Clinimetrics Company
Industry: Book by Alvan R. Feinstein
DescriptionOriginally published: 1987 Author: Alvan R. Feinstein
Clinimetrics List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Clinimetrics. You can filter them based on skills, years of employment, job, education, department, and prior employment.
Clinimetrics Salaries. You can even request information on how much does Clinimetrics pay if you want to. Learn about salaries, pros and cons of working for Clinimetrics directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
151 Clinimetrics employees in database. Find out everything there's to know about Clinimetrics employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
Clinimetrics Employees
Catalyst Pharmaceuticals March 2013 - Present
Leeward Research, Inc December 2009 - Present
PrexEra April 2008 - December 2009
Amgen 2005 - April 2008
Kos Pharmaceuticals December 2003 - June 2005
Aventis 2002 - 2003
Clinimetrics 1999 - 2002
Care Resource 1997 - 1999
Skills
CRA management, CRO management, Latin America, Clinical Study Design, Clinical Trials, CRO, CRA Management, Clinical Development, EDC, Oncology, Drug Development, GCP, Pharmaceutical Industry, Diabetes, Therapeutic Areas, CTMS, Clinical Operations, Dermatology, Medical Devices, Clinical Research, Urology, Pharmaceutics, Clinical Monitoring, Clinical Data Management, Protocol, Medical Writing, ICH-GCP, Vaccines, Infectious Diseases, Medical Affairs, Pharmacovigilance
Education
University of South Florida 2001 — 2003
Master, Public Health
Universidad Central de Venezuela 1985 — 1993
MD, Medical Doctor
Theorem Clinical Research June 2014 - Present
Theorem Clinical Research February 2013 - June 2014
Theorem Clinical Research (formerly Omnicare Clinical Research) February 2010 - February 2013
Clinimetrics November 2008 - February 2010
Kalypsys, Inc. January 2007 - November 2008
Neurocrine Biosciences, Inc. July 2004 - May 2006
Abbott Vascular Devices 2006 - 2006
Neurocrine Biosciences, Inc. July 2003 - July 2004
Skills
CRO, CTMS, Clinical Trials, Clinical Research, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Regulatory Affairs, Clinical Development, GCP, Validation, Medical Writing, FDA, IND
Education
Houston Community College 2003 — 2003
General
Pennfield High School 1987 — 1989
Westar Marine Services June 2012 - Present
The Home Depot March 2010 - June 2012
Westar Marine Services May 2000 - August 2008
Westar Marine Services July 1998 - May 2000
Cohesion Corporation October 1997 - January 1998
Drumbeat I Charters December 1994 - January 1998
Clinimetrics December 1994 - August 1997
Syntex May 1993 - December 1994
University of San Francisco April 1989 - May 1993
Skills
Infectious Diseases, Microsoft Office, Clinical Research, Leadership, Customer Service, Management, Microsoft Word, Project Management, Social Media, Logistics
Education
University of California, Davis
Bachelor of Science, Zoology
PRA International November 2013 - Present
Theorem Clinical Research October 2010 - Present
Omnicare Clinical Research February 2007 - November 2010
Synarc January 2006 - January 2007
Clinimetrics October 2002 - May 2004
Universidade de São Paulo January 1998 - March 1999
Skills
GCP, CTMS, EDC, CRO, Clinical Trials, Clinical Monitoring, Clinical Data Management, Clinical Development, Oncology, Oracle Clinical, Pharmaceutical Industry, Clinical Research, Sop, Regulatory Submissions, Biotechnology, FDA
Education
San Diego State University-California State University 1994 — 1997
MSc, Nutritional Sciences
Universidade de São Paulo 1988 — 1992
BS, Nutrition
Universidade de Santo Amaro 1987 — 1991
BS, Physical Education
Threshold Pharmaceuticals October 2011 - Present
Threshold Pharmaceuticals September 2008 - September 2011
Novacea April 2003 - July 2008
Clinimetrics 2001 - March 2003
Education
University of California, Davis 1993 — 1995
Bachelor of Science (BS), Genetics
PRA International May 2005 - Present
Gilead Sciences 2004 - 2005
Clinimetrics 2003 - 2004
Skills
Oncology, Pharmaceutical Industry, CTMS, CRO, Clinical Research, EDC, Biotechnology, Clinical Monitoring, GCP, Project Management, ICH-GCP, Clinical Development, Data Management, Clinical Trials, Lifesciences, Budgets, Clinical Data Management, Clinical Operations, Drug Development, Life Sciences, Therapeutic Areas, Program Development
Education
Boston University 2000 — 2002
MPH, Epidemiology & Biostatistics
University of California, Berkeley 1994 — 1998
BA, Human Biodynamics
ProTrials Research June 2014 - Present
PPD August 2010 - June 2014
Omnicare Clinical Research March 2010 - August 2010
Omnicare Clinical Research March 2008 - August 2010
Clinimetrics 2008 - 2010
Medford Women's Clinic February 2002 - February 2008
Skills
Clinical Research, CRO, CTMS, GCP, Clinical Monitoring, ICH-GCP, EDC, Clinical Trials, Infectious Diseases, Clinical Research..., 21 CFR Part 11, GLP, IRB, Clinical Data Management, Clinical Operations, Therapeutic Areas, Clinical Development, Drug Safety, Protocol, Inform, Regulatory Submissions, Oracle Clinical, Oncology, Medical Writing, Lifesciences
Education
Southern Oregon University 1999 — 2001
Bachelor's degree, Biology, General
Southern Oregon University 1998 — 2001
BS, Biology/Chemistry
BD December 2014 - Present
Amin Talati, LLC January 2013 - December 2014
Barnes & Thornburg LLP February 2012 - May 2012
Navistar Inc January 2011 - January 2012
U.S. Department of Energy May 2011 - August 2011
Clinimetrics January 2001 - October 2004
FDA January 1996 - December 2001
Skills
Legal Research, Legal Writing, Patent Prosecution, Patentability, FDA, Medical Devices, Clinical Trials, Patents, Intellectual Property, Due Diligence, Copyright Law, Licensing, Invention, Trademarks, Dietary Supplement and..., FDA Food Faciliy..., FDA Drug Facility..., Over the Counter (OTC)..., Patent Drafting, Homeopathic Drugs, Prosecution, Pharmaceutical Industry, Legal Issues, Client Counseling, Patent Applications, Trials, Tax Law, Legal Assistance, Document Review, Appeals, Registered Patent..., Product Liability, Lexis, Litigation Support, Trademark Infringement, Westlaw, Corporate Law, Administrative Law, Dispute Resolution, Alternative Dispute..., Criminal Law, Health Law, International Law, Courts, Class Actions, Legal Compliance
Education
Loyola University Chicago School of Law 2008 — 2012
J.D., Juris Doctor
The University of Chicago
Graham School of General Studies - Certificate, Clinical Trials Management
Marquette University
B.S., Biomedical Engineering
JA Consulting November 2010 - Present
Omnicare Clinical Research April 1987 - November 2010
Clinimetrics 1996 - 2009
Education
University of Arizona 1967 — 1971
BSN, Nursing
Johnson and Johnson May 2015 - Present
PAREXEL November 2014 - Present
Genentech March 2007 - November 2014
Organon January 2006 - March 2007
Clinimetrics March 2002 - January 2006
Skills
Breast Cancer, Clinical Development, Clinical Monitoring, CTMS, Oncology, Clinical Trials, Clinical Research, GCP, EDC, CRO, FDA, Therapeutic Areas, ICH-GCP, Infectious Diseases, Biotechnology, Pharmaceutical Industry
Education
Ashford University 2013 — 2016
Master of Business Administration (M.B.A.), Project Management, 3,8
The George Washington University School of Medicine and Health Sciences 2004 — 2006
Bachelor of Science (B.S.), Clinical Research Administration
Jackson Community College 1993 — 1996
Bachelor of Applied Science (BASc), Registered Nursing/Registered Nurse
INC Research January 2015 - Present
INC Research October 2011 - January 2015
INC Research November 2007 - October 2011
Clinimetrics February 2005 - May 2007
Clinimetrics November 2002 - February 2005
American Cardiovascular Research Institute June 2002 - November 2002
SpectRx August 2001 - June 2002
Ingenix Pharmaceutical Services August 1999 - August 2001
Skills
CTMS, EDC, CRO, Clinical Monitoring, GCP, Clinical Trials, Clinical Development, ICH-GCP, Therapeutic Areas, Pharmaceutical Industry, Clinical Research, Clinical Operations, Phase I, Drug Development, Project Management, Cross-functional Team..., Budgets, Psychiatry, Regulatory Submissions, Medical Devices, Protocol, Sop, Patient Recruitment, SOP
Education
Purdue University 1989 — 1993
Bachelor's Degree, Sports Medicine
PPD January 2015 - Present
PPD October 2012 - December 2014
PPD September 2003 - October 2012
Clinimetrics 2000 - 2003
Clinimetrics 1999 - 2000
Clinimetrics 1996 - 1999
Skills
EDC, Clinical Development, Lifesciences, CRO, Strategy, CTMS, Clinical Trials, Oncology, GCP, Drug Development, Strategic Alliances, Neurology, Bioanalysis, Team Leadership, Pharmaceutical Industry, Regulatory Submissions, Therapeutic Areas, Biopharmaceuticals
Education
University of North Carolina at Chapel Hill 1990 — 1993
Master of Public Health (MPH), Public Health Nutrition
University of North Carolina at Chapel Hill
Bachelor of Science, Public Health
BioMarin Pharmaceutical Inc. March 2015 - Present
BioMarin Pharmaceutical Inc. July 2013 - March 2015
Amgen June 2012 - July 2013
Amgen June 2011 - August 2011
Alexza Pharmaceuticals July 2008 - May 2010
Alexza Pharmaceuticals August 2007 - June 2008
Gentiae Clinical Research June 2005 - May 2006
Gentiae Clinical Research April 2005 - May 2005
Clinimetrics September 2004 - April 2005
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Biopharmaceuticals, Project Management, FDA, Clinical Development, Process Improvement, Business Strategy, Clinical Trials, Commercialization, Drug Development, Leadership
Education
Carnegie Mellon University 2010 — 2012
Master of Business Administration (MBA), Track - Management of Innovation and Product Development, Concentrations - Marketing, Organizational Behavior
University of Southern California 2000 — 2004
BS, Kinesiology
Menlo School
ProTrials Research December 2011 - Present
Pedro Point Community Association 1995 - Present
Abbott Labs January 2010 - December 2011
Clinimetrics Research Associates February 2008 - November 2009
Genentech July 2007 - January 2008
