Integrium Company
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Integrium Employees
Employee
Years
Job
Industry
Pierre Corin Pierre Corin's Integrium Experience 2004 - 2007
Job Sr. GPM at Genentech
Industry Pharmaceuticals
Experience
Genentech March 2015 - Present
Oufti Clinical & Development January 2014 - February 2015
Quark Pharmaceuticals Inc July 2013 - December 2013
Cerexa June 2012 - July 2013
KYTHERA Biopharmaceuticals April 2010 - July 2012
Allergan April 2007 - April 2010
Integrium 2004 - 2007
PPD 2002 - 2004
Covance 1999 - 2002
Pharmatech 1997 - 1999
Skills
Clinical Development, CRO, Clinical Operations, Clinical Research, Clinical Trials, Oncology, Drug Development, Biotechnology, Pharmaceutical Industry, CTMS, GCP, EDC, Clinical Data Management, Data Management, Clinical Monitoring, ICH-GCP, Medical Devices, Dermatology, FDA, Infectious Diseases, 21 CFR Part 11, Regulatory Submissions, Medical Writing, IND, GLP, Chairman, speaker and..., Advisor and Dir Clin Op..., Clinical Pharmacology, Clinical Study Design, Immunology, Pharmacology, GMP, Oracle Clinical, Asia Pacific, Aesthetics, Ophthalmology, Lean Six Sigma
Education
Université de Liège
MS, Pharmacolgy - Psychology - Educational Sciences - Fondamental Research
Genentech March 2015 - Present
Oufti Clinical & Development January 2014 - February 2015
Quark Pharmaceuticals Inc July 2013 - December 2013
Cerexa June 2012 - July 2013
KYTHERA Biopharmaceuticals April 2010 - July 2012
Allergan April 2007 - April 2010
Integrium 2004 - 2007
PPD 2002 - 2004
Covance 1999 - 2002
Pharmatech 1997 - 1999
Skills
Clinical Development, CRO, Clinical Operations, Clinical Research, Clinical Trials, Oncology, Drug Development, Biotechnology, Pharmaceutical Industry, CTMS, GCP, EDC, Clinical Data Management, Data Management, Clinical Monitoring, ICH-GCP, Medical Devices, Dermatology, FDA, Infectious Diseases, 21 CFR Part 11, Regulatory Submissions, Medical Writing, IND, GLP, Chairman, speaker and..., Advisor and Dir Clin Op..., Clinical Pharmacology, Clinical Study Design, Immunology, Pharmacology, GMP, Oracle Clinical, Asia Pacific, Aesthetics, Ophthalmology, Lean Six Sigma
Education
Université de Liège
MS, Pharmacolgy - Psychology - Educational Sciences - Fondamental Research
Joanna Coover Joanna Coover's Integrium Experience July 2004 - May 2006
Job IT Project Manager at HD Supply
Industry Internet
Experience
HD Supply February 2015 - Present
Sony Electronics May 2010 - 2014
Sony Electronics February 2009 - May 2010
Road Runner Sports April 2007 - January 2009
Kelley Blue Book May 2006 - March 2007
Integrium July 2004 - May 2006
Skills
Marketing Research, Project Portfolio..., Budgets, Project Management, SharePoint, Project Planning, Business Strategy, E-commerce, Microsoft Office, Analysis, Change Management, CRM, Web Analytics, SaaS, Brand Management, Data Analysis, Digital Media, Product Management, Leadership, XHTML, User Experience, Marketing Management, Photoshop, Copywriting, Resource Management, New Business Development, Management, Analytics, SEO, Digital Marketing, Competitive Analysis, Omniture, Cross-functional Team..., Information Architecture, Email Marketing, Digital Strategy, Software Documentation, Web Project Management, Multi-channel Marketing, Online Advertising, Google Analytics, Interactive Marketing, Content Management, Online Marketing, Content Strategy, Integrated Marketing, SEM, Product Marketing, Web Content Management, Mobile Marketing
Education
Northern Arizona University 1992 — 1996
Advertising
HD Supply February 2015 - Present
Sony Electronics May 2010 - 2014
Sony Electronics February 2009 - May 2010
Road Runner Sports April 2007 - January 2009
Kelley Blue Book May 2006 - March 2007
Integrium July 2004 - May 2006
Skills
Marketing Research, Project Portfolio..., Budgets, Project Management, SharePoint, Project Planning, Business Strategy, E-commerce, Microsoft Office, Analysis, Change Management, CRM, Web Analytics, SaaS, Brand Management, Data Analysis, Digital Media, Product Management, Leadership, XHTML, User Experience, Marketing Management, Photoshop, Copywriting, Resource Management, New Business Development, Management, Analytics, SEO, Digital Marketing, Competitive Analysis, Omniture, Cross-functional Team..., Information Architecture, Email Marketing, Digital Strategy, Software Documentation, Web Project Management, Multi-channel Marketing, Online Advertising, Google Analytics, Interactive Marketing, Content Management, Online Marketing, Content Strategy, Integrated Marketing, SEM, Product Marketing, Web Content Management, Mobile Marketing
Education
Northern Arizona University 1992 — 1996
Advertising
Dario J. Sunga, MD Dario J. Sunga, MD's Integrium Experience October 2003 - January 2005
Job Scientific Adviser and Consultant on Product Development, Nutraceutical Products at American Science Products
Industry Biotechnology
Experience
American Science Products June 2014 - Present
Amgen January 2005 - December 2013
Amgen June 2005 - August 2006
Amgen February 2005 - June 2005
Integrium October 2003 - January 2005
Clinical Trials and Research Associates, Inc. November 1999 - October 2003
Skills
Biotechnology, Lifesciences, Drug Discovery, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Trials, GMP, Biopharmaceuticals, CTMS, Life Sciences, Regulatory Affairs, CRO, Pharmacovigilance, FDA, GCP
Education
Davao Medical School Foundation 1981 — 1985
Doctor of Medicine (M.D.)
University of the Immaculate Conception 1977 — 1981
Bachelors degree in Medical Technology, Laboratory Sciences
American Science Products June 2014 - Present
Amgen January 2005 - December 2013
Amgen June 2005 - August 2006
Amgen February 2005 - June 2005
Integrium October 2003 - January 2005
Clinical Trials and Research Associates, Inc. November 1999 - October 2003
Skills
Biotechnology, Lifesciences, Drug Discovery, Oncology, Pharmaceutical Industry, Clinical Development, Clinical Trials, GMP, Biopharmaceuticals, CTMS, Life Sciences, Regulatory Affairs, CRO, Pharmacovigilance, FDA, GCP
Education
Davao Medical School Foundation 1981 — 1985
Doctor of Medicine (M.D.)
