 2002
Skills
Pricing Strategy, Market Access, Health Economics, Medical Devices, Wound Care, Oncology, Managed Care, Management Consulting, Wound Healing, Government Affairs, Public Policy Research, Neuroscience, Nephrology, Hematology, Diagnostics, Advisory Boards, Dialysis, Immunology, M&A due diligence, Blood Bank, Pharmaceutical Industry, Drug Development, Biotechnology, Clinical Trials, Global Marketing, Market Research, Healthcare, Neurology, Biopharmaceuticals, Regulatory Affairs, Strategy, Healthcare Reimbursement, Pricing, Sales Effectiveness, Hospital Sales, Pharmaceutical Sales, Hospitals, Health Policy, Clinical Development, Competitive Intelligence, Cardiology, Medical Writing, Commercialization
Education
University of Michigan 1997 — 1998
MA, English
University of Houston 1992 — 1996
BA, English
PAREXEL International September 2011 - August 2012
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany February 2011 - October 2011
Millennium Pharmaceuticals September 2007 - September 2010
Genzyme 2005 - 2007
Roche Pharmaceuticals April 2004 - February 2005
Purdue Pharma 2003 - 2004
AAI Development Services 2000 - 2003
PAREXEL International 1998 - 2000
Skills
Clinical Research, CRO, Clinical Trials, GCP, Pharmaceutical Industry, EDC, Strategy, Contract Negotiation, Leadership, Clinical Development, Outsourcing, Oncology, Management, Business Development, CTMS, Cross-functional Team..., Budgets, Proposal Writing
Education
Sweet Briar College
Bachelor's Degree, Psychology
inVentiv Health Sr. Clinical Research AssociateQuintilesSeptember 2013 - July 2014
PRA International August 2010 - August 2013
PAREXEL International May 2007 - August 2010
Beth Israel Deaconess Medical Center 2001 - 2007
Skills
Clinical Trials, Clinical Monitoring, CTMS, ICH-GCP, GCP, CRO, EDC, Oncology, Therapeutic Areas, Clinical Research, Infectious Diseases, Regulatory Submissions, IRB
Education
University at Albany, SUNY 1978 — 1982
VCHS
Georgia Southern University February 2009 - Present
Georgia Southern University January 2009 - Present
American Statistical Association - ASA January 2007 - Present
Statogen Consulting (sogenstad@Statogen-Consulting.com) August 2006 - Present
Innovalyst May 2008 - December 2012
BioBridges, LLC 2008 - 2012
American Statistical Association - ASA January 2009 - December 2009
Vertex Pharmaceuticals, Inc. August 1997 - June 2006
Amgen August 1995 - July 1997
Parexel International August 1993 - July 1995
Skills
Clinical Trials, Pharmaceutical Industry, SAS, Clinical Development, Biotechnology, Biostatistics, Statistics, Data Management, Drug Development, Oncology, Clinical Study Design, FDA, Strategy, Statistical Programming, Data Analysis, Clinical Research, Medical Devices, Lifesciences, Management, GCP, Business Strategy, Analysis, Life Sciences, Consulting, Start-ups, Data Mining, Management Consulting, Leadership, Business Planning, Analytics, Cross-functional Team..., Healthcare, Predictive Modeling, Training, CRO, Biopharmaceuticals, Program Management, Change Management, Leadership Development, Validation, Product Development, Statistical Modeling, Pharmaceuticals, Six Sigma, Thought Leadership, Sop, CDISC, EDC, Protocol, Biostatistical expert...
Education
Stockholm University
PhD, Statistics
PARTNERS+simons March 2012 - Present
PAREXEL March 2011 - September 2011
Parexel International March 2011 - September 2011
First Marblehead Corporation May 2007 - September 2010
First Marblehead Corporation May 2007 - September 2010
TA Realty Associates October 2005 - February 2007
State Street Corporation March 2003 - October 2005
State Street Corporation January 1999 - October 2005
State Street Corporation October 2001 - March 2003
State Street Corporation November 2000 - October 2001
Skills
Accounting, Finance, Financial Analysis, Financial Reporting, Sarbanes-Oxley Act, General Ledger
Education
Suffolk University - Sawyer Business School 2003 — 2005
Masters of Business Administration
Sufolk University 2003 — 2005
Masters of Business Administration, International Finance
Suffolk University (Boston)
Masters, Business Administration
University of Vermont
Bachelor of Science, Business Administration; International Finance
PAREXEL International September 2011 - Present
Accenture April 2003 - August 2011
Wyeth 1998 - 2003
Genetics Institute 1993 - 1998
Skills
21 CFR Part 11, Biotechnology, Business Process..., CRO, Clinical Data Management, Clinical Development, Clinical Research, Data Management, EDC, GCP, Pharmaceutical Industry, CTMS, Clinical Trials, Cross-functional Team..., Oncology
Education
The George Washington University
B.S., Biology, Zoology
Stiris Research Inc. November 2013 - Present
T Rose Clinical, Inc. October 2001 - Present
Covance June 2011 - October 2012
Allergan June 2006 - June 2008
Medtronic December 2005 - March 2007
PPD November 2004 - August 2005
PAREXEL International 1997 - 2001
Skills
Management, Oncology, Clinical Monitoring, Clinical Research, Clinical Trials, Biotechnology, GCP, Protocol, Pharmaceutical Industry, Sop, Therapeutic Areas, Diabetes, Medical Devices, Clinical Development, CTMS, CRO, Clinical Data Management, Infectious Diseases, ICH-GCP, EDC, Clinical Operations, Clinical Study Design, Oracle Clinical, Phase I, SOP
Education
The Ohio State University 1992 — 1996
BS
ClearRock Inc. June 2007 - Present
MSPP Executive Coaching Graduate Certificate Program 2008 - 2009
Fidelity Investments March 2006 - April 2007
Executive Destinations September 1999 - March 2006
Parexel International June 1989 - July 1998
Skills
Performance Management, Leadership, Human Resources, Organizational..., Executive Coaching, Coaching, Career Counseling, Talent Acquisition, Organizational..., Organizational Design, Leadership Development, Career Development, Recruiting, Succession Planning, Employee Engagement, Workshop Facilitation, Talent Management, Career Management, Workforce Planning, 360 Feedback, MBTI, Onboarding, Management Development, Training
Education
University of Houston
Masters, Human Resources
PAREXEL International November 2014 - Present
PAREXEL International May 2013 - October 2014
PAREXEL International January 2012 - April 2013
eClinical Solutions, a division of Eliassen Group (FSP for Pfizer Inc.) March 2008 - January 2012
University of Colombo August 2003 - August 2007
Institute of Human Resorces Advancment - University of Colombo August 2003 - April 2007
Graduate Foundation - University of Colombo April 2001 - September 2005
University of Colombo August 1998 - August 2003
British Business College June 2000 - December 2002
British Academy of Higher Education February 2001 - March 2002
Skills
SAS, Microsoft Office, Windows, CRO, Statistics, Analysis, Oncology, EDC, SDLC, Statistical Programming, SQL, GCP, Clinical Research, Programming, Databases, Oracle, HTML, CDISC
Education
St. Benedict's College - Collombo 13, Sri Lanka 1994 — 1996
General Certificate of Education (Advanced Level)
St. Lucia's College - Colombo 13, Sri Lanka 1983 — 1993
General Certificate of Education (Ordinary Level)
University of Colombo
Genentech December 2004 - Present
Wyeth Pharmaceuticals April 2004 - November 2004
Parexel International April 2002 - April 2004
Skills
Biotechnology, Clinical Trials
Education
University of Nevada-Las Vegas
Bachelor of Science, Kinesiology, Biology, Psychology
YMCA of San Diego County July 2015 - Present
YMCA of San Diego County September 2014 - July 2015
YMCA of San Diego County June 2010 - September 2014
PAREXEL International February 2008 - April 2010
Delaware North Companies Parks and Resorts 2005 - 2008
Eaton Corporation 2004 - 2005
Education
University of Phoenix 2010 — 2014
Bachelor of Science degree
University of California, San Diego 2008 — 2009
Certificate