Clinimetrics September 1993 - July 2007
Penederm, Inc. March 1991 - April 1993
Penederm, Inc. May 1988 - March 1991
Liposome Technology, Inc. October 1986 - May 1988
Bristol-Myers Products September 1985 - October 1986
Skills
Quality Assurance, Clinical Data Management, Clinical Trials, GCP, Therapeutic Areas, CRO, Clinical Research, EDC, Sop, Clinical Development, Protocol, CTMS, Clinical Operations, Clinical Monitoring, Clinical Study Design, SOP
Education
University of California, Santa Barbara 1980 — 1985
MA, Biology (Pharmacology emphasis)
San Francisco State University 1973 — 1979
BA, Biochemistry, Cell and Molecular Biology
Joe Laver Consulting April 2013 - Present
Pharmacyclics December 2011 - April 2013
Clinovo September 2010 - November 2011
Clinimetrics January 2004 - June 2010
Aviron (now MedImmune Vaccines) 2001 - 2003
MedImmune 2001 - 2003
Hoffmann-La Roche 1995 - 2001
Syntex 1991 - 1995
Skills
Clinical Data Management, EDC, Thesaurus, Lab data, Medical Devices, Biotechnology, Database Management, Database Design, Project Management, MS Project, Clinical Trials, Clinical Development, Computer System..., Data, Medidata, Thesauruses, Pharmaceutical Industry, Clinical Data, Sop, CRO, Oracle Clinical, Oracle RDC, CTMS, CDISC, Data Management, Regulatory Submissions, Oncology, GCP, Clinical Research, Validation, FDA, Medrio, CDMS, BioClinica, Merge eClinical OS, ICH-GCP, CRF design, Medical Writing, 21 CFR Part 11, Infectious Diseases, Protocol, Lifesciences, MedDRA, Database Administration, Therapeutic Areas, Statistical Programming, Database Admin, Inform, SDTM, Vaccines
Education
Coventry University 1987 — 1991
BS, Applied Biology
Job Corps January 2012 - Present
Avalon Transportation Service March 2013 - July 2014
Sustainable Silicon Valley June 2011 - December 2011
OMNICARE CLINICAL RESEARCH July 2010 - March 2011
CLINIMETRICS October 2000 - June 2010
Silicon Valley Affiliate of the National Council on Alcoholism and Drug Dependence 1994 - 2000
Skills
General Office Duties, Administrative Support, Postage Meter, Reconciliation, Mail Merge, Special Projects, Project Coordination, File Management, Data Interpretation, Information Retrieval, Microsoft Office 2007, Non-profits, Office Management, Clinical Research, Data Analysis, Administrative..., Account Reconciliation, Projects, Microsoft Office, Data Entry, Databases, Management, Research, Software Documentation, PowerPoint, Nonprofits, Leadership, Proposal Writing, Training, Data Management, Outlook, Recruiting, Microsoft Excel, Time Management, Payroll, Office Administration, Microsoft Word, Community Outreach, Employee Relations, Volunteer Management, Fundraising, Team Building, Customer Service, Editing
Education
San Jose State University
BA, Sociology
Experis January 2012 - Present
V. Ballard Consulting May 2011 - January 2012
Omnicare Clinical Research, Inc. March 2005 - March 2011
Clinimetrics (an Omnicare Inc. company) April 1998 - February 2005
Clinimetrics August 1993 - March 1998
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Outlook, Microsoft Office, Research, Management, Recruiting, Customer Service, Data Entry, Office Management, Human Resources, Team Leadership, Program Management, Accounting, Account Management, Contract Negotiation, Onboarding, Change Management, Sales, Process Improvement, Budgets, Team Building, Leadership, Administrative..., Salesforce.com, Software Documentation, Strategic Planning, Oracle Clinical, System Administration, Employee Relations, Nonprofits, Training, Time Management, Event Planning, Forecasting, Interviews, Process Scheduler
Education
De Anza College 1987 — 1987
Certificate of Completion, Medical Terminology
Independent Consultant June 2009 - Present
Pharmion/Celgene 2007 - 2009
Cerexa/Forest Lab January 2006 - May 2007
Cell Genesys 2003 - 2006
Clinimetrics 1998 - 2002
Palo Alto Medical Foundation 1994 - 1998
Skills
Clinical Trials, EDC, Clinical Research, Clinical Operations, Psychiatry, Pain Management, Clinical Development, GCP, CRO, Oncology, CTMS, Trial Management, Pharmaceutical Industry, Clinical Monitoring, Biotechnology, Drug Development
Education
San Francisco State University
Bachelor of Arts (B.A.), Clinical Psychology
Division of Pediatric Critical Care September 2007 - Present
PEGUS Research 2006 - 2007
Novacea 2005 - 2006
Gentiae Clinical Research January 2003 - October 2005
Clinimetrics 2003 - 2003
AAI Pharma 2001 - 2002
Skills
Data Validation, Protocol Development, Database Design, EDC, Data Management, Protocol, Clinical Data Management, Validation, Sop, Computer System..., Clinical Data, Clinical Trials, Clinical Development, ICH-GCP, Clinical Study Design, SOP, GCP, CTMS
Education
University of California Extension, Santa Cruz 1998 — 1999
Certificate, Clinical Trials Design and Management
University of California, Santa Cruz 1995 — 1997
BA, Biology
AHS
Puma Biotechnology, Inc. May 2015 - Present
Theorem Clinical Research March 2014 - May 2015
Theorem Clinical Research November 2013 - March 2014
Theorem Clinical Research July 2012 - October 2013
Theorem Clinical Research June 2011 - July 2012
Omnicare Clinical Research June 2010 - June 2011
Clinimetrics September 1995 - June 2010
Statprobe June 1995 - September 1995
Roche Pharmaceuticals (Syntex) June 1991 - June 1995
Skills
CRO, Clinical Development, CTMS, Clinical Trials, EDC
Education
Michigan State University 1987 — 1991
BS, Biochemistry
Synteract, Inc. October 2012 - Present
Quintiles April 2011 - October 2012
Quintiles November 2010 - April 2011
Aerotek May 2010 - November 2010
Clinimetrics Research Associates 2004 - 2009
Clinimetrics 2001 - 2004
Ingenix 1999 - 2001
Worldwide Clinical Trials, Inc. 1997 - 1999
Skills
Data Management, Proposal Writing, RFP
Education
American InterContinental University 2005 — 2006
AA, Business Administration
PRA International May 2011 - January 2013
Georgia Association of Latino Elected Officials August 2008 - April 2011
Clinimetrics 2007 - 2009
Clinimetrics 2005 - 2007
Clinimetrics 2002 - 2005
Skills
ICH-GCP, CRO, EDC, Clinical Research, Clinical Monitoring, CTMS, Clinical Trial..., GCP, Clinical Trials, FDA, Neurology, Oncology, Regulatory Submissions, Rheumatology, Clinical Development, Medical Devices, Cardiology
Education
Clayton State University 2013 — 2016
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
Florida State University - College of Business 1989 — 1994
BS, Finance
Florida State University - College of Business 1989 — 1994
BS, Multinational Business
Chiltern September 2015 - Present
Theorem Clinical Research September 2014 - September 2015
Theorem Clinical Research June 2011 - August 2014
Omnicare Clinical Research 2010 - June 2011
Clinimetrics Research Associates, Inc. 2006 - 2010
Clinimetrics Research Associates, Inc. 2006 - 2006
Clinimetrics Research Associates, Inc. 2004 - 2005
Clinimetrics 2000 - 2004
Clinimetrics Research Associates, Inc. 1997 - 2000
Clinimetrics Research Associates, Inc. 1995 - 1997
Skills
GCP, EDC, CTMS, CRO, Clinical Data Management, Clinical Development, Clinical Operations, Clinical Trials, Clinical Monitoring, Infectious Diseases, Oracle Clinical, Oncology, Pharmaceutical Industry, FDA, 21 CFR Part 11, Clinical Research, ICH-GCP, Sop, Therapeutic Areas, Endocrinology, Medical Writing, Regulatory Submissions, Drug Development, SOP, Cross-functional Team...
Education
California State University-Sacramento 1983 — 1987
B.A., Biological Sciences
Abbott October 2013 - Present
Cerexa, Inc. April 2012 - October 2013
Theorem Clinical Research July 2008 - March 2012
Clinimetrics November 2004 - July 2008
Planned Parenthood Mar Monte October 2004 - November 2004
Planned Parenthood Mar Monte July 2004 - October 2004
LifeScan July 2000 - December 2003
Skills
GCP, Sop, FDA, Clinical Trials, 21 CFR Part 11, Software Documentation, Quality Assurance, Oracle Clinical, Therapeutic Areas, Neurology, Oncology, Medical Devices, Validation, Clinical Data Management, Diabetes, EDC, Protocol, Clinical Development, Clinical Research, CTMS, Regulatory Submissions, Infectious Diseases, Biotechnology, CRO, Medical Writing, Pharmaceutical Industry, IND, Medical Affairs, Lifesciences, Computer System..., GxP, ICH-GCP, GMP, CDISC, Dermatology, Data Management, Biopharmaceuticals, Vaccines, Change Control, GLP, Clinical Operations, Medidata, Clinical Study Design, Regulatory Affairs, Clinical Monitoring, Phase I, Inform, Endocrinology, Pharmacovigilance, Drug Development
Education
University of California, Davis
Bachelor of Science, Biological Sciences
SynteractHCR February 2012 - Present
Theorem Clinical Rearch 2003 - March 2012
Clinimetrics May 2003 - June 2010
Parexel June 2000 - April 2004
Quintiles Transnational 1997 - 2000
Skills
Advanced Excel, Advanced MicroSoft Word, Proposal Writing, Budgeting, Proposal Management, Pricing, Contract Management, CRO, Biotechnology, Cross-functional Team..., Analysis, Pharmaceutical Industry, Process Improvement, Team Building, EDC, Management, Project Planning, Budgets, Contract Negotiation, Strategic Planning, SharePoint, Research Proposals, Clinical Trials, Business Development, Project Management, Strategy
Education
Pacific Lutheran University - School of Business 1980 — 1984
Bachelor Business Administration, Marketing
GCP Consultants, LLC December 2010 - Present
Omnicare Clinical Research July 2010 - December 2010
Clinimetrics October 2008 - July 2010
Clinimetrics September 2004 - September 2008
Clinimetrics May 2003 - August 2004
Clinimetrics August 2001 - April 2003
Quintiles May 1999 - September 2001
Quintiles February 1998 - September 2001
Solvay Pharmaceuticals March 1996 - January 1998
Solvay Pharmaceuticals January 1994 - March 1996
Skills
Hypertension, Chronic Pain, Kidney Transplant, Incontinence, GCP, FDA, CRO, Sop, Auditing, Clinical Trials, IND, Clinical Development, Regulatory Requirements, Clinical Monitoring, Clinical Research, Quality Auditing, EDC, Regulatory Affairs, GxP, Regulatory Submissions, Quality Assurance, Biotechnology, Clinical Data Management, ICH-GCP, 21 CFR Part 11, Medical Writing, Pharmaceutical Industry, CTMS
