Chiltern International
Industry: Company
DescriptionHeadquarters: United Kingdom Founded: 1982 Subsidiaries: Integrated Development Associates Co., Ltd., Vigiun, Pacific Clinical Research Pte Ltd, Chiltern International Bvba Parent organization: Chiltern International Group Limited
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Chiltern International Employees
Wright Avenue Partners September 2015 - Present
Chiltern International July 2014 - August 2015
Ockham October 2009 - July 2014
Intellicisions Data, Inc February 1999 - June 2011
Ockham April 2006 - October 2009
Sapiens July 1996 - January 1999
Sapiens June 1993 - August 1996
Hewlett-Packard September 1993 - June 1996
DePuy Orthopedics December 1991 - August 1993
IBM January 1987 - November 1992
Skills
Oncology, Biotechnology, Clinical Development, Clinical Trials, CRO, SAS, New Business Development, Business Development, Pharmaceutical Industry, Data Management, GCP, Leadership, Lifesciences, FDA, Strategy, Management, Pharmacovigilance, Therapeutic Areas, Clinical Research, Drug Development, Data Analysis, CTMS, Statistics, Infectious Diseases, Regulatory Affairs, 21 CFR Part 11, Biostatistics, EDC, Validation, Medical Devices, Regulatory Submissions, Sop, Clinical Data Management, Vaccines, SAS programming, Pharmaceutics, Immunology, Protocol, Cardiology, Life Sciences, SAS Programming, Analytics, SOP, Leadership Development, Thought Leadership, Resourcing Strategy, FSP
Education
The George Washington University 1981 — 1984
Bachelor of Business Administration (B.B.A.), Finance, General
Chaminade High School 1977 — 1981
HS Diploma
Chiltern International August 2012 - Present
Bristol Compressors May 2001 - December 2011
Skills
Change Management, FMLA, Process Improvement, Employee Relations, Labor Relations, Human Resources, Workforce Planning, Strategic Planning, Performance Management, HRIS, Deferred Compensation, Leadership, Personnel Management, Continuous Improvement, Employee Benefits, New Hire Orientations, Lean Manufacturing, Purchasing, Employee Training, Leadership Development, Interviews, Benefits Administration, Management, Onboarding, Manufacturing, Training, Employee Engagement
Education
Radford University 1999 — 2001
Bachelor of Applied Science (BASc), Business Administration and Management, General
QGenda July 2014 - Present
QGenda July 2013 - June 2014
Chiltern International November 2011 - May 2013
WakeMed May 2010 - May 2012
TriStar Medical Transport May 2009 - January 2010
Skills
Datalabs, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Exchange, Lotus Notes, Active Directory, SharePoint, iMedidata/Rave, Research, CRM, Healthcare, Management, Clinical Research, Data Entry, Sales, Leadership
Education
University of North Carolina at Wilmington 2008 — 2013
Bachelors of Science in Clinical Research, Clinical Research
Novo Nordisk November 2013 - Present
Sarah Cannon Research Institute August 2011 - November 2013
Chiltern International June 2008 - August 2011
KCI April 2007 - May 2008
Kinetic Concepts Inc 2007 - 2008
ICON Clinical Research November 2002 - August 2006
ICON 2002 - 2006
Concepts in Pharmaceutical Research 2001 - 2002
PPD 1998 - 2000
Skills
Oncology, CTMS, Clinical Monitoring, Regulatory Affairs, EDC, FDA, GCP, ICH-GCP, Sop, Clinical Development, Clinical Research, Medical Devices, CRO, Therapeutic Areas, Pharmaceutical Industry, Biotechnology, Clinical Trials, Clinical Research..., Infectious Diseases, Medical Writing, Lifesciences, Drug Development, Data Management, Project Management, Regulatory Submissions, Research, Clinical Data Management, Oncology Clinical..., Oracle Clinical, Patient Recruitment, IRB, Clinical Operations, CRF design, Clinical Study Design, IND, Informed Consent, Medidata, Pharmacovigilance, Inform, Protocol, Trial Management, Hematology, Vaccines, 21 CFR Part 11, Immunology, Regulatory Requirements, Cancer, Diabetes, Endocrinology, Neurology
Education
Texas State University 1993 — 1995
BS, Biology / Minor Chemistry
Seguin High School 1984 — 1988
Chiltern International June 2008 - Present
Skills
EDC, CRO, Clinical Data Management, Clinical Trials, SAS Programming, Clinical Research, Database Design, Medidata, eCRF
Education
University of North Carolina at Wilmington 2004 — 2008
BS, Management Information Systems
Chiltern International January 2014 - Present
UNCW 2013 - Present
SEAHEC January 2012 - January 2014
Skills
Clinical Research, Lifesciences, GCP, ICH-GCP, Clinical Trials, EDC, Feasibility, start-up..., Phlebotomy, Oncology
Education
UNCW 2012 — 2014
Master of Science (MS), Clinical Research
UNCW 2006 — 2008
Bachelor's degree
University of North Carolina at Chapel Hill
Quintiles October 2010 - Present
Chiltern International May 2008 - February 2010
University of Oklahoma Health Sciences Center October 2006 - May 2008
Skills
CRO, Clinical Monitoring, CTMS, Protocol, Clinical Research, ICH-GCP, EDC, Clinical Trials, GCP, Clinical Development, Pharmaceutical Industry, IRB, Oncology, Clinical Data Management, Therapeutic Areas, Biotechnology, Regulatory Submissions, SOP
Education
Oklahoma Christian University 2006 — 2006
MBA, Health Management
Oklahoma State University 2000 — 2005
BS, Business Management
Boehringer Ingelheim March 2014 - Present
PAREXEL November 2012 - March 2014
Chiltern International March 2012 - November 2012
PPD February 2007 - March 2012
CVS Pharmacy July 2000 - February 2007
Skills
Clinical Trials, Clinical Trial..., Management, Oncology, Clinical Research, Project Management, Clinical Monitoring, CTMS, CRO, Therapeutic Areas, GCP, ICH-GCP, Pharmaceutical Industry, Clinical, Hematology, EDC, Sop, Clinical Data Management, Clinical Development, Breast Cancer, Prostate Cancer, Pharmaceuticals, Multiple Myeloma
Education
University of North Carolina at Wilmington 2003 — 2005
BS, Biology
Chiltern International November 2010 - May 2012
PRA International January 2007 - October 2010
Kforce Clinical Research, Inc. 2004 - 2007
MDS Pharma Services 2001 - 2004
ICSL-Clinical Studies 1998 - 2001
Skills
Clinical Monitoring, EDC, ICH-GCP, CRO, CTMS, GCP, Therapeutic Areas, Clinical Research..., Pharmaceutical Industry, Clinical Trials, Clinical Development, Clinical Research
Education
Slippery Rock University of Pennsylvania 1992 — 1996
B.S, Health Sciences
PAREXEL 2012 - Present
Chiltern International August 1999 - September 2011
Clinical Trial Management Services August 1999 - February 2008
Skills
CRO, CTMS, Clinical Data Management, Clinical Monitoring, Clinical Operations, Clinical Research, Clinical Trials, Data Management, EDC, GCP, ICH-GCP, Oncology, Pharmaceutical Industry
Education
Old Dominion University
BSN, BSN Nursing
Chiltern January 2015 - Present
Chiltern International June 2013 - January 2015
PPD September 2011 - June 2013
UNC Wilmington August 2010 - August 2011
Rowan County February 2005 - August 2010
Skills
EDC, Clinical Data Management, Medidata, Datalabs, Technology Training, Clinical Administration, Records Management, GoToMeeting, WebX, Webinars, User Acceptance Testing, Data Cleaning, Regulatory Documentation, Data Management, CRO
Education
University of North Carolina at Asheville 2006 — 2010
Bachelor of Arts (B.A.), Mass Communication/Media Studies
Rooster Teeth Productions June 2006 - Present
Y's Business Solutions, LLC June 2006 - October 2011
Chiltern International November 2000 - June 2006
Calendar Club June 1998 - August 2000
Skills
Accounting, Financial Reporting, Business Strategy, Target Costing, CMA, Cash Flow, Financial Analysis, Forecasting, Budget, Revenue Recognition, Managerial Finance, QuickBooks, Cost Accounting, Internal Controls, Due Diligence, Analysis, Budgets, Financial Accounting, Management, Management Consulting, Account Reconciliation, Strategic Financial..., Business Development, Finance, Sarbanes-Oxley Act
Education
St. Edward's University 2003 — 2005
MBA, Accounting
St. Edward's University 1999 — 2005
BBA, Accounting
Chiltern International December 2013 - May 2014
Children's National Medical Center September 2012 - August 2013
N Chapman Associates Inc June 2012 - August 2012
Chiltern International May 2011 - August 2011
Skills
Research, Legal Writing, Health Policy, Legal Research, Negotiation, Biostatistics, Literature Reviews, Public Health, Clinical Trials, GCP, SPSS
Education
Wake Forest University School of Medicine 2014 — 2016
Master of Medical Science, Physician Assistant
University of North Carolina at Chapel Hill 2008 — 2012
Bachelor of Science (B.S.) Public Health, Nutrition, Chemistry Minor
John T. Hoggard High School 2004 — 2008
Assisted Transition February 2012 - Present
Abt Associates Inc. November 2002 - September 2006
Chiltern International December 1999 - October 2002
Kimberly-Clark May 1989 - January 2000
Kimberly-Clark Health Care 1989 - 2000
Kimberly-Clark May 1989 - May 1994
pharmacia 1984 - 1988
Becton Dickinson Immunodiagnostics 1980 - 1984
Skills
Marketing Management, Acquisition Integration, New Business Development, Pharmaceuticals, Diagnostics, Medical Devices, Business Strategy, Biotechnology, Contract Negotiation, Consultative Selling, P&L, Business Planning, Marketing Strategy, Product Management, Pharmaceutical Industry, Income Statement, Elder Care, Hardware Diagnostics, Selling, Healthcare, Strategy, Sales Management, Negotiation, Strategic Planning, Marketing, Business Development
Education
UCLA 1986 — 1987
Executive Management
University of Iowa - Henry B. Tippie College of Business 1972 — 1976
BBA, major marketing minor psychology, advertising, management, distribution, product management, child psychology
Optum March 2010 - Present
Harvard Clinical Research Institute February 2008 - February 2010
Chiltern International December 2006 - February 2008
PAREXEL 1999 - 2004
American Cancer Society 1996 - 1999
Jimmy Fund 1994 - 1995
Skills
Clinical Trials, Leadership, EDC, Business Development, CRO, Market Research, Medical Devices, Lifesciences, Project Management, Strategic Planning, Oncology, Regulatory Affairs
Education
University of Massachusetts, Amherst 1992 — 1996
BS
Chiltern November 2014 - Present
Chiltern International July 2013 - November 2014
Chiltern International December 2011 - July 2013
Chiltern International October 2011 - December 2011
Chiltern International May 2011 - October 2011
Chiltern International April 2011 - October 2011
Chiltern International January 2011 - May 2011
Skills
Clinical Trials, EDC, 21 CFR Part 11, Microsoft Office, FDA, Research, ICH-GCP, CTMS, Regulatory Affairs, GCP, Clinical Research, CRO, Pharmacovigilance, Clinical Monitoring, Clinical Development, Pharmaceutical Industry
Education
University of North Carolina at Wilmington 2007 — 2011
Bachelor of Science, Clinical Research
PAREXEL November 2013 - Present
PAREXEL October 2011 - November 2013
Chiltern International October 2010 - September 2011
PPD February 2009 - September 2010
PPD January 2007 - February 2009
East Coast Mortgage August 2005 - January 2007
Skills
Clinical Trials, CRO, Pharmaceutical Industry, CTMS, Clinical Research, EDC, ICH-GCP, Sop, GCP, Clinical Monitoring, RFP, Therapeutic Areas, Oncology, Process Improvement, Cross-functional Team...