PAREXEL International March 2011 - Present
Premier Research Group December 2008 - March 2011
Tibotec Therapeutics November 2007 - December 2008
EMD Pharmceuticals (Subsidiary of Merck KGaA) 2002 - 2007
PPD 1997 - 2002
Skills
Biostatistics, Survival Analysis, CRO, Clinical Trials, Drug Development, CDISC, Oncology, Clinical Development, SDTM, Protocol, GCP, Clinical Data Management, Statistical Programming, Regulatory Submissions, CTMS, EDC, Clinical Study Design, Oracle Clinical
Education
University of North Carolina at Chapel Hill
PhD, Biostatistics
Quintiles April 2013 - Present
Quintiles January 2011 - March 2013
INC Research March 2010 - January 2011
INC Research October 2009 - March 2010
PAREXEL International November 2007 - October 2009
etrials Worldwide, Inc November 2006 - October 2007
PPD, Inc. January 2006 - November 2006
Tekelec June 2004 - July 2005
Tekelec August 1999 - September 2002
University of North Carolina at Chapel Hill August 1994 - February 1998
Skills
EDC, Clinical Data Management, Clinical Trials, CTMS, Clinical Research, CRO, Inform, GCP, Validation, ICH-GCP, Software Documentation, Project Management, Oracle Clinical, Therapeutic Areas, Medidata, Public Speaking, Program Management, 21 CFR Part 11, Clinical Study Design, Clinical Development, Pastoral Care, Pharmaceutical Industry, Clinical Monitoring, CRF design, Process Improvement, Medidata RAVE, Process Management, Staff Development, IVR, Research Project..., Christian Counseling, Spanish-speaking, InForm GTM, Leadership, Leadership Development, Training
Education
New Covenant International (NCI) Bible College 2009 — 2014
Doctor of Philosophy (Ph.D.), Christian Ministry
New Covenant International (NCI) Bible College 2009 — 2014
Master (M.B.S., en passant), Biblical Studies
University of North Carolina at Chapel Hill 1994 — 1997
Bachelor of Arts (B.A.), Foreign Language
FirTree Analytics & Media December 2012 - Present
CRAB 2015 - 2015
CRAB 2015 - 2015
CRAB 2015 - 2015
CRAB 2015 - 2015
CRAB 2015 - 2015
CRAB 2015 - 2015
CRAB 2015 - 2015
PRA Health Sciences 2013 - 2015
PAREXEL International 2011 - 2013
Skills
SAS, Data Management, CDISC, Statistics, Clinical Trials, Statistical Programming, Clinical Data Management, Pharmaceuticals, Clinical Research, Oncology, Biostatistics, Data Analysis, Clinical, SAS/SQL, Validation, Pharmacovigilance, SQL, FDA, SPSS, GCP, Databases, Excel, Analysis, R, 21 CFR Part 11, Research, Business Analysis, Unix, Epidemiology, Business Intelligence, Macro, SAS programming, Pharmaceutical Industry, Biotechnology, Access, CTMS, Clinical Development, Drug Development, Microsoft Excel, EDC, Oracle Clinical, CRO, Regulatory Submissions, CRF design, Protocol, Infectious Diseases, Sop, SAS Programming, SOP
Education
University of Missouri-Saint Louis 1989 — 1991
MBA, Accounting and Finance
Amgen January 2013 - Present
Research Pharmaceuticals Services January 2012 - January 2013
PAREXEL International September 2007 - January 2012
PAREXEL International November 2000 - September 2007
PAREXEL December 1999 - November 2000
The Scripps Research Institute April 1997 - December 1999
UCSD April 1997 - April 1999
Skills
Oncology, Pharmaceutical Industry, Clinical Trials, GCP, CRO, Clinical Development, Biotechnology, Clinical Research, CTMS, Immunology, Sop, EDC, ICH-GCP, Infectious Diseases, Clinical Monitoring, Clinical Data Management, Drug Development, Pharmacology, Therapeutic Areas, Regulatory Submissions, FDA, Protocol, Regulatory Affairs, Clinical Operations, Biopharmaceuticals, Medicine, Hematology, Pharmacovigilance, Cardiology, Vaccines, Phase I, Inform, 21 CFR Part 11, Lifesciences, Clinical Study Design, Cancer
Education
University of California, San Diego 1992 — 1996
B.S., General Biology
National Registry of Emergency Medical Technicians
Certification, EMT, Basic
The University of San Diego High School (USDHS) 1988 — 1992
Diploma
Vertex Pharmaceuticals April 2011 - October 2014
McKenna Clinical Contracts, Inc March 2000 - December 2013
Johnson & Johnson March 2006 - April 2011
Premier Research, Inc August 2007 - August 2008
AAi Pharma January 2006 - June 2006
Altus Pharmaceuticals July 2005 - January 2006
PAREXEL International December 2004 - May 2005
Boston Scientific March 2004 - December 2004
Quintiles, Inc January 2004 - February 2004
CombinatorX, Inc November 2003 - December 2003
Skills
Clinical Research, Clinical Trials, Clinical Monitoring, FDA, Conservative political...
Education
UMass M.Ed.
Master of Education, Counseling Psychology
University of Massachusetts Boston
Bachelor of Arts (B.A.), English
Univ.of Seville, Spain
Spanish Language
PAREXEL International October 2010 - Present
GlaxoSmithKline October 2005 - October 2010
GlaxoSmithKline December 2001 - October 2005
Joslin Diabetes Center July 2001 - December 2001
Extrio Corporation May 2000 - June 2001
Skills
Clinical Trials, Agile Methodologies, Business Analysis, Change Control, Data Warehousing, Databases, Leadership, Project Management, Java, Testing, Consulting, Integration, Cross-functional Team..., Agile Project Management, Quality Assurance, Outsourcing, SharePoint, Business Intelligence, Scrum, Database Design, Software Documentation, Project Portfolio..., Project Planning, Software Development, Management
Education
ASPE-IT 2009 — 2009
Certification, Utilizing SharePoint for Project Management
Winnow Management 2009 — 2009
Certification, Scrum Master, Agile Methodology
Project Management Institute, PMI Global Operations Center 2008 — 2008
PMP, Project Management
The George Washington University - School of Business 2002 — 2007
Masters Certification, Project Management
University of Illinois at Chicago 1994 — 2000
MS, Management Information Systems
University of Illinois College of Medicine 1994 — 1998
MS, Pathology
Prin. K. M. Kundnani College of Pharmacy 1988 — 1992
BS, Pharmaceutical Sciences
PAREXEL International December 2012 - Present
UC San Diego - Alzheimer's Disease Cooperative Study June 2011 - December 2012
UC Irvine Medical Center June 2010 - May 2011
Skills
Clinical Trials, Clinical Research, CTMS, GCP, Neuroscience, Clinical Development, IRB, Alzheimer's disease, Protocol, Clinical Study Design, Lifesciences, Phase I, ICH-GCP, Patient Recruitment, Sop, EDC, CRO
Education
University of California, Irvine 2006 — 2010
B.S., Biological Sciences
Barnett Educational Services
10 Week CRA and CRC Beginner Program Series
Merck January 2014 - Present
PAREXEL International January 2013 - August 2013
BlueCross BlueShield of Tennessee January 2011 - January 2013
BlueCross BlueShield of Tennessee August 2006 - January 2011
HealthSpring July 2005 - August 2006
Schaller Anderson November 2004 - July 2005
BlueCross BlueShield of Mississippi June 2001 - November 2004
Skills
Strategic Analysis and..., Requests for Proposals..., Program Development, Proposal Writing, Technical Writing, Critical Thinking, Pharmacy Benefit..., Strategic Consulting, Medicaid, Healthcare, Managed Care, Medication Therapy..., Pharmacy, Payer, Health Insurance, Medicine, Pharmacists, Pharmacueticals, Pharmaceutical Industry, Clinical Trials, Medicare, Market Access, Oncology, Pharmaceutics, Informatics, Clinical Research, Healthcare Management, Outcomes Research, Health Economics, Healthcare Consulting, Disease Management, Strategic Planning, Analysis, Long-term Care, Health Policy, Utilization Management, Diabetes, Medicare Part D, Pharmacy Automation, Healthcare Industry, HIPAA, Clinical Pharmacy, Hospitals, Medical Writing
Education
University of Tennessee College of Pharmacy
Doctor of Pharmacy (PharmD)
The University of Tennessee at Chattanooga
Pre-Pharmacy
PAREXEL International April 2014 - Present
Clinical Protocol Office, University of North Carolina at Chapel Hill September 2012 - April 2014
