Clinipace Worldwide
Industry: Company
DescriptionHeadquarters: Mumbai, India Founded: 2003 Subsidiaries: Paragon Biomedical, Inc., Accovion GmbH, Choice Pharma (HK) Limited, Regulus Pharmaceutical Consulting, Inc.
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Clinipace Worldwide Employees
Quintiles September 2015 - Present
Quintiles September 2014 - Present
PAREXEL February 2013 - September 2014
PMG Research May 2012 - February 2013
Clinipace Worldwide January 2012 - May 2012
Winston’s Grille January 2006 - January 2012
Vail Resorts, Keystone, COSpring Semester January 2010 - January 2011
Figure 8 Island Yacht Club January 2008 - January 2010
Skills
GCP, EDC, Clinical Trials, Clinical Research, Regulatory Affairs, ICH-GCP, CTMS, Protocol, CRO, Data Management, Clinical Data Management, Clinical Development, Clinical Monitoring, Sop, Oncology, Pharmaceutical Industry, Validation, Oracle Clinical, Therapeutic Areas, Inform, Clinical Operations, IRB, Patient Recruitment, 21 CFR Part 11, Drug Development, Vaccines, Cardiology, CRF design, Quality Assurance, Informed Consent, eCRF, Project Management, Laboratory, Dermatology, Pharmacology, Clinical Study Design
Education
The George Washington University School of Medicine and Health Sciences 2013 — 2015
Masters of Science in Health Sciences, Clinical Research Admistration
University of North Carolina at Wilmington 2007 — 2012
Bachelor of Science, Clinical Research
Premier Research February 2015 - Present
Clinipace Worldwide October 2014 - February 2015
Novella Clinical, Inc. August 2013 - October 2014
RTI International July 2007 - August 2013
Beaumont Family Chiropractic September 2005 - July 2007
Skills
Forecasting, Budgets, Leadership, Finance, Project Management, Accounting, Contract Management, Invoicing, Process Scheduler, Team Management, PeopleSoft, Cognos, Deltek, SAP Business ByDesign, Costpoint, Oracle, CRO, Clinical Trials, Profit Analysis
Education
University of Phoenix 2005 — 2009
Bachelor of Science, Business - Accounting
Clinipace Worldwide January 2012 - September 2013
Skills
CRO, Clinical Trials, CTMS, EDC, Clinical Development, Pharmaceutical Industry, Clinical Monitoring
Education
University of Northern Iowa
PPD April 2015 - Present
Sanguine, Inc. March 2014 - Present
Clinipace Worldwide November 2013 - April 2015
Anaheim Clinical Trials December 2009 - October 2013
Tutti Frutti Frozen Yogurt May 2008 - May 2013
Advanced Clinical Research Institute January 2009 - December 2009
Skills
Clinical Trials, Clinical Research, GCP, ICH-GCP, EDC, IRB, Research, Pharmaceutical Industry, CTMS, CRO, Infectious Diseases, Protocol, Medical Writing, Clinical Operations, Medidata, Oracle Clinical, Inform, Gastroenterology, Informed Consent, Study Coordination, Clinical Research..., Medical Research, Oncology
Education
University of Nebraska, Kearney 2009 — 2011
Master of Science (M.S.), Biology/Biological Sciences, General
University of California, Riverside 2001 — 2004
Bachelor of Science (B.S.), Biological Science
Clinipace Worldwide July 2015 - Present
Allied American University August 2015 - Present
University of Phoenix June 2008 - Present
Grand Canyon University December 2013 - Present
DCCCD August 2013 - June 2015
Kaplan University June 2013 - November 2014
Tarrant County College August 2013 - December 2013
Quintiles Transnational June 2008 - August 2012
Olathe School District August 2006 - August 2008
Rockwall ISD August 2003 - June 2006
Skills
Biology, Wetlands, Teaching, Research, Public Speaking, Microsoft Office, Environmental Science, Microsoft Excel, Environmental Awareness, PowerPoint, Microsoft Word, Science, Proposal Writing, Strategic Planning, Customer Service, Environmental Compliance, Leadership, Project Management, Data Analysis, Analysis, Corporate Training, Clinical Trials, Grant Writing, Phase I, Training, Data Management, Community Outreach, Laboratory, Soil, Software Documentation, Healthcare, Oncology, Biotechnology, Team Building, Clinical Research, Event Planning, Pharmaceutical Industry, Mentoring, Editing
Education
Texas A&M University-Commerce 2006 — 2008
MS, Biology, GPA 3.81
Texas A&M University-Commerce 1994 — 2001
BS, Earth Science
Clinipace Worldwide October 2014 - Present
Clinipace Worldwide January 2014 - October 2014
Intertek Pharmaceutical Services March 2013 - January 2014
Skills
Clinical Trials, Site Management, Microsoft Excel, CRO, Quality Control, Pharmaceutical Industry, GCP, Sop, Laboratory, Project Coordination, Clinical Research, GLP, Orthopedic..., Physical Therapy, Biotechnology, Life Sciences, Pharmacokinetics, TEMPO (TM)
Education
University of Miami Leonard M. Miller School of Medicine 2011 — 2012
Doctorate of Physical Therapy Candidate, Physical Therapy
University of the Pacific 2006 — 2009
Bachelor of Science (B.S.), Biological Sciences
Craig Consulting LLC August 2015 - Present
INC Research June 2014 - August 2015
Planet Pharma September 2013 - May 2014
Clinipace Worldwide March 2012 - September 2013
PAREXEL May 2010 - March 2012
Paragon Biomedical June 2007 - May 2010
PPD 2006 - 2007
Technical Resources International 2005 - 2006
Skills
Clinical Research, Clinical Monitoring, Clinical Trials, CTMS, GCP, EDC, CRO, ICH-GCP, Oncology, Therapeutic Areas, Infectious Diseases, Clinical Operations, Oracle Clinical, Vaccines, Cardiology, Inform, Diabetes, Endocrinology, Medical Devices, Dermatology, Trial Management, Patient Recruitment, Rheumatology, Gastroenterology, 21 CFR Part 11, IRB, Medidata
Education
University of Maryland Baltimore County 1996 — 1998