Education
University of North Carolina at Wilmington 1999 — 2003
BS, Business Administration (Finance)
Children's Healthcare of Atlanta July 2011 - Present
CIBA Vision (a division of Novartis) 2007 - March 2011
Chiltern International 2005 - 2007
Novartis 2004 - 2005
Skills
GCP, Clinical Trials
Education
The George Washington University
MS, Clinical Research
SynteractHCR September 2014 - Present
PAREXEL November 2007 - September 2014
Chiltern International 2005 - 2007
Education
University of California, Santa Barbara 1997 — 2001
BS, Biological Sciences
SK Hines Consulting August 2014 - Present
ICON plc April 2012 - July 2014
Chiltern International January 2008 - April 2012
Phase Forward 2000 - 2007
Walker Interactive Systems March 1994 - May 2000
Skills
Process Improvement, Vendor Management, EDC, Clinical Trials, Medical Devices, ePRO (eCOA), Consultancy, PRO, eDiary, eSource, Quality Management, User Acceptance Testing, Clinical Development, Business Analysis, Biotechnology, Data Management, Pharmaceutical Industry, Integration, Quality Assurance, Software Documentation, Program Management, Cross-functional Team..., Databases, Clinical Research, Testing, Management, Sop, SDLC
Education
Yale University 1967 — 1971
BA, History
The George Washington University
Master of Arts (MA), International Affairs
Noble and Greenough School
H.S. Diploma
Chiltern International October 2012 - Present
FileONE December 2010 - October 2012
Independent February 2010 - December 2010
Clinsys Clinical Research February 2007 - November 2009
INC Research April 2006 - February 2007
Cavu Corporation February 2001 - April 2002
PharmaResearch June 1996 - February 2001
Skills
Project Management, SDLC, Data Management, EDC, Database Administration, ETL, Business Intelligence, Leadership, Business Process..., IT Management, GCP, Data Analysis, SaaS, Databases, Operations Management, CRO, SAS programming, CRM, Cross-functional Team..., 21 CFR Part 11, Enterprise Software, CTMS, Biostatistics, Oracle Clinical, Clinical Development, Clinical Data Management, Clinical Trials, Regulatory Submissions, ICH-GCP, Protocol, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science, Biology
Chiltern International November 2012 - Present
INC Research January 2012 - November 2012
TranS1, Inc May 2008 - January 2012
South Eastern Area Health Education Center March 2003 - May 2008
Skills
Clinical Trials, Clinical, Clinical Research, Pharmaceuticals, Clinical Data Management, Medical Devices, Protocol Development, Protocol Analysis, Data Validation, Data Analysis, Databases, Database Administration, Data Entry, Database Design, Quality Systems, Quality Auditing, Quality Assurance, Data Quality, Clinical Monitoring, ISO standards, Procedure Development, Procedure Review, Procedure Analysis, Database Management, Reconciliation, Vendor Management, Regulatory Requirements, Regulatory Submissions, Regulatory Filings, Regulatory Reporting, Regulatory Research, Auditing, Internal Audit, External Audit, Compliance Audits, Health Research, Grant Writing, Grant Management, Grants Administration, Protocol, Biotechnology, Pharmaceutical Industry
Education
University of North Carolina at Wilmington 1999 — 2004
M.A, American History
University of North Carolina at Wilmington 1995 — 1998
BA, chemistry, history
inVentiv Health Clinical November 2014 - Present
PharmaNet/i3 Strategic Resourcing December 2010 - October 2014
Chiltern International September 2007 - December 2010
Chiltern International September 2004 - September 2007
Profil Institute for Clinical Research 2003 - 2004
Perlan Therapetutics/ CFY Biomedicals 2000 - 2003
Skills
Clinical Trials, CRO, Clinical Development, GCP, EDC, Oncology, CTMS, Clinical Research, Vendor Management Skills, Budget Proposals, Clinical Data Management, Biotechnology, Pharmaceutical Industry, Protocol, ICH-GCP, Clinical Monitoring, Regulatory Affairs, SOP, Cancer, Phase I, Therapeutic Areas
Education
University of California, San Diego 1998 — 2002
Bachelor or Science, General Biology
Cepheid May 2015 - Present
Cepheid May 2010 - Present
Chiltern International December 2007 - February 2010
Chiltern USA December 2007 - February 2010
Mentor Corp January 2001 - March 2009
Chiltern USA March 2002 - December 2007
Instrumentation Metrics Inc January 1995 - January 2000
Education
BSNEdward J Meyer Memorial School of Nursing State University of Buffalo
University at Buffalo
RN/BSN, Nursing
ICON plc July 2015 - Present
PAREXEL November 2014 - July 2015
PAREXEL June 2012 - November 2014
Castle Branch, Inc. August 2011 - June 2012
Kendle International November 2010 - August 2011
Kendle International August 2010 - November 2010
Chiltern International October 2008 - August 2010
Topsail High School August 2004 - October 2008
Skills
Clinical Trials, CRO, Pharmaceutical Industry, Budgets, EDC, Proposal Writing, Business Development, Biotechnology, Strategic Planning, Clinical Development
Education
University of North Carolina at Wilmington 2010 — 2012
Master's, Business Administration
North Carolina State University 2002 — 2004
B.S. Mathematics Education, Mathematics
Chiltern International May 2012 - Present
CEO, CFO, COO of Swinson Household September 2011 - Present
Chiltern International April 2007 - August 2011
Kendle International May 1999 - April 2007
Skills
CRO, Data Management, Clinical Trials, Sop, CTMS, GCP, Clinical Data Management, Oncology, Clinical Development, Pharmaceutical Industry, Management, Clinical Research
Education
University of North Carolina at Wilmington 1994 — 1999
Biology
PPD, Inc. May 2008 - Present
PPD March 2003 - April 2008
Chiltern International 2001 - 2003
XOMA 2000 - 2001
Elan Pharmaceuticals 1998 - 2000
Elan 1997 - 1999
Chiron Corporation 1996 - 1998
Amersham Pharmacia Biotech 1994 - 1996
Chiron Corporation 1992 - 1994
Education
University of California, Berkeley 1988 — 1992
The University of Texas at Austin 1982 — 1986
BA, Microbiology
Chiltern International May 2011 - February 2012
Chiltern International Pvt. Ltd April 2009 - November 2011
Chiltern International Pvt. Ltd January 2009 - April 2009
First Source Limited May 2008 - January 2009
Education
SIKKIM MANIPAL UNIVERSITY (DISTANCE EDUCATION) 2009 — 2011
M.Sc, Clinical Research and Regulatory Affairs2009
Clinical Research Education and Management Academy 2008 — 2009
Post Graduate Diploma in Clinical Data Management, Clinical Data Management
University of Mumbai 2005 — 2008
B.Sc, Biotechnology
MUMBAI UNIVERSITY
B; POST GRADUATE DIPLOMA, Sc Biotechnology2005-2008;
PRA International April 2013 - Present
PharmaNet/i3 July 2011 - March 2013
i3 Research 2009 - March 2013
inVentiv Health Clinical 2013 - 2013
Premier Research Group September 2001 - October 2009
SCIREX Corporation 2001 - 2007
Chiltern International 2000 - 2001
SkyePharma March 1999 - April 2000
Clinimetrics June 1996 - September 1998
Skills
Clinical Development, Clinical Trials, Drug Development, Oncology, CRO, Infectious Diseases, EDC, Clinical Research, Biotechnology, Clinical Monitoring, Clinical Data Management, CTMS, Pharmaceutical Industry, Regulatory Affairs, Lifesciences, Regulatory Submissions, Therapeutic Areas, GCP, Biopharmaceuticals, Data Management, Drug Discovery, ICH-GCP, Neurology, Vaccines, Life Sciences
Education
University of California, San Diego 1990 — 1995
Bachelor's Degree, Cellular Biology
La Jolla Country Day
Chiltern International Clinical Research Coordinator IIDana-Farber Cancer Institute2004 - 2006
Education
San Diego State University-California State University 1996 — 2000
BS, Kinesiology
Poor Boy Productions, Inc a literary production company January 2002 - Present
Eagle Scout January 1988 - Present
Chiltern International April 2008 - April 2009
Chiltern International April 2008 - April 2009
Regionally Based)RPS May 2005 - March 2008
Regionally Based)RPS May 2005 - March 2008
Otsuka Maryland Research Institute May 2000 - May 2005
Otsuka Maryland Research Institute May 2000 - May 2005
Ingenix International March 1998 - May 2000