Education
Kennesaw State University - Michael J. Coles College of Business 1995 — 2000
MBA, Business Administration
Pace University 1973 — 1977
BS, Biology/Chemistry
SAS May 2011 - Present
Integrium September 2009 - May 2011
invivodata 2007 - 2009
Catalent 2005 - 2007
Clinimetrics 2003 - 2005
The Phoenix 2002 - 2003
O'Neal, Inc. 2000 - 2002
Schering-Plough Pharmaceuticals 1992 - 2000
Skills
Clinical Research, Pharmaceutical Industry, Business Development, Pharmaceutical Sales, Enterprise Software, SaaS, Sales, Salesforce.com, Solution Selling, Account Management, New Business Development, Clinical Trials, Professional Services, Cross-functional Team..., Strategy
Education
University of Maryland College Park 1987 — 1990
Bachelor of Science, Business Management
INC Research July 2012 - Present
Quintiles October 2011 - July 2012
i3 Research May 2009 - October 2011
ADMA March 2006 - April 2009
UCB May 2005 - August 2006
Clinimetrics June 2004 - May 2005
Cardiovascular Research Institute 2003 - 2004
Novartis 2001 - December 2003
Emory University Hospital 1999 - 2001
Skills
CRO, Clinical Trials, CTMS, GCP, Clinical Development, EDC, Clinical Monitoring, Clinical Research, Oncology, ICH-GCP, Pharmaceutical Industry, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Cardiology, Sop, Neurology, Regulatory Submissions, FDA, Pharmacovigilance, IND, Medical Devices, Clinical Operations, Drug Development, Protocol, Trial Management, Central Nervous System, Phase I, Immunology, 21 CFR Part 11, Rheumatoid Arthritis, Hematology, Patient Recruitment, Regulatory Requirements, Clinical Study Design, Data Management, Biopharmaceuticals, Oracle Clinical, Vaccines, Regulatory Affairs, Lifesciences, Endocrinology, Gastroenterology, Biotechnology, CRF design, Medical Affairs, Rheumatology, Dermatology, Diabetes, Cancer
Education
The George Washington University 2004 — 2007
Master's of Science in Health Science, Clinical Research Administration and Leadership
School 13
University of Alabama at Birmingham
BSN, nursing
oak grove school district August 2011 - Present
Galileo Learning July 2012 - August 2012
American Cancer Society May 2000 - June 2012
Berryessa Union School District January 2011 - June 2011
San Jose Unified School District August 2010 - December 2010
Clinimetrics May 2004 - August 2010
San Jose State University December 2009 - May 2010
San Jose State University January 2009 - May 2010
San Jose State University August 2009 - December 2009
SJSU August 2008 - May 2009
Skills
Biotechnology, Science, Sop, FDA, Lifesciences, Laboratory, Teaching, Clinical Trials, Clinical Research, Medical Devices, Validation, Pharmaceutical Industry, Quality Assurance, Curriculum Design, Molecular Biology, Cross-functional Team..., Healthcare, PCR, Cell Culture, SDS-PAGE, Chemistry, Management, Gel Electrophoresis, SPSS, Leadership, Classroom, Editing, Biology, Research, Microbiology, Life Sciences
Education
San Jose State University 2009 — 2012
MA, Natural Science
San Jose State University 2009 — 2011
Single Subject Teaching Credential, Biological Science, K6-12
San Jose State University 2005 — 2009
BA, Biological Science - Prep for Teaching
Medtronic May 2008 - Present
Clinimetrics April 2006 - May 2008
Emory University May 2001 - April 2006
Emory University Hospital July 1993 - May 2001
Skills
Clinical Research, Cardiology, Nursing, Clinical, Clinical Trials, Medical Devices, Neurology, Pharmaceuticals, Pharmaceutical Industry, CTMS, Interventional..., Infectious Diseases, Therapeutic Areas, Oncology, EDC, Dermatology, Clinical Monitoring, GCP, Pharmaceutics, Clinical Development, CRO
Education
University of St. Francis 2001 — 2004
Bachelor of Science (B.S.), Health/Health Care Administration/Management
College of the Desert 1991 — 1993
Associate of Science (AS), Registered Nursing/Registered Nurse
CIC April 2015 - Present
NComputing April 2014 - March 2015
NComputing July 2007 - February 2014
Intacct Corporation April 2006 - October 2006
San Jose Evergreen Community College District October 2004 - February 2006
Clinimetrics December 2001 - October 2003
Santa Clara Plating Company April 2000 - April 2001
Skills
Financial Analysis, Account Reconciliation, Auditing, Revenue Recognition, Accounting, Financial Reporting, Process Improvement, Consolidation, Customer Service, Sarbanes-Oxley Act, Forecasting, Salesforce.com, Cost Accounting, US GAAP, Competitive Analysis, Strategic Financial..., Start-ups, Capital Equipment, Budgets, Cloud Computing
Education
San Jose State University
Bachelor's Degree, Bachelor of Science Degree in Accounting & Information System December 2004
De Anza College
Certificate of Achivement, Accounting June 2000
Gujarat University
Bachelor's Degree, Bachelor of Commerce in Advanced Accounting & Auditing January 1997
Partners in AIDS Care and Education (PACE) Clinic, Santa Clara Valley Medical Center June 2013 - Present
County of Santa Clara, Santa Clara Valley Health & Hospital System 2011 - June 2013
County of Santa Clara, Santa Clara Valley Health & Hospital System February 2012 - March 2013
County of Santa Clara, Santa Clara Valley Health & Hospital System 2000 - 2007
Clinimetrics August 1998 - March 1999
City of San Jose, Office of the City Attorney October 1996 - May 1998
Mount St. Joseph-St. Elizabeth (renamed The Epiphany Center) 1990 - 1996
Skills
Non-profits, Program Development, Fundraising, Grant Writing, Research, Grants, Program Evaluation, Microsoft Office, PowerPoint, Volunteer Management, Project Planning, Strategic Planning, Budgets, Nonprofits, Project Management, Mental Health, Training, Program Management, Policy, Data Analysis, System Administration, Government, Healthcare
Education
Saint Mary's College of California 1994 — 1996
MS, Health Services Administration
University of California, Berkeley 1978 — 1983
BA, Anthropology
Data to Information to Knowledge to Wisdom March 2008 - Present
Coursera November 2013 - January 2014
Bryan University January 2013 - June 2013
Alza Corporation November 2006 - February 2008
Novartis Vaccines and Diagnostics August 2005 - November 2006
Clinimetrics March 2003 - February 2004
Alexion Pharmaceuticals, Inc. June 2001 - August 2003
Silico Insights May 2000 - March 2001
Quintiles June 1998 - January 2000
Amgen 1991 - 1998
Skills
Biostatistics, SAS Enterprise Guide, R programming, Friend of JMP, Clinical Trials, Clinical Development, Clinical Study Design, CDISC, Data Mining, Biopharmaceuticals, GCP, Oncology, Clinical Data Management, Bioinformatics, Clinical Research, Big Data, Predictive Analytics, Data Visualization, Machine Learning, Data Management, Social Intelligence, Emotional Intelligence, SAS, SAS Programming
Education
Coursera
University of Toronto
Ph.D.
Pepperdine University
Master of Science in Technology Management (MSTM)
Theorem Clinical Research June 2011 - Present
Omnicare Clinical Research January 2010 - June 2011
Clinimetrics July 2001 - January 2010
Quintiles 1997 - 2000
Education
Santa Clara University
SynteractHCR January 2014 - Present
SynteractHCR April 2012 - November 2013
PPD October 2011 - March 2012
Omnicare Clinical Research February 2010 - September 2010
Clinimetrics June 2005 - February 2010
Clinimetrics 2003 - 2005
Clinimetrics Research Associates, Inc. January 2003 - June 2003
Parexel International January 2001 - August 2002
Quintiles January 1999 - December 2000
Quintiles 1994 - 1999
Skills
CRO, Proposal Writing, Cross-functional Team..., EDC, CTMS, Team Leadership, Project Management, Business Development, Strategy, Clinical Data Management, Data Management, Budgets, Management, Medical Devices, Oncology, Clinical Research, CRM, Pharmaceutical Industry, Clinical Trials, Clinical Development, Process Improvement, Leadership
Education
University of Phoenix
Bachelor of Science, Business Management
ReSearch Pharmaceutical Services September 2010 - Present
Clinimetrics 2002 - 2010
VA Medical Center 2001 - 2002
InfoTek Research 2000 - 2000
Skills
Research, Data Analysis, FDA, Compliance, EDC, IVRS/ IWRS, CTMS, Microsoft Office
Education
Portland State University 1998 — 2000
BS, Speech and Language Pathology and Audiology
Washington State University 1997 — 1998
Audiology/Audiologist and Speech-Language Pathology/Pathologist
Oregon State University 1995 — 1997
Illumina January 2015 - Present
Illumina July 2013 - December 2014
SynteractHCR, Inc. October 2007 - June 2013
Synteract, Inc. June 2006 - October 2007
Elan Pharmaceuticals 2006 - 2006
Clinimetrics 2002 - 2004
Symphonix Devices 2001 - 2002
Genentech 1998 - 2000
Skills
Clinical Trial..., GCP, Clinical Monitoring, Clinical Research, Clinical Trials, CTMS, CRO, Oncology, Pharmaceutics, Biotechnology, Medical Devices, Project Management, Clinical Development, Strategic Planning, Project Planning, Risk Management, Budget Forecasts, Budget Monitoring, Business Strategy, Business Development, Team Leadership, Team Mentoring, Data Management, EDC, Statistical Data..., Regulatory Submissions, ICH-GCP, 21 CFR, Client Relations Skills, Infectious Diseases, Cardiovascular Disease, Clinical Operations, Clinical Study Design, Drug Development, Pharmaceutical Industry, FDA, Life Sciences, SOP, Clinical Data Management, Management, 21 CFR Part 11, Biopharmaceuticals, Therapeutic Areas
Education
University of California, Santa Cruz 2000 — 2002
Certificate of Clinical Trials Design & Management
University of Oklahoma 1993 — 1998
B.S., Microbiology / Chemistry
OncoMed Pharmaceuticals February 2011 - Present
ProTrials Research August 2010 - February 2011
Omnicare Inc. August 2004 - August 2010
Clinimetrics January 1996 - August 2004
Chiron Corporation February 1995 - August 1996
Roche Pharmaceuticals (formerly Syntex Research) June 1991 - January 1995
Skills