BS, Biological Sciences
Clinipace Worldwide October 2012 - May 2015
Spectrum Pharmaceuticals September 2012 - September 2012
Allos Therapeutics September 2008 - September 2012
Gilead Sciences April 2004 - August 2008
Baxter Healthcare September 1988 - November 2003
Skills
Regulatory Submissions, Clinical Development, Regulatory Affairs, IND, Biotechnology, FDA, Clinical Trials, Pharmaceutical Industry, Oncology, NDA, GCP, GMP, Centralised Procedure, MAA, Orphan Drugs, Hemoglobin Therapeutics, Technology Transfer, Lifesciences, Biopharmaceuticals, Clinical Research, CMC, Drug Development, Validation
Education
University of Delaware 1977 — 1982
MS, Marine Studies - Biology
University of Wisconsin-Madison 1973 — 1977
BA, Zoology
PPD July 2015 - Present
Clinipace Worldwide April 2015 - July 2015
Clinipace Worldwide April 2014 - April 2015
Clinipace Worldwide September 2012 - April 2014
University Clinical Investigators, Inc. July 2009 - August 2012
University of Southern California August 2008 - May 2009
Skills
Clinical Trials, Clinical Research, Biotechnology, Regulatory Affairs, IRB, FDA, Pharmaceutical Industry, Lifesciences, CTMS, ICH-GCP, EDC, GCP, Regulatory Submissions, CRO, Diabetes, Patient Recruitment, CRF design, Clinical Monitoring, Life Sciences
Education
University of Southern California 2005 — 2009
Bachelor of Science (B.Sc.), Biological Sciences
ICON plc June 2015 - Present
Clinipace Worldwide December 2014 - April 2015
INC Research November 2012 - July 2014
PAREXEL January 2012 - November 2012
ImClone Systems December 2008 - July 2011
Duke Clinical Research Institute February 2008 - November 2008
RPS May 2007 - February 2008
Keryx Biopharmaceuticals June 2005 - April 2007
Kaiser Permanente Center for Health Research June 2002 - May 2005
UCSF February 1998 - December 1998
Skills
Oncology, Clinical Trials, Clinical Monitoring, ICH-GCP, Cardiovascular Disease, EDC, CRO, CTMS, Pharmaceutical Industry, Regulatory Affairs, Oracle Clinical, Psychiatry, Protocol, Clinical Research, Women's Health, Ophthalmology, Clinical Development, Medical Writing, GCP
Education
University of California, Santa Cruz 1993 — 2000
BA, Medical Anthropology
El Cerrito High School 1989 — 1993
High School
Clinipace Worldwide February 2013 - Present
University of Alabama at Birmingham October 2001 - September 2011
University of Alabama at Birmingham August 1993 - October 2002
Skills
Clinical Research, Clinical Trials, EDC, Analysis, Management, Statistics, Healthcare Management, HIPAA, Marketing, Inform, IRB, CTMS, Administration, Oncology, Public Health, Infectious Diseases, GCP, Epidemiology, SPSS, Data Management
Education
University of Alabama at Birmingham
Bachelor of Arts (B.A.), Sociology
Clinipace Worldwide June 2011 - Present
Paragon Biomedical (Now Clinipace Worldwide) October 2005 - June 2011
Skills
Clinical Site Monitoring, Clinical Monitoring, CTMS, Clinical Research, Clinical Trials, GCP
Education
University of Nebraska at Omaha
Bachelor's of General Studies, Business Administration and Management, General
University of Nebraska Medical Center 1979 — 1981
Associate's degree, Registered Nursing/Registered Nurse
Clovis Oncology September 2015 - Present
Clinipace Worldwide June 2012 - September 2015
Agilent Technologies February 2008 - June 2012
Agilent Technologies March 2005 - February 2008
Eyetech Pharmaceuticals March 2005 - 2006
FDA September 1998 - March 2005
Lab Support, a division of On Assignment August 1997 - August 1998
Guernsey Bel, Inc. March 1995 - August 1997
The NutraSweet Company July 1993 - March 1995
Skills
GMP, Pharmaceutical Industry, CAPA, FDA, GLP, Validation, Sop, Quality Auditing, Quality System, 21 CFR Part 11, Technology Transfer, Medical Devices, Microbiology, Risk Management, Clinical Trials, API manufacturing, Deviation Management, Regulatory Submissions, ICH guidelines, Clinical Quality, cGMP, Pre-Approval Inspections, Quality Risk Management, Quality Systems, GCP, Quality Assurance, SOP
Education
University of Illinois at Urbana-Champaign 1989 — 1993
BS, Microbiology
Quintiles November 2014 - December 2014
Clinipace Worldwide February 2013 - September 2014
Quintiles October 2011 - February 2013
The University of Alabama at Birmingham October 2002 - October 2011
The University of Alabama at Birmingham September 1993 - September 2002
The University of Alabama at Birmingham May 1985 - September 1993
Skills
Clinical Trials, Clinical Research, Data Management, EDC, Research, Microsoft Office, IRB Certified, HIPPA Certified, DSG1 Certified, Microsoft Excel, Microsoft Word, PowerPoint, GCP Certified, Management, Rave Certified, Inform Certified, Phase Forward Certified, RDC Certified, Oncology, Training, Leadership, FDA, Documentation, Data Analysis, Interviews, Pharmaceutical Industry, Protocol, Biotechnology, Life Sciences, Healthcare, SOP, Medical Devices, Medicine, Regulatory Requirements, Clinical Development
Education
University of Alabama at Birmingham 2002 — 2007
Bachelor's Degree, Sociology
Clinipace Worldwide July 2013 - Present
ReSearch Pharmaceutical Services June 2011 - July 2013
Quintiles December 2005 - June 2011
Virginia Commonwealth University - Massey Cancer Center November 1994 - December 2005
Skills
Clinical Research, Oncology, Type 2 Diabetes, Clinical Trials, GCP, Diabetes, ICH-GCP, CTMS, Clinical Monitoring, Therapeutic Areas, Sop, EDC, Protocol, CRO
Education
Mary Washington College 1987 — 1991
BS, Business Administration
Clinipace Worldwide July 2015 - Present
Clinipace Worldwide December 2013 - June 2015