University of the Immaculate Conception 1977 — 1981
Bachelors degree in Medical Technology, Laboratory Sciences
Cristina Damatarca MD Cristina Damatarca MD's Integrium Experience 1998 - 2001
Job Global Drug Safety, Pharmacovigilance, and Risk Management Executive
Industry Pharmaceuticals
Experience
Avanir Pharmaceuticals 2014 - Present
Roche January 2013 - January 2014
Roche January 2012 - February 2013
Amgen June 2007 - November 2011
Amylin Pharmaceuticals 2005 - 2007
Ligand Pharmaceuticals 2004 - 2005
Neuroscience Education Institute 2002 - 2004
Elan Pharmaceuticals 2001 - 2002
Integrium 1998 - 2001
Skills
Pharmacovigilance, Medical Education, Risk Management, Oncology, Internal Medicine, Neuroscience, Clinical Research, Clinical Trials, Pharmaceuticals, Neurology, Immunology, Diabetes, Patient Safety, Drug Discovery, Protocol, Drug Safety, Drug Development, Biopharmaceuticals, Medical Affairs, Medicine, Clinical Study Design, IND, Central Nervous System, MedDRA, Health Economics, Clinical Development, Pharmaceutical Industry, Cross-functional Team..., REMS, Medical Review, Regulatory Filings, Biologics, ICH-GCP, Outcomes Research, Publications, Inflammation, Monoclonal Antibodies, Signal detection, Benefit-risk assessment, NDA, Integrated Risk..., Risk Mitigation, Risk Minimization..., Product Core Safety..., Regulatory Submissions, Lifesciences, Biotechnology, Protocol Development, Pain, Public Health
Education
1979 — 1985
MD, Medicine
University of Hertfordshire - School of Life and Medical Sciences 2012 — 2014
Pharmacovigilance MSc - ongoing, Pharmacovigilance
Avanir Pharmaceuticals 2014 - Present
Roche January 2013 - January 2014
Roche January 2012 - February 2013
Amgen June 2007 - November 2011
Amylin Pharmaceuticals 2005 - 2007
Ligand Pharmaceuticals 2004 - 2005
Neuroscience Education Institute 2002 - 2004
Elan Pharmaceuticals 2001 - 2002
Integrium 1998 - 2001
Skills
Pharmacovigilance, Medical Education, Risk Management, Oncology, Internal Medicine, Neuroscience, Clinical Research, Clinical Trials, Pharmaceuticals, Neurology, Immunology, Diabetes, Patient Safety, Drug Discovery, Protocol, Drug Safety, Drug Development, Biopharmaceuticals, Medical Affairs, Medicine, Clinical Study Design, IND, Central Nervous System, MedDRA, Health Economics, Clinical Development, Pharmaceutical Industry, Cross-functional Team..., REMS, Medical Review, Regulatory Filings, Biologics, ICH-GCP, Outcomes Research, Publications, Inflammation, Monoclonal Antibodies, Signal detection, Benefit-risk assessment, NDA, Integrated Risk..., Risk Mitigation, Risk Minimization..., Product Core Safety..., Regulatory Submissions, Lifesciences, Biotechnology, Protocol Development, Pain, Public Health
Education
1979 — 1985
MD, Medicine
University of Hertfordshire - School of Life and Medical Sciences 2012 — 2014
Pharmacovigilance MSc - ongoing, Pharmacovigilance
Jennie Hakim Jennie Hakim's Integrium Experience March 2004 - May 2009
Job Freelance Writer, Editor, Graphic Designer
Industry Graphic Design
Experience
JBH Books June 2012 - Present
Jennie Brown Hakim June 2009 - Present
Jennie Brown Hakim 2009 - Present
Integrium March 2004 - May 2009
Direct Impressions December 2000 - March 2004
Recycler Classifieds December 1991 - June 2000
Skills
Proofreading, Graphic Design, Editing, Writing, Copy Editing, Copywriting, Logo Design, Photoshop, InDesign, Adobe Creative Suite, Research, Publishing, Creative Writing, Publications, Corporate Identity, Blogging, Social Media, Brochures, Stories, Web Content, Layout, Editorial, Graphics, Books, Posters, Logos, Newsletters, Packaging, Advertising, Fact-checking, Magazines, Illustrator, Photography, Freelance Writing, Direct Mail
Education
Brandman University 2011 — 2011
University of California, Los Angeles 1984 — 1989
Bachelor of Arts, English
JBH Books June 2012 - Present
Jennie Brown Hakim June 2009 - Present
Jennie Brown Hakim 2009 - Present
Integrium March 2004 - May 2009
Direct Impressions December 2000 - March 2004
Recycler Classifieds December 1991 - June 2000
Skills
Proofreading, Graphic Design, Editing, Writing, Copy Editing, Copywriting, Logo Design, Photoshop, InDesign, Adobe Creative Suite, Research, Publishing, Creative Writing, Publications, Corporate Identity, Blogging, Social Media, Brochures, Stories, Web Content, Layout, Editorial, Graphics, Books, Posters, Logos, Newsletters, Packaging, Advertising, Fact-checking, Magazines, Illustrator, Photography, Freelance Writing, Direct Mail
Education
Brandman University 2011 — 2011
University of California, Los Angeles 1984 — 1989
Bachelor of Arts, English
Anca Raluca Ciuciui Anca Raluca Ciuciui's Integrium Experience September 2013 - July 2014
Job Student at LBCC
Industry Hospital & Health Care
Experience
Long Beach City College September 2014 - Present
Integrium September 2013 - July 2014
Coury & Buehler Physical Therapy May 2013 - September 2013
Skills
Hospitals, Teamwork, Healthcare Management, Healthcare, Data Analysis, HIPAA, Microsoft Excel, Visio, PowerPoint, Public Health, Microsoft Office, Microsoft Word, Healthcare Information..., EHR, Data Entry, Project Management, Program Development, Medical Terminology, EMR, Process Improvement, Access, CPT, Epic Systems, Health Education, Medicare, Patient Safety, Clinical Research, Informatics, SPSS, Outlook, Administration, Research, Cpr Certified, Customer Service, Health Promotion, Medical Devices, Medical Records, Quality Improvement, Online Research, Quality Patient Care
Education
California State University-Long Beach 2009 — 2012
Master of Healthcare Administration, Health/Health Care Administration/Management
Long Beach City College September 2014 - Present
Integrium September 2013 - July 2014
Coury & Buehler Physical Therapy May 2013 - September 2013
Skills
Hospitals, Teamwork, Healthcare Management, Healthcare, Data Analysis, HIPAA, Microsoft Excel, Visio, PowerPoint, Public Health, Microsoft Office, Microsoft Word, Healthcare Information..., EHR, Data Entry, Project Management, Program Development, Medical Terminology, EMR, Process Improvement, Access, CPT, Epic Systems, Health Education, Medicare, Patient Safety, Clinical Research, Informatics, SPSS, Outlook, Administration, Research, Cpr Certified, Customer Service, Health Promotion, Medical Devices, Medical Records, Quality Improvement, Online Research, Quality Patient Care
Education
California State University-Long Beach 2009 — 2012
Master of Healthcare Administration, Health/Health Care Administration/Management
Noelle Martinez Noelle Martinez's Integrium Experience November 2005 - Present
Job Sr. Clinical Study Coordinator at Integrium
Industry Pharmaceuticals
Experience
Integrium November 2005 - Present
Integrium November 2005 - May 2008
Ultimate Staffing September 2005 - November 2005
Lim & Nascimento Engineering Corporation June 2003 - May 2005
The Lighthouse Bookstore May 2001 - June 2003
Gymboree July 2000 - April 2001
Skills
Clinical Monitoring, GCP/ICH Guidelines, Trial File Audits, IRB/EC Regulations, Trial Essential..., FDA Regulations, EDC, Clinical Operations, Regulatory Submissions, CTMS, Sop, SOP, ICH-GCP, Oncology, Pharmaceutical Industry, FDA, CRO, Regulatory Affairs, Clinical Trials, Therapeutic Areas
Education
Orange Coast College 2005 — 2007
Associate's degree, Liberal Arts and Sciences/Liberal Studies
Integrium November 2005 - Present
Integrium November 2005 - May 2008
Ultimate Staffing September 2005 - November 2005
Lim & Nascimento Engineering Corporation June 2003 - May 2005
The Lighthouse Bookstore May 2001 - June 2003
Gymboree July 2000 - April 2001
Skills
Clinical Monitoring, GCP/ICH Guidelines, Trial File Audits, IRB/EC Regulations, Trial Essential..., FDA Regulations, EDC, Clinical Operations, Regulatory Submissions, CTMS, Sop, SOP, ICH-GCP, Oncology, Pharmaceutical Industry, FDA, CRO, Regulatory Affairs, Clinical Trials, Therapeutic Areas
Education
Orange Coast College 2005 — 2007
Associate's degree, Liberal Arts and Sciences/Liberal Studies
Timothy Minh, MD, PhD Timothy Minh, MD, PhD's Integrium Experience January 2014 - September 2014
Job Medical Director @ Drug Safety Alliance | Pharmacovigilance Physician | Clinical Scientist
Industry Pharmaceuticals
Experience
Drug Safety Alliance Ashfield Pharmacovigilance May 2015 - Present
Quintiles September 2014 - May 2015
Integrium January 2014 - September 2014
UC Irvine August 2006 - June 2014
Orange County Research Center September 2013 - October 2013
Universities Allied for Essential Medicines August 2005 - June 2012
Drexel University College of Medicine February 2006 - May 2006
Lawrence Berkeley National Laboratory September 2004 - February 2006
UC Irvine May 2005 - August 2005
Argonne National Laboratory May 2004 - August 2004
Education
University of California, Irvine 2006 — 2014
Doctor of Medicine (M.D.), Medicine, Distinction in Research, Distinction in Service
University of California, Irvine 2006 — 2012
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology, 3.95 GPA
University of California, Berkeley 2002 — 2006
B.A, Chemistry
Drug Safety Alliance Ashfield Pharmacovigilance May 2015 - Present
Quintiles September 2014 - May 2015
Integrium January 2014 - September 2014
UC Irvine August 2006 - June 2014
Orange County Research Center September 2013 - October 2013
Universities Allied for Essential Medicines August 2005 - June 2012
Drexel University College of Medicine February 2006 - May 2006
Lawrence Berkeley National Laboratory September 2004 - February 2006
UC Irvine May 2005 - August 2005
Argonne National Laboratory May 2004 - August 2004
Education
University of California, Irvine 2006 — 2014
Doctor of Medicine (M.D.), Medicine, Distinction in Research, Distinction in Service
University of California, Irvine 2006 — 2012
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology, 3.95 GPA
University of California, Berkeley 2002 — 2006
B.A, Chemistry
Keila Guzman Keila Guzman's Integrium Experience June 2006 - November 2014
Job Quality Assurance
Industry Pharmaceuticals
Experience
WCCT Global April 2015 - Present
Integrium June 2006 - November 2014
Integrium January 2012 - July 2012