Ingenix International March 1998 - May 2000
Education
Pennsylvania State UniversityUniversity
Bachelor of Science, Kinesiology and Education
Penn State University 1988 — 1994
BS, Kinesiology
Stason Animal Health, Inc. September 2011 - Present
Stason Pharmaceuticals, Inc. June 2008 - Present
Chiltern International January 2003 - June 2008
Chugai Pharmaceuticals July 2002 - January 2003
Maxim Pharmaceuticals October 1996 - August 2002
Wood & Associates February 1996 - March 1997
Medication Delivery Devices, Inc. October 1993 - February 1996
Block Medical, Inc. January 1991 - October 1993
IVAC corporation June 1989 - January 1991
Research Medical Center 1983 - 1990
Skills
Oncology, Clinical Development, Pharmaceutical Industry, CRO, Biotechnology, Clinical Trials, Drug Development, Medical Devices, Lifesciences, CTMS, Infectious Diseases, Product Development, Biopharmaceuticals, FDA, GCP
Education
Rockhurst University 1981 — 1983
BSN, Nursing
Research College of Nursing
Endologix Inc July 2015 - Present
Green Key Resources February 2014 - July 2015
Research Pharmaceutical Services Inc. 2012 - 2014
Premier Research 2011 - 2012
Covance 2011 - 2011
CLIN-Rx, LLC 2009 - 2011
Chiltern International 2008 - 2009
PPD 2003 - 2004
PPD 2003 - 2004
PPD 2003 - 2004
Skills
Clinical Trials, Oncology, Clinical Research, Infectious Diseases, Therapeutic Areas, Protocol, Sop, Cardiology, Medical Devices, Data Management, Immunology, Validation, LMS,CTMS, EDC Medidata..., Premier EDC, PPD EDC,..., Outlook, Lotus Notes
Education
University of North Carolina at Pembroke
BS, Bachelor of Science in Health, Physical Education & Recreation Management
Medidata Solutions August 2015 - Present
Vivonoetics, Inc. September 2009 - August 2015
Oracle August 2013 - March 2014
VivoMetrics, Inc. June 2002 - August 2009
Chiltern International October 1998 - May 2002
PAREXEL January 1997 - October 1998
University of California, San Diego 1994 - 1995
Skills
Medical Technology, New Business Development, Client Relationship..., Healthcare, Biotechnology, Clinical, Research, Life Sciences, Clinical Trials, Strategic Planning, Marketing Strategy, Sales Management, Product Development, Contract Negotiation, Start-ups, Business Strategy, Customer Relations, Medical Devices, Team Building, Negotiation, Account Management, Pharmaceuticals, Direct Sales, Cross-functional Team..., Consultative Selling, Strategic Partnerships, Market Development, Key Account Management, Business Planning, Clinical Research, Lifesciences, Pharmaceutical Industry, Strategy, Product Launch, Sales, Commercialization, Corporate Development, Analysis, CRM, Cardiology, Business Development, Leadership, Management, Product Marketing, Product Management, Marketing, Mergers & Acquisitions, Competitive Analysis, Proposal Writing, CRO
Education
Queen's University Belfast 1989 — 1992
Ph.D., Medical Genetics, Cell Biology, Tissue Engineering
Queen's University Belfast 1984 — 1988
Bachelor of Science, Zoology and Genetics
PRA Health Sciences August 2015 - Present
PRA Health Sciences August 2013 - August 2015
PRA (previously ReSearch Pharmaceutical Services) January 2012 - August 2013
Advanced Recruiting Partners July 2010 - April 2012
Chiltern International 2008 - July 2010
Kendle International 2006 - 2008
PPD 2005 - 2006
James R Nelson, MD 2002 - 2005
Skills
Neurology, Myasthenia Gravis, Muscular Dystrophy, Duchenne, Clinical Research, Biotechnology, ICH-GCP, GCP, Clinical Trials, Musculoskeletal, Clinical Monitoring, Biologics, Ophthalmology, Infectious Diseases, CRO, Clinical Pharmacology, Pediatrics, EDC, Clinical Development, Therapeutic Areas, Oracle Clinical, CTMS, Gastroenterology, Immunology, Hematology, Pharmaceutical Industry, SOP, Inform, Regulatory Submissions, Regulatory Affairs, Drug Development, Protocol, Pharmacovigilance, Clinical Operations, Medical Devices
Education
University of California, Berkeley 2000 — 2005
Bachelor's Degree, Integrative Biology/Human Biodynamics
University of California, San Diego 2008 — 2009
Master's degree, Clinical Research
Engineering For Kids May 2015 - Present
Accenture September 2010 - June 2015
Accenture September 2008 - September 2010
Self Employed March 2005 - December 2009
Chiltern International January 2007 - September 2008
The EMMES Corporation July 2002 - January 2007
Skills
SDLC, Requirements Gathering, Program Management, Data Management, Management, Business Analysis, Business Process..., Pharmaceutical Industry, Project Management, IT Strategy, Requirements Analysis, PMP, Healthcare Information..., Health Information..., IT Management, Stakeholder Management, Vendor Management, Affordable Care Act, EDC, Clinical Research, Management Consulting, Process Improvement, Access, Business Intelligence, Software Project..., Data Analysis, Change Management, User Acceptance Testing, Agile Methodologies, Provider Relations, Healthcare, Public Health, Technology Management, Risk Management, Issue Management, Financial Accounting, Contract Management, Small Business, Franchising, Telecommunications, Program Delivery..., Business Planning, Coaching
Education
University of Maryland University College 2003 — 2009
MS, Technology Management
Penn State University 1996 — 2002
BS, Biology
PRA Health Sciences October 2014 - Present
PRA Health Sciences August 2012 - September 2014
ProjectPharm and Eastern Clinical Trials (ECT) November 2011 - July 2012
Chiltern International July 2006 - October 2011
ClearTrial January 2006 - June 2006
Medpace March 1998 - December 2005
P&G Pharmaceuticals June 1992 - February 1998
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Clinical Development, Business Development, EDC, Global Business..., Clinical Research, Biometrics, Budget Proposals, Risk Based Monitoring, Analytics
Education
State University of New York at Buffalo 1988 — 1992
BA, Statistics
Quintiles November 2011 - Present
Quintiles Transnational March 2011 - November 2011
Chiltern International 2007 - 2011
PPD February 2007 - November 2007
PPD May 1999 - February 2007
Skills
Microsoft Office, ARIS, Clintrace, Pharmacovigilance, Drug Safety, CRO, ICH-GCP, Clinical Trials, Pharmaceutical Industry, Oncology, Clinical Development, Clinical Research, GCP, CTMS, Sop, Therapeutic Areas, Regulatory Affairs, FDA, Regulatory Submissions, EDC, MedDRA, SOP
Education
Mount Olive College 1997 — 1999
BS, Business
Cape Fear Community College 1993 — 1995
LPN, Nursing
Green Key Resources September 2013 - Present
Kenexa, an IBM Company June 2013 - August 2013
Chiltern International November 2012 - May 2013
Ockham Development Group May 2012 - August 2012
Skills
Microsoft Office, Customer Service, Teamwork, Outlook, Microsoft Word, PowerPoint, Recruiting, CRO, Clinical Trials, Oncology, Clinical Monitoring, Biotechnology, Clinical Research, Pharmaceutical Industry, Microsoft Excel, Applicant Tracking..., Sourcing, Lotus Notes, Medical Writing, Biostatistics, Human Resources, Quality Assurance, Management, Regulatory Affairs, EDC, Clinical Operations, Technical Recruiting
Education
University of North Carolina at Wilmington 2009 — 2013
Community Health Education, School of Health and Human Services
Green Hope High School 2004 — 2009
Davis Drive Elementary
Chiltern International April 2011 - Present
Wise Window Treatment LLC/Wise Contracts May 2010 - April 2011
Granicus, Inc. August 2008 - April 2010
First Republic Bank May 2008 - August 2008
Wise Window Treatment LLC/Wise Contracts August 2007 - April 2008
Security Business Bank December 2006 - July 2007
San Diego Community Bank December 2004 - December 2006
Citibank July 2003 - January 2005
Certified Personal Fitness Trainer April 1997 - July 2003
St John Westshore Hospital September 1993 - March 1997
Skills