Clinipace Worldwide January 2013 - November 2013
Medicis October 2011 - December 2012
Paragon Biomedical March 2008 - October 2011
Paragon Biomedical June 2005 - March 2008
Cyberonics Inc. April 2004 - June 2005
Plus Orthopedics August 2003 - December 2003
University of California, San Francisco February 2002 - July 2003
Skills
Clinical Trials, CTMS, GCP, EDC, CRO, Clinical Development, Clinical Monitoring, Clinical Research, Infectious Diseases, Oncology, Clinical Data Management, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Therapeutic Areas, Data Management, Dermatology, ICH-GCP, FDA, Protocol, Drug Development, Clinical Operations, Clinical Study Design, CRF design
Education
Tulane University 2000 — 2001
MPH, Epidemiology
Tulane University 1996 — 2000
B.S., Psychology and Biology
Clinipace Worldwide January 2015 - Present
inVentiv Health Clinical November 2013 - January 2015
inVentiv Health Clinical March 2013 - November 2013
ICON plc August 2012 - March 2013
Genesis HealthCare January 2012 - August 2012
PharmaNet Development Group September 2007 - January 2012
Skills
Clinical Trials, Clinical Research, ICH-GCP, TMF, CTMS, Regulatory Documentation, Feasibility, Oncology, CRO, EDC, GCP, FDA, Protocol, Regulatory Requirements, Microsoft Excel, Microsoft Word, PowerPoint, IRB, Therapeutic Areas, Clinical Data Management, Software Documentation
Education
University of Phoenix 2009 — 2012
Bachelor of Science (B.S.), Health Administration
Philadelphia High School For Girls 1998 — 2002
HS Diploma
Clinipace Worldwide August 2015 - Present
Clinipace Worldwide November 2014 - August 2015
ESP Associates, P.A. November 2013 - October 2014
Morgan Creek Capital Management May 2012 - July 2012
Something Fishy August 2011 - April 2012
Skills
Microsoft Office, PowerPoint, Microsoft Excel, Event Planning, Microsoft Word, Social Media, Data Analysis, Time Management, Customer Service, Teamwork, Leadership, Social Networking, Fundraising, Team Leadership, Marketing, Research, Public Speaking
Education
University of North Carolina at Wilmington 2009 — 2013
Bachelor's of Science, Biology, General
Arbor Pharmaceuticals December 2014 - Present
PAREXEL August 2014 - December 2014
Clinipace Worldwide October 2013 - August 2014
Complete Nutrition July 2011 - August 2013
UNC Health Care-Neurosciences Hospital-Memory Disorders Clinic May 2010 - February 2011
UNC-CH-FPG Child Development Institute May 2010 - February 2011
UNC-CH School of Social Work April 2010 - February 2011
University of North Carolina at Chapel Hill September 2008 - May 2010
Cary Family YMCA May 2004 - August 2009
Skills
Management, Clinical Trials, Sales, Clinical Data Management, Clinical Research, Literature Reviews, Site Visits, Research Development, IRB, SPSS, New Client Acquisitions, Maintaining Strong..., Marketing, Data Analysis, Leadership, Research, Customer Service
Education
University of North Carolina at Chapel Hill 2006 — 2010
Bachelor of Arts (B.A.), Psychology
Clinipace Worldwide April 2014 - July 2014
Quintiles May 2002 - January 2014
Truman Medical Centers November 1998 - May 2002
Overland Park Regional Medical Center June 1997 - November 1998
Skills
Oracle Clinical, Clinical Data Management, Inform, Data Validation, GCP, CRO, ICH-GCP, Clinical Trials, EDC, Data Management, CDISC, CRF design, CTMS, MedDRA, Therapeutic Areas, 21 CFR Part 11, Clinical Development, Protocol, Oncology, Pharmacovigilance, Clinical Research, Pharmaceutical Industry, FDA, Sop, Validation, SAE Reconciliation, Computer System..., SDTM, Hospitals, Quality Auditing, Microsoft Excel, Microsoft Word, Utilization Management, Medical Terminology, PowerPoint, Clinical Monitoring, SAS
Education
University of Kansas
Bachelor's degree, Health Information Management
Medtronic July 2015 - Present
Clinipace Worldwide July 2013 - July 2015
Clinipace Worldwide February 2013 - July 2013
Children's Hospital Los Angeles CHLA September 2011 - February 2013
Skills
Clinical Trials, Research, Microbiology, CTMS, GCP, Clinical Research, Oncology, Laboratory, Microsoft Office, Data Entry, Protocol, Pharmaceutical Industry, Site Management, TMF, Microsoft Excel, EDC, CRO, IRB, REDCap, Immunology, Regulatory Affairs, Remote Monitoring, ICH-GCP, SOP, Life Sciences
Education
UCSD extension 2013 — 2015
Professional Certificate, Clinical Trials Design and Management
Coursera
University of California, Los Angeles
BS, Microbiology, Immunology, Molecular Genetics
Clinipace Worldwide November 2012 - Present
CutDeals.com October 2011 - October 2012
AdamRayTV July 2012 - July 2012
Our Own Company September 2010 - March 2011
Illumin January 2009 - December 2009
45LLC June 2007 - August 2007
Nexterra May 2001 - August 2001
Skills
Character Animation, Scripting, Making you laugh, Flash, Animation, Maya, After Effects, Computer Animation, Visual Effects, Premiere, Texturing, Motion Graphics, 3D, Flash Animation, Mental Ray, Lighting, Computer Graphics, Photoshop, Film
Education
University of Southern California, School of Cinematic Arts, MFA in Animation 2007 — 2010
Animation and Digital Art
University of Colorado at Boulder 2003 — 2007
Bachelor of the Arts, History
Junta de Andalucía October 2014 - Present
Speaking School October 2014 - May 2015
Clinipace Worldwide May 2014 - August 2014
Skills
Microsoft Office, Customer Service, PowerPoint, Microsoft Word, Microsoft Excel, Outlook, Data Analysis, Social Networking, Editing, Facebook
Education
University of North Carolina at Chapel Hill 2010 — 2014
Clinipace Worldwide June 2015 - Present
Premier Research January 2015 - June 2015