Integrium September 2007 - June 2009
Integrium May 2007 - September 2007
Integrium October 2006 - May 2007
Integrium June 2006 - September 2006
Karsten Homes January 2005 - March 2006
Wet Seal October 2000 - October 2003
Carasso Construction January 1999 - July 2000
Skills
Training, Human Resources, FDA, Software Documentation, Quality Assurance, Management, Auditing, Biotechnology, CRO, CTMS, Clinical Development, Clinical Trials, Employee Training, GCP, Sop, SOP
Education
Chaffey College
Bilingual Studies
San Bernardino Valley College
General and Bilingual Studies
WCCT Global April 2015 - Present
Integrium June 2006 - November 2014
Integrium January 2012 - July 2012
Integrium September 2007 - June 2009
Integrium May 2007 - September 2007
Integrium October 2006 - May 2007
Integrium June 2006 - September 2006
Karsten Homes January 2005 - March 2006
Wet Seal October 2000 - October 2003
Carasso Construction January 1999 - July 2000
Skills
Training, Human Resources, FDA, Software Documentation, Quality Assurance, Management, Auditing, Biotechnology, CRO, CTMS, Clinical Development, Clinical Trials, Employee Training, GCP, Sop, SOP
Education
Chaffey College
Bilingual Studies
San Bernardino Valley College
General and Bilingual Studies
Cassy Nguyen, MBA's Integrium Experience January 2010 - May 2010
Job Global Expansion Manager
Industry Health, Wellness and Fitness
Experience
Arbonne International July 2011 - Present
Endologix Inc February 2011 - July 2011
Edwards Lifesciences July 2010 - February 2011
Integrium January 2010 - May 2010
Allergan January 2008 - January 2009
Children's Hospital of Orange County February 2007 - January 2008
UCI Diabetes Research Center September 2005 - October 2006
Skills
FDA, Nutrition, Competitive Analysis, Cross-functional Team..., Leadership, Dietary Supplements, Brand Development..., Dietary Guidelines, Product Certification, Product Development, Project Management, Financial Analysis, Training, Sales Operations, Quality Assurance, Supplements, Analysis, Market Planning, Pharmaceutical Industry, Business Development, Sales, Entrepreneurship, Manufacturing, Marketing, Management, Medical Devices, Advertising, Sop, Budgets, Integrated Marketing, Finance, Strategic Planning, Supply Chain, Team Building, Marketing Strategy, Risk Management, Forecasting, Process Improvement, Pricing, Product Launch, Strategy, Consumer Products, Market Research, R&D, Analytics, Data Analysis, Business Strategy, Market Analysis, Product Marketing
Education
University of Southern California - Marshall School of Business 2010 — 2013
Master, Management, Marketing, Entrepreneur
University of California, Irvine 2002 — 2006
BS, Biological Sciences
Arbonne International July 2011 - Present
Endologix Inc February 2011 - July 2011
Edwards Lifesciences July 2010 - February 2011
Integrium January 2010 - May 2010
Allergan January 2008 - January 2009
Children's Hospital of Orange County February 2007 - January 2008
UCI Diabetes Research Center September 2005 - October 2006
Skills
FDA, Nutrition, Competitive Analysis, Cross-functional Team..., Leadership, Dietary Supplements, Brand Development..., Dietary Guidelines, Product Certification, Product Development, Project Management, Financial Analysis, Training, Sales Operations, Quality Assurance, Supplements, Analysis, Market Planning, Pharmaceutical Industry, Business Development, Sales, Entrepreneurship, Manufacturing, Marketing, Management, Medical Devices, Advertising, Sop, Budgets, Integrated Marketing, Finance, Strategic Planning, Supply Chain, Team Building, Marketing Strategy, Risk Management, Forecasting, Process Improvement, Pricing, Product Launch, Strategy, Consumer Products, Market Research, R&D, Analytics, Data Analysis, Business Strategy, Market Analysis, Product Marketing
Education
University of Southern California - Marshall School of Business 2010 — 2013
Master, Management, Marketing, Entrepreneur
University of California, Irvine 2002 — 2006
BS, Biological Sciences
Narielle Ayala's Integrium Experience August 2013 - Present
Job Proposal Coordinator at Integrium
Industry Pharmaceuticals
Experience
Integrium August 2013 - Present
Forever 21 July 2013 - August 2013
New Student and Family Programs September 2009 - May 2013
Skills
Communication, Leadership, Scientific Analysis, Training, Research, Public Speaking, Fundraising, Recruiting, Finance, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, Financial Analysis, PowerPoint, Management, Microsoft Office, Project Management, Time Management, Clinical Research, Biotechnology
Education
University of the Pacific 2009 — 2013
Bachelor of Science (B.S.), Biochemistry
University of California, Riverside 2011 — 2011
Yosemite High School 2005 — 2009
High School Diploma; International Baccalaureate Certificate
Integrium August 2013 - Present
Forever 21 July 2013 - August 2013
New Student and Family Programs September 2009 - May 2013
Skills
Communication, Leadership, Scientific Analysis, Training, Research, Public Speaking, Fundraising, Recruiting, Finance, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, Financial Analysis, PowerPoint, Management, Microsoft Office, Project Management, Time Management, Clinical Research, Biotechnology
Education
University of the Pacific 2009 — 2013
Bachelor of Science (B.S.), Biochemistry
University of California, Riverside 2011 — 2011
Yosemite High School 2005 — 2009
High School Diploma; International Baccalaureate Certificate
Melissa Vrabel's Integrium Experience October 2014 - Present
Job Clinical Study Coordinator at Integrium
Industry Pharmaceuticals
Experience
Integrium October 2014 - Present
Community Service Programs (CSP, Inc) February 2013 - October 2014
Pontificia Universidad Católica de Chile March 2011 - December 2012
College Hospital Costa Mesa 2008 - 2010
Huntington Beach Union High School District 2008 - 2010
AmeriCorps 2007 - 2008
Skills
Health Education, SPSS, Psychology, Spanish, Microsoft Excel, PowerPoint, Health Promotion, Microsoft Word, Health Program Planning, Behavioral Health, Quantitative Research, Tobacco, Clinical Research, Translation, Grant Writing, Clinical Trials, Writing, SAS, Mplus, ESL, ICH-GCP, HIPPA, Drug Development, CTMS, Regulatory Affairs, Budgets, FDA Regulations
Education
Pontificia Universidad Católica de Chile 2011 — 2012
Master's degree, Health Psychology
University of Arizona 2003 — 2008
Bachelor of Science (B.S.), Community Health Education
University of Arizona 2003 — 2008
Bachelor of Arts (B.A.), Spanish Language and Literature
Integrium October 2014 - Present
Community Service Programs (CSP, Inc) February 2013 - October 2014
Pontificia Universidad Católica de Chile March 2011 - December 2012
College Hospital Costa Mesa 2008 - 2010
Huntington Beach Union High School District 2008 - 2010
AmeriCorps 2007 - 2008
Skills
Health Education, SPSS, Psychology, Spanish, Microsoft Excel, PowerPoint, Health Promotion, Microsoft Word, Health Program Planning, Behavioral Health, Quantitative Research, Tobacco, Clinical Research, Translation, Grant Writing, Clinical Trials, Writing, SAS, Mplus, ESL, ICH-GCP, HIPPA, Drug Development, CTMS, Regulatory Affairs, Budgets, FDA Regulations
Education
Pontificia Universidad Católica de Chile 2011 — 2012
Master's degree, Health Psychology
University of Arizona 2003 — 2008
Bachelor of Science (B.S.), Community Health Education
University of Arizona 2003 — 2008
Bachelor of Arts (B.A.), Spanish Language and Literature
Thomas Wells Thomas Wells's Integrium Experience May 2003 - May 2006
Job Director, Product Management at Predixion Software
Industry Biotechnology
Experience
Predixion Software, Inc. May 2013 - Present
Citi August 2011 - April 2013
PAREXEL June 2010 - July 2011
Merck October 2009 - May 2010
OmniComm Systems May 2008 - October 2009
Amgen May 2006 - May 2008
Integrium May 2003 - May 2006
UltraLink 2001 - 2003
HNC Software 1999 - 2001
COCENSYS 1997 - 1999
Skills
SDLC, Clinical, Data Management, Pharmaceuticals, Healthcare, Clinical Trials, Biotechnology, Clinical Research, Process Improvement, Medical Devices, Agile, Program Management, Pharmaceutical Industry, Agile Methodologies, CRO, Software Development, Cross-functional Team..., Enterprise Architecture, Senior Program..., IT Enabled Business..., Cloud Computing, Applications..., Systems Development..., Global Application..., Leadership, Leading..., Third Party Vendor..., Global Infrastructure..., IT Performance..., Off-shore Team..., Six Sigma, Lean Culture, Continuous Improvement..., eClinical, Quality Assurance, Business Intelligence, Business Development, Management, Data Analysis, Validation, PMP, Software Project..., CTMS, Regulatory Requirements, 21 CFR Part 11, IT Strategy, Vendor Management, Data Warehousing, Agile Project Management, Project Portfolio...
Education
University of California, Riverside 1992 — 1994
MS, Biochemsitry
Rochester Institute of Technology 1988 — 1991
BS, Biomedical Computing
Predixion Software, Inc. May 2013 - Present
Citi August 2011 - April 2013
PAREXEL June 2010 - July 2011
Merck October 2009 - May 2010
OmniComm Systems May 2008 - October 2009
Amgen May 2006 - May 2008
Integrium May 2003 - May 2006
UltraLink 2001 - 2003
HNC Software 1999 - 2001
COCENSYS 1997 - 1999
Skills
SDLC, Clinical, Data Management, Pharmaceuticals, Healthcare, Clinical Trials, Biotechnology, Clinical Research, Process Improvement, Medical Devices, Agile, Program Management, Pharmaceutical Industry, Agile Methodologies, CRO, Software Development, Cross-functional Team..., Enterprise Architecture, Senior Program..., IT Enabled Business..., Cloud Computing, Applications..., Systems Development..., Global Application..., Leadership, Leading..., Third Party Vendor..., Global Infrastructure..., IT Performance..., Off-shore Team..., Six Sigma, Lean Culture, Continuous Improvement..., eClinical, Quality Assurance, Business Intelligence, Business Development, Management, Data Analysis, Validation, PMP, Software Project..., CTMS, Regulatory Requirements, 21 CFR Part 11, IT Strategy, Vendor Management, Data Warehousing, Agile Project Management, Project Portfolio...