Lineberger Comprehensive Cancer Center, University January 2001 - September 2012
University of Kansas August 1995 - January 2001
University of Kansas August 1995 - January 2001
University of Kansas January 1992 - January 1995
Themis laboratories February 1992 - April 1992
US Vitamin December 1990 - October 1991
Skills
Virology, Clinical Trials, Molecular Biology, GCP, Preclinical Oncology..., ICH guidelines, Clinical Research, Microbiology, Regulatory Affairs, SOP, Clinical Development, Protocol, Life Sciences, ICH-GCP
Education
University of Kansas 1995 — 2001
Ph.D, Microbiology
Durham Technical Community College 2008 — 2010
Certificate (Level I), Clinical Trials Research
University of Bombay 1988 — 1990
M.Sc, Organic Chemistry
D. G. Ruparel College 1985 — 1988
B.Sc., Chemistry
Parle Tilak Vidyalaya 1973 — 1983
Astellas Pharma April 2015 - Present
Astellas Pharma April 2011 - Present
PAREXEL International March 2005 - March 2011
Paragon Biomedical (Now Clinipace Worldwide) January 2004 - March 2005
PAREXEL June 2001 - July 2003
Skills
Drug Development, Clinical Trials, Pharmaceutical Industry, Oncology, CTMS, Clinical Development, CRO, GCP, EDC, Clinical Operations, ICH-GCP, Therapeutic Areas, Biotechnology, FDA
Education
University of Dayton 1997 — 2001
Bachelor's degree, Human Biology
Comcast Cable November 2013 - Present
Comcast Business Class July 2012 - November 2013
PAREXEL November 2008 - January 2012
PAREXEL International June 2007 - November 2008
Workout Club & Wellness Center May 2004 - June 2007
Skills
Microsoft Office, Customer Service, Outlook, PowerPoint, Microsoft Excel, Customer Satisfaction, Microsoft Word, Call Center, Windows 7, Sales
Education
University of New Hampshire 2002 — 2006
B.A, Communications
University of New Hampshire-Manchester 2002 — 2006
Commuinications, Media and Communications
PAREXEL International 2015 - Present
GlaxoSmithKline 2013 - 2015
GlaxoSmithKline 2010 - 2012
GlaxoSmithKline 1995 - 2010
GlaxoSmithKline 1981 - 1995
Skills
Clinical Development, Clinical Trials, Clinical Research, Pharmaceutical Industry, Sop, Drug Development, FDA, GCP, Six Sigma, Change Management, CRO, Business Process..., Protocol, Regulatory Submissions, Medical Writing, R&D, Coaching, Regulatory Affairs, CTMS, Lean Sigma, Clinical Trial..., Protocol Development, Pharmaceuticals, Risk Management, Business Transformation, Program Management, Project Management, Clinical Operations, Risk Assessment, Governance, Outsourcing Management, Regulation Submissions, Public Speaking, SOP
Education
Syracuse University
Bachelor of Science, Biology
University of North Carolina
Masters of Science, Pharmacy Administration
DT Clinical Consulting, LLC 2010 - Present
Otsuka Pharmaceutical Development & Commercialization, Inc. August 2013 - March 2014
Alcon Laboratories, Inc. June 2012 - August 2013
Alcon Laboratories, Inc. July 2011 - June 2012
Otsuka Pharmaceutical Development & Commercialization, Inc. July 2010 - July 2011
sanofi-aventis June 2002 - March 2010
sanofi-aventis January 2005 - April 2008
sanofi-aventis June 2002 - January 2005
sanofi-aventis 2003 - 2003
PAREXEL International 1997 - 2002
Skills
CTMS, Clinical Trials, CRO, Clinical Research, Sop, FDA, Protocol, Endocrinology, Clinical Monitoring, Oncology, EDC, GCP, Informed Consent, GCPs, Clinical Study Design, 21 CFR Part 11, Medical Devices, Drug Development, Diabetes, Cardiology, ICH-GCP, Clinical Operations, Pharmaceutical Industry, Phase I, Clinical Development, Regulatory Affairs
Education
University of Mary Washington 1989 — 1993
B.S., Biology
PAREXEL International January 2013 - Present
PAREXEL International March 2011 - January 2013
PAREXEL International November 2009 - March 2011
Skills
Clinical Trials, GCP, Pharmaceutical Industry, CRO, 21 CFR Part 11, CTMS, Quality Assurance, Sop, Software Documentation, Validation, Clinical Research, Regulatory Affairs, FDA, Clinical Development, EDC, Medical Devices, SOP
Education
University of Massachusetts Lowell 1997 — 2002
BS, Information Systems
University of Massachusetts Lowell
Graduate Certificate, Health Informatics
PAREXEL International November 2014 - Present
The EMMES Corporation September 2011 - April 2013
Technical Resources International October 2008 - September 2011
Giant Pharmacy April 2004 - September 2008
Skills
Clinical Data Management, EDC, Clinical Trials, GCP, Data Management, CRO, ICH-GCP, CTMS, SAS, Data Analysis, CRF design, Lifesciences, Clinical Research, Clinical Development, Data Collection, Biotechnology, Clinical Study Design, Regulatory Affairs, Clinical Monitoring, Pharmaceutical Industry
Education
The Johns Hopkins University 2013 — 2014
Master's degree, Regulatory Science
Towson University
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
E Ink Corporation July 2010 - Present
Procter & Gamble April 2009 - April 2010
PAREXEL International October 2008 - February 2009
Optical Society of America February 2008 - June 2008
Tufts University June 2006 - February 2008
SleepQuest Incorporate July 2004 - August 2005
Data Analyst Sleep Solutions July 2003 - June 2004
Skills
Labview, Biomedical Engineering, Signal Processing, Engineering, Medical Devices, Biomaterials, Medical Imaging, Image Processing, Digital Imaging, Matlab, Quality Control, Programming, Image Analysis, R&D, Testing, Sensors, Microscopy, Product Development, Software Development
Education
Tufts University 2006 — 2008
MS, Biomedical Engineering
University of California, Santa Barbara 1999 — 2003
BS, Electrical Engineering
Parexel International March 2013 — Present
Boca Raton Physicians October 2011 — July 2013
US Food and Drug June 2010 — August 2010
Refugee Aid Serbia/North star, Belgrade, Serbia October 2017 — October 2017
Habitat For Humanity, Ghana February 2005 — August 2006
Eastbrook Elementary January 2010 — May 2010
Rebecca Awuah, Accra, Ghana October 2006 — March 2007
Skills
Blogging, Research, Editing, Management, Clinical Monitoring; Clinical Research and Trials, Drug Safety, ICH-GCP; FDA, Therapeutic Indications/Areas, Clinical Data Management, CRM, Analysis, Training,/Coaching, Microsoft Office, Public Speaking, PowerPoint, Microsoft Excel, Microsoft Word, Market Research, Microsoft PowerPoint, EDC, CTMS, IWRS, eTMF
Education
University of Central Florida 2009 — 2012
Bachelor of Science
ICN Business School, Nancy, France 2010 — 2011
BBA Exchange Program in International Business
PAREXEL International December 2011 - June 2015
PAREXEL International March 2010 - December 2011
PPD April 2007 - October 2009
ALTANA Pharma US / Nycomed May 2006 - April 2007
PPD November 2005 - April 2006
PPD November 2004 - November 2005
Skills
Clinical Trials, Data Management, Clinical Operations, Healthcare, Therapeutic Areas, Clinical Development, Clinical Data Management, Team Leadership, Software Documentation, Outlook, Quality Assurance, Site Initiation, Budgets, Mentoring, PowerPoint, Inform, Oracle Clinical, Microsoft Office, Microsoft Excel, Customer Relations, Customer Service, Customer Satisfaction, Customer Focus, Customer Acquisition, Documentation, Databases, Database Management, Data Entry, Excel, Forecasting, Financial Planning, Internet, Inventory Management, Leadership Development, Lotus Notes, Newsletters, Quality, Quality Management, Social Media, Team Building, Teamwork, Team Management, Telephone Skills, Word, Writing, Windows, Web, XP, Mac OS X
Education
University of North Carolina at Chapel Hill 2000 — 2003
BSN, Nursing
Western Carolina University 1999 — 2000
Pre-Nursing
Fresenius Medical Care September 2013 - Present
PAREXEL International November 2006 - September 2013
NMS Communications November 2005 - November 2006
Sun Life Financial 1999 - 2005
Skills