PPD May 2013 - January 2015
PPD September 2012 - May 2013
Guilford Performance Textiles May 2012 - August 2012
Skills
Financial Analysis, Microsoft Excel, Budgets, Financial Reporting, Leadership, Corporate Finance, Auditing, Data Analysis, PowerPoint, Account Reconciliation, Forecasting, Microsoft Office, Microsoft Word, Outlook, Access, SAP, Variance Analysis, Teamwork, Cash Flow Forecasting, Revenue Recognition, CRO, Gross Profit Analysis, Finance, Clinical Trials, FDA, Project Management, Process Improvement, Financial Audits, Personal Training
Education
University of North Carolina at Wilmington 2009 — 2013
Bachelor of Science, Business Administration, Finance and Economics
PPD July 2015 - Present
Clinipace Worldwide June 2014 - July 2015
Clinipace Worldwide October 2012 - June 2014
Paragon Biomedical (Now Clinpace Worldwide) October 2011 - October 2012
Skills
Clinical Research, CTMS, CRO, Clinical Monitoring, GCP, Clinical Trials, EDC, ICH-GCP, Clinical Development, Oncology, Therapeutic Areas, Clinical Data Management, Regulatory Affairs, Protocol, SOP, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, FDA, Life Sciences
Education
University of California, Los Angeles 2007 — 2011
Bachelor of Science (BS), Biology/Biological Sciences, General
University of California, Los Angeles 2007 — 2011
Bachelor of Science (B.S.), Biology, General
Clinipace Worldwide August 2014 - August 2015
Sandoz- A Novartis Company September 2013 - September 2014
RA Solutions July 2012 - August 2013
Amgen 2011 - 2012
Covidien September 2010 - September 2011
Medtronic 2011 - 2011
Carestream Health April 2008 - September 2010
Johnson and Johnson 2005 - 2008
Johnson & Johnson 2001 - 2005
Cornell University January 1998 - January 2001
Skills
Regulatory Affairs, FDA, Six Sigma, Regulatory Submissions, ISO 14971, Medical Devices, Process Improvement, Regulatory Intelligence, Compliance, GxP, Quality System, AAMI TIR45, Agile & Waterfall..., DMAIC, Lean Operations, Combination Products, Product Development, ISO 62304, International..., Quality Assurance, ISO 62366, Consulting, 21 CFR Part 11, Program Management, Project Management, Leadership, Validation, ISO 13485, Software, Agency Inspection..., Regulatory Operations, Quality Auditing, Biopharmaceuticals, Clinical Trials, Cross-functional Team..., Biotechnology, GCP, Team Building, 21 CFR, CMC Regulatory Affairs, Supplier Quality, Bid Preparation, Quality Systems Design, Advertising and..., Remediation, Vigilance, 483 Response Management, ICH guidelines, Clinical Study Design, Government Policy
Education
State University of New York College of Environmental Sciences and Forestry
BS, Microbiology
Clinipace Worldwide March 2012 - Present
Paragon Biomedical February 2009 - Present
Premier Research Group October 2006 - December 2008
ICON Clinical Research 2005 - 2006
Moffitt Cancer Center and Palliative Care 2002 - 2005
Skills
Medical Writing, Pain Management, Regulatory Submissions, ICH-GCP, Inform, Neurology, Clinical Research, Protocol, 21 CFR Part 11, Clinical Monitoring, Clinical Operations, Clinical Development, Clinical Data Management, Research, Clinical Trials, GCP, Regulatory Affairs, CTMS, Rheumatology, CRF design, Biotechnology, Phase I, Dermatology, Endocrinology, Lifesciences, Oracle Clinical, Psychiatry, Gastroenterology, Medical Devices, Infectious Diseases, Pharmaceutical Industry, CRO, Cardiology, Therapeutic Areas, Trial Management, Data Management, IRB, Patient Recruitment, Sop, EDC, Quality Assurance, FDA, Healthcare, Hypertension, Vaccines, Diabetes, Drug Development, Oncology, Pharmacovigilance, Clinical Study Design
Education
University of South Florida
B.A., Psychology
Clinipace Worldwide November 2014 - Present
LabCorp September 2012 - Present
Contemporary Services Corporation August 2009 - January 2013
Herzl Camp June 2012 - August 2012
University of Minnesota October 2011 - July 2012
World Altering Medicine May 2011 - July 2011
Hennepin County Medical Center September 2010 - January 2011
University of Minnesota - Dr. Jennifer Hall Laboratory May 2010 - August 2010
Skills
Clinical Research, Public Speaking, Leadership, Teaching, Teamwork, Microsoft Office, Public Health Data..., Public Health, Community Outreach, Research, Nonprofits, PCR, Data Analysis, Program Development, Fundraising, SPSS, Social Media, Social Networking
Education
University of Minnesota-Twin Cities 2008 — 2012
Bachelor of Science (B.S.), Biology, African American & African Studies Minor, 3.74
Clinipace Worldwide 2010 - Present
PTC 2008 - 2010
Informatica 2005 - 2008
THX Ltd. 2004 - 2005
Oracle 2001 - 2004
myWebHR.com 1999 - 2001
ESI Enterprise Solutions 1995 - 1999
Skills
Software Development, Start-ups, Cross-functional Team..., Program Management, Enterprise Software, IT Operations, Management Consulting, Healthcare Information..., Business Strategy, IT Strategy, Outsourcing, Management, Project Portfolio..., Product Development, Strategy, Cloud Computing, P&L Management, Product Management, SaaS, Strategic Partnerships
Education
Stanford University
Advanced Project Management
United States Military Academy at West Point
Military Science
University of Florida
Intl. Political Economics
Clinipace Worldwide January 2014 - Present
Campbell University September 2012 - September 2013
UNC Dept of Statistical Genetics December 2008 - April 2013
Program on Aging, Yale University January 2004 - February 2005
UNC, Department of Biostatistics, Biometrics Consulting Lab August 1998 - June 2003
Dana Farber Cancer Institute 1995 - 1998