Education
University of California, Riverside 1992 — 1994
MS, Biochemsitry
Rochester Institute of Technology 1988 — 1991
BS, Biomedical Computing
Jonathan Likowski's Integrium Experience February 2005 - February 2006
Job Senior Site Manager/ Certified Clinical Research Associate
Industry Research
Experience
Planet Pharma November 2014 - Present
TFS Trial Form Support 2014 - 2014
ICON plc 2013 - 2014
Atlantic Research Group April 2011 - April 2013
PAREXEL February 2006 - November 2010
Integrium February 2005 - February 2006
PRA International August 2001 - February 2005
Skills
CCRA, ACRP, ICH guidelines, 21 CFR Part 11, Regulatory Submissions, HTML, Research, EDC, CSS, Microsoft Office, Illustrator, PowerPoint, Microsoft Excel, Oncology Clinical..., CTMS, Inform, Hemphillia (Factor VIII), Recurrent Stroke, Common Variable Immune..., Orthostatic Hypotension, Pain Device, Sepsis, Lupus, CRO, Clinical Trials, Clinical Research, Protocol, Oncology, Biotechnology, Pharmaceutical Industry, Clinical Development, GCP, Clinical Monitoring, ICH-GCP, Clinical Data Management, SOP, Infectious Diseases, Regulatory Affairs, Pharmaceutics, FDA, Regulatory Requirements, Drug Development, Validation, Management, Medical Devices, Pharmacovigilance, Life Sciences, Neurology, Clinical Operations, Cardiology
Education
Mary Washington College 1997 — 2001
Bachelor's of Science, Business Administration and Management, Health Sciences
University of Mary Washington 1997 — 2001
Bachelor of Science (BS), Bachelor of Science
Planet Pharma November 2014 - Present
TFS Trial Form Support 2014 - 2014
ICON plc 2013 - 2014
Atlantic Research Group April 2011 - April 2013
PAREXEL February 2006 - November 2010
Integrium February 2005 - February 2006
PRA International August 2001 - February 2005
Skills
CCRA, ACRP, ICH guidelines, 21 CFR Part 11, Regulatory Submissions, HTML, Research, EDC, CSS, Microsoft Office, Illustrator, PowerPoint, Microsoft Excel, Oncology Clinical..., CTMS, Inform, Hemphillia (Factor VIII), Recurrent Stroke, Common Variable Immune..., Orthostatic Hypotension, Pain Device, Sepsis, Lupus, CRO, Clinical Trials, Clinical Research, Protocol, Oncology, Biotechnology, Pharmaceutical Industry, Clinical Development, GCP, Clinical Monitoring, ICH-GCP, Clinical Data Management, SOP, Infectious Diseases, Regulatory Affairs, Pharmaceutics, FDA, Regulatory Requirements, Drug Development, Validation, Management, Medical Devices, Pharmacovigilance, Life Sciences, Neurology, Clinical Operations, Cardiology
Education
Mary Washington College 1997 — 2001
Bachelor's of Science, Business Administration and Management, Health Sciences
University of Mary Washington 1997 — 2001
Bachelor of Science (BS), Bachelor of Science
Adam Steadman's Integrium Experience September 2005 - March 2012
Job Innovating to Improve Success in Clinical Trials
Industry Biotechnology
Experience
Quintiles September 2013 - Present
Quintiles March 2012 - August 2013
Integrium September 2005 - March 2012
Knurr 2000 - 2005
National Savings 2000 - 2000
InvestorCare Services 1997 - 2000
Paracor Group - Marketing Division 1990 - 2000
Paracor Group - Office Products Division 1990 - 2000
Paracor Group - Financial Services Division 1990 - 2000
Pim Goldby - Now Deloitte. 1984 - 1990
Skills
New Business Development, Contract Negotiation, Clinical Trial..., Clinical Trials, CRO, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, Business Development, CTMS, Cardiology, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, Cross-functional Team..., Data Management, Drug Development, EDC, FDA, GCP, Leadership, Life Sciences, Lifesciences, Management Consulting, Marketing, Medical Devices, Pharmaceutical Industry, Pharmacovigilance, Phase I, Protocol, Regulatory Affairs, Regulatory Submissions, Sales, Sop, Strategy, Validation
Education
Institute of Chartered Accountants of Zimbabwe 1990 — 1991
FQE, Accounting, Auditing, Economics
University of South Africa/Universiteit van Suid-Afrika 1985 — 1989
B.Compt. (Hons), Accounting Science
Churchill Boys High School 1979 — 1984
Quintiles September 2013 - Present
Quintiles March 2012 - August 2013
Integrium September 2005 - March 2012
Knurr 2000 - 2005
National Savings 2000 - 2000
InvestorCare Services 1997 - 2000
Paracor Group - Marketing Division 1990 - 2000
Paracor Group - Office Products Division 1990 - 2000
Paracor Group - Financial Services Division 1990 - 2000
Pim Goldby - Now Deloitte. 1984 - 1990
Skills
New Business Development, Contract Negotiation, Clinical Trial..., Clinical Trials, CRO, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, Business Development, CTMS, Cardiology, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, Cross-functional Team..., Data Management, Drug Development, EDC, FDA, GCP, Leadership, Life Sciences, Lifesciences, Management Consulting, Marketing, Medical Devices, Pharmaceutical Industry, Pharmacovigilance, Phase I, Protocol, Regulatory Affairs, Regulatory Submissions, Sales, Sop, Strategy, Validation
Education
Institute of Chartered Accountants of Zimbabwe 1990 — 1991
FQE, Accounting, Auditing, Economics
University of South Africa/Universiteit van Suid-Afrika 1985 — 1989
B.Compt. (Hons), Accounting Science
Churchill Boys High School 1979 — 1984
Greg Dodds Greg Dodds's Integrium Experience 2009 - 2011
Job Director, Business Development at Vince & Associates
Industry Pharmaceuticals
Experience
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Cara Francis Cara Francis's Integrium Experience November 2008 - January 2011
Job Lead Clinical Site Manager at Alcon, a Novartis company/Execupharm
Industry Pharmaceuticals
Experience
Alcon, a Novartis company/Execupharm May 2015 - Present
Theorem Clinical Research December 2014 - May 2015
Amgen January 2013 - December 2014
RPS/Amgen November 2011 - January 2013
ExecuPharm/ Pfizer January 2011 - November 2011
Integrium November 2008 - January 2011
inVentiv Clinical Solutions (for Eli Lilly) February 2006 - November 2008
Certus International February 2000 - March 2006
The Heart Health Center 1998 - 2000
Education
Saint Louis University 1993 — 1994
BS, Nuclear Medicine Technology
Southern Illinois University, Edwardsville 1988 — 1991
BS, Psychology
Hazelwood East 1981 — 1985
Alcon, a Novartis company/Execupharm May 2015 - Present
Theorem Clinical Research December 2014 - May 2015
Amgen January 2013 - December 2014
RPS/Amgen November 2011 - January 2013
ExecuPharm/ Pfizer January 2011 - November 2011
Integrium November 2008 - January 2011
inVentiv Clinical Solutions (for Eli Lilly) February 2006 - November 2008
Certus International February 2000 - March 2006
The Heart Health Center 1998 - 2000
Education
Saint Louis University 1993 — 1994
BS, Nuclear Medicine Technology
Southern Illinois University, Edwardsville 1988 — 1991
BS, Psychology
Hazelwood East 1981 — 1985
Nicholas Cariato Nicholas Cariato's Integrium Experience September 2005 - February 2006
Job Project Manager at ICON Clinical Research
Industry Pharmaceuticals
Experience
ICON plc December 2013 - Present
Aptiv Solutions, an ICON plc company June 2011 - December 2013
Aptiv Solutions, an ICON plc company March 2009 - June 2011
Aptiv Solutions, an ICON plc company August 2007 - February 2009
MDS Pharma Services February 2006 - August 2007
Integrium September 2005 - February 2006
Leigh Ann Buydos, DDS, MS January 1999 - September 2005
Integrium October 2002 - February 2004
Integrium April 2001 - October 2002
Integrium October 2000 - April 2001
Skills
CRO, EDC, CTMS, Clinical Trials, Clinical Data Management, Data Management, Project Management, 21 CFR Part 11
Education
California State University-Fullerton
BA, Business Administration / Management Information Systems
ICON plc December 2013 - Present
Aptiv Solutions, an ICON plc company June 2011 - December 2013
Aptiv Solutions, an ICON plc company March 2009 - June 2011
Aptiv Solutions, an ICON plc company August 2007 - February 2009
MDS Pharma Services February 2006 - August 2007
Integrium September 2005 - February 2006
Leigh Ann Buydos, DDS, MS January 1999 - September 2005
Integrium October 2002 - February 2004
Integrium April 2001 - October 2002
Integrium October 2000 - April 2001
Skills
CRO, EDC, CTMS, Clinical Trials, Clinical Data Management, Data Management, Project Management, 21 CFR Part 11
Education
California State University-Fullerton
BA, Business Administration / Management Information Systems
James Morton, Pharm.D. James Morton, Pharm.D.'s Integrium Experience February 2010 - May 2010
Job Associate Director Clinical Development at Quest Diagnostics
Industry Hospital & Health Care
Experience
Quest Diagnostics January 2012 - Present
Quest Diagnostics September 2010 - January 2012
Integrium February 2010 - May 2010
Amgen January 2009 - January 2010
ISTA Pharmaceuticals October 2008 - January 2009
Allergan February 2008 - October 2008
Therapeutics Inc March 2005 - February 2008
University of Southern California March 2001 - June 2005
Allergan August 1996 - March 2001
Skills
Oncology, Clinical Trials, Clinical Development, Clinical Research, Pharmaceutical Industry, Biotechnology, FDA, Medical Writing, GCP, Infectious Diseases, CTMS, Drug Development, Clinical Monitoring, Dermatology, Protocol, EDC, Cross-functional Team..., Neurology, Therapeutic Areas, CRO, Diabetes