Windows, Troubleshooting, Active Directory, Testing, Windows Services, Hardware, Servers, Clinical Trials, Integration, Operating Systems, Computer System..., Documentation, Windows Server, VMware Infrastructure, Citrix, Disaster Recovery, Project Planning, Software Documentation, VMware ESX, VMware, ITIL, System Deployment, SharePoint, Microsoft Exchange, Virtualization, DNS, IT Management, Data Center, SAN, Group Policy, System Administration, Unix, TCP/IP, SCCM
Education
University of Massachusetts at Lowell 1993 — 1997
Bachelor of Science (B.S.), Information Technology
Santarus, Inc. November 2008 - Present
Paramount BioSciences October 2006 - May 2008
Neurocrine BioSciences November 2000 - August 2006
Parexel International 1996 - 1999
PAREXEL 1996 - 1999
Skills
Pharmaceutical Sales, CTMS, Training, Diabetes, Validation, Lifesciences, Medical Devices, GMP, Managed Care, Oncology, GCP, Clinical Trials, Biotechnology, Clinical Development, Regulatory Submissions, CRO, Pharmaceutical Industry, Clinical Research, FDA, Cross-functional Team..., Protocol
Education
University of Cincinnati
Fidelity Investments August 2014 - Present
WorkLife Strategy April 2009 - Present
Siemens February 2011 - 2014
100 Black Men of America 2010 - February 2012
CenturyLink November 2009 - February 2011
Blue Cross Blue Shield of North Carolina September 2000 - March 2009
PAREXEL International 1996 - 2000
Kaiser Permanente 1990 - 1994
UNC Hospitals 1987 - 1990
Skills
Strategic Planning, Team Building, Program Management, Business Development, Negotiation, Budgets, Change Management, Contract Negotiation, Contract Management, Vendor Management, Account Management, Business Strategy, Management Consulting, Process Improvement, Sales Management, Marketing Strategy, Leadership, Project Management, New Business Development, Marketing, Strategy, Facilities Management, Cross-functional Team..., Public Speaking, Team Leadership, Management, Project Planning, Operations Management, Business Planning, Mergers & Acquisitions, Business Process..., Organizational..., Training, CRM, Leadership Development, Analysis, Coaching, Corporate Real Estate, Entrepreneurship, Start-ups, Risk Management, Recruiting, Outsourcing, Human Resources, Performance Management
Education
University of North Carolina at Chapel Hill 1982 — 1986
Industrial Relations
Orexigen Therapeutics January 2014 - Present
Orexigen Therapeutics, Inc. March 2008 - December 2013
PAREXEL Consulting March 2003 - September 2007
PAREXEL International March 2002 - February 2003
Miravant Medical Technologies 1996 - March 2002
Norton-Lambert 1993 - 1996
Skills
Regulatory Submissions, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Sop, Oncology, Drug Development, Therapeutic Areas, IND, Cross-functional Team..., Protocol, Clinical Research, Strategy, Neurology, Clinical Development
Education
University of California, Santa Barbara 1991 — 1995
Sociology
Cerecor Inc. March 2014 - Present
Cerecor Inc. October 2012 - March 2014
Questcor Pharmaceuticals January 2011 - October 2012
PAREXEL INTERNATIONAL August 2003 - February 2011
Ruxton Pharmaceuticals, Inc June 2006 - December 2006
Guilford Pharmaceuticals, Inc April 2001 - August 2003
Otsuka Maryland Research Institute, LLC June 2000 - April 2001
SmithKline Beecham Pharmaceuticals June 1998 - June 2000
University of Maryland June 1993 - June 1998
Children's National Medical Center June 1992 - June 1993
Skills
Clinical Study Design, Clinical Development
Education
University of Maryland, Baltimore, School of Pharmacy 1994 — 1998
PharmD, Pharmacy
University of Maryland College Park 1988 — 1992
BS, Microbiology
PAREXEL International November 2014 - Present
PAREXEL 2010 - Present
PAREXEL International April 2010 - November 2014
Kendle International July 2001 - July 2003
Skills
EDC, Clinical Trials, GCP, CTMS, Clinical Development, Team Building, CRO, Clinical Monitoring, Clinical Data Management, Therapeutic Areas, ICH-GCP, Oncology, Pharmaceutical Industry, SOP
Education
University of California, Irvine 1993 — 1995
Bachelor of Science (BS), Biological Sciences
University of California, Los Angeles 1988 — 1991
Bachelor of Arts (BA), Psychology
Acerta Pharma B.V. May 2015 - Present
Pharmacyclics Inc. February 2014 - May 2015
Mirati Therapeutics Inc. (Formerly MethylGene Inc.) January 2007 - December 2013
Bellus Health Inc. (Formerly Neurochem Inc.) 2004 - 2006
Bristol-Myers Squibb 2004 - 2004
PRA International 2003 - 2003
PAREXEL International 1999 - 2003
Bayer 1996 - 1998
Skills
Clinical Monitoring, GCP, CRO, ICH-GCP, CTMS, Oncology, Clinical Trials, Clinical Development, Medical Writing, EDC, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Protocol, Pharmacovigilance
Education
Université de Montréal
M.Sc., Pharmacology
PAREXEL International March 2015 - Present
GlaxoSmithKline October 2007 - Present
GlaxoSmithKline June 2003 - October 2007
Quintiles, Inc February 1995 - June 2003
ClinTrials Research November 1992 - February 1996
Skills
Clinical Trials, Drug Development, Clinical Development, Clinical Operations, Clinical Research, CRO, Protocol, GCP, CTMS, Pharmaceutical Industry, Clinical Monitoring, Sop, Therapeutic Areas, ICH-GCP, R&D, Vendor Management, Cross-functional Team..., Pharmaceutics, Line Management, Clinical Study Design, EDC, Asthma, Oncology, Regulatory Affairs, Clinical Data Management, Pharmacology, 21 CFR Part 11, Regulatory Submissions, Infectious Diseases, Medical Writing, IND, Lifesciences, Biopharmaceuticals, Medical Affairs, Pharmacovigilance, Endocrinology, Diabetes, Clinical Trial..., Pharmaceuticals, Biotechnology, FDA, Neurology, Vaccines, Cardiology, Dermatology, Rheumatology, Validation, Clinical, Medical Devices, Strategy
Education
University of North Carolina at Chapel Hill 1984 — 1989
Bachelor's degree, Biology, General
Bishop McGuinness Memorial 1980 — 1984
Lash Group October 2013 - Present
Xcenda October 2012 - September 2013
Xcenda October 2008 - October 2012
Bayer September 2005 - September 2008
sanofi-aventis 1999 - 2005
Aventis 1999 - 2005
Aventis 1999 - 2005
Aventis Oncology 2001 - 2003
PAREXEL International 1993 - 1999
Skills
Oncology, Managed Care, Pharmaceutical Industry, Market Access, Pharmaceutical Sales, Hematology, Urology, Biotechnology, Health Economics, Neurology, Diabetes, Infectious Diseases, Outcomes Research, Gastroenterology, Pharmacy Benefit..., Lifesciences, Therapeutic Areas, Clinical Research, Medical Devices, CRO, Rheumatology, Immunology, Healthcare, Biopharmaceuticals, Sales Effectiveness, Product Launch, Clinical Trials, Pharmacovigilance, Pharmacoeconomics, Medical Writing, Dermatology, Cross-functional Team..., Hospitals, Commercialization, Pharmacy, Health Policy, Healthcare Reimbursement, Medical Affairs, Clinical Development, Medicare, Endocrinology, Healthcare Consulting, Nephrology, Hospital Sales, Medicaid, Regulatory Affairs, Cancer, Drug Development, Pulmonology, Competitive Intelligence
Education
The Catholic University of America 1995 — 1997
MSW, Policy, Planning, Administration
University of Illinois at Urbana-Champaign 1988 — 1992
BS, Biology
Shire Pharmaceuticals June 2014 - Present
Cubist Pharmaceuticals August 2011 - June 2014
Biogen Idec June 2008 - August 2011
Vertex Pharmaceuticals May 2006 - June 2008
BattelleCRO October 1998 - April 2006
PAREXEL 1997 - 1998
PAREXEL International 1993 - 1998
Skills
CRO, Clinical Trials, GCP, Data Management, Quality Management, Clinical Research, Project Management, Leadership, ICH-GCP, Outsourcing, Pharmaceutical Industry, Clinical Development, Drug Development, 21 CFR Part 11, CTMS
Education
Tufts University
MS, Nutrition
Duke Clinical Research Institute 2003 - Present
PAREXEL International 2000 - 2003
Quintiles Transnational 1999 - 2000