Clinical Research, EDC, 21 CFR Part 11, CRO, GCP, Pharmaceutical Industry, Medical Affairs, Clinical Trials, Clinical Development, Oncology, Biotechnology, Clinical Data Management, CTMS, Project Management, FDA, Therapeutic Areas, Infectious Diseases, IND, Lifesciences, Regulatory Affairs, Data Management, Drug Development, Clinical Monitoring, Regulatory Submissions, Clinical Operations, Immunology, Biopharmaceuticals, Protocol, Drug Discovery, Sop, Medical Writing, Clinical Study Design, ICH-GCP, Cancer, Pharmacovigilance, Hematology, Endocrinology, Biostatistics, Neurology, Cardiology, Dermatology, Pharmacology, Vaccines, Oracle Clinical, Phase I, Neuroscience, Medical Devices, Diabetes, GLP, Biomarkers
Education
University of California, Davis 1987 — 1991
BS, Biochemistry
Baden Senior School at CFB Baden–Soellingen Germany
INC Research October 2011 - Present
Johns Hopkins University September 2009 - October 2011
Clinimetrics January 2008 - June 2009
Johns Hopkins University 1996 - 2008
Skills
Clinical Research, Clinical Trials, Infectious Diseases, Oncology, Clinical, CRO, EDC, GCP, Pediatrics, Pharmaceutical Industry, ICH-GCP, Clinical Monitoring, CTMS, FDA, Therapeutic Areas, Medical Devices, Clinical Development, Regulatory Submissions
Education
The Johns Hopkins University 1988 — 1989
BSN, Nursing
The Johns Hopkins University
PAREXEL August 2014 - Present
PAREXEL September 2013 - July 2014
Novo Nordisk A/S November 2012 - July 2013
Quintiles April 2008 - November 2012
Quintiles April 2008 - December 2008
Amgen April 2006 - April 2008
Clinimetrics July 2003 - April 2006
PPD April 2002 - July 2003
Kendle 1999 - 2002
Skills
CRO, Biotechnology, Pharmaceuticals, Change Management, People Management, Cross-functional Team..., Cost Reduction..., Pharmaceutical Industry, Job Coaching, Project Management, Collaborative Leadership, Strategic Leadership, GCP, ICH-GCP, Management, Hematology, Phase I, Clinical Research, FDA, Oncology, Clinical Trials, Clinical Operations, Biopharmaceuticals, CTMS, Protocol, Clinical Development, Therapeutic Areas, EDC, Clinical Monitoring, SOP
Education
Thomas Edison State College 2007 — 2012
M.S. Applied Science/Trial Management, Clinical Trial Management
Drexel University College of Medicine 2010 — 2010
Graduate Course, Clinical Research Operations and Management
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1999
BS, Public Health
NBTHS 1990 — 1994
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
PPD August 2015 - Present
SynteractHCR September 2010 - August 2015
ChemDiv, Inc. 2009 - 2010
ICON plc 2007 - 2009
MediciNova, Inc. 2006 - 2007
INC Research 2004 - 2004
Clinimetrics 2002 - 2004
Neurocrine Biosciences 2000 - 2002
Omnicare Inc. 1998 - 2000
Quintiles 1997 - 1998
Skills
Clinical Research, R&D, CRO, Clinical Trials, Clinical Development, CTMS, GCP, Oncology, Pharmaceutical Industry, Biotechnology, Clinical Monitoring, Drug Development, ICH-GCP, FDA, Protocol
Education
University of North Carolina at Greensboro 1988 — 1991
Master of Arts (M.A.), Psychology
Guilford College 1982 — 1986
Bachelor of Arts (B.A.), Psychology
Gilead Sciences March 2015 - Present
Gilead Sciences March 2014 - March 2015
Gilead Sciences April 2009 - March 2014
CV Therapeutics January 2004 - April 2009
Clinimetrics October 2000 - January 2004
Roche Global Development September 1996 - October 2000
University of California, Davis July 1995 - August 1996
University of California, Davis June 1994 - December 1994
Skills
Clinical Data Management, EDC, Clinical Trials, CRO, CTMS, CDISC, Medidata, Data Management, 21 CFR Part 11, Sop, Data Quality, Clinical Development, Oracle Clinical, SDTM, MedDRA, Quality Management, CRF design, GCP, Statistical Programming, Team Leadership, SOP development, Department Budget..., Data Standards, Protocol, ICH-GCP, Drug Development, Clinical Research, Computer System..., Global Resource..., Offshore Outsourcing, Portal Development, Cross Functional..., Organizational..., OneNote, Clinical Data, Biomarkers, eCRF, Department Budgeting, Planning Budgeting &..., SOP
Education
University of California, Davis 1992 — 1996
Genetics, Molecular and Cellular Biology
University of California, Santa Cruz
Certificate, Clinical Trials Design & Management / Team Development
JD Clinical Consulting March 2007 - Present
XenoPort 2006 - 2007
Johnson & Johnson Pharmaceutical Research & Development 2005 - 2006
Clinimetrics 2000 - 2005
Clinimetrics 1999 - 2000
Clinimetrics 1996 - 1999
Clinimetrics 1993 - 1996
IDEC 1991 - 1993
Genentech 1988 - 1991
Syntex 1986 - 1988
Skills
Clinical Development, Oncology, CRO, Clinical Trials, GCP, Management, Change Control, In Vitro, Infectious Diseases, CTMS, Psychiatry, IND, Drug Development, Pharmacovigilance, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Clinical Research, Sop, Clinical Operations, Clinical Study Design, FDA, Cardiology, Rheumatology, Regulatory Submissions, Endocrinology, Therapeutic Areas, Medical Writing, Protocol, Clinical Data Management, Clinical Monitoring
Education
University of California, Davis
BS, Biological Sciences
Kim Hirsch & Associates, LLC November 2014 - Present
Quintiles November 2013 - Present
Middlesex Community College June 2013 - June 2013
Sanofi 2002 - 2013
Bristol-Myers Squibb 2000 - 2002
Clinimetrics 1999 - 2000
MDS Harris 1997 - 1999
Deerpath Medical Associates 1991 - 1997
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, Oncology, Clinical Development, ICH-GCP, EDC, Rheumatology, GCP, CTMS, Clinical Monitoring, Cardiology, Infectious Diseases, Patient Recruitment, Best Practices, Diabetes, CRO, Neurology, Presentations, Phlebotomy, Nursing Process, IV, Medication..., Wound Care, Legal Nurse Consulting
Education
Kaplan University 2009 — 2011
Bachelor of Science (BS), Registered Nursing/Registered Nurse
College of Lake County 1995 — 1997
Associate's degree, Registered Nursing/Registered Nurse
New Hampshire Vocational Technical College 1986 — 1987
Diploma in Nursing, Licensed Practical/Vocational Nurse Training
Pelvalon June 2014 - Present
Stryker Neurovascular November 2011 - May 2014
Concentric Medical January 2005 - November 2011
Independent Consultant June 2004 - January 2005
Clinimetrics 2002 - 2004
Clinimetrics 2002 - 2004
Skills
Clinical Trials, Medical Devices, Clinical Research, FDA, Protocol, GCP, CTMS, Biotechnology, Clinical Monitoring, Cross-functional Team..., Clinical Development, EDC, Biopharmaceuticals, Clinical Data Management, Regulatory Affairs, SOP, Neurology, GLP, Pharmaceutical Industry
Education
The George Washington University School of Medicine and Health Sciences 2000 — 2002
BSc, Clinical Research Administration
Genentech June 2014 - Present
Gilead Sciences April 2013 - June 2014
Genentech October 2011 - April 2013
Nektar Therapeutics May 2010 - October 2011
ArthroCare Corporation January 2010 - May 2010
Clinimetrics February 2008 - November 2009
ev3 (formerly FoxHollow Technologies) March 2007 - February 2008
Covidien (formerly Tyco Healthcare - Nellcor Puritan Bennett October 2005 - February 2007
Alta Bates Medical Center Oncology/Hematology Unit June 2004 - December 2006
Diablo Clinical Research 2006 - 2006
Skills
Clinical Operations, Clinical Trials, Oncology, Clinical Research, Neurology, Infectious Diseases, FDA, Endocrinology, CRO, Diabetes, Microsoft Excel, Hematology, Quality Assurance, Medical Devices, Urology, Time Management, Therapeutic Areas, EDC, Psychiatry, Clinical Development, CTMS
Education
University of San Francisco 2004 — 2006
Master's Degree, Nursing
INC Research July 2009 - May 2013
Clinimetrics September 2000 - September 2008
Worldwide Clinical Trials September 1997 - September 2000
Skills
CNS disorders, CRO, Clinical Monitoring, CTMS, Infectious Diseases, Clinical Operations, Clinical Development, GCP, Oncology, ICH-GCP, EDC, Clinical Research, Psychiatry, Therapeutic Areas, Clinical Trials
Education
Illinois State University 1983 — 1986
Bachelor of Science (BS), Social Work
LinkedIn August 2009 - Present
Clinimetrics April 2009 - June 2009
SEMI October 2008 - March 2009
IBM December 2003 - October 2008
Skills
Active Directory, Troubleshooting, Technical Support, Networking, Software Installation, Microsoft Office, Help Desk Support, Linux, Outlook, Windows 7, Laptops, DNS, Blackberry Enterprise..., Mac OS X, Windows Server, Hardware, DHCP, VPN, Blackberry, XP, Norton Ghost, Computer Hardware, OS X, Software Documentation, Android, System Deployment, Red Hat Linux, iPhone, Symantec Endpoint..., Wireless Networking, VMware, Lenovo, ActiveSync, Lotus Notes, TCP/IP, Operating Systems, General Awesomeness, Network Administration, Windows XP, Microsoft Exchange, VMware Fusion, Dell, Windows XP Professional, Desktop Support, Workstations, Decision Support, Crashplan, LANDesk
Education
ITT Technical Institute 2002 — 2004
Associates
Hogan High School 1994 — 1997
Mission College
CARA Therapeutics, Inc. June 2015 - Present
Amgen April 2013 - June 2015
Amgen, Inc. March 2008 - February 2015
Amgen, Inc. January 2005 - March 2008
Eible Research Consulting, LLC May 2002 - December 2004
Target Research Associates December 2000 - May 2002
Medical University of South Carolina at Charleston June 2000 - December 2000
Clinimetrics August 1999 - June 2000
New Hanover Regional Medical Center May 1998 - April 2000
PPD, Inc. February 1999 - August 1999
Skills
Clinical Trial..., Oncology, Clinical Trials, Clinical Research, Infectious Diseases, EDC, Clinical, GCP, Psychiatry, Pain, CRO, Pediatrics, Clinical Development, Hematology, CTMS, Cardiology, Rheumatology, Dermatology, FDA, Pharmaceuticals, Biotechnology, Urology, Cancer, Clinical Monitoring, Healthcare, Ophthalmology, Gastroenterology, Patient Recruitment, SOP, IND, Osteoporosis, Research, Treatment, Health, Therapeutic areas, Change Management, Pharmaceutical Industry, Drug Development, Therapeutic Areas, Protocol, Clinical Data Management, Medical Writing, Sop
Education
Hartwick College 1994 — 1997
BSN, Nursing
Utica College 1992 — 1994
Gilead Sciences October 2012 - April 2013
Axistat May 2012 - October 2012