Training, Vendor Management, Leadership, Account Management, Recruiting, Customer Service, Sales, Management, Salesforce.com, Business Development, Marketing, Customer Satisfaction, Cold Calling, Product Management, Banking, Team Leadership, Employee Training, Relationship Management, Financial Services..., Video Conferencing, Team Building, Mergers & Acquisitions, Cloud Computing, Business Planning, Cross-functional Team..., Selling, Consulting, Healthcare, Data Management, Clinical Data Management, Vendor Relationship..., Software Web-Based..., Acquisition..., Risk Management/ Audit..., GoToMeeting, Skype, Mergers, Technical Product Sales, SaaS
Education
Roosevelt University 1999 — 2002
Bachelors Degree in Corporate Communication, Organizational Communications
Cleveland Institute Of Medical 1992 — 1993
Certified Medical Labortatory Technician, Hospital Laboratory
Chiltern International Inc
Certified Technical Trainer / Data Manager, eClinical Solutions
Granicus Inc
Certified Granicus University Software Trainer, Software
U.S.F.S.A Gold Medalist
Gold Frestyle
Arena Pharmaceuticals August 2015 - Present
Covance November 2013 - July 2015
Chiltern International January 2012 - August 2013
PAREXEL 2007 - December 2011
Kos Pharmaceuticals 2005 - 2006
IVAX Corp 2001 - 2005
Cleveland Clinic Florida 2001 - 2003
Skills
Oncology, Clinical Development, Clinical Research, Pharmacovigilance, Clinical Trials, Surgery, Gastroenterology, Pharmaceuticals, Diabetes, CRO, ICH-GCP, Drug Development, CTMS, Pharmaceutical Industry, Medicine, Drug Safety, Neurology, Regulatory Submissions, GCP, Clinical Monitoring, Therapeutic Areas, FDA, Clinical Study Design, Protocol, Medical Affairs, Clinical Data Management, Infectious Diseases, Regulatory Affairs, Medical Writing
Education
Universidad de Buenos Aires 1994 — 1999
Board Certified General Surgeon, Doctor in Medicine
INC Research June 2010 - Present
INC Research June 2010 - March 2014
Chiltern International September 2007 - February 2010
Austin IVF August 2005 - September 2007
Skills
Clinical Trials, CRO, ICH-GCP, Vendor Management, Outlook, CTMS, Clinical Research, Protocol, Software Documentation, Sop, Clinical Data Management, Clinical Development, Clinical Monitoring, EDC, GCP, Pharmaceutical Industry, Regulatory Submissions, SOP
Education
St. Edward's University
Bachelor of Business Administration (BBA), Business Administration and Management, General
richard king high school
Medidata Solutions March 2012 - Present
Chiltern International March 2010 - March 2012
Chiltern International July 2006 - March 2012
Skills
EDC, Medidata, Programming, Clinical Data Management, Data Management, CRO, Clinical Trials, Database Design, ICH-GCP, Life Sciences
Education
Old Dominion University
Bachelor of Science (BS), Health Professions and Related Clinical Sciences, Other
Chiltern International February 2015 - Present
Patricia Conley Consulting, Inc. February 2010 - February 2015
International Partnership for Microbicides January 2008 - February 2010
SFBC International/Pharmanet INC. January 2004 - June 2005
OMRI 1998 - 2004
Shire Pharmaceuticals 2001 - 2002
Covance Laboratories 1989 - 1998
Skills
Pharmaceutical Industry, GMP, FDA, Validation, Regulatory Affairs, CAPA, Clinical Trials, GCP, Sop, Biotechnology, Clinical Research, Training, Clinical Data Management, Clinical Development, Computer System..., GLP, Quality Assurance, CRO, 21 CFR Part 11, Quality System, ICH-GCP, Regulatory Submissions, Quality Management, Vaccines, CTMS, SOP
Education
University of Maryland College Park
BS, Microbiology
University of Maryland College Park
MS Science Education, Biology
ICON plc November 2013 - Present
INC Research November 2011 - November 2013
Quintiles January 2008 - November 2011
Quintiles August 2005 - January 2008
Chiltern International October 2004 - August 2005
Skills
CTMS, GCP, Clinical Monitoring, CRO, Clinical Trials, EDC, Clinical Development, ICH-GCP, Oncology, Therapeutic Areas, Regulatory Submissions, Clinical Research, Clinical Data Management, Infectious Diseases, Medical Writing, Neurology, Drug Development, Cardiology, FDA, Protocol, Diabetes, Vaccines, Regulatory Affairs, Sop, 21 CFR Part 11, Phase I, Data Management, Pharmacovigilance, Pharmaceutical Industry, Oracle Clinical, Clinical Operations, Clinical Study Design
Education
Texas State University-San Marcos 2008 — 2010
MS, Health Research
St. Edward's University 2005 — 2008
MBA, Business Administration
St. Mary's University 2000 — 2004
BA, Biology
The EMMES Corporation November 2010 - August 2011
Clinical PRofessionals Network 2009 - 2011
Clinsys Clinical Research March 2008 - March 2010
COVANCE INCORPORATED March 2007 - February 2008
Kendle International December 2005 - February 2007
Chiltern International June 2004 - November 2005
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" June 2003 - June 2004
Phoenix Data Systems October 2002 - June 2003
Bayer CropScience March 2002 - October 2002
PAREXEL - CONTRACT December 2000 - February 2002
Education
Villanova University
UNIVERSITY OF NORTH CAROLINA
North Carolina Central University 1987 — 1991
B.A., Political Science (minor) Life Sciences
Medidata Solutions February 2014 - Present
Medidata Solutions August 2011 - February 2014
Chiltern International November 2010 - August 2011
Chiltern International January 2009 - October 2010
Chiltern International January 2008 - January 2009
Chiltern International January 2006 - June 2008
Pearland ISD August 2002 - January 2006
University of Houston August 2001 - May 2002
Pearland ISD August 1998 - May 2001
Skills
CRO, Clinical Trials, EDC, CTMS, Randomization, Clinical Data Management, Pharmaceutical Industry, ICH-GCP, Training Delivery, Education, Technology, Instructional Technology, Teaching, Educational Leadership, Clinical Development, Clinical Research, Medical Devices, Biotechnology, Biostatistics, Medidata, 21 CFR Part 11, Training, Sop, Leadership, Computer System..., Process Improvement, GCP, Oncology, Lifesciences, CDISC, FDA, Validation, SAS, Integration, SAS programming, Regulatory Affairs
Education
University of Houston 2000 — 2002
Master of Education
Texas A&M University 1993 — 1997
Bachelor of Arts
GSK Vaccines (Through acquisition of Novartis Vaccines on March 2015) October 2013 - Present
Novartis Vaccines September 2011 - September 2013
Novartis Vaccines and Diagnostics November 2010 - September 2011
Chiltern International April 2009 - November 2010
Vigiun Clinical & Epidemiological Research 2000 - April 2009
Pasteur Merieux 1995 - 1999
Wyeth Pharmaceuticals 1993 - 1995
Skills
Clinical Development, Clinical Trials, Vaccines, Medicine, Pharmaceutical Industry, Oncology, GCP, CRO, Pharmacovigilance, Infectious Diseases, Clinical Research, Regulatory Submissions, Lifesciences, Drug Development
Education
Federal University of Sao Paulo 1992 — 1994
Master of Pediatrics
Federal University of Sao Paulo 1988 — 1990
Medical Residency - Pediatrics / Pediatric Infectology
University of Brasilia 1981 — 1987
Doctor of Medicine (MD)
INC Research June 2014 - Present
Parallon November 2010 - May 2014
Chiltern International February 2005 - September 2009
Pharmaceutical/biotech companies, CROs, clinical and academic environments 2005 - 2009
Seton Family of Hospitals May 1996 - February 2005
University of Texas Medical Branch April 1992 - May 1996
Skills
Analysis, Vendor Management, Healthcare, Project Management, Research, Data Analysis, Marketing, Workshop Facilitation, Software Documentation, Budgets, GCP, Clinical Research, Team Building, Healthcare Information..., Medical Devices, Program Management, Business Analysis, Clinical Trials, Data Management, Pharmaceutical Industry, Hospitals, Healthcare Management, Process Improvement, CTMS, Biotechnology, Strategic Planning, Policy, Clinical Development, Forecasting, Management, Oncology, Contract Management, Business Development, Cross-functional Team..., Physicians, Leadership, Clinical Data Management, Managed Care, Procurement, Healthcare Consulting, Training, EHR, Informatics
Education
The University of Texas at Austin 1985 — 1987
MBA, Marketing
The University of Texas at Austin 1977 — 1980
BM, Music Theory
University of Houston
BA, Psychology
Momentum Event Group February 2013 - Present
CBG Solutions, LLC November 2007 - Present
The Conference Board November 2007 - Present