Duke Medical Center 1996 - 1999
Skills
Clinical Data Management, Clinical Trials, SAS, Statistical Programming, CDISC, CRO
Education
The University of Georgia 1991 — 1995
B.S., Statistics
Premier Research October 2012 - Present
Parexel International April 2012 - October 2012
Impax Laboratories September 2008 - April 2012
DURECT Corporation February 2008 - September 2008
Alza March 2007 - February 2008
Gentiae Clinical Research November 2005 - December 2006
Skills
CDISC, SDTM, Clinical Trials, CRO, Clinical Data Management, Pharmaceutical Industry, SAS programming, SAS, GCP, Clinical Development, Data Management
Education
University of Mysore
Xcenda November 2013 - Present
Independent Consultant February 2013 - November 2013
United BioSource Corporation July 2000 - February 2013
PAREXEL International 1987 - 2000
Skills
Market Research, Project Management, Biotechnology, Strategic Planning, Oncology, Pharmaceutical Industry, Lifesciences, Health Policy, Commercialization, Qualitative Research, Marketing Strategy, Immunology, Management Consulting, Business Strategy, Diabetes, Healthcare Consulting, Medicare/Medicaid..., Reimbursement, Market Access, Managed Care, Product Launch, Rheumatology, Strategy
Education
The University of Texas at Austin
Master of Science (M.Sc.), Health Policy
University of Texas
M.Sc. Health Policy, Health/Health Care Administration/Management
Amgen January 2014 - Present
Amgen June 2012 - January 2014
AMGEN / RPS June 2010 - June 2012
Integrium November 2008 - March 2010
ClinAssure, Inc. July 2006 - November 2008
Valeant Pharmaceuticals August 2004 - July 2006
Parexel International November 1999 - August 2004
Skills
Clinical Operations, Clinical Monitoring, Data Management, Clinical Trials, Project Management, Line Management, CRO, CTMS, EDC, ICH-GCP, Drug Development, Pharmacovigilance, Regulatory Affairs, Clinical Research, GCP, Clinical Development, Oncology
Education
University of California, Los Angeles 1994 — 1998
BS, Biochemistry
PAREXEL November 2010 - Present
PAREXEL International September 2006 - October 2010
PAREXEL International 2005 - 2006
Skills
Clinical Operations, GCP, CRO, CTMS, Clinical Research, Clinical Trials, EDC, ICH-GCP, Lifesciences
Education
University of California, Los Angeles 1996 — 2000
PAREXEL International March 2015 - Present
GlaxoSmithKline December 2012 - February 2015
Human Genome Sciences 2002 - December 2012
Otsuka 1997 - 2002
Procter & Gamble 1980 - 1997
Skills
Drug Development, Clinical Development, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, GLP, Drug Discovery, Clinical Trials, Lifesciences, IND, FDA, Oncology, Pharmacokinetics, CRO, Life Sciences, Regulatory Submissions
Education
State University of New York College at Geneseo 1974 — 1976
Bachelor's degree, Biology, General
PAREXEL International April 2013 - Present
Gilead Sciences October 2010 - March 2013
Amgen Inc April 2006 - October 2010
MedImmune 2001 - 2005
Watson Pharmaceuticals 1999 - 2001
Schein Pharmaceutical 1999 - 2001
Schein Pharmaceuticals 1999 - 2001
Advance Tissue Sciences 1998 - 2000
Gensia-Sicor January 1996 - July 1998
Chesapeake Biological Labs 1991 - 1996
Skills
Microbiology, Biotechnology, Quality Control, Pharmaceutical Industry, GLP, Biopharmaceuticals, CAPA, Aseptic Processing, Sop, FDA, GMP, Fermentation, LIMS, V&V, 21 CFR Part 11, Vaccines, Quality Assurance, Change Control, Aseptic Technique, Validation, Technology Transfer, Quality System, HPLC, Regulatory Affairs, Chromatography, Lifesciences, Pharmaceutics
Education
University of Mumbai 1975 — 1984
Ph.D, Microbiology
Haffkine Institute 1979 — 1983
Ph.D., Microbiology, General
FORUM Pharmaceuticals (formerly Envivo Pharmaceuticals) August 2010 - Present
Pfizer Pharmaceuticals September 2008 - August 2010
Ipsen (Biomeasure, Inc.) August 2007 - September 2008
PAREXEL International February 2006 - August 2007
Skills
Clinical Operations, ICH-GCP, Phase I-III Global..., Oncology Clinical..., CNS Clinical Trials, Protocol, ICF, Plan..., Essential Document..., Investigator Meeting..., Clinical Trials
Education
University of Delaware 1998 — 2002
BA, Biology
PAREXEL January 2014 - Present
PAREXEL International June 2001 - August 2013
Quintiles CNS Therapeutics 2000 - 2001
Skills
CRO, ICH-GCP, GCP, Clinical Trials, Clinical Monitoring, CTMS, Clinical Development, Clinical Data Management, Pharmaceutical Industry, EDC, Drug Development, Therapeutic Areas, Protocol
Education
University of California, Irvine 1987 — 1992
Liberty Mutual Insurance October 2013 - Present
Granite State College 2013 - Present
Liberty Mutual Insurance April 2012 - October 2013
Liberty Mutual Insurance 2005 - April 2012
PAREXEL 2001 - 2002
PAREXEL International 1997 - 2002
Skills
Project Portfolio..., MS Project, Vendor Management, Project Management, Process Improvement, Quality Assurance, Business Analysis, ITIL, Program Management, Risk Management, Integration, Six Sigma, Change Management
Education
The George Washington University 2009 — 2012
Master of Science, Project Management
The George Washington University - School of Business 2009 — 2012
MSPM, Project management
University of Phoenix
BS, Information Technology/Visual Communication
PAREXEL International 2014 - Present
PAREXEL 2010 - 2014
PAREXEL International 2004 - 2010
Ora, Inc. 1988 - 1998
Ora, Inc. 1988 - 1998
Skills
CTMS, Clinical Trials
Education
University of Massachusetts, Amherst 1984 — 1988
Parexel International March 2015 - Present
GSK July 1989 - February 2015
Skills
Clinical Research, Clinical Pharmacology, Pharmaceutical Industry, Clinical Development, Drug Discovery, Pharmacology, Regulatory Submissions, Clinical Trials, Oncology, Pharmacokinetics, CRO, IND, Pharmacodynamics, Life Sciences, Translational Medicine, Drug Development
Education
University of Kentucky
Doctor of Pharmacy (Pharm.D.)
PRA International June 2013 - Present
PAREXEL International October 2007 - June 2013
PAREXEL February 2013 - May 2013
PAREXEL 2007 - May 2013
PRA Intl 2003 - 2007
PRA International 2001 - 2004
Kendle International 1997 - 2001
Skills
Clinical Research, Clinical Operations, Clinical Research..., CTMS, CRO, GCP, EDC, Clinical Trials, Clinical Monitoring, Clinical Development, ICH-GCP, Therapeutic Areas, Oncology, Pharmaceutical Industry, ELISA, Clinical Data Management, Neurology, Regulatory Submissions, Pharmacovigilance, Infectious Diseases
Education
University of Cincinnati 1995 — 1998
Christopher-Clark Fine Art 2007 - 2009
Sharon Art Studio 2007 - 2009
Museum of Photographic Arts 2006 - 2006
PAREXEL International 2004 - 2006
UCSD Visual Arts Department 2003 - 2004
ALZA 2001 - 2003
Fountains of Youth 1997 - 2002
Education
University of California, San Diego 2003 — 2004
Graduate Dept: Visual Arts History, Theory, & Criticism
University of Arizona 1997 — 2001
PAREXEL International March 2015 - Present
GlaxoSmithKline November 2012 - March 2015
GlaxoSmithKline June 2007 - November 2012
GSK 2001 - June 2007
Burroughs Wellcome 1989 - 2002
Burroughs Wellcome 1989 - 2002
Skills
Clinical Development, Pharmaceutical Industry, CRO, Clinical Trials, GCP, CTMS, Drug Development, Cross-functional Team..., Clinical Research, Strategic Sourcing, Life Sciences, FDA, EDC, Regulatory Affairs, Regulatory Submissions, SOP, Biotechnology, Team Management, Strategy, Clinical Outsourcing, Clinical Contracting
Education
University of North Carolina at Chapel Hill 1983 — 1987
Bachelors, Psychology
Agility Clinical, Inc. January 2014 - Present
Parexel International 2007 - Present
PAREXEL November 1999 - June 2007
Skills
Therapeutic Areas, Clinical Data Management, Infectious Diseases, Pharmaceutical Industry, Biotechnology, Clinical Operations, Clinical Site Monitoring, In-house monitoring, CRO, Clinical Research...