University of Michigan, Dept of Biostatistics June 1994 - August 1995
University of Michigan, Department of Biostatistics August 1993 - June 1994
Unisys Corporation November 1988 - August 1993
Skills
Biostatistics, Clinical Trials, Clinical Study Design, Statistics, SAS programming, Survival Analysis, Phase I, Categorical Data..., SAS, Statistical Modeling, Statistical Programming, Statistical Consulting, Logistic Regression, Clinical Data Management
Education
University of North Carolina at Chapel Hill 1998 — 2003
Dr.P.H., Biostatistics
University of Michigan 1993 — 1995
M.S., Biostatistics
Trinity University 1984 — 1988
B.S., Engineering Science/Math
Clinipace Worldwide April 2012 - Present
OPX Biotechnologies, Inc. January 2010 - April 2012
Dicerna Pharmaceuticals, September 2008 - January 2010
Replidyne October 2006 - June 2008
OSI Pharmaceuticals April 2004 - September 2006
Ambion Diagnostics 2003 - 2004
Proligo October 2000 - January 2003
UT Southwestern 1998 - 2000
BASF 1989 - 1990
Skills
HPLC, IC, STM, SEC, GMP, LC-MS, GC-MS, Project Management, Regulatory Affairs, Technical Staff..., Biotechnology, Chromatography, Analytical Chemistry, Technology Transfer, Validation, Chemistry, Sop, R&D, Drug Development, Pharmaceutical Industry, IND, High Throughput..., DNA, Laboratory, Gas Chromatography, SOP
Education
The University of Texas Southwestern Medical Center at Dallas 1998 — 2000
Research Fellow, Biotechnology, Laboratory Automation
The University of Texas at Dallas 1992 — 1997
Ph.D., Analytical Chemistry
Texas Tech University 1984 — 1988
BS, Chemistry
Clinipace Worldwide December 2014 - Present
Hyginex September 2012 - November 2014
Acenovo USA January 2010 - October 2012
Harris Interactive September 2005 - November 2009
TVG November 2004 - September 2005
Access Biotech 2003 - 2005
Quintiles 1999 - October 2004
Argus Software 1998 - 2000
Quantimetrix 1991 - 1998
Skills
Dysfunctional Team..., Business Development, Strategy, New Business Development, Leadership, Cross-functional Team..., CRM, Management, Marketing, Market Research, Sales Operations, Sales Management, Sales, B2B, CRO, Selling, Marketing Strategy, Strategic Partnerships, Entrepreneurship, Competitive Analysis, Business Strategy, Executive Management, Business Intelligence, Digital Marketing, Integrated Marketing, Email Marketing, Competitive Intelligence, Business Planning, Product Development, Marketing Research, Product Management, Strategic Planning, Product Marketing, Lead Generation, Marketing Management, Brand Development, Social Networking, Segmentation, Start-ups, Product Launch, Customer Insight, Market Analysis, E-commerce, P&L Management, Direct Marketing, Online Marketing, Pharmaceutical Industry, Oncology, Account Management
Education
University of Rochester
Clinipace Worldwide March 2011 - Present
Regulus Pharmaceutical Consulting, Inc. 2003 - Present
NaPro BioTherapeutics Inc 1999 - 2003
Amgen, Inc 1994 - 1998
Synergen Inc January 1992 - December 1994
Collagen Corporation 1990 - 1992
Education
Stanford University
BS, MS, Biological Sciences
Clinipace Worldwide October 2014 - Present
Boulder Medical Writing, LLC January 2010 - Present
Boulder Medical Writing, LLC January 2010 - Present
University of Colorado Boulder and the BioFrontiers Institute January 2010 - October 2014
Gilead Sciences February 2008 - December 2009
University of Colorado May 2006 - February 2008
Myogen, Inc. June 2003 - May 2006
Skills
Molecular Biology, Clinical Research, Lifesciences, Biotechnology, Oncology
Education
University of Colorado Boulder 1999 — 2003
PhD, Integrative Physiology
University of Colorado Boulder 1995 — 1997
MS, Exercise Physiology
The Johns Hopkins University 1986 — 1991
BA, Biology
Clinipace Worldwide April 2013 - Present
Clinipace Worldwide October 2012 - Present
Clinipace Worldwide September 2011 - October 2012
Clinipace Worldwide May 2008 - September 2011
Array BioPharma July 2006 - May 2008
Array BioPharma July 2006 - October 2007
QLT Inc. (formerly Atrix Laboratories) November 2004 - December 2006
QLT Inc. 2004 - 2006
Atrix Laboratories January 2003 - November 2004
Atrix Laboratories June 2001 - January 2003
Skills
Clinical Development, Clinical Trials, Oncology, Infectious Diseases, Medical Writing, Clinical Research, Dermatology, Endocrinology, Clinical Operations, CTMS, CRO, GCP, Clinical Monitoring, EDC, Phase I, ICH-GCP, Therapeutic Areas, Drug Development, Protocol, Clinical Data Management, Regulatory Submissions, Regulatory Affairs, Sop, Pharmacovigilance, IND, Clinical Study Design, Vaccines, Inform, Data Management, Biotechnology, FDA, Pharmaceutical Industry, 21 CFR Part 11, Neurology, Lifesciences, Diabetes, Immunology, Oracle Clinical, Pharmacology, IRB, Hematology, Cardiology, Drug Discovery, Cancer, Biopharmaceuticals, Patient Recruitment, Clinical Pharmacology, CRF design, Medical Affairs
Education
University of Colorado Anschutz Medical Campus 2004 — 2007
PhD, Clinical Science
University of Northern Colorado 2000 — 2002
MPH, Public Health
University of Massachusetts, Amherst 1995 — 1999
BS, Biology
Clinipace Worldwide March 2012 - Present
Regulus Pharmaceutical Consulting, Inc. 2005 - Present
Origin USA, Inc. 2003 - 2005
NaPro BioTherapeutics, Inc. 1998 - 2002
IVAX Pharmaceuticals 1995 - 1998
IVAX Pharmaceuticals 1993 - 1995
IVAX Pharmaceuticals 1992 - 1993
U.S. Coast Guard 1985 - 1992
Skills
Pharmaceutical Industry, Biotechnology, Clinical Development, FDA, Regulatory Affairs, Regulatory Submissions, Lifesciences, Medical Devices, Quality Assurance, Clinical Trials, Quality System, Drug Development, 21 CFR Part 11, GMP, Oncology, Technology Transfer