Medivation April 2011 - March 2012
Affymax May 2008 - April 2011
Alza Corporation March 2007 - May 2008
CVT November 2005 - March 2007
Alza Corporation July 2004 - November 2005
Clinimetrics March 2004 - June 2004
Elanco July 2003 - January 2004
ALZA Corporation March 2002 - July 2003
Skills
Clinical Trials, GCP, 21 CFR Part 11, Pharmaceutical Industry, Pharmacovigilance, FDA, Validation, EDC, Clinical Development, Biotechnology, CRO, Oncology, Clinical Data Management, Data Management, CTMS, CDISC
Education
Texas A&M University 1983 — 1987
Bachelor of Science (BS), Computer Science
Alcon, a Novartis company September 2013 - Present
Terumo Cardiovascular Systems April 2013 - July 2013
Boehringer Ingelheim March 2013 - April 2013
Patel Consultants Corporation December 2012 - March 2013
Novartis Healthcare Ltd. May 2012 - September 2012
Bristol-Myers Squibb September 2008 - October 2009
Johnson and Johnson September 2006 - September 2008
Clinimetrics March 2006 - August 2006
Watson Pharmaceuticals 2004 - 2006
Biogen Idec 2004 - 2004
Skills
21 CFR Part 11, Network Qualification, Computer System..., GxP, Validation, FDA, Change Control, Pharmaceutical Industry, Sop, GMP, CAPA, Quality Assurance, Quality System, V&V, Quality Auditing, Software Documentation, ISO 13485, LIMS, Testing, GAMP, SDLC
Education
University of South Florida 2001 — 2004
Master of Science (MS), Electrical and Electronics Engineering
Bangalore University 1996 — 2000
B.E, Electronics and Communciations
OUSL
OUSL
Finger Lakes Associates, LLC 1998 - Present
Clinical Device Group 1997 - 2011
Carticept Medical, Inc. 2008 - 2009
Bausch & Lomb April 1994 - July 2003
Clinimetrics May 1997 - May 1999
Skills
Clinical Monitoring, Clinical Trial..., Protocol Development, Protocol, CTMS, Clinical Trials, FDA, GCP
Education
Roberts Wesleyan College 1990 — 1991
B.S., Management
Alfred State College - SUNY College of Technology 1981 — 1983
AAS, Medical Laboratory Technology
Genentech June 2015 - Present
Genentech October 2011 - June 2015
Quintiles April 2011 - September 2011
Gilead Sciences October 2009 - March 2011
MedImmune Vaccines September 2008 - October 2009
Genentech January 2004 - September 2008
Clinimetrics March 2003 - January 2004
West Marine January 2003 - March 2003
Macys August 2002 - March 2003
ross products January 2002 - August 2002
Skills
EDC, Clinical Trials, Data Management, Clinical Research, Clinical Data Management, GCP, CRO, Oracle Clinical, CTMS, Clinical Development, 21 CFR Part 11, Oncology, Sop, ICH-GCP, CDISC, Biotechnology, Pharmaceutical Industry
Education
University of California, Davis 2006 — 2007
Project Management
North Carolina State University 1998 — 2000
n/a, technical communication
Appalachian State University 1988 — 1991
BS, business-hospiltality
Gilead Sciences January 2014 - Present
Gilead Sciences January 2012 - December 2013
Gilead Sciences, Foster City, CA February 2010 - December 2011
Clinimetrics October 2004 - January 2010
Education
The Johns Hopkins University 2000 — 2004
Regulatorium March 2007 - Present
UCSC Extension in Silicon Valley 2005 - Present
Barnett Educational Services February 2009 - February 2015
APT Pharmaceuticals February 2008 - July 2010
PDL BioPharma, Inc. 2005 - 2007
Clinimetrics 2005 - 2005
NeurogesX, Inc. 2002 - 2004
Oculex 2000 - 2002
ORATEC Interventions, Inc. 1999 - 2000
RBI/IBAH 1996 - 1997
Skills
Regulatory Research, Regulatory Affairs, FDA, IND, Regulatory Submissions, Regulatory intelligence, Marketing Applications, NDA, Clinical Trials, Articles, Clinical Development, GCP, Biotechnology, Pharmaceutical Industry, Drug Development, eCTD, Oncology, Medical Writing, Regulatory Requirements, Sop, Medical Devices, Clinical Research, Biopharmaceuticals, MAA, Infectious Diseases, Protocol, Electronic Submissions, Biologics, Regulatory Documentation, Clinical Study Design, Neuroscience, Clinical Data Management, Regulatory Guidelines, ICH-GCP, Regulatory Intelligence, Regulations, CRO, SOP, Pharmacovigilance, Life Sciences
Education
University of California, Santa Cruz 1999 — 2000
Clinical Trials Design and Management
San Jose State University 1988 — 1996
BA, Neuroscience
Threshold Pharmaceuticals February 2012 - Present
Threshold Pharmaceuticals September 2007 - February 2012
novacea 2003 - 2006
Clinimetrics 2001 - 2003
Roche Pharmaceuticals 2001 - 2002
Skills
Biotechnology, CRO, Clinical Development, Clinical Trials, Oncology, Pharmaceutical Industry, FDA, EDC, Clinical Data Management, GCP, CTMS, Clinical Research, Lifesciences, Medical Devices, Sop, Regulatory Submissions, Drug Development, Life Sciences, SOP
Education
Santa Clara University School of Law 2012 — 2016
Ongoing, Law
California State University-Stanislaus 1992 — 1996
BS, Biology
Merial, a Sanofi Company December 2014 - Present
Merial May 2008 - Present
Merial 2004 - 2008
Clinimetrics January 2005 - June 2005
Merial January 2001 - 2003
Skills
Pharmaceuticals, Validation, GMP, Manufacturing, Project Management, Product Development, FDA, Drug Development, Pharmaceutical Industry, Technology Transfer, R&D, Cross-functional Team..., IND, CAPA, Drug Discovery, Leadership, CTMS, Immunology, Formulation, Clinical Data Management, Clinical Research, Drug Delivery, Change Control, 21 CFR Part 11, Aseptic Processing, Pharmacology, Regulatory Requirements
Education
Vanderbilt University 1997 — 1998
Neuroscience
Georgia Institute of Technology 1992 — 1996
BS, Applied Psychology, Physics, Philosophy
ProTrials Research, Inc. April 2013 - Present
ProTrials Research, Inc. December 2011 - March 2013
FibroGen 2010 - 2011
Children's Hospital Oakland Research Institute 2008 - 2011
Intarcia Therapeutics 2001 - 2006
Clinimetrics 1999 - 2001
Scios 1998 - 1999
Abgenix 1996 - 1998
Dade-Behring Diagnostics, Syva Co. 1992 - 1996
Skills
Biotechnology, Clinical Development, Project Management, FDA, Clinical Trials, Oncology, GCP, Drug Development, Lifesciences, Pharmaceutical Industry, Infectious Diseases, CRO
Education
University of California, Davis
PaxVax, Inc. June 2013 - Present
Clinical Research Consulting January 2004 - Present
Institute for One World Health 2005 - 2006
Masters of Public Health 2003 - 2005
InterMune 2000 - 2003
Clinimetrics 1998 - 2000
CardioGenesis Corp 1997 - 1998
Immune Response Corporation 1994 - 1997
Skills
Clinical Development, GCP, CRO, CTMS, Clinical Research, Clinical Monitoring, Clinical Trials, Oncology, Pharmaceutical Industry, Infectious Diseases, Drug Development, Biotechnology, Biopharmaceuticals, FDA
Education
Tulane University 2003 — 2004
MSPH, Parasitology
San Diego State University-California State University
Microbiology
Genomic Health Inc February 2015 - Present
Genomic Health August 2012 - January 2015
Genomic Health August 2009 - July 2012
Genomic Health June 2006 - July 2009
Clinimetrics 2000 - 2006
UCSF 1999 - 2000
The University of Texas Health Science Center at Houston 1996 - 1999
Georgia Tech 1995 - 1996
Education
The University of Texas Health Science Center at Houston 1996 — 2000
PhD, Biostatistics
Georgia Institute of Technology 1994 — 1995
MS, Health Systems Engineering
University of Florida 1989 — 1994
BS, Industrial and Systems Engineering
Genentech September 2005 - Present
Clinimetrics August 1999 - September 2005
Education
University of California, Irvine 1994 — 1998
Adrian Wilcox HS
Nextrials, Inc. Clinical OperationsNextrials, Inc.1999 - Present
Clinimetrics 1994 - 1999
Genentech 1994 - 1999
Syntex Research 1983 - 1994
Education
Stanford University
INC Research August 2013 - Present
nSpire Respiratory Health Company March 2010 - Present
Clinimetrics January 2007 - October 2009
Medtronic December 2005 - January 2007
Corautus Genetics January 2005 - November 2005
Quintiles January 2001 - January 2005
Emory University Hospital January 1999 - January 2001
Skills
Clinical Research, Medical Devices, CTMS, Biotechnology, Clinical Trials, Cardiology, Pharmaceutical Industry, Clinical Development, Respiratory Disease, Critical Care Medicine, Osteoporosis, Cardiac Surgery, General Surgery, Protocol, Sop, FDA, CRO, SOP, GCP
Education
Kennesaw State University - Michael J. Coles College of Business 2003 — 2005
MBA, Business
The University of Tennessee at Chattanooga 1992 — 1997
Bachelor of Science (BS), Biology/Biological Sciences, General
Chiltern September 2015 - Present
Theorem Clinical Research - (now Chiltern) October 1998 - September 2015
Omnicare Clinical Research October 1998 - July 2011
Clinimetrics September 1998 - March 2010
Clinimetrics Research Assoc. October 1998 - January 2009
DLS Associates September 1997 - October 1998
Astra Pharmaceuticals September 1997 - September 1998
United States Army Reserve October 1994 - September 1998
University of California August 1990 - September 1997
United States Navy September 1990 - August 1994
Skills
Clinical Trials, Clinical Development, CRO, Oncology, Medical Devices, Clinical Research, Drug Development, Biotechnology, CTMS, GCP, Regulatory Affairs, Pharmacovigilance, Immunology, Biopharmaceuticals, Dermatology, Infectious Diseases, Medical Writing, Process Improvement, Protocol, Regulatory Submissions, Clinical Data Management, Pharmaceutical Industry, Medical Affairs, FDA, Therapeutic Areas, Cardiology, ICH-GCP, Management, Neurology, 21 CFR Part 11, Clinical Monitoring, Clinical Operations, Data Management, Diabetes, Drug Discovery, EDC, Endocrinology, GLP, GMP, Gastroenterology, Hematology, Lifesciences, Medicine, Pharmaceutics, Rheumatology, Regulatory Requirements, Sop, Urology, Vaccines, Validation
Education
Northcentral University 2015 — 2018
Pending - Doctorate Dissertation, Doctor of Business Administration (D.B.A)
La Salle University 1996 — 1999
PhD, Management
National University 1992 — 1996
MA, Management
Southern Illinois University, Carbondale 1988 — 1992
BS, Health Care Management; emphasis long term care
San Diego City College 1986 — 1988
General Studies, General Studies
United States Navy B School 1986 — 1987
Military, Dermatology Speciality; MOHS