Education
University of California, San Diego 1993 — 1998
Bachelor of Science (BS), Animal Physiology and Neuroscience
Quintiles August 2011 - Present
PAREXEL International December 2008 - November 2010
PPD Inc September 2006 - December 2008
Skills
CTMS, Clinical Trials, GCP, CRO, Clinical Research, Pharmaceutical Industry, Oncology, Infectious Diseases, Clinical Development, Clinical Data Management, Therapeutic Areas, Regulatory Submissions, Microsoft Office, Training, Sop, Research, FDA, Management, Protocol, Oracle Clinical
Education
The University of Connecticut 1996 — 2000
BA, English
Shelton High School 1992 — 1996
PAREXEL International July 2010 - July 2011
Indevus Pharmaceuticals September 2005 - December 2009
PAREXEL October 2001 - September 2005
Skills
Clinical Trials, Clinical Research, CTMS, GCP, CRO, Pharmaceutical Industry, Clinical Data Management, Sop, EDC, ICH-GCP, Regulatory Affairs, Biotechnology
Education
University of Massachusetts at Lowell
Fonville Morisey Realty September 2014 - Present
PAREXEL International November 2011 - October 2013
PAREXEL August 2010 - November 2011
PAREXEL International September 2007 - August 2010
Skills
GCP, Clinical Trials, CRO, Pharmaceutical Industry, ICH-GCP, Real Estate, Real Estate Transactions
Education
Towson University 2001 — 2004
Bachelor of Science (BS), Psychology
University of Maryland College Park 1997 — 1999
Biogen Idec June 2002 - Present
PAREXEL International 1997 - 2000
Skills
CDISC, Clinical Research, CRO, Lifesciences, SDTM, Clinical Trials, ICH guidelines, Pharmacovigilance, Clinical Data Management, GCP, EDC, ICH-GCP, Therapeutic Areas, Clinical Development
Education
University of Massachusetts, Amherst 1992 — 1996
PAREXEL International July 2014 - Present
Novartis Animal Health July 2011 - July 2014
Novartis Animal Health September 2010 - July 2011
Novartis Animal Health June 2007 - September 2010
Skills
Clinical Development, Clinical Trials, Data Analysis, Lifesciences, GLP, GCP, Statistics, Regulatory Submissions, Drug Development, FDA, Clinical Research, Pharmaceutical Industry, Biostatistics, SAS programming, Clinical Study Design, Oncology, CRO, Protocol, SAS, Pharmacovigilance, Infectious Diseases
Education
University at Buffalo 1996 — 1999
Masters, Mathematics
University at Buffalo 1990 — 1996
BS and BA, Mathematics and Psychology
PAREXEL International January 2008 - Present
American Red Cross October 2000 - December 2003
Aventis Pharmaceuticals January 1996 - December 2001
Wyeth Corporation March 1986 - June 1994
US Food and Drug Admnistration July 1972 - March 1986
Education
Temple University
BS, Biochemistry
PAREXEL International March 2015 - Present
GlaxoSmithKline September 1995 - February 2015
Positive Marketing Inc./Buffalo Manufacturing Inc. January 1991 - August 1995
Skills
Lifesciences, Outsourcing, Clinical Development, Biotechnology, Pharmaceutical Industry, GCP, CRO, CTMS, Clinical Trials, R&D, Oncology, Clinical Monitoring, Clinical Research, Drug Development, EDC, Sop, Cross-functional Team..., Negotiation, Life Sciences, SOP
Education
State University of New York College at Brockport 1989 — 1990
State University of New York College of Agriculture and Technology at Morrisville 1986 — 1988
Pine Bush High School
JK Regulatory Consulting ConsultantJK Regulatory Consulting2008 - 2008
Salix Pharmaceuticals September 2005 - September 2007
Parexel International January 2002 - September 2005
Alpharma September 1999 - February 2002
Schein Pharmaceutical/Marsam February 1995 - September 1999
Premier Research September 1993 - December 1994
Skills
FDA, Regulatory Submissions, Regulatory Affairs, Pharmaceutics, IND, Pharmaceutical Industry, NDA, Quality Assurance, Clinical Trials, Regulatory Requirements, Clinical Development, ANDA, Sop
Education
Temple University 1997 — 1999
M.S., Regulatory Affairs/Quality Assurance
Temple University, Pennsylvania College of Podiatric Medicine 1992 — 1993
None
The College of New Jersey 1987 — 1991
B.S., Biology
AbbVie October 2013 - Present
inVentiv Health Clinical December 2011 - October 2013
Merck January 2010 - December 2011
Schering-Plough July 2006 - December 2009
ReSearch Pharmaceutical Services May 2006 - March 2007
MDS Pharma Services October 2003 - June 2006
Parexel International February 2001 - September 2003
Minor and James Medical April 1997 - January 2001
University of Texas Southwestern Medical Center September 1995 - March 1997
VA Medical Center June 1992 - August 1995
Skills
Clinical Trials, Clinical, Clinical Research, Clinical Monitoring, Protocol, Neurology, Endocrinology, Infectious Diseases
Education
University of Evansville 1986 — 1990
BS, Psychology / Research
PPD December 2014 - Present
Quintiles December 2011 - November 2014
PMG Research January 2008 - December 2011
PMG Research August 2007 - December 2007
PAREXEL International March 2007 - July 2007
PMG Research May 2002 - February 2007
Skills
ICH-GCP, CTMS, EDC
Education
University of North Carolina at Greensboro 1998 — 2002
BS, Public Health Education
FHI 360 August 2013 - Present
FHI 360 May 2012 - August 2013
Otsuka America Pharmaceutical, Inc. June 2010 - April 2012
PAREXEL International January 2009 - June 2010
US Regulatory Operations Life Cycle Management May 2004 - August 2008
GlaxoSmithKline January 1993 - January 2008
GlaxoSmithKline May 2001 - May 2004
GlaxoSmithKline July 1998 - April 2001
GlaxoWellcome May 1996 - July 1998
Glaxo Inc December 1993 - May 1996
Skills
FDA, Pharmaceutics, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, CTMS, Oncology, Sop, Pharmacovigilance, eCTD, Biotechnology, CRO, GMP, Drug Development, Medical Writing, Immunology, IND, EDC, ICH-GCP, Infectious Diseases, Regulatory Requirements, Clinical Monitoring, Protocol
Education
University of North Carolina at Chapel Hill 1984 — 1988
Bachelor of Science, Nursing
Alexion Pharmaceuticals, Inc. June 2014 - Present
Alexion Pharmaceuticals October 2012 - June 2014
Novella Clinical, Inc. December 2010 - October 2012
Parexel International November 2007 - March 2011
INC Research March 2006 - November 2007
INC Research March 2005 - April 2006
PPD October 2002 - March 2005
Sinochem September 1992 - April 1995
Skills
SAS, Clinical Data Management, Team Building, Oracle Clinical, Documentation, Programming, Inform, Clinical Trials, Clinical Research, Pharmaceuticals, Data Management, CRO, Oncology, Validation, FDA, SOP, EDC, Biotechnology, Medical Devices, Clinical Trial..., Infectious Diseases, Life Sciences, Data Analysis, GCP, CDISC, Diabetes, Mentoring, CTMS, Databases, ICH-GCP, SQL, Analysis, Medidata, Clinical Study Design, Clinical Development, Software Documentation, Pharmaceutical Industry, Sop, Therapeutic Areas, CRF design, Lifesciences, Phase Forward InForm, 21 CFR Part 11, Management, Computer System..., Project Management
Education
University of Houston 1997 — 2000
MBA, Management Information System
Tianjin University of Finance and Economics 1988 — 1992
BBA, International Business
PAREXEL International March 2010 - Present
Abiomed March 2009 - March 2010
Dyax November 2007 - September 2008
PAREXEL International November 2004 - August 2007