Education
University of Miami 1989 — 1992
Undergraduate, Chemistry, History, Philosophy
Sucampo Pharmaceuticals, Inc. August 2015 - Present
Clinipace Worldwide January 2013 - June 2015
MedImmune August 2009 - January 2013
Sucampo Pharmaceuticals August 2008 - August 2009
Cato Research March 2004 - August 2008
Giant Pharmacy 1996 - 2004
Skills
Clinical Monitoring, CRO, CTMS, Clinical Trials, GCP, Clinical Development, Therapeutic Areas, EDC, Infectious Diseases, Oncology, ICH-GCP, Vaccines, Clinical Data Management, Biotechnology, Clinical Research, Protocol, Medical Writing, Pharmaceutical Industry, Drug Development, Clinical Operations, IND, FDA, Sop, Regulatory Affairs, Oracle Clinical, Clinical Study Design, Immunology, Regulatory Submissions, CRF design, Biopharmaceuticals, Lifesciences, Trial Management, 21 CFR Part 11, IRB, Pharmacovigilance, Patient Recruitment, SOP
Education
University of Maryland Baltimore County 1998 — 2003
B.S., Biology
PRA Health Sciences August 2015 - Present
Clinipace Worldwide February 2013 - July 2015
Clinipace Worldwide September 2012 - April 2013
Paragon Biomedical July 2012 - September 2012
Covance October 1997 - December 2010
Skills
CTMS, CRO, GCP, Clinical Development, Clinical Trials, Clinical Monitoring, Pharmacovigilance, Lifesciences, Regulatory Submissions, Regulatory Affairs, EDC, Pharmaceutical Industry, Protocol, Clinical Data Management, ICH-GCP, FDA, Vaccines, Drug Development, Data Management, Sop, Oncology, Infectious Diseases, Clinical Research, Cardiology, Biotechnology, 21 CFR Part 11, Clinical Operations, Diabetes, Therapeutic Areas, Neurology, Phase I, Oncology Clinical..., Clinical Study Design, Medical Writing, Endocrinology, Medical Affairs, Oracle Clinical, Immunology, Hematology, Dermatology, Rheumatology, Clinical Pharmacology, Cancer, Biopharmaceuticals, Hypertension, Patient Recruitment, Gastroenterology, Outcomes Research, CDISC, CRF design
Education
University of North Carolina at Chapel Hill 1993 — 1995
MHA, Health Administration
INC Research October 2014 - Present
Clinipace Worldwide July 2013 - October 2014
Clinipace Worldwide/formerly Paragon Biomedical November 2011 - July 2013
Paragon Biomedical February 2009 - November 2011
ZARS Pharma January 2007 - December 2008
Medtronic 2006 - 2007
Ela Medical 2005 - 2005
Skills
Biotechnology, Pharmaceutical Industry, Clinical Trials, Clinical Research, Sop, Medical Devices, Lifesciences, Regulatory Affairs, FDA, GCP, Healthcare, Neurology, CTMS, Clinical Monitoring, CRO, Research, EDC, ICH-GCP, Therapeutic Areas, Clinical Development, Infectious Diseases, Clinical Data Management, Protocol
Education
University of Iowa 1999 — 2002
M.S., Biological Sciences
University of Wisconsin-Milwaukee 1996 — 1999
B.S., Biology
John Marshall 1993 — 1997
Sunset
Clinipace Worldwide August 2012 - Present
PharmaNet/i3 February 2006 - August 2012
Esoterix 2000 - 2006
Skills
Clinical Trials, Sop, CTMS, Vaccines, CRO, GCP, Protocol, Clinical Research, EDC, Infectious Diseases
Education
The University of Texas at San Antonio
BS, Biology
Clinipace WorldWide April 2000 - Present
Houston Medical Research Associates July 1996 - April 2000
Skills
CRO, Clinical Research, Clinical Monitoring, Clinical Trials, CTMS, Clinical Development, ICH-GCP, EDC, GCP, Oncology, Pharmaceutical Industry, Infectious Diseases, Protocol, Oracle Clinical, Sop, CRF design, IRB, Clinical Study Design, Vaccines, Clinical Data Management, Pharmacovigilance, Oncology Clinical..., Medidata, Dermatology, Biotechnology, Therapeutic Areas, Medical Writing, Patient Recruitment, Inform, Regulatory Submissions, Clinical Operations, Regulatory Affairs, Phase I
Education
University of Nebraska-Lincoln
Clinipace Worldwide September 2013 - February 2015
Array BioPharma May 2012 - August 2013
Novella Clinical February 2010 - May 2012
OSI Pharmaceuticals Inc January 2007 - February 2010
Skills
Oncology, Clinical Trials, Therapeutic Areas, CTMS, Clinical Development, GCP, Clinical Research, Regulatory Submissions, EDC, CRO, Protocol, Biotechnology
Education
University of Houston
B.A., English Literature
Clinipace Worldwide March 2015 - Present
DOCS February 2013 - January 2015
ClinForce September 2007 - February 2013
Metropolitan Research Associates December 2005 - September 2007
Alteon January 2004 - December 2005
ClinPro Inc. 1998 - 2003
Skills
Clinical, Clinical Trials, Clinical Research, Clinical Trial..., CRO, Operations Management, Team Management, Budget Management, Budget Analysis, Client Services, Productivity Enhancement, Project Planning, Project Implementation, Program Management, CTMS
Education
University of Pittsburgh 1991 — 1996
BS, Neuroscience, Biochemistry
Yoh Clinical 2005 - Present
Clinipace Worldwide 2009 - 2010
BD Medical June 2008 - October 2009
Becton Dickinson Diagnostics - Diagnostic Systems, TriPath 2008 - 2009
Purdue Pharma 2003 - 2005
Education
University of Mobile 1991 — 1995
BSN, Nursing
UBC - An Express Scripts Company August 2013 - Present
Clinipace Worldwide May 2008 - April 2013
PRA International April 1999 - May 2007
Skills
CRO, ICH-GCP, Clinical Trials, GCP, Oncology, Therapeutic Areas, Infectious Diseases, IRB, Pharmaceutical Industry, Protocol, Clinical Operations, Neurology, FDA, Sop, Cardiology, 21 CFR Part 11, Medidata, Microsoft Office, Regulatory Requirements, PowerPoint, CTMS, SOP development, Quality Assurance, Oncology Clinical..., Informed Consent, Trial Management, ICH guidelines, Clinical Data Management, SOP