Education
University of Southern California 2001 — 2005
Pharm.D., Pharmaceutics and Drug Design
Occidental College 1992 — 1996
a.B.A., Chemistry
Quest Diagnostics January 2012 - Present
Quest Diagnostics September 2010 - January 2012
Integrium February 2010 - May 2010
Amgen January 2009 - January 2010
ISTA Pharmaceuticals October 2008 - January 2009
Allergan February 2008 - October 2008
Therapeutics Inc March 2005 - February 2008
University of Southern California March 2001 - June 2005
Allergan August 1996 - March 2001
Skills
Oncology, Clinical Trials, Clinical Development, Clinical Research, Pharmaceutical Industry, Biotechnology, FDA, Medical Writing, GCP, Infectious Diseases, CTMS, Drug Development, Clinical Monitoring, Dermatology, Protocol, EDC, Cross-functional Team..., Neurology, Therapeutic Areas, CRO, Diabetes
Education
University of Southern California 2001 — 2005
Pharm.D., Pharmaceutics and Drug Design
Occidental College 1992 — 1996
a.B.A., Chemistry
Fareen Ahmed's Integrium Experience August 2013 - May 2014
Job Clinical Trial Operations, Specialist at Edwards Lifesciences
Industry Hospital & Health Care
Experience
Edwards Lifesciences November 2014 - Present
Orange Country Research Center August 2013 - May 2014
Integrium August 2013 - May 2014
Ukleja Center for Ethical Leadership January 2013 - July 2013
HARRIMAN JONES MEDICAL GROUP December 2012 - April 2013
San Dimas Dialysis Center January 2013 - March 2013
LA PALMA FAMILY DENTISTRY February 2012 - November 2012
Skills
TIME MANAGEMENT, CLIENT RELATIONSHIP..., PROCESS IMPROVEMENT, ORGANIZATION, PLANNING,..., LEADERSHIP AND..., Healthcare, Process Improvement, Leadership, Program Management, Time Management, Data Entry, Marketing, Hospitals, Microsoft Excel, Public Speaking, PowerPoint, Microsoft Word, Research, Customer Service
Education
California State University-Long Beach 2011 — 2013
Master of Science (MS), Health/Health Care Administration/Management
California State University-Long Beach 2007 — 2011
Bachelor of Arts (B.A.), Psychology
Edwards Lifesciences November 2014 - Present
Orange Country Research Center August 2013 - May 2014
Integrium August 2013 - May 2014
Ukleja Center for Ethical Leadership January 2013 - July 2013
HARRIMAN JONES MEDICAL GROUP December 2012 - April 2013
San Dimas Dialysis Center January 2013 - March 2013
LA PALMA FAMILY DENTISTRY February 2012 - November 2012
Skills
TIME MANAGEMENT, CLIENT RELATIONSHIP..., PROCESS IMPROVEMENT, ORGANIZATION, PLANNING,..., LEADERSHIP AND..., Healthcare, Process Improvement, Leadership, Program Management, Time Management, Data Entry, Marketing, Hospitals, Microsoft Excel, Public Speaking, PowerPoint, Microsoft Word, Research, Customer Service
Education
California State University-Long Beach 2011 — 2013
Master of Science (MS), Health/Health Care Administration/Management
California State University-Long Beach 2007 — 2011
Bachelor of Arts (B.A.), Psychology
Kristine Afansev's Integrium Experience January 2007 - December 2007
Job Senior Director of Business Development and Project Management
Industry Pharmaceuticals
Experience
BioClinica 2015 - Present
FMD-Fountain Medical Development December 2013 - Present
Cardinal Health 2011 - Present
SGS Life Science Services December 2008 - Present
Integrium January 2007 - December 2007
Aris Global 2003 - 2005
NetGenics 2000 - 2002
Skills
Medical Devices, Pharmaceutical Industry, Biotechnology, Clinical Trials, Regulatory Affairs, Lifesciences, Drug Development, Analytical Chemistry, Clinical Research, Pharmaceutics, CRO, Clinical Development, GCP, FDA, Toxicology, Life Sciences, Oncology, Management, SOP, Biopharmaceuticals, Regulatory Submissions, CTMS
Education
Project-Management Certification-Learn Smart 2014 — 2015
Bachelor's of Arts, PMI® as a Charter-Global Registered Education Provided (REP)®
Aquinas
California State University-San Bernardino
Bachelor of Arts (B.A.)
Kriger International
Clinical Research Associate Program (CRA) + GCP Certificate
BioClinica 2015 - Present
FMD-Fountain Medical Development December 2013 - Present
Cardinal Health 2011 - Present
SGS Life Science Services December 2008 - Present
Integrium January 2007 - December 2007
Aris Global 2003 - 2005
NetGenics 2000 - 2002
Skills
Medical Devices, Pharmaceutical Industry, Biotechnology, Clinical Trials, Regulatory Affairs, Lifesciences, Drug Development, Analytical Chemistry, Clinical Research, Pharmaceutics, CRO, Clinical Development, GCP, FDA, Toxicology, Life Sciences, Oncology, Management, SOP, Biopharmaceuticals, Regulatory Submissions, CTMS
Education
Project-Management Certification-Learn Smart 2014 — 2015
Bachelor's of Arts, PMI® as a Charter-Global Registered Education Provided (REP)®
Aquinas
California State University-San Bernardino
Bachelor of Arts (B.A.)
Kriger International
Clinical Research Associate Program (CRA) + GCP Certificate
Daphne Crossley, MBA Daphne Crossley, MBA's Integrium Experience September 2005 - September 2007
Job Project Consultant at Crossley Clinical Research Consulting, LLC
Industry Pharmaceuticals
Experience
Crossley Clinical Research Consulting, LLC July 2015 - Present
TKL Research June 2011 - June 2015
Allergan June 2009 - April 2010
PPD September 2007 - November 2008
Integrium September 2005 - September 2007
Integrium June 2004 - August 2005
Target Research Associates (Clinsys) June 1998 - December 2003
Otsuka America Pharmaceutical, Inc. 1991 - 1994
Skills
EDC, CRO, Trial Management, Clinical Research, GCP, CTMS, Clinical Monitoring, Pharmaceutics, Clinical Trials, Clinical Development, Program Management, Software Documentation, Process Simulation, Respiration, Regulatory Submissions, ICH-GCP, Clinical Data Management, Pharmaceutical Industry
Education
Pennsylvania State University-Great Valley Graduate Center 1995 — 1998
MBA, Master of Management
Crossley Clinical Research Consulting, LLC July 2015 - Present
TKL Research June 2011 - June 2015
Allergan June 2009 - April 2010
PPD September 2007 - November 2008
Integrium September 2005 - September 2007
Integrium June 2004 - August 2005
Target Research Associates (Clinsys) June 1998 - December 2003
Otsuka America Pharmaceutical, Inc. 1991 - 1994
Skills
EDC, CRO, Trial Management, Clinical Research, GCP, CTMS, Clinical Monitoring, Pharmaceutics, Clinical Trials, Clinical Development, Program Management, Software Documentation, Process Simulation, Respiration, Regulatory Submissions, ICH-GCP, Clinical Data Management, Pharmaceutical Industry
Education
Pennsylvania State University-Great Valley Graduate Center 1995 — 1998
MBA, Master of Management
Janice Flynn-Bailey Janice Flynn-Bailey's Integrium Experience 2008 - Present
Job Senior Clinical Research Associate at Evaheart
Industry Biotechnology
Experience
Evaheart July 2014 - Present
Integrium 2008 - Present
Bailey & Bailey Clinical Research Services January 2006 - Present
Contract CRA, Bailey and Bailey Clinical Services May 2003 - Present
Clinipace Worldwide CRO February 2014 - August 2014
Montreal Heart Institute October 2009 - March 2014
TFS, INc. December 2012 - April 2013
GE Healthcare 2006 - 2008
Clinsys Clinical Research January 2005 - November 2007
PPD June 2004 - February 2006
Skills
CTMS, Clinical Trials, GCP, Clinical Monitoring, EDC, CRO, ICH-GCP, Medical Devices, Clinical Research, Clinical Data Management, Clinical Research..., Therapeutic Areas, Clinical Development, Pharmaceutical Industry, Cardiology, Oncology, Clinical Operations
Education
Saint Louis University 1980 — 1984
Bachelor of Science (BS), Human Biology, 3.3
Evaheart July 2014 - Present
Integrium 2008 - Present
Bailey & Bailey Clinical Research Services January 2006 - Present
Contract CRA, Bailey and Bailey Clinical Services May 2003 - Present
Clinipace Worldwide CRO February 2014 - August 2014
Montreal Heart Institute October 2009 - March 2014
TFS, INc. December 2012 - April 2013
GE Healthcare 2006 - 2008
Clinsys Clinical Research January 2005 - November 2007
PPD June 2004 - February 2006
Skills
CTMS, Clinical Trials, GCP, Clinical Monitoring, EDC, CRO, ICH-GCP, Medical Devices, Clinical Research, Clinical Data Management, Clinical Research..., Therapeutic Areas, Clinical Development, Pharmaceutical Industry, Cardiology, Oncology, Clinical Operations
Education
Saint Louis University 1980 — 1984
Bachelor of Science (BS), Human Biology, 3.3
Chris O'Neal Chris O'Neal's Integrium Experience September 2009 - May 2011
Job Senior Advisor at SAS: Helping companies drive revenues with Analytics
Industry Pharmaceuticals
Experience
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
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
Stephanie Fellman Stephanie Fellman's Integrium Experience March 2007 - February 2009
Job Sr. Global Trial Budget Manager at Novartis
Industry Pharmaceuticals
Experience
Novartis October 2013 - Present
Novartis October 2011 - September 2013
Novartis February 2009 - October 2011
Integrium March 2007 - February 2009
Novartis March 2006 - March 2007
Novartis July 2004 - March 2006
Forest Laboratories July 2002 - July 2004
Skills