United States Navy A School 1986 — 1986
Military, Corpsman; field medic
Trevecca Nazarene University 1985 — 1986
General Studies; physical therapy
Bree Martin April 2009 - Present
Exelixis July 2007 - April 2009
Genentech 2003 - 2007
Clinimetrics 2000 - 2003
Skills
CRO, Clinical Trials, CTMS, GCP, Clinical Development, Biotechnology, Oncology, Pharmaceutical Industry, Clinical Operations, Drug Development
Education
Arizona State University 1997 — 2001
Bachelor of Science (BS), Biology, General
ACT Oncology December 2014 - Present
ACT Oncology September 2011 - December 2014
Vivus Inc April 2010 - December 2011
Cerimon Pharmaceuticals September 2005 - April 2010
Clinimetrics 2004 - 2005
IntraBiotics January 2001 - August 2004
Pfizer Pharmaceuticals August 1995 - December 2000
Bayer October 1993 - August 1995
Pfizer 1991 - 1993
MetPath Clinical Laboratory 1989 - 1990
Skills
Analysis, Biotechnology
Education
Rensselaer Polytechnic Institute 1994 — 1997
Master of Science, Management
Eastern Connecticut State University 1988 — 1990
BS, Biology/Chemistry
Medivation September 2008 - Present
NeurogesX, Inc. June 2006 - September 2008
Clinimetrics 2002 - 2006
Skills
Clinical Development, Pharmaceutical Industry, Clinical Trials
Education
Santa Clara University 1990 — 1994
Clinimetrics Operations Planning AssociateClinimetrics Research Associates2006 - Present
Education
University of Central Missouri 1987 — 1992
Jayne M Dito Consulting January 2006 - Present
Clinimetrics 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research 2002 - 2005
Clinimetrics Research Associates 2002 - 2005
Matrix Pharmaceutical 1988 - 1999
Matrix Pharmaceuticals 1988 - 1999
Education
University of San Francisco 1952 — 1958
Puma Biotechnology August 2014 - Present
Theorem Clinical Research April 2010 - August 2014
Omnicare Clinical Research April 2009 - November 2011
Clinimetrics November 2008 - January 2011
Clinimetrics Research, Inc. February 2008 - November 2008
Clinimetrics July 2006 - January 2008
Scios April 2005 - June 2006
Discovery Parent-Child Preschool June 2003 - May 2006
Clinimetrics January 2000 - March 2001
Clinimetrics July 1998 - December 1999
Skills
CRO, Clinical Trials, Microsoft Office, Pharmaceutical Industry, Clinical Research, Clinical Development, GCP, Data Management, Oncology, Pharmacovigilance, Oracle Clinical, Clinical Data Management, Therapeutic Areas, 21 CFR Part 11, Biopharmaceuticals, Biostatistics, Biotechnology, CTMS, Cardiology, Clinical Monitoring, Clinical Operations, Clinical Study Design, Computer System..., Dermatology, Diabetes, Drug Development, Drug Safety, EDC, Endocrinology, FDA, Gastroenterology, GxP, Hematology, ICH-GCP, IND, Infectious Diseases, Lifesciences, Medical Affairs, Medical Devices, Neurology, Phase I, Protocol, Regulatory Requirements, Regulatory Submissions, Sop, Vaccines
Education
University of California, Davis 1988 — 1992
Menlo Atherton High School 1984 — 1988
Clinimetrics Assoc. Dir QA & ComplianceClinimetrics Research Associates2004 - Present
Education
Saint Mary's College of California
Receptos, Inc. August 2015 - Present
Amgen January 2009 - August 2015
Amgen September 2006 - December 2008
Valeant Pharmaceuticals August 2005 - August 2006
Pfizer November 2004 - August 2005
Allergan June 2003 - November 2004
Clinimetrics June 2002 - June 2003
Isis Pharmaceuticals September 2001 - June 2002
Clinimetrics June 2000 - September 2001
Quintiles June 1999 - June 2000
Skills
CRO, 21 CFR Part 11, Clinical Development, CDM, Clinical Data Management, Pharmaceutical Industry, Clinical Study Design, Oracle Clinical, EDC, Clinical Trials, Clinical Research, GCP, Oncology, Biotechnology, CTMS
Education
Southern Connecticut State University 1992 — 1997
Bachelor's degree, Psychology
Clinimetrics 2008 - Present
Quintiles April 1998 - May 2008
Education
Liberty University
Business Administration
Milam Consulting, LLC August 2013 - Present
RxTrials April 2011 - August 2013
Sanofi Pasteur May 2007 - April 2011
sanofi-aventis April 2002 - April 2007
Clinimetrics May 2000 - April 2002
State of Ohio - Bureau of Workers' Compensation 1999 - 2000
Abbott Nutrition 1998 - 1999
Abbott Nutrition 1992 - 1998
Skills
CTMS, GCP, Clinical Research, EDC, Clinical Development, Clinical Trials, Pharmaceutical Industry, Vaccines, FDA, Therapeutic Areas, Regulatory Affairs, CRO, Infectious Diseases, Neuroscience, Biotechnology, Regulatory Submissions, Clinical Data Management, Lifesciences, Drug Development, Protocol, Sop, Diabetes, Oncology, Pharmaceutics, Medical Writing, ICH-GCP, Pharmacovigilance, Immunology, Neurology, Dermatology, Cardiology, Medical Devices, Hematology, Medical Affairs, SOP, Life Sciences
Education
Greenville College 1989 — 1993
Biology
Pacific Gas and Electric Company November 2012 - August 2014
Genentech July 2011 - October 2012
PMI Silicon Valley Chapter February 2010 - December 2010
Genentech 2006 - 2007
Clinimetrics July 2006 - September 2006
Pfizer 2003 - 2006
Apple Computer 2000 - 2002
Pfizer 1997 - 2000
Tata Consultancy Services 1993 - 1996
Skills
Software Project..., Data Profiling, Consulting, Enterprise Software, PMP, Business Analysis, Business Intelligence, Business Process..., Data Analysis, Mobile Applications, Workforce Management
Education
National Institute of Technology Calicut
B Tech
Genentech February 2011 - Present
Teikoku Pharma USA November 2007 - February 2010
NeurogesX, Inc. 2007 - 2007
Clinimetrics 2001 - 2007
Clingenix 2000 - 2001
Oculex 1998 - 2000
Celtrix 1997 - 1998
Kendle 1996 - 1997
Chemtrak 1993 - 1996
Skills
CTMS, Clinical Trials, Clinical Study Design, CRO, GCP, Clinical Monitoring, Oncology, Clinical Research, EDC, Clinical Development, Pharmaceutical Industry, Biotechnology, Clinical Data Management, Drug Development, Sop, FDA, ICH-GCP, Therapeutic Areas, Medical Devices
Education
California Polytechnic State University-San Luis Obispo 1989 — 1992
BS, Bio-Chemistry
343 Industries November 2013 - Present
Plus Five Solutions March 2009 - Present
Centers for Disease Control and Prevention February 2010 - October 2013
Clinimetrics March 2005 - March 2009
Skills
C#, Microsoft SQL Server, ASP.NET, .NET, IIS, WCF, CQRS, C++, Software Development, Web Applications, Java, Linux
Education
Iowa State University 1998 — 2002
BS, Computer Engineering
Amgen April 2015 - Present
Amgen March 2012 - Present
SCDM 2005 - 2014
Amgen March 2009 - March 2012
Clinimetrics September 2008 - March 2009
Allergan August 2007 - September 2008
Amgen 2005 - 2007
Eli Lilly 2002 - 2005
Education
University of California, Santa Barbara
Bachelor of Science (BS), Biopsychology
University of Phoenix
Master of Arts (M.A.), Organizational Management
Profil Institute for Clinical Research, Inc. March 2010 - Present
Clinimetrics September 2006 - March 2010
Synteract, Inc. January 2006 - August 2006
Elan Pharmaceuticals October 2004 - November 2005
Allergan March 2004 - September 2004
Pfizer 1998 - 2004
Quintiles September 1992 - March 1998
Skills
CTMS, Clinical Study Design, EDC, Clinical Data Management, Data Management, Strategic Planning, Clinical Research, GCP, Clinical Trials, CRO, Phase I, Oracle Clinical, Clinical Development, Infectious Diseases, Oncology, Pharmaceutical Industry, 21 CFR Part 11, FDA, Clinical Monitoring, Therapeutic Areas, CRF design, Medidata, Inform, ICH-GCP, Biotechnology, CDISC, Regulatory Submissions, Sop, Biopharmaceuticals, Computer System..., Diabetes, Drug Development, Lifesciences, MedDRA, Protocol, Regulatory Affairs, SDTM
Education
University of Phoenix 2002 — 2005
MBA, Technology Management
University of California, San Diego 1987 — 1992
BA, Psychology
Fountain Valley High School 1983 — 1987
ARINCAL June 2010 - Present
Independent Consultant May 2008 - Present
Halt Medical 2010 - 2010
eStudySite August 2006 - May 2008
Clinimetrics October 2001 - July 2006
Roche Pharmaceuticals April 1999 - September 2001
Roche Bioscience 1999 - 2001
Education
University of Hertfordshire 1991 — 1995
DURECT Corporation April 2006 - Present
ICON Clinical Research October 2004 - April 2006
NeurogesX, Inc. May 2004 - September 2004
Clinimetrics March 2002 - March 2004
IntraBiotics Pharmaceuticals, Inc July 1998 - May 2001
Sequus Pharmaceuticals, Inc. May 1997 - July 1998
Shaman Pharmaceuticals, Inc June 1996 - May 1997
Cygnus Therapeutic Systems October 1991 - June 1996
Skills
IND, NDA, Drug Development, FDA, Regulatory Submissions, Regulations, Regulatory Affairs, GCP, Pharmaceutical Industry, Biopharmaceuticals, CRO, Clinical Trials, eCTD, Technology Transfer, Clinical Development, Sop, GMP
Education
University of California, San Diego 1986 — 1991
Anacor, Inc. October 2012 - Present
KH Consulting April 2007 - Present
Affymax January 2009 - October 2012
XenoPort March 2004 - March 2007
Clinimetrics July 2001 - March 2004
Hoffmann-La Roche 1998 - 2001
Roche 1993 - 2001
Roche Global Development 1993 - 2001
Roche Pharmaceuticals 1993 - 2001
Pfizer Pharmaceuticals March 1991 - December 1993
Skills
Clinical Research, Biotechnology, Clinical Trials, Pharmaceutical Industry, Drug Development, CRO, Clinical Development, GCP, IND, FDA
Education
California State University-Chico 1980 — 1984
CLINICAN RESEARCH AND QUALITY ASSURANCE INC. June 2010 - Present
Sterling Life Sciences 2013 - 2013
VENN LIFE SCIENCE LTD 2007 - February 2009
CLINICAL RESEARCH CONSULTAN September 2005 - October 2007
PRA INTERNATIONAL 2004 - 2005
PFIZER (CANADA / INDIA). 1996 - 2004
CLINIMETRICS 2000 - 2001
Skills
Clinical Research, Clinical Monitoring, GCP, Clinical Research..., ICH-GCP, CRO, EDC, Clinical Trials, CTMS, Clinical Data Management, Clinical Development, Clinical Trial..., SOP, Endocrinology, Oncology, Pharmacovigilance, Inform, Protocol Development, Therapeutic areas, Regulatory Submissions, Pharmaceutical Industry, Infectious Diseases
Education
National Institute of Information Technology
Software Technology & Systems Management Curriculum
Pfizer Regulatory Education Network (P.R.E.N.)