Chiltern International August 2006 - November 2007
Chiltern International May 2004 - August 2006
Institute for International Research (IIR) April 2002 - May 2004
National Institute for Government Innovation September 2001 - April 2002
Skills
Conferences, Market Research, Program Development, Outsourcing, Change Management, Negotiation, Program Management, Procurement, Account Management, Customer Relations, New Business Development, Business Strategy, Operations Management, Event Management, Research, Shared Services, Consultative Selling, Vendor Management, Proposal Writing, Strategy, Business Development, CRM, Leadership, Management Consulting, Organizational..., Cross-functional Team..., Budgets
Education
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor of Arts, Psychology and Political Science
ProTrials Research April 2013 - September 2015
ICON September 2011 - April 2013
Texas Box Office May 2011 - September 2011
Manpower May 2011 - September 2011
Chiltern International July 2005 - January 2011
Contract July 2004 - March 2005
PPD March 1998 - July 2004
PPD 1998 - 2004
Skills
Clinical Trials, Clinical Monitoring, Neurology, CTMS, Vaccines, Ophthalmology, CRO, EDC, ICH-GCP, Pharmaceutical Industry, Pharmacovigilance, Patient Recruitment, Clinical Research, Regulatory Affairs, Oncology, Clinical Development, Biotechnology, Clinical Data Management, Sop, Drug Development, Rheumatoid Arthritis, Medical Writing, Therapeutic Areas, Infectious Diseases, GCP, Regulatory Submissions, Protocol
Education
The University of Texas at Austin 1991 — 1997
B.A., Classics
Quintiles October 2011 - Present
Worldwide Clinical Trials, Inc October 2008 - August 2010
Chiltern International February 2007 - October 2008
Chiltern International November 2003 - February 2007
PPD 1997 - 2003
Skills
CRO, CTMS, Clinical Monitoring, Clinical Research, Clinical Trials, EDC, GCP, Leadership, Therapeutic Areas, Pharmaceutical Industry, Clinical Development, ICH-GCP, Clinical Data Management, Regulatory Submissions, Regulatory Affairs
Education
St. Edward's University 1999 — 2001
MBA, Business Management
The University of Texas at Austin 1993 — 1997
BA, Microbiology
Nomad Clinical Consulting, Inc January 1999 - Present
Chiltern International August 2009 - January 2010
ICON Clinical Research 1995 - 1999
ICON Clinical Research 1995 - 1999
US Navy/Navy Reserve 1982 - 1997
Southeastern Clinical Research Consultants 1994 - 1995
Education
Southern Illinois University, Carbondale
Austin Energy October 2013 - Present
Health & Human Services November 2008 - October 2013
Brazos Higher Education Service Corp. August 2003 - August 2008
Chiltern International October 2001 - March 2003
Minco Technology Labs May 1984 - May 1999
Skills
Information Security, CISSP, Penetration Testing, Security, Vulnerability Assessment, Information Security..., Vulnerability Management, Security Awareness, Troubleshooting, Risk Management, PCI DSS, Network Security, Risk Assessment
Education
St. Edward's University 1998 — 2001
BS, Computer Science
SynteractHCR July 2014 - Present
Chiltern International November 2012 - July 2014
Pierrel Research USA, Inc. August 2010 - February 2012
PharmaNet August 1998 - August 2010
IRI (a division of J&J) August 1997 - August 1998
Phoenix International Life Sciences, Inc. October 1994 - August 1997
Johnson & Johnson 1982 - 1994
Skills
EDC, Clinical Trials, CTMS, Clinical Development, CRO, Pharmaceutical Industry, Biotechnology, Therapeutic Areas, Regulatory Affairs, Business Development, GCP, Clinical Research, Drug Development, Oncology, Lifesciences, Vaccines, Infectious Diseases, Pharmacovigilance, Sop, Diabetes, Medical Devices, Pharmaceutics, Health Economics, IND, Regulatory Submissions, 21 CFR Part 11, Neurology, Medical Affairs, Clinical Monitoring, Protocol, Biopharmaceuticals, Medical Writing, Dermatology
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree, Biology
Texas Physicians Medical Research Group July 2015 - Present
Premier Research July 2013 - July 2015
Actavis (now Allergan) 2015 - 2015
Chiltern International April 2012 - June 2013
Quintiles 2009 - 2010
AstraZeneca April 2005 - November 2007
Skills
Pharmaceutical Industry, Oncology, Drug Discovery, Clinical Development, Clinical Trials, GCP, CTMS, CRO, Therapeutic Areas, ICH-GCP, Clinical Monitoring, Medicinal Chemistry, Biotechnology, Drug Development, Cardiology, Clinical Research
Education
The University of Texas at Arlington 1989 — 1995
Bachelor of Science (BS), Biology, General
Chiltern International October 2012 - Present
Pfizer October 2011 - October 2012
Medimag MS December 2007 - October 2011
Fromvoulevs Ltd. December 2006 - November 2007
Skills
Pharmaceutical Industry, Sales, Medical Devices, Currently - Clinical..., Product management of..., GCP, Clinical Trials, Regulatory Submissions, Clinical Monitoring, ICH-GCP
Education
Sofia University St. Kliment Ohridski 2000 — 2006
Master of Science (MS), Biochemistry and Molecular Biology
English Language School Plovdiv 1994 — 1999
Chiltern International March 2013 - Present
Auxilium Pharmaceuticals, Inc. May 2012 - March 2013
CSL Behring April 2008 - May 2012
ViroPharma Incorporated September 2006 - October 2007
Genaera Corporation March 2004 - September 2006
Wyeth Research 2000 - 2004
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, FDA, Biotechnology, Clinical Research, Oncology, Infectious Diseases, Validation, Clinical Data Management, Medical Writing, GCP, Biostatistics, Data Management, EDC, Therapeutic Areas, IND, Drug Development, Vaccines, Regulatory Affairs, Protocol, Clinical Study Design, CRO, CDISC, Regulatory Submissions
Education
Stevens Institute of Technology
BS, MS, PhD, Mathematics
AbbVie April 2009 - Present
KForce/Pfizer 2007 - March 2009
Chiltern International January 2006 - January 2007
Berlex Laboratories 2001 - 2006
Quintiles October 1997 - September 2001
University of Florida January 1995 - October 1997
Shands Hospital May 1993 - October 1997
Skills
Cardiology, Oncology, Neurology, Endocrinology, Rheumatology, Sales Effectiveness, Pharmaceutical Sales, Clinical Trials, Sop, OB/GYN, CRO, GCP, Clinical Research, Therapeutic Areas, Pharmaceutics, Clinical Development, Diabetes, Dermatology, Infectious Diseases, Nephrology, Vaccines, Regulatory Affairs, Gastroenterology, ICH-GCP, Clinical Monitoring, Biopharmaceuticals, EDC, FDA, Medical Devices, Pulmonology, Regulatory Submissions, Regulatory Requirements, Product Launch, Drug Development, Neuroscience, Selling Skills, Pain Management, Protocol
Education
University of Florida 1989 — 1993
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
Premier Research August 2012 - Present
Chiltern International February 2011 - August 2012
The EMMES Corporation November 2009 - February 2011
INC Research August 2007 - November 2009
Washington University School of Medicine May 2006 - July 2007
Saint Louis University School of Public Health January 2003 - April 2006
Washington University School of Medicine July 1999 - December 2002
Skills
Clinical Research, Clinical Trials, CRO, CTMS, IRB, Clinical Monitoring, GCP, Oncology, Infectious Diseases, Biotechnology, Pharmaceutical Industry, Clinical Development, Regulatory Affairs, Neuroscience, Regulatory Submissions
Education
Saint Louis University 1997 — 1999
MPH, Public Health/Epidemiology
University of Missouri-Saint Louis 1989 — 1992
BA, Psychology
Chiltern International August 2015 - Present
The Bobbitt Group, Inc. 2008 - July 2015
The Bobbitt Group, Inc. 2004 - 2007
Duke Health Community Care 2003 - 2004
Deloitte & Touche, LLP 2000 - 2003
EY 1999 - 2000
Skills
Leadership, Construction, Financial Accounting, Nonprofits, Finance, CPA, Budgets, Contract Negotiation, Contract Management, Strategic Planning, Tax Accounting, Financial Reporting, Negotiation, Operations Management, Organizational..., IT Management, Team Building, Management, Forecasting, Project Planning, Financial Analysis, Project Management
Education