Education
The University of Kansas 1996 — 1999
BA, Business & Interpersonal Communications
Clinipace Worldwide November 2011 - Present
Angreal Solutions LLC May 2009 - Present
Clinipace Worldwide November 2009 - October 2011
TEXAS INSTRUMENTS July 2007 - January 2009
Texas Instruments November 1999 - June 2007
UNITRODE CORPORATION May 1994 - July 1999
Ford Motor Company June 1992 - May 1994
HARRIS SEMICONDUCTOR May 1986 - June 1992
GE Global Research July 1984 - May 1986
Skills
Perl, Unix, Linux, Software Development, Disaster Recovery, Solaris, Cross-functional Team..., Shell Scripting, Program Management, Hardware, Requirements Analysis, IC
Education
University of Missouri-Columbia 1983 — 1984
MS, Electrical Engineering
University of Missouri-Columbia 1979 — 1983
BS, Electrical Engineering
Clinipace Worldwide September 2014 - Present
Clinipace Worldwide April 2012 - September 2014
CBR International Corp. May 2010 - April 2012
Johns Hopkins University September 2008 - December 2011
Aktiv-dry October 2005 - May 2010
Pfizer Global R&D July 2004 - January 2005
Skills
Regulatory Affairs, Clinical Trials, IND, Pharmaceutical Industry, Medical Devices, Clinical Development, Biotechnology
Education
The Johns Hopkins University 2008 — 2011
MS, Bioscience Regulatory Affairs, 3.85
University of Mumbai 2002 — 2004
M. Pharm., Pharmaceutical Sciences, 3.93/4.0
University of Mumbai 1998 — 2002
B. Pharm, Pharmaceutical Science, 3.88/4.0
Mitsky Consultants June 2013 - Present
Clinipace Worldwide October 2012 - June 2013
Paragon Biomedical 2006 - 2012
IDM 2002 - 2006
Baxter Biotech - Immunotherapy / Nexell 1991 - 2006
Skills
EDC, Clinical Trials, Clinical Research, CTMS, ICH-GCP, Clinical Development, Biotechnology, Clinical Monitoring, GCP, CRF design, Regulatory Affairs, Patient Recruitment, Therapeutic Areas, Drug Safety, Clinical Operations, Pharmaceutical Industry, CRO, Protocol
Education
University of California, Davis
BS, MS, Zoology, Entomology
Quintiles March 2014 - Present
CliniPace Worldwide October 2012 - July 2014
Mount Sinai Medical Center July 2010 - September 2012
Watermark Research Partners, Inc. April 2010 - September 2010
NJ Heart May 2009 - April 2010
Clinwell Research 2008 - 2009
Skills
GCP, Clinical Trials, Therapeutic Areas, EDC, Oncology, Clinical Research, Healthcare, CRO, ICH-GCP, Hematology, Patient Recruitment, CTMS, Clinical Data Management, SOP, Medical Devices, 21 CFR Part 11, Cancer
Education
Clinical Research Academy of America 2008 — 2009
Diploma, Clinical Research, Pharmacology
University of Bridgeport 2001 — 2003
MBA, Finance
University of Lagos 1992 — 1996
BS, Microbiology
Clinipace Worldwide April 2013 - Present
Banyan Biomarkers May 2011 - Present
Duke Clinical Research Institute July 2010 - May 2011
Novo Nordisk A/S August 2009 - August 2010
Metropolitan Research Associates March 2008 - June 2009
PPD 2005 - 2008
Radiant Research May 2005 - October 2005
Emory University School of Medicine June 2001 - 2004
ST. LOUIS METROPOLOTIAN PSYCHIATRIC HOSPITAL January 2000 - June 2000
Skills
Clinical Trial..., Clinical Research, Clinical Trials, CRO, Oncology, CTMS, eCRF (Inform), Protocol, IRB
Education
University of Missouri-Saint Louis 1998 — 2000
Bachelor of Science (BS), Psychology
PRA Health Sciences January 2015 - Present
Quintiles August 2013 - December 2014
Clinipace Worldwide March 2012 - August 2013
PAREXEL June 2011 - October 2011
Medpace June 2008 - June 2011
TriHealth August 2007 - June 2008
Greater Cincinnati Associated Physicians January 2007 - August 2007
Skills
Clinical Trials, Corporate Wellness, Healthcare, Clinical Research, Clinical Monitoring, Patient Recruitment, CTMS, Trial Management, CRO
Education
Xavier University 2005 — 2007
Masters, Health Services Administration
University of Cincinnati 1999 — 2003
Bachelors, Health Promotion and Education
Clinipace Worldwide March 2015 - Present
Genentech / Roche Pharmaceuticals April 2007 - March 2015
PPD February 2005 - April 2007
Bailer Research July 2003 - February 2005
Cardiovascular Research Institute of Dallas January 2000 - September 2003
Skills
Clinical Monitoring, CTMS, Interventional..., Oncology Clinical..., Cardiovascular Disease, CNS disorders, ICH-GCP, Clinical Development, EDC, GCP, Clinical Trials, Therapeutic Areas, Excel, Customer Service, Word, Customer Relations, Clinical Trial Monitor, Clinical Trial..., Public Speaking, Volunteering, Training, Microsoft Excel, Microsoft Office, Clinical Data Management, Clinical Research, CRO, Pharmaceutical Industry, Infectious Diseases, Biotechnology, Oncology
Education
The University of Texas at Arlington
BSN, Registered Nursing/Registered Nurse
Clinipace Worldwide August 2013 - Present
Clinipace Worldwide November 2011 - January 2014
Ernst & Young August 2005 - November 2011
Skills
Financial Reporting, Auditing, GAAP, US GAAP, SEC filings
Education
University of North Carolina at Wilmington
Masters of Science, Accountancy
University of North Carolina at Wilmington
Bachelor of Science (B.S.), Business Administration: Management and Marketing
Clinipace Worldwide April 2012 - Present
Paragon Biomedical June 2009 - April 2012
Tratum Technologies January 2004 - April 2008
Hindustan Aeronautics Limited October 2002 - January 2004
Skills
Financial Reporting, Business Analysis, MIS, Variance Analysis, Account Reconciliation, Internal Audit, Financial Analysis, Fixed Assets, Auditing, Accounts Receivable
Education
University of Calicut 1998 — 2000
Master's Degree, Commerce, 2nd Rank
Vimala College, Thrissur 1995 — 1998