GTC Biotherapeutics February 1997 - February 2004
Skills
CTMS, Clinical Research, Biotechnology, Clinical Development, Pharmaceutical Industry, GCP, Life Sciences, Oncology, FDA, CRO
Education
Worcester State University 2002 — 2004
MS, Biotechnology
University of Massachusetts, Amherst 1989 — 1993
BS, Animal Science
Pfizer March 2010 - Present
Pfizer March 2008 - February 2010
Biogen Idec March 2000 - October 2007
Parexel International 1999 - 2002
Education
University of California, San Diego 1992 — 1996
BS, Biochemistry and Cell Biology
PAREXEL International April 2012 - Present
PAREXEL International January 2008 - July 2010
PAREXEL March 2002 - December 2007
Skills
Clinical Monitoring, EDC, CTMS, CRO, ICH-GCP
Education
University of North Carolina at Chapel Hill 1990 — 1994
BSPH, Health Policy and Administration
PAREXEL International May 2014 - Present
PAREXEL International November 2010 - Present
PAREXEL International January 2009 - October 2010
PPD, Inc. July 2007 - October 2008
Kendle International March 1998 - June 2007
Self Employed June 1991 - June 1998
USCI Division of C.R.Bard, Inc. January 1984 - August 1989
Framingham Board of Health October 1982 - December 1983
Lexington Board of Health April 1982 - September 1982
St. Joseph's Hospital May 1981 - September 1982
Skills
Clinical Trials, CTMS, CRO, GCP, EDC, Clinical Monitoring, Clinical Research, Therapeutic Areas, Pharmaceutical Industry, ICH-GCP, Oncology, Clinical Development, FDA, Protocol, Regulatory Affairs
Education
University of Massachusetts Lowell 1978 — 1982
BS, Health Services Administration
PAREXEL August 2012 - Present
PAREXEL International May 2011 - August 2012
PAREXEL May 2010 - May 2011
PAREXEL December 2009 - May 2010
PAREXEL International August 2007 - December 2009
UCSD Medical Center 2006 - 2007
Caltag 2005 - 2006
UC Davis February 2004 - January 2005
UC Davis Department of Cell Physiology 2004 - 2005
Skills
Regulatory Submissions, ICFs, Contract Negotiation, Clinical Monitoring, Auditing, Quality Control, Document Review, Drug Accountability, Query Resolution, Microsoft Office, CTMS, Electronic Data..., Training, Electronic data capture, Timelines, GCP, CRO, Clinical Trials, Rheumatoid Arthritis, Phase 2, phase 3, ICH-GCP, Patient Recruitment, EDC
Education
University of California, Davis 2000 — 2005
BS, Biological Science
PAREXEL International June 2011 - Present
Paragon Biomedical Inc January 2005 - May 2011
Rush University Medical Center 2003 - 2003
Rush University Medical Center 2001 - 2003
Education
University of Pittsburgh 1975 — 1977
University of Pittsburgh
University of Illinois at Chicago
MPH, Public Health
TPS Pharmaceutical Consulting 2007 - Present
Aastrom Biosciences August 2010 - July 2012
PAREXEL International September 2009 - April 2010
Metabasis Therapeutics 2007 - 2009
metabasis therapeutics 2007 - 2009
Pfizer 2003 - 2007
Pfizer 2002 - 2003
Parke Davis 1998 - 2002
Skills
Pharmaceutical Industry, Clinical Development, GCP, Statistics, Oncology, CRO, Biotechnology, GMP, Clinical Trials, Drug Development, FDA, Clinical Research, Data Quality, Data Review
Education
The Ohio State University 1991 — 1997
PhD, Statistics
West Virginia University 1987 — 1991
BS, Math
Parexel International March 2015 - Present
GlaxoSmithKline April 2008 - Present
GlaxoSmithKline January 2001 - April 2008
Glaxo Wellcome January 1996 - January 2001
Glaxo Inc June 1986 - January 1996
Skills
Clinical Development, Pharmaceutical Industry, Oncology, CRO, Biotechnology, Clinical Trials, GCP
Education
University of North Carolina at Chapel Hill 1982 — 1986
Bachelor's Degree, Biostatistics
University of North Carolina at Chapel Hill
Master of Public Health (MPH), Biostatistics
University of Pennsylvania March 2011 - April 2015
The Children's Hospital of Philadelphia 2010 - 2011
AstraZeneca LP 2001 - 2009
Kforce Clinical Research, Inc. 2000 - 2001
PAREXEL International 1996 - 2000
University of Pittsburgh Medical Center 1989 - 1996
Skills
Clinical Trials
Education
University of Maryland College Park
Bachelor of Arts (B.A.), English Language and Literature, General
University of Pittsburgh
MSW Course Work
Faber Daeufer & Itrato PC January 2014 - Present
Shire Human Genetic Therapies, Inc. October 2009 - January 2014
Sepracor Inc. August 2007 - May 2009
Faber Daeufer & Rosenberg 2004 - 2007
PAREXEL International 1994 - 1999
ImmuLogic Pharmaceutical Corporation 1991 - 1994
Blackbaud Inc. 1989 - 1991
Skills
Biotechnology, Intellectual Property, Program Management, Training, Clinical Trials, CRO, Lifesciences, Strategic Planning, Negotiation, Corporate Law, Commercialization, Human Resources, Healthcare, Pharmaceutical Industry, Licensing
Education
Tufts University
B.A., English
Retail Solutions Inc. 2014 - 2015
PAREXEL International 2013 - 2014
American Tower 2010 - 2012
Monster Worldwide 2006 - 2010
Fidelity Investments June 2000 - December 2006
Various IT Consulting Firms January 1993 - June 2000
Skills
Dynargie Leadership..., Monster Worldwide..., Dale Carnegie..., SDLC, Data Center, System Deployment, ITIL, VMware, System Administration, Active Directory, Disaster Recovery, Microsoft Exchange, DNS, Windows Server, Technical Documentation, IT Operations, Unix, Virtualization, Network Administration, Project Management, SAN, IT Management, Networking, Servers, TCP/IP
Education
State University of New York at Albany
Psychology and English
University of Phoenix
Associates Degree, MIS
Momentum Research August 2010 - Present
Quintiles Transnational November 2009 - July 2010
Parexel International August 1999 - November 2009
Skills
Clinical Data Management, Clinical Trials, GCP, CRO, ICH-GCP, Oracle Clinical, CRF design
Education
University of North Carolina at Chapel Hill 1992 — 1996
Biology B.A, Biology
Enloe High School 1988 — 1992
High School Diploma
ICON Clinical Research October 2012 - Present
The Reading Hospital and Medical Center October 2011 - 2012
PSI CRO 2010 - 2011
PAREXEL International October 2007 - February 2009
PAREXEL International October 2007 - February 2009
Pfizer Inc August 2006 - October 2007
Pfizer Inc August 2006 - October 2007
Bayada Nurses October 2003 - October 2004
Bayada Nurses October 2003 - October 2004
Interactive Clinical Technologies, Inc April 2002 - July 2003
Skills
CRO
Education
Mercer Medical Center School of Nursing
RN diploma program
Mercer Medical Center School of Nursing
RN diploma program
Thomas Jefferson University
Bachelor of Science, Nursing
Thomas Jefferson University
Bachelor of Science, Nursing
Biogen Idec July 2014 - Present
Biogen Idec November 2013 - July 2014
PAREXEL September 2013 - November 2013
Parexel International September 2011 - September 2013
Massachusetts General Hospital March 2010 - September 2011
Joslin Diabetes Center March 2009 - March 2010
Toxikon Corporation October 2008 - April 2009
Skills
IRB, Clinical Research, Clinical Trials, Oncology, Regulatory Submissions, Feasibility, Regulatory Document..., ICF Review &..., in-house monitoring, Protocol, GLP, Clinical Monitoring, Sop, FDA, ICH-GCP
Education
Worcester Polytechnic Institute 2014 — 2017
Master of Business Administration (M.B.A.)