CRA Certification
University of Mumbai
Bachelor of Science (BSc), Chemistry
Gilead Sciences June 2013 - Present
Medtronic May 2006 - June 2012
PDL 2005 - 2006
Sunesis Pharmaceuticals 2005 - 2006
Exelixis 2003 - 2005
Allergenics June 1999 - February 2003
Clinimetrics August 1996 - February 1999
Quintiles July 1995 - July 1996
Syntex 1987 - 1995
Palo Alto YMCA 1965 - 1975
Skills
Research, PowerPoint, Lifesciences, Oncology, Budgets, Change Management, SharePoint, CAPA, Business Analysis, Auditing, Risk Management, Visio, FDA, Clinical Operations, Regulatory Affairs, Clinical Trials, Life Sciences
Education
Awalt High School
Stanford University
MS, Biology
Whitman College
BA, Biology
Allergan November 2007 - May 2013
Allergan 2007 - 2010
Clinimetrics April 2008 - April 2009
Amgen Inc October 1999 - November 2007
National Childhood Cancer Foundation March 1993 - October 1999
Education
Moscow State University of Civil Engineering (MSUCE) 1974 — 1979
MS, Computer Science and Information Systems
Theorem Clinical Research June 2011 - Present
Omnicare Clinical Research June 2010 - June 2011
Clinimetrics 2009 - July 2010
Clinimetrics 1996 - 2009
Clinimetrics 1993 - 1996
Syntex Pharmaceuticals 1991 - 1993
Skills
Medical Writing, Clinical Research, Oncology, CRO, Clinical Study Design, Clinical Monitoring, FDA, Protocol, Hematology, Therapeutic Areas, Neurology, Clinical Development, Dermatology, Clinical Trials, Quality Assurance, GCP, CTMS, Validation
Education
Stanford University 1975 — 1981
BA, MA
Avillion, LLP February 2015 - Present
PPD October 2012 - January 2015
C & G Clinical Research, LLC August 2008 - October 2012
PRA International October 2006 - August 2008
ICON September 2002 - May 2006
Alexion October 2000 - August 2002
Bayer Corporation April 2000 - September 2000
Abt Associates March 1999 - November 1999
Clinimetrics September 1996 - December 1998
Bristol-Myers Squibb, Wallingford, CT July 1990 - September 1996
Skills
Clinical Research, Vaccines, Pediatrics, Diabetes, CRO, Epidemiology, Pharmaceuticals, Infectious Diseases, Clinical Trials, Pharmacovigilance, Study Design, GCP, Clinical Development, Compliance, Type 2 Diabetes, Autoimmune Diseases, Protocol Writing, Clinical Monitoring, CRF design, EDC, CTMS, Protocol Development, Budget Negotiation, Clinical, Literature Reviews, Protocol, Medical Writing, Clinical Study Design, Regulatory Submissions, Clinical Operations, Pharmaceutical Industry, Clinical Data Management
Education
New York Medical College 1985 — 1990
Master of Public Health, Epidemiology
State University of New York College at Oneonta 1979 — 1983
BS, Psychology
PRA Health Sciences April 2010 - Present
Clinimetrics March 2007 - April 2010
Saint Joseph's Research Institute October 2005 - March 2007
Discovery Alliance, Inc. May 2002 - October 2006
US Army Aeromedical Research Laboratory (USAARL) August 1998 - June 2002
Skills
Research, Project Management, CRO, Clinical Research, Clinical Trials, Biotechnology, Business Process..., CTMS, Cardiology, Data Analysis, EDC, FDA, GCP, Healthcare, Medical Devices, Pharmaceutical Industry, Protocol, Regulatory Affairs, Sop, Vaccines, Training, Therapeutic Areas, Quality Assurance, Clinical Development, Lifesciences, Neurology, Clinical Study Design, Clinical Monitoring, Regulatory Submissions, 21 CFR Part 11, Hospitals, Statistics, Phase I, Business Strategy, Oracle Clinical, Regulatory Requirements, ICH-GCP, Budgets, Immunology, Data Management, Drug Development, Clinical Data Management, Program Management, Infectious Diseases, Time Management, Internal Medicine, R&D, Pharmacovigilance, Recruiting, SOP
Education
University of Maryland University College 1990 — 1993
AA, General Studies
Troy University Dothan
BS / MS, Biology / Psychology
Chiltern September 2015 - Present
Theorem Clinical Research April 2013 - September 2015
Theorem Clinical Research January 2012 - March 2013
Theorem Clinical Research June 2011 - June 2012
Omnicare Clinical Research October 2008 - July 2011
Clinimetrics October 2007 - September 2008
Clinimetrics September 2005 - September 2007
Skills
CRO, Biotechnology, Business Development, CTMS, Clinical Development, Clinical Trials, EDC, GCP, Life Sciences, Medical Devices, Oncology, Pharmaceutical Industry, Clinical Research, FDA, Management
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2001 — 2005
MBA
University of Pittsburgh - Joseph M. Katz Graduate School of Business 2001 — 2005
MS, Management of Information Systems
University of Pittsburgh 1990 — 1995
BS, Biology/Business
MedImmune January 2014 - Present
Ockham Oncology March 2012 - December 2013
Allos July 2008 - March 2012
Clinimetrics 2004 - 2008
Matrix Pharmaceuticals 2000 - 2003
Matrix Pharmaceuticals 1997 - 2000
Skills
Oncology, Clinical Trials, Clinical Development, GCP, CTMS, CRO, EDC, Pharmaceutical Industry, Clinical Monitoring, Biotechnology, ICH-GCP, Clinical Data Management, Drug Development, Regulatory Submissions
Education
Santa Clara University 1992 — 1996
BS, Combined Sciences
Homestead 1988 — 1992
Clinimetrics February 2004 - Present
Roche Pharmaceuticals 1990 - 2001
Education
Notre Dame de Namur University
MS, Project Management
San Jose State University 1990 — 1993
BS, Business Administration
Outer Banks Clinical Research Monitoring, LLC August 2008 - Present
Outer Banks Clinical Research Monitoring September 2004 - Present
Clinimetrics April 2000 - September 2004
Clintrials Research August 1999 - April 2000
Charlotte Gastroenterology September 1997 - August 1999
World Access July 1995 - September 1997
Medical College of Virginia Hospitals August 1988 - July 1995
Durham Regional Hospital 1975 - 1988
Independent consultant 1977 - 1987
Education
University of North Carolina at Chapel Hill 1979 — 1985
BA, Psychology
Watts Hospital School of Nursing 1973 — 1975
RN, Professional nursing
PRA Health Sciences January 2012 - Present
INC Research February 2011 - January 2012
PharmaNet Development Group, Inc. April 2009 - October 2010
Telik, Inc. February 2005 - November 2008
BioMarin May 2004 - December 2004
Clinimetrics May 2002 - May 2004
Quintiles Transnational March 1997 - May 2002
Skills
Clinical Trials, Rheumatoid Arthritis
Education
Acalanes
Northern Arizona University
Biology
University of Arizona
BS, General Biology
ProTrials Research, Inc. 1998 - Present
Clinimetrics 1996 - 1998
Syntex 1990 - 1996
Skills
CTMS, Clinical Monitoring, GCP
Education
California State University, Fresno
BSN, Nursing
PRA Health Sciences Senior Regional MonitorReSearch Pharmaceutical ServicesFebruary 2008 - October 2013
Clinimetrics 2005 - 2008
Clinimetrics Research Associates, Inc. 2000 - 2004
Skills
Clinical Monitoring, EDC, Neurology, CTMS, GCP, CRO, Clinical Research..., ICH-GCP, Clinical Data Management, Therapeutic Areas, Clinical Trials, Clinical Development, Clinical Operations, Pharmaceutical Industry, Oncology
Education
Murray State University 1983 — 1987
BSN, Nursing
Richland High School, Essex, MO
Agility Clinical, Inc. March 2014 - Present
ReSearch Pharmaceutical Services August 2008 - March 2014
Clinimetrics August 2005 - August 2008
CTI Clinical Trials and Consulting October 2003 - August 2005
INC Research November 2002 - November 2003
INC Research April 2001 - November 2002
INC Research October 2000 - April 2001
INC Research January 1999 - October 2000
Skills
Clinical Trials, Clinical Research, EDC, Clinical Data Management, Infectious Diseases, Hematology, Dermatology, Phase I, Data Management, Oracle Clinical, Oncology, Clinical Monitoring, CTMS, GCP, Pharmaceutical Industry
Education
Xavier University 2001 — 2002
Bachelor of Arts (B.A.), Business Administration, Management and Operations
Northern Kentucky University 1994 — 1997
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Genentech May 2010 - Present
Pharmacyclics October 2009 - March 2010
Elan Pharmaceuticals July 2007 - December 2008
Pharmacyclics October 2003 - June 2007
ICON Clinical Research October 2001 - August 2003
Clinimetrics March 2000 - September 2001
Skills
EDC, Clinical Development, Clinical Research, Budget, Oncology, Clinical Trials, CTMS, GCP, Biotechnology, Pharmaceutical Industry, Budgets, Clinical Operations, CRO, FDA, Data Management, Clinical Monitoring, Drug Development, Regulatory Submissions, IND, Sop, Protocol, Therapeutic Areas, Neurology, ICH-GCP
Education
Project Management Institute 2009 — 2009
Certification
University of California, Santa Cruz 1995 — 1999
BA
SourceCorp Deliverex June 2007 - Present
Wilson, Sonsini, Goodrich & Rosati September 2006 - April 2007
Alien Technology January 2006 - August 2006
Clinimetrics 2001 - 2005
Skills
SharePoint, Microsoft SQL Server, IT Operations, Active Directory, Virtualization, VMware, Microsoft Office, Windows Server, Databases, Data Center, Windows, Vendor Management, Process Improvement, Software Documentation, Project Management, Cisco Technologies, Cloud Computing, SQL
Education
Univeristy of Phoenix 2002 — 2004
MS, Computer Information Systems
Chaminade University of Honolulu 1981 — 1982
Bachelors, Computer Science
Biogen July 2014 - Present
Covance August 2011 - July 2014
Sarah Cannon Research Institute August 2009 - August 2011
UCB September 2008 - June 2009
Clinimetrics 2005 - 2007
Skills
Clinical Monitoring, CTMS, Clinical Trials, GCP, Clinical Development, Pharmaceutical Industry, CRO, Clinical Research, EDC
Education
Middle Tennessee State University 1996 — 1998
Bachelor of Science (BS), Psychology
Puma Biotechnogy March 2014 - Present
ReSearch Pharmaceutical Services February 2011 - March 2014
Clinimetrics/OCR 2006 - 2010
Clinimetrics 2004 - 2006
Clinimetrics 2002 - 2004
Clinimetrics 1998 - 2002
Cardiovascular Medicine 1988 - 1994
Skills
CTMS, EDC, CRO, Clinical Monitoring, Clinical Trials, Infectious Diseases, ICH-GCP, Project Management, Clinical Operations, Clinical Research, GCP, Process Improvement, Oncology, Clinical Development, Clinical Data Management, Therapeutic Areas
Education
University of California, Davis 1983 — 1987
B.S., Exercise Physiology
INC Research July 2009 - Present
PPD May 2008 - July 2009
Clinimetrics August 2000 - August 2007
Worldwide Clinical Trials, Inc. September 1997 - October 2000
Education
Illinois State University 1983 — 1986
BS, Social Work, Sociology
von der Groeben Consulting, LLC 2011 - Present
Affymax, Inc. 2008 - 2011
Genentech 2001 - 2007
Clinimetrics 2000 - 2001
Clinimetrics Research Associates 2000 - 2001
ALZA Corporation 1996 - 2000
Syntex 1988 - 1995
Skills
Clinical QA, GCP, Clinical Trials, Quality Assurance, Clinical Research, Regulatory Affairs, Oncology, Clinical Development, GLP, FDA, Biotechnology, 21 CFR Part 11, CRO, Drug Development, Infectious Diseases
Education
UCSF 1982 — 1984
MS, Cardiovascular Nursing, Medical
Skidmore College
BS, Nursing
Theorem Clinical Research April 2013 - Present
Quintiles July 2009 - April 2013
ICON Clinical Research March 2004 - April 2009
Clinimetrics February 2000 - March 2004
Skills
EDC, Clinical Trials, Oracle Clinical
Education
De Anza College 1998 — 1999
AS, GE
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
Blackwell Clinical Consulting, LLC November 2005 - Present
Clinimetrics November 1995 - November 2005
Syntex Research (Syntex was purchased by Roche Pharmaceuticals in 1995) January 1995 - November 1995
Genelabs Technologies January 1992 - January 1995
XOMA January 1990 - January 1992
Syntex Pharmaceuticals (Purchased by Roche 1995) January 1989 - January 1990
Syntex Pharmaceuticals (Purchased by Roche in 1995) January 1986 - January 1989
Syntex Pharmaceuticals (Purchased by Roche in 1995) January 1985 - January 1986
Skills
Clinical Trials, Clinical Research, FDA, Data Management, Infectious Diseases, Stroke, Oncology, GCP, Clinical Data Management, Sop, CRO, EDC, Cancer
Education
Huntingdon College 1980 — 1984
BA, Psychology
ProTrials Research June 2013 - Present
Worldwide Clinical Trials, Inc. 2011 - June 2013