Drug Development, Cardiology, Clinical Operations, Clinical Trial..., Budgeting, CNS, Monitoring, Study Coordinator, Psychiatric Nursing, IVF Nursing, CTMS, Budgets, Nursing, Central Nervous System, 21 CFR Part 11, Quality Assurance, System Monitoring, Psychiatry, Regulatory Affairs, Sop, GCP, Clinical Development, Medical Affairs
Education
Miami Dade College 1993 — 1993
AS, Nursing
University of Miami 1984 — 1987
BA, Psychology/Biology/Chemistry
Novartis October 2013 - Present
Novartis October 2011 - September 2013
Novartis February 2009 - October 2011
Integrium March 2007 - February 2009
Novartis March 2006 - March 2007
Novartis July 2004 - March 2006
Forest Laboratories July 2002 - July 2004
Skills
Drug Development, Cardiology, Clinical Operations, Clinical Trial..., Budgeting, CNS, Monitoring, Study Coordinator, Psychiatric Nursing, IVF Nursing, CTMS, Budgets, Nursing, Central Nervous System, 21 CFR Part 11, Quality Assurance, System Monitoring, Psychiatry, Regulatory Affairs, Sop, GCP, Clinical Development, Medical Affairs
Education
Miami Dade College 1993 — 1993
AS, Nursing
University of Miami 1984 — 1987
BA, Psychology/Biology/Chemistry
Debi Davis Debi Davis's Integrium Experience May 2000 - September 2002
Job Independent Consultant for pharmaceutical and biotech industry
Industry Pharmaceuticals
Experience
Pharmaceutical and biotech industry October 2012 - Present
PPD January 2012 - September 2012
Genzyme Corporation May 2010 - November 2010
pharmaceutical and biotech industry May 2009 - June 2010
Valeant Pharmaceuticals December 2006 - April 2009
Abbott Vascular November 2005 - June 2006
Guilford Pharmaceuticals August 2004 - June 2005
BDH Clinical Research Services, Inc. September 2002 - May 2004
Integrium May 2000 - September 2002
Skills
GCP, CRO, CTMS, Sop, Oncology, Clinical Trials, Compliance, Infectious Diseases, Neurology, Quality Assurance, Clinical Research, Data Management, Quality System, Pharmaceutics
Education
Orange Coast College
AA, Respiratory Care
University of Phoenix
BS, Business
Pharmaceutical and biotech industry October 2012 - Present
PPD January 2012 - September 2012
Genzyme Corporation May 2010 - November 2010
pharmaceutical and biotech industry May 2009 - June 2010
Valeant Pharmaceuticals December 2006 - April 2009
Abbott Vascular November 2005 - June 2006
Guilford Pharmaceuticals August 2004 - June 2005
BDH Clinical Research Services, Inc. September 2002 - May 2004
Integrium May 2000 - September 2002
Skills
GCP, CRO, CTMS, Sop, Oncology, Clinical Trials, Compliance, Infectious Diseases, Neurology, Quality Assurance, Clinical Research, Data Management, Quality System, Pharmaceutics
Education
Orange Coast College
AA, Respiratory Care
University of Phoenix
BS, Business
Gregory Burke Gregory Burke's Integrium Experience January 2005 - January 2007
Job Associate Director, Drug Safety Medical Evaluation at Bracco
Industry Pharmaceuticals
Experience
Bracco January 2015 - Present
Warner Chilcott October 2011 - December 2014
Brystol-Myers Squibb November 2010 - September 2011
Assent Consulting (client: Ranbaxy, Inc January 2009 - November 2009
Allergan Inc February 2007 - October 2008
Integrium January 2005 - January 2007
Allergan Inc January 2004 - January 2005
Brodie's Pharmacy January 1996 - January 1998
Karl Heushner Memorial Hospital January 1996 - January 1997
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Development, GCP, Drug Safety, Medical Affairs, FDA, Medicine, Medical Writing, Sop, Healthcare, Cross-functional Team..., Protocol, Pharmacovigilance, Regulatory Affairs, CTMS, SOP
Education
Walden University 2008 — 2011
Masters, Public Health
University of California, San Diego 2008 — 2010
Master's degree, Regulatory Science
Walden University 2008 — 2010
MPH, public health
Bracco January 2015 - Present
Warner Chilcott October 2011 - December 2014
Brystol-Myers Squibb November 2010 - September 2011
Assent Consulting (client: Ranbaxy, Inc January 2009 - November 2009
Allergan Inc February 2007 - October 2008
Integrium January 2005 - January 2007
Allergan Inc January 2004 - January 2005
Brodie's Pharmacy January 1996 - January 1998
Karl Heushner Memorial Hospital January 1996 - January 1997
Skills
Clinical Research, Clinical Trials, Pharmaceutical Industry, Clinical Development, GCP, Drug Safety, Medical Affairs, FDA, Medicine, Medical Writing, Sop, Healthcare, Cross-functional Team..., Protocol, Pharmacovigilance, Regulatory Affairs, CTMS, SOP
Education
Walden University 2008 — 2011
Masters, Public Health
University of California, San Diego 2008 — 2010
Master's degree, Regulatory Science
Walden University 2008 — 2010
MPH, public health
Carla Daley Carla Daley's Integrium Experience February 2008 - October 2011
Job Sr. CRA at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences November 2011 - Present
PRA International January 2013 - January 2014
PRA International November 2011 - January 2013
Integrium February 2008 - October 2011
W.L. Gore & Associates January 2006 - February 2008
W.L. Gore & Associates June 2003 - January 2006
W.L. Gore & Associates March 2000 - June 2003
W.L. Gore & Associates March 1994 - March 2000
Skills
ACRP, Clinical Research, CTMS, EDC, GCP, Medical Devices, Cardiology, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Lifesciences, CRO, Sop, Clinical Development, Hypertension, Therapeutic Areas, Endocrinology, Dermatology, SOP, Life Sciences, Clinical Trials
Education
Northern Arizona University 1983 — 1986
BS, Journalism/Public Relations
ACRP
certification, GCP
PRA Health Sciences November 2011 - Present
PRA International January 2013 - January 2014
PRA International November 2011 - January 2013
Integrium February 2008 - October 2011
W.L. Gore & Associates January 2006 - February 2008
W.L. Gore & Associates June 2003 - January 2006
W.L. Gore & Associates March 2000 - June 2003
W.L. Gore & Associates March 1994 - March 2000
Skills
ACRP, Clinical Research, CTMS, EDC, GCP, Medical Devices, Cardiology, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Lifesciences, CRO, Sop, Clinical Development, Hypertension, Therapeutic Areas, Endocrinology, Dermatology, SOP, Life Sciences, Clinical Trials
Education
Northern Arizona University 1983 — 1986
BS, Journalism/Public Relations
ACRP
certification, GCP
Ann (Adams) Horner, BA, CPM, PMP's Integrium Experience 2004 - 2005
Job Sr. Project Manager at Covance
Industry Pharmaceuticals
Experience
Covance 2007 - Present
Omnicare 2005 - 2007
Integrium 2004 - 2005
Allergan 2001 - 2004
Neurocrine Biosciences 2000 - 2001
Pfizer Pharmaceuticals/Agouron July 1999 - September 2000
Covance 1995 - July 1999
Skills
Sop, Infectious Diseases, 21 CFR Part 11, Clinical Operations, Biotechnology, Protocol, Regulatory Submissions, Cardiology, Oncology Clinical..., CRO, Pharmaceutical Industry, Clinical Monitoring, Clinical Trials, Project Management
Education
Carleton University 1986 — 1988
B.A., French; English Literature; Education
Memorial University of Newfoundland 1964 — 1968
B.A., Education
Covance 2007 - Present
Omnicare 2005 - 2007
Integrium 2004 - 2005
Allergan 2001 - 2004
Neurocrine Biosciences 2000 - 2001
Pfizer Pharmaceuticals/Agouron July 1999 - September 2000
Covance 1995 - July 1999
Skills
Sop, Infectious Diseases, 21 CFR Part 11, Clinical Operations, Biotechnology, Protocol, Regulatory Submissions, Cardiology, Oncology Clinical..., CRO, Pharmaceutical Industry, Clinical Monitoring, Clinical Trials, Project Management
Education
Carleton University 1986 — 1988
B.A., French; English Literature; Education
Memorial University of Newfoundland 1964 — 1968
B.A., Education
Maria Frane's Integrium Experience June 2012 - July 2013
Job Director, Business Development
Industry Pharmaceuticals
Experience
WCCT Global May 2015 - Present
Pharm-Olam International July 2013 - April 2015
Integrium June 2012 - July 2013
PPD April 2011 - June 2012
AAPS SCPDG August 2008 - January 2012
Contractlaboratory.com December 2010 - April 2011
SGS Life Science Services August 2008 - December 2010
SGS Life Science Services August 2007 - December 2010
SGS Life Science Services August 2007 - August 2008
2003-2007 November 2003 - August 2007
Skills
New Business Development, Consultative Selling, Sales Presentations, Strategy Development, Building Relationships, Clinical Development, Drug Testing, Drug Development, Strategic Negotiations, Strategy, Selling, CRO, Pharmaceutical Industry, Biotechnology, Clinical Trials, Oncology, Biopharmaceuticals, Clinical Research, GMP, Drug Discovery, Lifesciences, Sales Operations, Pharmaceutics, Regulatory Submissions, Business Development, Regulatory Affairs, CTMS, Leadership, FDA, Technology Transfer, Vaccines, Infectious Diseases, Commercialization, Sop, Immunology, GCP, GLP, Validation, Pharmacology, R&D, EDC, Laboratory, Pharmacovigilance, Chromatography, Analytical Chemistry, Regulatory Requirements, Neurology, Clinical Data Management, Life Sciences, Sales
Education
Wright College, Chicago 1994 — 1994
EMT, Emergency Medicine
Columbia College Chicago 1989 — 1991
Dance, Physics
College of Lake County
Maplewood School
WCCT Global May 2015 - Present
Pharm-Olam International July 2013 - April 2015
Integrium June 2012 - July 2013
PPD April 2011 - June 2012
AAPS SCPDG August 2008 - January 2012
Contractlaboratory.com December 2010 - April 2011