B. Com, Commerce, First Class
INC Research September 2015 - Present
Clinipace Worldwide July 2012 - September 2015
Paragon Biomedical July 2010 - September 2015
Takeda November 2009 - July 2010
Paragon Biomedical March 2009 - November 2009
Paragon Biomedical August 2007 - March 2009
Paragon Biomedical June 1998 - August 2007
Parke-Davis / Warner Lambert July 1991 - March 1997
Skills
Biotechnology, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, Clinical Trials, EDC, GCP, ICH-GCP, Infectious Diseases, Regulatory Affairs, Oncology, Sop, Clinical Data Management, Pharmaceutical Industry, Regulatory Submissions, Diabetes, FDA, Protocol, Therapeutic Areas, Vaccines, Medical Writing
Education
University of Michigan 1986 — 1990
Pharm.D., Pharmacy
American Express Global Business Travel 2015 - Present
Vertex Pharmaceuticals December 2014 - 2015
Clinipace Worldwide 2013 - 2014
EMD Serono, Inc 2007 - 2013
EMD Serono, Inc 2005 - 2007
Paragon Biomedical 2004 - 2005
Cape Cod Community College 2002 - 2005
Ocean Edge Resort & Golf Club 1999 - 2001
Skills
Pharmaceutical Industry, Clinical Trials, Biotechnology, Customer Service, CTMS, Project Management, Management, Project Planning, Marketing, Negotiation, Clinical Research, Contract Management, Event Management, Event Planning, Corporate Events, Coordinating Events, Fundraising, Meeting Planning, Social Media Marketing, Social Networking, Social Media, Clinical Development, Logistics, Strategy, Strategic Planning, Time Management, Public Speaking, Leadership, Hotels, Trade Shows, Training, Sales, Contract Negotiation, Team Building, Program Management, Analysis, Customer Satisfaction, Teamwork, Incentives, Hospitality, Marketing Communications, Account Management, Marketing Strategy, Public Relations, Food & Beverage, Sponsorship, Oncology, Procurement
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics 1995 — 1999
BS, Hospitality Management
Regents College 1998 — 1998
Study Abroad Program, London, England
Boyce Consulting, LLC 2006 - Present
Clinipace Worldwide July 2013 - Present
Skills
Diabetes, Rheumatology, Transplant, Heart Failure, Clinical Trials, CTMS, Clinical Development, Hemophilia, GCP, Clinical Monitoring, Multiple Therapeutic..., Phase Forward InForm, SAE Reconciliation, Protocol Review, eCRF, Drug Accountability, Query Resolution, Liver Disease, Alzheimer's disease, Women's Health, CNS disorders, Sleep Disorders, Crohns/IBD, GERD, Stroke, Epilepsy, Allergy/Angioedema, Hepatitis, Arthritis, Incontinence, Birth Control, Hormone Replacement..., Depression, Acute MI, Hypertension, Sickle Cell Disease, Source Document...
Education
University of Arizona 1980 — 1981
M.S.
University of North Carolina at Chapel Hill 1976 — 1980
B.A.
Clinipace Worldwide July 2014 - Present
Clinipace Worldwide February 2013 - July 2014
Clinipace Worldwide January 2012 - February 2013
Clinipace Worldwide December 2010 - January 2012
PAREXEL 2010 - 2010
PMG Research 2009 - 2010
PPD 2006 - 2009
Advanced Research Corporation 2002 - 2006
SCIREX Corporation 2001 - 2002
Photogen, Inc 2000 - 2001
Skills
Oncology, CRO, Clinical Trials, Clinical Research, Clinical Trial..., EDC, GCP, Biotechnology, Clinical Development, Patient Recruitment, Data Management, SOP, Pharmaceuticals, Pharmacovigilance, Clinical, Clinical Monitoring, Budgeting, Contract Negotiation, Microsoft Office, Phase I, Quality Assurance, Proposal Writing, Inform, Cross-functional Team..., Vendor Management, Customer Relations, Protocol Development, IRB, Problem Solving, ICH-GCP, Budgets, CTMS, Therapeutic Areas, Sop, Pharmaceutical Industry, Clinical Data Management, Protocol, Customer Service, FDA, Clinical Operations, Regulatory Submissions, Clinical Study Design, Drug Development, CRF design, Neurology, Infectious Diseases, Medical Writing
Education
UMass Dartmouth 1996 — 2000
Bachelor of Science (BS), Biology, Pre-Med
UMass Dartmouth 1996 — 2000
Bachelor of Arts (BA), Women's Studies
Clinipace Worldwide January 2014 - Present
Angel Medical Systems May 2012 - December 2013
Nevro Corp July 2010 - January 2012
Biotronik 2002 - 2009
ELA (formerly Sorin) 2000 - 2003
Skills
Medical Devices, Electrophysiology, Pacemakers, Cardiac, Clinical Trials
Education
University of Washington 1992 — 1995
MPH, Epidemiology, Public Health
University of California, Los Angeles 1984 — 1988
BA, Anthropology
Los Angeles County - USC School of Nursing
Clinipace Worldwide March 2015 - Present
University of North Florida September 2010 - March 2015
University of North Florida August 2007 - September 2010
Skills
Troubleshooting, Active Directory, Windows 7, Windows, Visio, SQL, Microsoft Office, Access, Databases, Java, Visual Basic, Team Leadership, Project Management, Data Analysis, XP, Business Analysis, Business Process
Education
University of North Florida 2011 — 2014
Bachelor of Science (BS), Computing & Information Science
Florida State College at Jacksonville 2008 — 2011
Associates of Arts
Clinipace Worldwide May 2013 - Present
USDA Western Human Nutrition Research Center August 2012 - March 2013
Food For Health Institute January 2012 - March 2013
VA Hospital Mather June 2012 - January 2013
Eddie Bauer May 2010 - January 2011
Sacramento Food Bank and Family Services March 2010 - June 2010
Veterinary Centers of America May 2009 - September 2009
Skills
Clinical Research, Data Analysis, Food, Nutrition, Public Speaking, Research
Education
University of California, Davis 2009 — 2013
University of California, Davis
Bachelors of Science; High HonorsDegree, Clinical Nutrition, 3.8