Annette C. Henry, Clinical Consulting June 2010 - 2011
Clinimetrics 1992 - 2010
Skills
Clinical Trials, Rheumatology, CRO, Transplant, Diabetes, GCP, Infectious Diseases, Clinical Research, Hematology, Immunology, Dermatology, CTMS, Endocrinology, 21 CFR Part 11, FDA
Education
Pacific Lutheran University
BA/BSN, Biology/ Nursing
Emory Healthcare - Saint Joseph's Research Institute December 2014 - Present
Winship Cancer Institute of Emory University February 2014 - November 2014
Saint Joseph's Hospital August 2011 - February 2014
CIBA Vision January 2010 - July 2011
Clinimetrics October 2007 - January 2010
Saint Joseph's Hospital March 2005 - October 2007
The Chattanooga Heart Institute August 2001 - December 2004
Skills
Access, CRO, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, EDC, Endocrinology, FDA, GCP, ICH-GCP, Infectious Diseases, Medical Devices, Microsoft Excel, Microsoft Office, Oncology, Pharmaceutical Industry, Process Improvement, Project Management, Regulatory Submissions, Sop, Therapeutic Areas, Clinical Operations, Clinical Study Design, Drug Development, 21 CFR Part 11, Regulatory Affairs, Neurology, Data Management, Oracle Clinical, Medical Writing, Cardiology, Pharmacovigilance
Education
The University of Tennessee at Chattanooga 1994 — 1998
BS, Biology
Theorem Clinical Research 2010 - Present
Synteract, Inc. 2010 - 2010
Clinimetrics 2005 - 2009
Clinimetrics 2001 - 2005
The Immune Response Corporation 1998 - 2001
Skills
Clinical Monitoring, Clinical Research, GCP, Clinical Operations, Clinical Trials, Clinical Development, CRO, Biotechnology, CTMS
Education
The University of Memphis
PAREXEL October 2014 - Present
ReSearch Pharmaceutical Services June 2011 - September 2014
Clinimetrics 1994 - June 2011
Kidney Disease & Critical Care Associates, PA 1986 - 1994
Skills
Clinical Monitoring, Clinical Research, CTMS, Pharmaceutical Industry, ICH-GCP, CRO, Medical Devices, Regulatory Submissions, FDA, EDC, Vaccines, Clinical Development, Data Analysis, GCP, Research, Oracle Clinical, Clinical Trials, Endocrinology, Clinical Data Management, Sop, Biotechnology, Oncology, Clinical Operations, Phase I, Infectious Diseases
Education
Marian University 1971 — 1975
BSN, nursing
Theorem Clinical Research April 2015 - Present
Theorem Clinical Research October 2014 - May 2015
Theorem Clinical Research June 2011 - September 2014
Omnicare Global Clinical Research October 2010 - June 2011
Clinimetrics Research Associates Inc. June 2003 - November 2009
Clinimetrics March 2002 - June 2003
Scripps Clinic September 2001 - March 2002
UCLA School of Medicine September 1997 - June 2001
Skills
Clinical Trials, Oncology, Diabetes, Clinical Research, Sop, Therapeutic Areas, Clinical Development, EDC, Protocol, Pharmaceutical Industry, Clinical Monitoring, Clinical Data Management, SOP
Education
University of California, Los Angeles 1992 — 1996
B.S., Biology
University of California, Los Angeles
Biology/Physiology
Advanced Clinical Services, Inc. April 2010 - Present
Advanced Clinical Services, LLC February 2013 - June 2014
Clinimetrics Research Associates January 2004 - April 2010
Clinimetrics Research ASSOCIATES January 1996 - April 2010
Clinimetrics 1996 - 2010
Clinimetrics Research Associates January 2000 - January 2004
Clinimetrics Research Associates January 1996 - January 2000
Tulane University Medical Center January 1994 - January 1996
Telemetry and CCU January 1993 - January 1994
Slidell Memorial Hospital and Medical Center January 1992 - January 1993
Skills
CTMS, Clinical Trials, Clinical Research, Clinical Monitoring, Diabetes, Medical Devices, FDA, Protocol, Data Management, GCP, CRO, Clinical Operations, Endocrinology, EDC, Neurology, Cardiology, Phase I, Medidata, SharePoint, TrialCentralNet, PHT Study Works, INC Research Trial..., IMPACT Standard and..., ELVIS - Quintiles, INC Project Point
Education
University of New Orleans 1986 — 1989
MBA, Business Administration
University of New Orleans
Master’s Degree, Business Administration
Southeastern Louisiana University 1974 — 1977
BSN, Nursing
Southeastern Louisiana University
Bachelors of Science, Nursing
Genentech/ Lab Support September 2014 - Present
Jazz Pharmaceuticals 2010 - September 2014
Actelion 2005 - 2010
Clinimetrics 2003 - 2005
Skills
Clinical Data Management, GCP, CTMS, Clinical Trials, ICH-GCP, ARISg, Microsoft Excel, Patient Advocacy, Teamwork, Reimbursement, Communication, Drug Safety, Transcribing, CRO, Pharmacovigilance, Livelink, Medicare, Medicaid, Oracle Clinical, Argus Safety, 21 CFR Part 11
Education
San Jose State University 2008 — 2012
Bachelor's degree, Behavioral Sciences
De Anza College 2003 — 2005
Associate's degree, Liberal Arts with Behavioral Science emphasis
Elo Touch Solutions January 2013 - Present
ZAG Technical Services June 2011 - January 2013
ZAG Technical Services August 2010 - January 2013
Clinimetrics August 2005 - July 2010
ArthroCare Corporation 2002 - 2003
Adaptec 1995 - 2001
Caere Corporation 1994 - 1995
Skills
System Administration, Active Directory, Cisco Technologies, VMware, IT Operations, Windows Server, Virtualization, Windows 7, XP, Windows, Network Administration, Microsoft SQL Server, SharePoint, DNS, Data Center, Disaster Recovery, Servers, TCP/IP, SAN, Firewalls, Hyper-V, Network Security, VPN, VMware ESX, Microsoft Exchange, Technical Support, Networking, Cloud Computing, Citrix, Storage, DHCP, Group Policy, System Deployment, MCITP, Security, IT Service Management, Red Hat Linux, Operating Systems, Software Installation, vSphere, Microsoft Certified..., Troubleshooting, Hardware, VMware Infrastructure, Switches, Linux, Microsoft Technologies, Windows XP
Education
University of California, Santa Cruz 1994 — 1995
Certificate, Network Managment
Ohlone College
Chiltern September 2015 - Present
Theorem Clinical Research April 2012 - September 2015
PRA International June 2011 - April 2012
Clinimetrics / Omnicare Clinical Research / Theorem Clinical Research December 2006 - June 2011
Clinimetrics December 2005 - December 2006
ICON plc August 2005 - November 2005
ICON Clinical Research February 2001 - August 2005
Skills
Clinical Research, Clinical Research..., CTMS, CRO, GCP, Clinical Monitoring, EDC, Clinical Trials, ICH-GCP, Clinical Development, Oncology, Therapeutic Areas
Education
Messiah College 1996 — 2000
BS, Biology
Messiah College 1996 — 2000
Bachelor of Science (B.S.), Biology/Biological Sciences, General
GCP Solutions Inc. October 1999 - Present
Clinimetrics 2008 - 2010
Vasogen Inc 2004 - 2006
Boehringer Ingelheim 1988 - 1999
Skills
Clinical Development, Clinical Research, Clinical Trials, Project Management, GCP Training, Pharmaceutical Industry, Cross-functional Team..., Quality Assurance, CRO, Health Canada, FDA, CTMS, Biotechnology, Sop, Medical Devices, Oncology
Education
McMaster University 1977 — 1981
B.Sc, Biology
ProTrials Research May 2012 - Present
ReSearch Pharmaceutical Services April 2011 - May 2012
Clinimetrics 2004 - 2010
Roche Global Development 2000 - 2001
Roche Global Development 1999 - 2000
Roche Global Development 1996 - 1999
Roche Global Development 1996 - 1996
Skills
Project Management, Clinical Trials, FDA, CTMS, Clinical Operations, IND, Clinical Research, Biotechnology, Pharmaceutical Industry, Infectious Diseases, Validation, CRO, Clinical Data Management, 21 CFR Part 11, Lifesciences, Quality Assurance, Regulatory Affairs, Clinical Development, EDC, Clinical Monitoring, Regulatory Submissions, Sop, GCP, Oncology, Management, Inform, Clinical Study Design, Process Improvement, ICH-GCP, Therapeutic Areas, Change Control, Cross-functional Team..., Endocrinology, Medical Writing, Budgets, Phase I, Dermatology, SAS, Oracle Clinical, Protocol, Diabetes, Medical Devices, Cardiology, Data Management, Vaccines, Drug Development, Neurology, Pharmacovigilance, Biopharmaceuticals, Vendor Management
Education
Notre Dame de Namur University
MSM, Project Management
San Jose State University
BS, Business Administration (Accounting)
Seppa Research, LLC July 2002 - Present
Clinimetrics September 1994 - July 2002
Boehringer Ingelheim Pharmaceuticals November 1993 - September 1994
Bristol-Myers Squibb June 1990 - November 1993
Education
University of Connecticut 1984 — 1988
BS, Clinical Dietetics
Red Hawk Fire & Security March 2007 - Present
Clinimetrics October 1997 - January 2007
Precision Tune Auto Care January 1996 - December 1996
Skills
Sarbanes-Oxley, Sarbanes-Oxley Act, Revenue Recognition, Invoicing, Accounts Payable, Accounting, Account Reconciliation, Accounts Receivable, General Ledger, GAAP, Spreadsheets, Journal Entries, Process Improvement, Bank Reconciliation, US GAAP
Education
De Anza College
Accounting & Environmental
SynteractHCR November 2014 - Present
Quintiles June 2012 - November 2014
Contract CRA January 2012 - June 2012
Innovative Clinical Trials June 1999 - May 2012
Clinimetrics January 1997 - June 2000
In-Site Clinical Trials January 1995 - December 1995
Skills
CRO, Dermatology, Clinical Development, Clinical Trials, Clinical Monitoring, CTMS, Clinical Operations, Clinical Data Management, ICH-GCP, Pharmacovigilance, EDC, Hematology, GCP, Diabetes, Oracle Clinical, Regulatory Affairs, Oncology, Infectious Diseases, Protocol, Clinical Research, Therapeutic Areas, Regulatory Submissions, Rheumatology, Endocrinology
Education
Emory University 1991 — 1992
MPH, Health Administration
University of Florida 1985 — 1989
B.S., Corporate Wellness/Exercise Phisiology
Clinimetrics 2000 - 2010
Education
Heald College
A.A., Computer Business Administration
Independent Real Estate Property Investor and Manager January 1988 - Present
Winship Cancer Institute @ Emory University June 2005 - June 2014
Winship Cancer Institute / Emory University November 2003 - May 2005
Winship Cancer Institute of Emory University August 2003 - October 2003
Winship Cancer Institute of Emory University August 2003 - October 2003
Clinimetrics January 2002 - June 2002
Clinimetrics May 2000 - December 2001
Chiron June 1996 - May 2000
Letterman Army Institute of Research October 1989 - May 1996
US Army March 1985 - March 1988
Skills
Biotechnology, Clinical Trials, Monitoring, Project Management, Research, Process Improvement, Quality Assurance, Regulatory Affairs, Data Analysis, Clinical Research
Education
North Georgia College and State University 1976 — 1981
Biology, Biology/Biological Sciences, General
California State Hayward
Training Certificate 2001
Habersham Central
Habersham Central
San Francisco State University
No, Business classes
Work at home August 1995 - Present
Clinimetrics 1998 - 2004
Gen-Probe Inc. 1984 - 1992
Skills
Exploring artistic side, Research
Education
San Diego State University-California State University 1955 — 1960
Medical Microbiology and Bacteriology
Kearny High School, SDSU, National Univ. 1953 — 1955
Bachelor of Science (BS), Medical Microbiology and Bacteriology
National University San Diego
MBA Health Care Administration, Medical Microbiology and Bacteriology
Clinimetrics January 2001 - January 2002
QUANTUM CORPORATION January 2000 - January 2001
INTERPATH COMMUNICATIONS January 1999 - January 2000
Cato Research Ltd. January 1998 - January 1999
Cato Research Ltd. 1999 - 1999
Cato Research Ltd. 1998 - 1999
Cato Research Ltd. January 1996 - January 1997
Education
University of North Carolina at Chapel Hill
B.A, Psychology
ExecuPharm, Inc. 2011 - May 2012
Roche Palo Alto July 2006 - December 2010
Roche Bioscience April 1999 - July 2006
Roche Pharmaceuticals 1999 - 2006
Clinimetrics June 1997 - November 1998
Collagen Corporation April 1990 - May 1997
Education
Ball State University
M.A., Audiology
Indiana University Bloomington
B.A., Speech Pathology & Audiology
ReSearch Pharmaceutical Services 2011 - Present
Omnicare Inc. September 2010 - March 2011
Clinimetrics May 2006 - September 2010
Education
Brigham Young University 1989 — 1999
Bachelor's Degree, Geography