University of Connecticut 2004 — 2008
B.S., Molecular & Cell Biology; Physiology & Neurobiology
University of Connecticut
Bachelor of Science (B.S.), Physiology, Pathology and Related Sciences
PAREXEL International March 2010 - February 2011
FIRC Istituto di Oncologia Molecolare January 2006 - August 2008
CuraGen Corporation 2000 - 2003
Education
University of California, Davis 1992 — 1997
BSc, Genetics
PAREXEL International April 2010 - Present
Fresenius Medical Care March 1997 - February 2010
North American Industries 1993 - March 1997
Whiteley Industries 1989 - 1993
Whistler Corp. 1986 - 1988
H.H. Scott Inc. 1979 - 1986
U.S. Air Force May 1969 - January 1973
Skills
Supply Chain Management, Medical Devices, Supply Chain, Purchasing, Logistics, FDA, Materials Management, Supply Management, Program Management, Cross-functional Team..., Negotiation, Six Sigma, Process Improvement, Procurement, Strategic Sourcing, Global Sourcing, SAP, Sourcing, Contract Negotiation, Quality System, MRP, GMP, Quality Management, Vendor Management, Continuous Improvement, Leadership, CAPA, Pharmaceutical Industry, ISO 13485, CRO, ISO, Manufacturing, Supplier Development, Quality Assurance, Sop, Lean Manufacturing, Operational Excellence, Change Control, Biotechnology, Drug Development, Product Development, Software Documentation, Outsourcing, Supply Chain..., Clinical Development
Education
Suffolk University 1973 — 1977
BS, Biology/Chemistry
PAREXEL International ManagerPAREXEL2002 - Present
Skills
GCP, Clinical Development, Sop, Clinical Trials, Clinical Research, EDC, CRO, Clinical Data Management, CTMS
Education
University of Maine at Farmington 1991 — 1995
Bachelor's degree, Mathematics
ECommunity Research, LLC February 2012 - Present
North Oaks Neurology October 2009 - August 2012
PAREXEL International May 2006 - December 2008
University of Kentucky July 2002 - April 2006
Skills
CTMS, Clinical Trials, GCP, Clinical Research, CRO, Sop, Biotechnology, Pharmaceutical Industry, Clinical Monitoring, EDC, Medicine
Education
The George Washington University 2008 — 2011
MSHS, Clinical Research Adminstration
Universidad Central del Ecuador 1993 — 2001
MD, General Practitioter
PAREXEL October 2012 - Present
PAREXEL International April 2007 - October 2012
Advantage Components June 2005 - April 2007
USMC June 2001 - June 2005
Skills
Ariba, Business Process, Contract Management, Cross-functional Team..., Global Sourcing, Logistics, Microsoft Excel, Negotiation, Oracle, Oracle E-Business Suite, PL/SQL, Process Improvement, Procurement, Purchasing, RFP, SQL, Sourcing, Strategic Sourcing, Contract Negotiating, Management, Project Management, Supply Management, Vendor Management
Education
University of Massachusetts at Lowell 2007 — 2011
B.S.B.A. Cum Laude, Management
FDA November 2012 - Present
Pharma Regulatory Science Consulting, LLC April 2012 - October 2012
PAREXEL International March 2011 - March 2012
Biovail Technologies Ltd January 2007 - January 2011
Biovail Technologies Ltd October 2000 - December 2006
PHARMA MEDICA RESEARCH, INC February 1999 - September 2000
BIOVAIL CORPORATION INTERNATIONAL July 1991 - February 1999
Skills
Regulatory Affairs, Due Diligence, Technology Transfer, Pharmaceutical Industry, Clinical Development, Drug Development, Clinical Pharmacology, Pharmacokinetics, FDA, Recruiting, ADME, Clinical Trials, GMP, Bioanalysis, Formulation, CRO, Biotechnology, Clinical Research, NDA, GLP, Sop, Pharmacology, R&D, Biologics
Education
University of Alberta 1983 — 1987
Ph.D., Pharmaceutical Sciences (Pharmacokinetics)
Obafemi Awolowo University (University of Ife) 1982 — 1983
Master of Science, Pharmaceutics
Obafemi Awolowo University (University of Ife) 1978 — 1981
Bachelor of Pharmacy
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2014 - Present
Sangart June 2012 - August 2013
Upsher-Smith Laboratories June 2011 - June 2012
Optimer Pharmaceuticals March 2011 - May 2011
BIOGEN IDEC May 2002 - January 2011
PAREXEL International 1998 - 2002
3M COMPANY 1997 - 1998
Kuwait University- Faculty of Medicine 1995 - 1997
Medtronic 1995 - 1995
Skills
Clinical Trials, Biotechnology, Oncology, Clinical Development, Biostatistics, Bayesian statistics
Education
University of Minnesota-Twin Cities
Ph.D., Biostatistics
University of Minnesota-Twin Cities
MS, Statistics
PAREXEL International May 2013 - Present
Human Genome Sciences May 2011 - January 2013
MacroGenics October 2008 - May 2011
Vanda Pharmaceuticals November 2007 - September 2008
PAREXEL April 2006 - November 2007
Human Genome Sciences November 2002 - April 2006
Chiron Corporation June 2000 - November 2002
PAREXEL March 1997 - June 2000
Skills
Oncology, Clinical Development, CRO, Clinical Trials, CTMS, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, GCP, Clinical Research, SOP, Infectious Diseases, Drug Development, Protocol, Clinical Operations, Regulatory Affairs, Vaccines
Education
University of Delaware
BA, Biology
Waters Corporation June 2004 - Present
PAREXEL International June 1998 - June 2004
Education
Suffolk University Law School 1992 — 1995
JD, Law
University of Massachusetts, Amherst 1985 — 1989
BBA, Marketing
Pharmaceutical Product Development Inc October 2011 - Present
PAREXEL International March 2010 - August 2011
University of Maryland Baltimore CountyCatonsville September 2010 - May 2011
University of Maryland Baltimore County October 2009 - December 2009
Maryland Baltimore County August 2007 - January 2008
Skills
Cell, Biotechnology, Cell Culture, Flow Cytometry, GLP, Molecular Biology, Sop, Clinical Research
Education
University of Maryland Baltimore County 2006 — 2011
University of Maryland
M.S, Applied Molecular Biology
University of Maryland
B.S, Biology
Covance September 2015 - Present
NKM RESEARCH CONSULTING, LLC February 2015 - August 2015
JANIX BIOSCIENCES, LLC September 2012 - February 2015
PAREXEL, INTERNATIONAL January 2012 - July 2012
DUKE UNIVERSITY EYE CENTER June 2001 - January 2012
RETINA AND VITREOUS ASSOCIATES October 1993 - October 2000
Medical College of Georgia 1990 - 1993
Skills
Healthcare, Clinical, Clinical Research, Hospitals, Healthcare Management, Medical Imaging, Research, Clinical Trials, BLS, Auditing, Leadership, Problem Solving, CTMS, Clinical Monitoring, Ophthalmology, CRO, ICH-GCP, GCP, Clinical Development, Protocol, Medicine, EDC, Clinical Data Management, Medical Affairs, Medical Devices, Medical Writing, Pharmaceutical Industry, FDA, Regulatory Submissions, Biotechnology, Diabetes, IRB, Patient Recruitment, Drug Development, Cardiology, Clinical Operations, Regulatory Affairs, Trial Management, Inform, Medical Education, Therapeutic Areas, Clinical Study Design, Immunology, Infectious Diseases, Neurology, Dermatology, Pharmacovigilance, Lifesciences, Sop, Data Management
Education
The University of Georgia
Parexel International November 2014 - Present
H&M Statistical Consultants LLC January 2013 - October 2014
EMD Serono, Inc. October 2006 - January 2013
EMD Serono, Inc. July 2003 - October 2006
Skills
Biostatistics, Clinical Development, Clinical Trials, Statistical Programming
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Mathematical Statistics
Greater Boston Area Associate Director, Medical Alliances & GrantsVertex Pharmaceuticals2011 - 2013
Vertex Pharmaceuticals 2006 - 2011
Vertex Pharmaceuticals 2004 - 2006
Parexel International 2002 - 2004
Parexel International 2001 - 2002
Parexel International 1999 - 2001
Skills
Global Alliance..., Global Clinical..., Team Leadership, Contract Management, Clinical Operations, Drug Development, Cross-functional Team..., Strategy, GCP, Clinical Trials, Clinical Development, Life Sciences, Medical Writing, Clinical Research, CRO, Infectious Diseases, Regulatory Affairs
Education
University of Massachusetts Boston
Master of Business Administration (MBA)
University of Massachusetts Boston
Master of Business Administration (MBA)
University of Rochester
Bachelor of Arts (B.A.), Pyschology
Milton Academy
NuScriptRX April 2014 - Present
PAREXEL International March 2012 - March 2014
Education
University of Maryland University College 2008 — 2012
Bachelor's degree, Business Management