University of North Carolina - Kenan Flagler Business School 1998 — 1999
Masters of Accounting
University of North Carolina at Chapel Hill 1994 — 1998
Bachelor of Science
OXON Epidemiology May 2015 - Present
CONTINUUM CLINICAL September 2014 - April 2015
CSAPharma March 2013 - August 2014
Chiltern International September 2007 - December 2012
REGISTRAT, Inc. May 2003 - September 2007
Medpace International February 2002 - April 2003
CSA Pharma Systems April 1995 - February 2002
Clintrials Research March 1991 - April 1995
SCI Statitical Consultants April 1986 - March 1991
Skills
CRO, CTMS, Clinical Development, GCP, Clinical Trials, EDC, Pharmaceutical Industry, Clinical Monitoring, Oncology, ICH-GCP, Biotechnology, Clinical Research, Drug Development, Regulatory Submissions
Education
University of Kentucky
Bachelor of Science (BS)
Chiltern International May 2010 - Present
Mountain States Health Alliance September 2008 - June 2010
REGISTRAT, Inc. 2007 - 2008
REGISTRAT, Inc. 2005 - 2007
Central Baptist Hospital 1999 - 2005
Skills
Clinical Trials, Clinical Research, GCP, CRO, Cross-functional Team..., Pharmaceutical Industry, CTMS, Medical Affairs
Education
University of Florida
MN, Nursing
University of Kentucky
PhD, Nursing
Caritas Clinical Consulting January 2014 - Present
INC Research October 2012 - December 2013
AMGEN (Functional Service Provider Contracted from Quintiles) October 2009 - October 2012
Quintiles March 2008 - October 2009
Chiltern International April 2007 - March 2008
Chiltern International October 2005 - April 2007
Cru / Vida Estudiantil August 2004 - August 2005
UCLA School of Medicine November 2000 - February 2005
Skills
Clinical Monitoring, Clinical Research, EDC, Clinical Trials, ICH-GCP, Pharmacovigilance, CRO, Oncology, GCP, Inform, Neurology, Vaccines, Endocrinology, Phase I, II, III, and..., Hematology, Asthma, Rheumatology, Cardio-Renal, Cardiovascular, Infectious Diseases, Dermatology, Pediatrics, Mentoring, CCRA, Oracle Clinical, INNTRAX, Lead CRA, Phase Forward, DataTrak, Arthritis, Schizophrenia, Ulcerative Colitis, MDS, NSCLC, HCC, Hyponatremia, CHF, RECIST, Hepatitis C, Diabetic Neuropathy, Breast Cancer, Myocardial Infarction, Psoriasis, Parkinson's Disease, Anxiety Disorders, Diagnostic Studies, Crohn's Disease, RECIST 1.1, Diabetes, HIV/AIDS
Education
University of California, Los Angeles
BS, Psychobiology / English (minor)
Chiltern International February 2011 - Present
Biostudy Solutions, LLC February 2007 - February 2011
AAIPharma Inc. October 2003 - February 2007
Skills
CRO, Clinical Trials, SDTM, Biostatistics, Clinical Development, CDISC, EDC, Sop, GCP, FDA, Therapeutic Areas, Data Management, Clinical Study Design, ICH-GCP, Protocol, Oracle Clinical, Pharmaceutical Industry, Statistical Programming, Clinical Research, Clinical Data Management, CTMS, Phase I, Pharmacokinetics, Regulatory Submissions, SAS programming, Pharmacodynamics, Statistics
Education
University of North Carolina at Wilmington 2003 — 2007
M.S., Mathematics & Statistics
University of North Carolina at Wilmington 1999 — 2003
B.S., Mathematics & Statistics
Optum October 2011 - Present
Chiltern International July 2007 - June 2012
etrials Worldwide 2004 - 2007
Quintiles January 2001 - April 2004
Skills
Microsoft Excel, Proposal Writing, Management, Research, Budgets, Clinical Trials, CRO, Project Management, Contract Management, Business Development, Outsourcing, Team Management, Human Resources, Sales, Pharmaceutical Industry, Oncology, GCP, Cross-functional Team..., Clinical Development, CTMS, Biotechnology, Life Sciences, EDC, Data Management, Clinical Research, Leadership, Medical Devices
Education
St. Thomas Aquinas College 1994 — 1994
Accounting and Business/Management
INC Research November 2011 - Present
INC Research August 2006 - November 2011
Chiltern International September 2000 - August 2006
Clinicor, Inc. March 1997 - August 2000
Pharmaco 1991 - 1996
Pharmaco August 1989 - December 1990
Skills
Proposal Writing, CRO, Clinical Research, Contract Negotiation, Clinical Trials, Therapeutic Areas, Clinical Monitoring, CTMS, Pharmaceutical Industry, Clinical Development, Biotechnology, EDC, GCP, Sop, Oncology, ICH-GCP, Regulatory Submissions, Infectious Diseases, Regulatory Affairs, Drug Development, Pharmacovigilance, Data Management, Clinical Data Management
Education
St. Mary's University 1987 — 1989
MBA, Business
University of Wyoming 1968 — 1973
BA, MS, Microbiology
Chiltern International April 2011 - Present
AAIPharma Services Corp. March 2008 - May 2011
AAI Development Services July 2005 - March 2008
AAI Development Services July 2000 - July 2005
Columbus Christian Academy August 1999 - June 2000
Skills
FDA, CRO, Pharmaceutical Industry, Regulatory Affairs, Sop, Clinical Research, Regulatory Submissions, Regulatory Requirements, Formulation, IND, Laboratory, Technology Transfer, GMP, Protocol, GLP, Quality Assurance, Analytical Chemistry, Medical Writing, Chemistry
Education
University of North Carolina at Wilmington
MS, Chemistry
University of North Carolina at Wilmington 1997 — 1999
Bachelor, Chemistry
Chiltern International May 2014 - Present
Chiltern International August 2010 - March 2013
King Pharmaceuticals February 2010 - August 2010
King Pharmaceuticals February 2010 - August 2010
PPD January 2003 - July 2009
PPD January 2006 - September 2007
PPD February 2005 - December 2005
Skills
Clinical Research, CRO
Education
University of North Carolina at Wilmington 1998 — 2001
Ardea Biosciences August 2012 - Present
Pfizer 2010 - August 2012
Chiltern International August 2006 - September 2009
PRACS Institute, Ltd. July 2005 - July 2006
PPD June 2002 - July 2004
VivoMetrics, Inc. July 2001 - July 2002
HemoTherapies, Inc. January 2000 - July 2001
CCS Associates May 1997 - January 2000
Medtronic August 1995 - May 1997
Skills
GCP, Regulatory Affairs, CRO, Clinical Research, CTMS, Clinical Trials, Clinical Development
Education
Southeast Missouri State University
BS, Biology
SynteractHCR April 2013 - Present
Synteract, Inc. June 2008 - April 2013
Chiltern International 2004 - 2006
Education
University of Colorado Boulder 1992 — 1996
BA, Biology
Chiltern April 2015 - Present
Merz North America August 2014 - March 2015
Chiltern International March 2013 - August 2014
BioCryst Pharmaceuticals May 2009 - December 2012
BioCryst Pharmaceuticals August 2007 - May 2009
MGI Pharma December 2003 - July 2007
PharmaResearch Corporation 1997 - 2003
Skills
Global Drug Development, eCTD, Cross-functional Team..., Clinical Trials, Project Planning, Operating Budgets, Strategic Partnerships, Clinical Study Design, Clinical Development, Protocol Design, Clinical Monitoring, Clinical Operations, Productive Teams, Risk Assessment, Key Opinion Leaders, Risk Management, Vendor Management, EDC, Medidata, Phase 1, Phase 2, Pivotal Studies, IND, Code of Federal..., ICH-GCP, Collaborative Problem..., CTMS, Oncology, CRO, FDA, Therapeutic Areas, GCP, Protocol, Clinical Data Management, Drug Development, Infectious Diseases, Pharmacovigilance, Phase I, Data Management, Regulatory Submissions, 21 CFR Part 11, Biopharmaceuticals, Vaccines, Rheumatology, CRF design, Trial Management, Patient Recruitment, Cancer
Education
North Carolina State University 1989 — 1993
BS, Zoology, Pre-med
PPD June 2015 - Present
CTI BioPharma February 2015 - May 2015
Quintiles October 2012 - June 2014
Quintiles August 2011 - October 2012
Quintiles October 2009 - September 2011
Quintiles April 2007 - September 2009
Quintiles August 2005 - April 2007
Chiltern International 2003 - 2005
California Neuropsychopharmacology Clinical Research Institute 1998 - 2003
Skills
Clinical Monitoring, CRO
Education
University of Phoenix 2003 — 2005
Master of Business Administration (MBA), Global Management
San Diego State University-California State University 1997 — 2001
Bachelor of Applied Science (BASc), Cellular and Molecular Biology
Chiltern International April 2014 - Present
Chiltern International February 2010 - March 2014
Chiltern International April 2002 - January 2010