SGS Life Science Services August 2008 - December 2010
SGS Life Science Services August 2007 - December 2010
SGS Life Science Services August 2007 - August 2008
2003-2007 November 2003 - August 2007
Skills
New Business Development, Consultative Selling, Sales Presentations, Strategy Development, Building Relationships, Clinical Development, Drug Testing, Drug Development, Strategic Negotiations, Strategy, Selling, CRO, Pharmaceutical Industry, Biotechnology, Clinical Trials, Oncology, Biopharmaceuticals, Clinical Research, GMP, Drug Discovery, Lifesciences, Sales Operations, Pharmaceutics, Regulatory Submissions, Business Development, Regulatory Affairs, CTMS, Leadership, FDA, Technology Transfer, Vaccines, Infectious Diseases, Commercialization, Sop, Immunology, GCP, GLP, Validation, Pharmacology, R&D, EDC, Laboratory, Pharmacovigilance, Chromatography, Analytical Chemistry, Regulatory Requirements, Neurology, Clinical Data Management, Life Sciences, Sales
Education
Wright College, Chicago 1994 — 1994
EMT, Emergency Medicine
Columbia College Chicago 1989 — 1991
Dance, Physics
College of Lake County
Maplewood School
Elizabeth (Lisa) Teubert Elizabeth (Lisa) Teubert's Integrium Experience December 2006 - January 2013
Job Senior Data Manager at Celgene (contract)
Industry Pharmaceuticals
Experience
Celgene May 2014 - Present
Integrium December 2006 - January 2013
BioCor February 2005 - October 2006
Johnson & Johnson August 2004 - February 2005
Covance June 2000 - July 2004
Janssen, Pharmaceutical Companies of Johnson and Johnson 1999 - June 2000
Merck 1997 - 1999
Hunterdon Medical Center 1989 - 1997
Hunterdon Convalescent Center 1988 - 1989
Skills
Data Management, GCPs, CRO, SOP development, Clinical Data Management, Pharmaceutical Industry, Oncology, Clinical Research, Clinical Trials, Protocol, CTMS, EDC, Biotechnology, Medicine, Oracle Clinical, Clinical Development, Inform, Cardiology, 21 CFR Part 11, Therapeutic Areas, ICH-GCP, Diabetes, FDA, Central Nervous System, Clinical Monitoring, Quality Assurance, Pharmacovigilance, CRF design, Medidata, GCP, Computer System...
Education
University of Phoenix 1999 — 2001
Bachelor of Science, Business Administration and Management
Raritan Valley Community College 1989 — 1991
Associate of Applied Science, Registered Nursing/Registered Nurse
Hunterdon County Adult Education 1987 — 1988
Diploma, Licensed Practical Nurse
Celgene May 2014 - Present
Integrium December 2006 - January 2013
BioCor February 2005 - October 2006
Johnson & Johnson August 2004 - February 2005
Covance June 2000 - July 2004
Janssen, Pharmaceutical Companies of Johnson and Johnson 1999 - June 2000
Merck 1997 - 1999
Hunterdon Medical Center 1989 - 1997
Hunterdon Convalescent Center 1988 - 1989
Skills
Data Management, GCPs, CRO, SOP development, Clinical Data Management, Pharmaceutical Industry, Oncology, Clinical Research, Clinical Trials, Protocol, CTMS, EDC, Biotechnology, Medicine, Oracle Clinical, Clinical Development, Inform, Cardiology, 21 CFR Part 11, Therapeutic Areas, ICH-GCP, Diabetes, FDA, Central Nervous System, Clinical Monitoring, Quality Assurance, Pharmacovigilance, CRF design, Medidata, GCP, Computer System...
Education
University of Phoenix 1999 — 2001
Bachelor of Science, Business Administration and Management
Raritan Valley Community College 1989 — 1991
Associate of Applied Science, Registered Nursing/Registered Nurse
Hunterdon County Adult Education 1987 — 1988
Diploma, Licensed Practical Nurse
Phyllis (Clark) Mast's Integrium Experience June 2012 - June 2013
Job Clinical Project Director at Innovative Research Associates
Industry Pharmaceuticals
Experience
Innovative Research Associates May 2014 - Present
Novella Clinical, A Quintiles Company November 2013 - May 2014
RAM Consulting Group, LLC July 2013 - October 2013
Integrium June 2012 - June 2013
PharmaNet/i3 June 2009 - June 2012
Advanced Research Corporation September 2003 - December 2008
Purdue Pharma LP 1997 - 2001
Skills
Clinical Research, Project Management, Clinical Monitoring, Staff Management, Budget Process, RFP Generation, Medical Writing, Quality Assurance, Contract Negotiation, Clinical Trials, CTMS, EDC, ICH-GCP, Therapeutic Areas, GCP, Clinical Operations, Protocol, Regulatory Submissions, Clinical Data Management, Clinical Development, Oracle Clinical, Oncology, Drug Development
Education
Long Island University
Master of Arts (M.A.), Psychology
State University of New York College at Buffalo
Bachelor of Arts (B.A.), Psychology
Innovative Research Associates May 2014 - Present
Novella Clinical, A Quintiles Company November 2013 - May 2014
RAM Consulting Group, LLC July 2013 - October 2013
Integrium June 2012 - June 2013
PharmaNet/i3 June 2009 - June 2012
Advanced Research Corporation September 2003 - December 2008
Purdue Pharma LP 1997 - 2001
Skills
Clinical Research, Project Management, Clinical Monitoring, Staff Management, Budget Process, RFP Generation, Medical Writing, Quality Assurance, Contract Negotiation, Clinical Trials, CTMS, EDC, ICH-GCP, Therapeutic Areas, GCP, Clinical Operations, Protocol, Regulatory Submissions, Clinical Data Management, Clinical Development, Oracle Clinical, Oncology, Drug Development
Education
Long Island University
Master of Arts (M.A.), Psychology
State University of New York College at Buffalo
Bachelor of Arts (B.A.), Psychology
Jessica Landis Jessica Landis's Integrium Experience May 2007 - March 2008
Job Lead Data Manager at Novartis Pharmaceuticals Corporation
Industry Pharmaceuticals
Experience
Novartis August 2015 - Present
Bellerophon Therapeutics February 2014 - August 2015
IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals. October 2010 - February 2014
IKARIA, Inc. March 2008 - October 2010
Integrium May 2007 - March 2008
Skills
Clinical Trial Data..., CRO, Clinical Data Management, Clinical Development, Clinical Trials, Data Management, EDC, GCP, Pharmaceutical Industry, SOP, Oncology, Drug Development
Education
College of Saint Elizabeth 2009 — 2013
Master of Science (M.S.), Health/Health Care Administration/Management
Kean University 2000 — 2004
Bachelor of Science (B.S.), Marketing
Novartis August 2015 - Present
Bellerophon Therapeutics February 2014 - August 2015
IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals. October 2010 - February 2014
IKARIA, Inc. March 2008 - October 2010
Integrium May 2007 - March 2008
Skills
Clinical Trial Data..., CRO, Clinical Data Management, Clinical Development, Clinical Trials, Data Management, EDC, GCP, Pharmaceutical Industry, SOP, Oncology, Drug Development
Education
College of Saint Elizabeth 2009 — 2013
Master of Science (M.S.), Health/Health Care Administration/Management
Kean University 2000 — 2004
Bachelor of Science (B.S.), Marketing
Randa Wahid Randa Wahid's Integrium Experience August 2015 - Present
Job Project Manager at Integrium, (714) 2106660
Industry Pharmaceuticals
Experience
Integrium August 2015 - Present
Integrium 2015 - Present
Integrium / Orange County Research Center 2013 - 2015
Integrium / Orange County Research Center March 2013 - August 2013
Total Body Physical Therapy December 2009 - December 2012
Skills
Healthcare Management, Medical Records, Medical Terminology, CPT, EMR, Medical Billing, Appointment Scheduling, Health Information..., EHR, Physical Therapy, Leadership, HIPAA, Healthcare, Access, Insurance, Clinical Research, Physician Relations, Clinical Trials, Hospitals, Physicians, New Business Development, Business Development, Patient Satisfaction, Practice Management, ICD-9, Insurance Verification, Insurance Billing, HCPCS, Healthcare Consulting, Process Improvement, CRO, Biotechnology, Pharmaceutical Industry, Management, Strategy, Clinical Development, Life Sciences, Oncology, Medical Devices, Product Development
Education
California State University-Long Beach 2009 — 2012
Master of Science, Health Care Administration, GPA: 3.8
California State University-Fullerton 2005 — 2009
Bachelor of Science, Health Science
Integrium August 2015 - Present
Integrium 2015 - Present
Integrium / Orange County Research Center 2013 - 2015
Integrium / Orange County Research Center March 2013 - August 2013
Total Body Physical Therapy December 2009 - December 2012
Skills
Healthcare Management, Medical Records, Medical Terminology, CPT, EMR, Medical Billing, Appointment Scheduling, Health Information..., EHR, Physical Therapy, Leadership, HIPAA, Healthcare, Access, Insurance, Clinical Research, Physician Relations, Clinical Trials, Hospitals, Physicians, New Business Development, Business Development, Patient Satisfaction, Practice Management, ICD-9, Insurance Verification, Insurance Billing, HCPCS, Healthcare Consulting, Process Improvement, CRO, Biotechnology, Pharmaceutical Industry, Management, Strategy, Clinical Development, Life Sciences, Oncology, Medical Devices, Product Development
Education
California State University-Long Beach 2009 — 2012
Master of Science, Health Care Administration, GPA: 3.8
California State University-Fullerton 2005 — 2009
Bachelor of Science, Health Science
Mai Chi Nguyen's Integrium Experience 2003 - 2008
Job Clinical Oversight Lead at Otsuka Pharmaceutical Development & Commercialization Inc.