Chiltern International September 2000 - April 2002
PPD 1998 - 2000
Eye Research Associates 1984 - 1998
Skills
ICH-GCP, CRO, Clinical Trials, Clinical Monitoring, GCP, EDC, CTMS, Clinical Development, Cardiology, Therapeutic Areas, Pharmacovigilance, Oncology, Pharmaceutical Industry, Clinical Research
Education
Texas A&M University 1978 — 1982
Bachelor of Science, Biomedical Science
Synteract, Inc. August 2010 - Present
Chiltern International April 2007 - February 2010
TimePoint Clinical Research November 2006 - April 2007
Retina Research Center June 2005 - November 2006
Self Employed October 2004 - July 2005
CHILDREN'S RESEARCH LABORATORY May 2003 - December 2003
Learning Express November 2001 - July 2002
FIRST UNITED METHODIST CHURCH September 2001 - February 2002
Education
The University of Texas at Austin
B.A, Psychology
ClinDatrix, Inc. May 2010 - Present
Chiltern International January 2009 - October 2009
Valeant Pharmaceuticals October 2007 - November 2008
Gen Probe June 2007 - August 2007
Roche Molecular Systems May 2004 - April 2007
Anderol April 2000 - April 2004
Skills
CRO, Microbiology, Regulatory Submissions, Validation, Clinical Research
Education
Seton Hall University 1995 — 1999
BS, Biology
Eurofins Central Laboratory September 2014 - Present
ReSearch Pharmaceutical Services July 2013 - December 2013
ACM Global Central Laboratory Mumbai Ltd. December 2011 - April 2013
ACM Global Central Laboratory November 2010 - April 2013
RPS 2013 - 2013
ACM Global Central Laboratory June 2006 - January 2011
Chiltern International June 2004 - June 2006
PPD January 1990 - June 2004
Pharmaco 1990 - 1995
Skills
Clinical Trials, Biotechnology, CRO, Pharmaceuticals, Clinical Development, Data Management, Pharmaceutical Industry, ICH-GCP, Immunology, CTMS, EDC, Operations Management, Oncology, Validation, Clinical Data Management, GCP, Drug Development, FDA, Lifesciences, Protocol, Life Sciences, Clinical Research, Infectious Diseases, SOP, Regulatory Affairs, Management, Medical Devices, Clinical Monitoring
Education
Ohio University 1995 — 1999
BS, Health Science
University of Southern California 1986 — 1989
Film & Television
Chiltern international June 2015 - Present
Chiltern International November 2013 - July 2015
Chiltern International November 2011 - November 2013
Chiltern International July 2009 - November 2011
Chiltern International October 2007 - July 2009
Chiltern International April 2007 - October 2007
Skills
EDC, Oracle Clinical, Clinical Trials, Clinical Data Management, SDTM, ICH-GCP, GCP, Data Management, Clinical Research
Education
Mount Olive College 2012 — 2015
Business Management
Alcon, a Novartis company January 2015 - Present
Chiltern International May 2012 - September 2013
ReSearch Pharmaceutical Services May 2011 - May 2012
sanofi-aventis March 2002 - May 2011
Bayer Pharmaceuticals 2000 - 2002
AstraZeneca Pharmaceuticals 1998 - 2000
Children's Hospital of Philadelphia 1996 - 1998
Skills
Oncology, Diabetes, Endocrinology, Pediatrics, Neurology, Clinical Trial..., Opthalmology
Education
Thomas Jefferson University
Bachelor’s Degree, Nursing
University of Pittsburgh
Biology/Biological Sciences, General
Green Key Resources August 2015 - Present
Chiltern International July 2014 - August 2015
Ockham Development Group April 2012 - September 2014
Trinity Healthcare Staffing Group April 2008 - April 2012
Trinity Healthcare April 2008 - April 2010
Skills
Customer Service, Customer Relations, Outlook, Financial Planning, Budgeting, Problem Solving, Microsoft Office, CRO, Business Development, Strategic Financial..., Clinical Trials, Budgets, Clinical Research, Biotechnology, Clinical Development, Pharmaceutical Industry, SAS, Biostatistics, Data Management, CTMS, Clinical Data Management, ICH-GCP, Oncology, Oracle Clinical, SAS programming, Applicant Tracking..., Internet Recruiting, Clinical Monitoring, Contract Recruitment, Regulatory Affairs
Education
North Carolina State University 2003 — 2007
BA, Applied Psychology
Chiltern International May 2011 - Present
Astellas Pharma October 2006 - April 2011
TAP Pharmaceuticals March 2003 - September 2006
Pharmacia 2000 - 2003
Trilogy 1990 - 1992
Skills
CDISC, Clinical Trials, Oncology, Pharmacovigilance, Clinical Research, FDA, Clinical Study Design, Drug Development, CRO, Clinical Development, SAS programming, Pharmaceutical Industry, Data Management, EDC, GCP, SAS Programming, Therapeutic Areas, Clinical Data Management
Education
University of Illinois at Chicago
Bachelor of Science (BS), Mathematics and Computer Science
Allergan June 2011 - November 2014
Baxter Healthcare September 2009 - December 2011
ISTA Pharmaceuticals July 2008 - August 2009
Collagenex/Galderma 2007 - 2008
Pfizer/KForce Alliance 2005 - 2007
MDS Pharma Services 2005 - 2006
Chiltern International 2004 - 2005
Maxim Pharmaceuticals 2001 - 2004
dj Orthopedics 1999 - 2001
Cypros Pharmaceuticals 1999 - 1999
Skills
Healthcare, Clinical Research, Clinical Trials, GCP, Regulatory Submissions
Education
Rutgers University – Camden
Certificate, Management
Columbus University, New Orleans, LA
BS, Healthcare
University of California, San Diego 2000 — 2001
Certificate, Clinical Research / Regulatory Affairs
MediVector, Inc. July 2013 - Present
Millennium Pharmaceuticals August 2011 - June 2013
Chiltern International January 2010 - August 2011
PPD June 2004 - October 2009
Diagnostic Oncology CRO, Inc. 2000 - 2003
Skills
Clinical Trials, Clinical Development, CRO, Clinical Monitoring, Protocol, Clinical Research, CTMS, Sop, Drug Development, EDC, Clinical Research..., Oncology, GCP, Pharmaceutical Industry, ICH-GCP, SOP
Education
Southern Connecticut State University 1989 — 1994
B.S., Biology
Social and Scienfific Systems, Inc 2011 - Present
PPD September 2011 - November 2011
Duke University May 2011 - August 2011
Kelly Services July 2009 - November 2010
Clinimetrics June 2007 - June 2009
PAREXEL 2003 - 2004
Chiltern International 1999 - 2001
Clinicor 1999 - 2000
Education
University of Houston 1984 — 1986
BS, Business Admin
INC Research July 2012 - Present
Chiltern International March 2009 - March 2011
Chiltern International March 2006 - 2009
Paragon Biomedical (Now Clinipace Worldwide) 2003 - 2006
Paragon Biomedical (Now Clinipace Worldwide) 2003 - 2006
Skills
Clinical Trials, Clinical Research, CTMS, EDC, CRO, Clinical Monitoring, ICH-GCP, GCP, Cardiology
Education
Santa Fe Community College 1981 — 1985
ADN, Nursing
Chiltern International March 2012 - Present
The EMMES Corporation January 2008 - March 2012
Skills
Clinical Monitoring, ICH-GCP, EDC, Clinical Data Management, Protocol Development, Regulatory Requirements, SOP Development
Education
University of Maryland College Park 1993 — 1996
BS, Biological Resources Engineering
Chiltern International 2011 - Present
Astellas Pharma April 2000 - April 2011
PAREXEL January 1998 - April 2000
ZS Associates April 1994 - September 1997
Skills
Clinical Data Management, EDC, Clinical Research, SAS, CTMS, Data Management, Protocol, Oncology, CRO, GCP, Clinical Trials, 21 CFR Part 11, Clinical Development, Regulatory Submissions, Pharmacovigilance
Education
University of Illinois at Chicago
BS, Computer Science
Bristol-Myers Squibb December 2014 - Present
Bristol-Myers Squibb December 2014 - Present
Bristol-Myers Squibb June 2011 - December 2014
Bristol-Myers Squibb, Princeton, New Jersey August 2008 - December 2010
Bristol-Myers Squibb, Princeton, New Jersey August 2008 - December 2010
Chiltern International Spain January 2007 - July 2008
Chiltern International Spain November 2006 - July 2008
Chiltern International January 2003 - July 2008
Chiltern International January 2003 - January 2007
Hepathology January 2003 - December 2004
Skills
Project Coordination, Project Management, Leadership, Clinical Trials, Pharmaceuticals, Oncology, Therapeutic areas, Inform, Coordination, Time Management, Protocolo, Ensayos clínicos, Industria farmacéutica, Normas ICH de buenas..., Oncología, Organización de..., Sistema de gestión de...
Education
EPHOS 2002 — 2003
2002 MASTER; Master
Universidad Complutense de Madrid 1994 — 1999
Bachelor's degree, Pharmacy
IntegraLabs, Inc. March 2014 - Present
PharmaDirections June 2013 - March 2014
Merck -via TSS September 2008 - March 2012
United Therapeutics 2006 - 2007
Covance 2006 - 2007
Cumberland Pharmacal Co. 2001 - 2007
Chiltern International 2005 - 2006
Novartis 2001 - 2003
GlaxoSmithKline 1991 - 2001
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Product Management, Product Marketing, New Business Development, Biotechnology, CRO, Marketing Strategy, Successful Business..., Specialty Pharmaceutical, Product Launch, Website Development, Website Promotion, Patient Advocacy, Patient Education, Sales Effectiveness, Dermatology, Neurology, Sales
Education
University of Maryland College Park
Accelovance, Inc. September 2014 - Present
Chiltern International February 2009 - August 2014
Pharm-Olam International September 2006 - February 2009
PharmaResearch Corp 2000 - 2004
Skills
CRO, GCP, CTMS, Clinical Development, Clinical Trials, Oncology, Pharmaceutical Industry, Business Development, ICH-GCP, Clinical Monitoring, EDC, Clinical Data Management, Infectious Diseases, Drug Development, Pharmacovigilance, Therapeutic Areas, Regulatory Submissions, Biotechnology
Education
University of Cincinnati
Biology
Novo Nordisk A/S January 2013 - Present
Chiltern International January 2013 - Present
Executive Health Resources March 2012 - January 2013
Skills
Clinical Research, Medicine, Clinical Trials, Medical Affairs, Medical Writing, Pharmaceutical Industry, Oncology, Clinical Development, CTMS, Pharmacovigilance, GCP, CRO, Diabetes, Clinical Monitoring, Therapeutic Areas
Education
The Johns Hopkins University 1986 — 1991
Doctor of Medicine (MD), Public Health
UNC Greensboro 1982 — 1986
Bachelor of Science (BSc), Bochemical Nutrition
UNC Greensboro 1982 — 1986
Bachelor's degree, Biochemical Nutrition
Chiltern April 2015 - Present
Chiltern International September 2013 - April 2015
Chiltern International July 2012 - September 2013
PPD August 2011 - July 2012
PPD September 2006 - August 2011
Skills
CRO, GCP, Sop, Clinical Trials, Clinical Development, Protocol, FDA, EDC, Therapeutic Areas, Clinical Research, Analysis, Clinical Data Management, Oncology, Clinical Monitoring, CTMS
Education
University of North Carolina at Wilmington 2004 — 2006
Chiltern International 2010 - Present
Skills
Clinical Research, Clinical Trials, CRO, CTMS, Clinical Development, GCP, Clinical Monitoring, EDC, ICH-GCP, Oncology, Pharmaceutical Industry, Therapeutic Areas, Neurology, Clinical Operations
Education
Pepperdine University 1992 — 1994
MA, Clinical Psychology
Chiltern International October 2012 - Present
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Clinical Development, CTMS, GCP, Oncology, Data Management, Clinical Research, Regulatory Submissions, Biotechnology, Phase I, Sop, Regulatory Affairs, Vaccines, FDA, SAS programming, Medical Devices, EDC, Line Management
Education
University of North Carolina at Chapel Hill 1990 — 1993
MPH, Biostatistics
North Carolina State University 1984 — 1989
BS, Statistics
Washington High School
Washington High School
Chiltern International December 2011 - Present
PPD, Hamilton, NJ April 2011 - November 2011
Covance Clinical Data, Analysis and Reporting Organization (CDARO) November 2010 - April 2011
American Institutes for Research January 2010 - October 2010
Education
University of Madras 1996 — 2001
B.E, Electrical and Electronics Engineering
Cmed November 2012 - Present
Cmed January 2010 - October 2012
Chiltern International October 2007 - December 2010
Clinical Trial Management Services, Inc. (CTMS, Inc.) September 1995 - October 2007
Skills
CRO, Clinical Data Management, EDC, CRF design, CDISC, GCP, Clinical Trials, ICH-GCP, 21 CFR Part 11, Data Management, Sop, Therapeutic Areas, Clinical Research
Education
Holston Valley Community Hospital School of Medical Technology 1978 — 1979
Medical Technology, Clinical Laboratory Medicine
Tennessee Technological University 1974 — 1978
BS, Biology
Quintiles April 2012 - Present
Takeda Pharmaceuticals July 2008 - March 2012
TAP Pharmaceuticals December 2005 - July 2008
TAP Pharmaceuticals June 2004 - December 2005
Chiltern International April 2003 - June 2004
Chiltern International September 2002 - March 2003
Chiltern International July 2001 - September 2002
Chiltern International September 2000 - July 2001
Clinicor January 2000 - August 2000
Skills
Clinical Monitoring, EDC, GCP, CTMS, Protocol, Endocrinology, Clinical Trials, Clinical Research, Cardiology, Sop, Clinical Operations, Rheumatology, CRO, FDA, Gastroenterology, Urology, Pharmaceutical Industry, Ophthalmology, Nephrology, Management
Education
Texas A&M University 1995 — 1999
B.S., Biomedical Science
Chiltern International April 2014 - Present
Chiltern International April 2008 - April 2014
Rho April 2007 - April 2008
PharmaResearch / Inveresk / Charles River / Kendle February 2002 - April 2007
RTI International August 1999 - February 2002
Skills
Clinical Trials, SAS, CDISC, SDTM, ADaM, Biostatistics, Clinical Data Management, CRO, Clinical Development
Education
University of North Carolina at Chapel Hill 1997 — 1999
Master of Science, Biostatistics
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor of Science in Public Health, Biostatistics
Chiltern International CSAChiltern InternationalNovember 2002 - Present
Education
The University of Texas at El Paso 1982 — 1986
BSN, Nursing
AstraZeneca May 2014 - Present
Chiltern International December 2013 - May 2014
Chiltern International October 2010 - December 2013
Chiltern International June 2009 - October 2010
Skills
SAS programming, CDISC, SDTM, SQL, C#, Visual Basic, Java, Visual Studio, Lotus Notes, Microsoft Office, Eclipse, Clinical Data Management, Oracle Clinical, EDC, SAS Programming
Education
University of North Carolina at Wilmington 2006 — 2009
BS, Computer Science
Chiltern International April 2010 - Present
Astellas Pharma December 2006 - April 2010
Skills
SAS programming, SAS Programming, CRO, Clinical Trials, Clinical Data Management
Education
The University of Texas at San Antonio
Master's degree, Biotechnology
Chiltern International August 2010 - Present
Chiltern International June 2008 - August 2010
Chiltern International May 2003 - June 2008
Medtronic Sofamor Danek November 1999 - May 2003
Universtiy of Illinois at Chicago September 1996 - May 1999
Saint Francis Hospital January 1996 - September 1996
Skills
Clinical Monitoring, CTMS, CRO, EDC, Clinical Trials, GCP, ICH-GCP, Clinical Development, Clinical Research, Regulatory Submissions, IRB, Protocol, CRF design, Pharmaceutical Industry, Vaccines, Biotechnology
Education
University of Illinois at Chicago 1996 — 1999
Master of Science (M.S.), Bioengineering
University of Illinois at Urbana-Champaign 1993 — 1995
Bachelor of Science (B.S.), Liberal Arts and Sciences / Bionengineering
Chiltern International January 2012 - Present
Chiltern International November 2010 - March 2012
Chiltern International November 2010 - March 2012
Chiltern International June 2010 - November 2010
Chiltern International December 2005 - June 2010
CTMS, Inc. November 2004 - December 2005
Bristol Virginia Utility Board September 2003 - November 2004
Bristol Tennessee Electric System 1999 - July 2003
Skills
Adapt Quickly to Change, Microsoft Excel, Microsoft Word, PowerPoint, Outlook, Lotus Notes, Coordinating Tasks, Switchboard Operator, Data Management, Clinical Research, Training, Medical Transcription, Project Management, Teamwork, Microsoft Office, Clinical Trials
Education
Northeast State Community College 2001 — 2004
Associate of Applied Science, Office Administration Technology/Medical Office
Chiltern International November 2013 - Present
Skills
Pharmacovigilance, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Teamwork, Photoshop, English, Java, HTML, Clinical Research, ICH-GCP, CRO, Databases, Data Entry, Time Management, SOP, SAE tracking
Education
University of North Carolina at Wilmington 2005 — 2013
Bachelor's Degree, Criminology
Northern Virginia Community College 1997 — 2004
Associate of Science (AS), Science
Chiltern International May 2011 - Present
Education
University of Iowa 2011 — 2011
Certificate in Vocology
University of Kentucky 1979 — 1990
Doctor of Philosophy (Ph.D.), Music Pedagogy
Dalcroze School of Music 1970 — 1972
Full Certificate
Chiltern International November 2013 - Present
Duke Clinical Research Institute September 2007 - November 2013
Education
Shaw University 1999 — 2002
Bachelor of Arts (B.A.)
Chiltern International January 2013 - Present
INC Research October 2011 - December 2012
Novella Clinical, Inc. January 2009 - June 2010
Skills
Clinical Research, Clinical Trials, CRO, Oncology, GCP, Clinical Development, ICH-GCP, CTMS, EDC, Pharmaceutical Industry, Clinical Monitoring, Clinical Data Management, Biotechnology, Infectious Diseases, Pharmacovigilance, Therapeutic Areas, Lifesciences, Diabetes, Regulatory Affairs
Education
UNC Greensboro 1995 — 2000
Bachelor of Science (B.S.), Biology with concentration in Biotechnology
University of North Carolina at Greensboro 1995 — 2000
Bachelor of Science (B.S.), Biology with concentration in Biotechnology
Chiltern International April 2014 - Present
Education
University of North Carolina at Chapel Hill
Master of Public Health (MPH), Biostatistics