Industry Pharmaceuticals
Experience
Otsuka Pharmaceutical Development & Commercialization Inc. 2010 - Present
Millenium CRA Inc June 1999 - Present
Millenium CRA Inc. 1999 - 2015
Millenium CRA Inc. 1999 - 2015
Theorem Clinical Research (previously Omnicare) 1996 - April 2014
CARTaGENE 2009 - 2009
Debiopharm 2006 - 2009
Integrium 2003 - 2008
Rhone-Poulenc Rorer (now Sanofi) 1995 - 1996
Rhone-Poulenc Rorer (now Sanofi) 1991 - 1995
Skills
Endocrinology, CTMS, ICH-GCP, GCP, Clinical Trials, Clinical Research, Lung, Nephrology, Clinical Monitoring, Alzheimer's disease, CRO, Cardiology, Oncology, EDC, Clinical Development, Neurology, Vaccines, Therapeutic Areas, Pharmaceutical Industry, Regulatory Submissions, FDA, Sop, Drug Development, Protocol, Clinical Operations, Medical Affairs, Psychiatry, Infectious Diseases, SOP
Education
Université de Montréal 1985 — 1989
M.Sc., Public Health (Faculty of Medicine)
Université de Montréal 1980 — 1983
BSc., Nursing
Otsuka Pharmaceutical Development & Commercialization Inc. 2010 - Present
Millenium CRA Inc June 1999 - Present
Millenium CRA Inc. 1999 - 2015
Millenium CRA Inc. 1999 - 2015
Theorem Clinical Research (previously Omnicare) 1996 - April 2014
CARTaGENE 2009 - 2009
Debiopharm 2006 - 2009
Integrium 2003 - 2008
Rhone-Poulenc Rorer (now Sanofi) 1995 - 1996
Rhone-Poulenc Rorer (now Sanofi) 1991 - 1995
Skills
Endocrinology, CTMS, ICH-GCP, GCP, Clinical Trials, Clinical Research, Lung, Nephrology, Clinical Monitoring, Alzheimer's disease, CRO, Cardiology, Oncology, EDC, Clinical Development, Neurology, Vaccines, Therapeutic Areas, Pharmaceutical Industry, Regulatory Submissions, FDA, Sop, Drug Development, Protocol, Clinical Operations, Medical Affairs, Psychiatry, Infectious Diseases, SOP
Education
Université de Montréal 1985 — 1989
M.Sc., Public Health (Faculty of Medicine)
Université de Montréal 1980 — 1983
BSc., Nursing
Alexandra Dilis, J.D. Alexandra Dilis, J.D.'s Integrium Experience May 2006 - May 2008
Job Global Head of Quality and Compliance at SFJ Pharmaceuticals Group
Industry Pharmaceuticals
Experience
SFJ Pharmaceuticals, Inc. April 2013 - Present
Bayer HealthCare October 2011 - April 2013
Celerion (formerly MDS Pharma Services) August 2009 - October 2011
ARD Scientific February 2007 - August 2009
Integrium May 2006 - May 2008
Shuster Laboratories Inc (STR) May 2004 - May 2006
Biopharmaceutical, Clinical, Non-Clinical Firms 1993 - 2004
Skills
Leadership, Global Regulatory..., Quality Management, Quality Auditing, CRO, Computer System..., 21 CFR Part 11, Crisis Management, Biotechnology, GMP, GxP, Food and Drug Law, Clinical Research, Regulatory Inspection..., Program Management, Contract Management, Consulting, Strategic Planning, Risk Management, CMO management, Regulatory Interactions, Supplier Quality..., QAA, Engaging Public Speaker, GCP, GLP, Pharmaceutical Industry, Quality Assurance, Lifesciences, Biopharmaceuticals, Quality Control, CAPA, Sop, Regulatory Submissions, Change Control, SOP, Life Sciences
Education
New England School of Law 2001 — 2005
JD, Law
Providence College 1998 — 2001
BS, Management
Rigas Tehniska Universitate 1988 — 1992
Civil Engineering
SFJ Pharmaceuticals, Inc. April 2013 - Present
Bayer HealthCare October 2011 - April 2013
Celerion (formerly MDS Pharma Services) August 2009 - October 2011
ARD Scientific February 2007 - August 2009
Integrium May 2006 - May 2008
Shuster Laboratories Inc (STR) May 2004 - May 2006
Biopharmaceutical, Clinical, Non-Clinical Firms 1993 - 2004
Skills
Leadership, Global Regulatory..., Quality Management, Quality Auditing, CRO, Computer System..., 21 CFR Part 11, Crisis Management, Biotechnology, GMP, GxP, Food and Drug Law, Clinical Research, Regulatory Inspection..., Program Management, Contract Management, Consulting, Strategic Planning, Risk Management, CMO management, Regulatory Interactions, Supplier Quality..., QAA, Engaging Public Speaker, GCP, GLP, Pharmaceutical Industry, Quality Assurance, Lifesciences, Biopharmaceuticals, Quality Control, CAPA, Sop, Regulatory Submissions, Change Control, SOP, Life Sciences
Education
New England School of Law 2001 — 2005
JD, Law
Providence College 1998 — 2001
BS, Management
Rigas Tehniska Universitate 1988 — 1992
Civil Engineering
Kim O'Malia MBA Health Care Management Kim O'Malia MBA Health Care Management's Integrium Experience March 2013 - March 2014
Job Associate Director, Clinical Trial Management at Puma Biotechnology
Industry Pharmaceuticals
Experience
Puma Biotechnology March 2014 - March 2015
Integrium March 2013 - March 2014
Medicis Pharmaceuticals March 2011 - December 2012
Duke Clinical Research Institute 2007 - 2011
Boston Scientific 2003 - 2007
Eli Lilly and Company June 2003 - November 2004
Eli Lilly and Company 1994 - 1997
Eli Lilly and Company May 1990 - May 1994
Skills
Clinical Development, Clinical Research, Clinical Trials, Oncology, Dermatology, Aesthetics, Cardiovascular, Diabetes, Infectious Diseases, Preclincal Research /..., Electronic Data Capture, Clinical Data Management, Clinical Events..., Drug Development, Medical Devices, Clinical Study Design, Inform, Oracle Clinical, Protocol, Sop, Medical Writing, GCP, Endocrinology, Regulatory Submissions, Cardiology, Biotechnology, FDA, ICH-GCP, Medical Affairs, CRO, CTMS, Pharmaceutical Industry, Therapeutic Areas, EDC, Clinical Monitoring, Regulatory Affairs, Neurology, 21 CFR Part 11, Lifesciences, IND, Pharmacovigilance, Trial Management, Data Management, Regulatory Requirements, CRF design, Drug Safety
Education
Regis University 2004 — 2006
MBA, Health Care Management
Bellevue University, Bellevue Nebraska
Bachelor of Science, Health Care Administration
Puma Biotechnology March 2014 - March 2015
Integrium March 2013 - March 2014
Medicis Pharmaceuticals March 2011 - December 2012
Duke Clinical Research Institute 2007 - 2011
Boston Scientific 2003 - 2007
Eli Lilly and Company June 2003 - November 2004
Eli Lilly and Company 1994 - 1997
Eli Lilly and Company May 1990 - May 1994
Skills
Clinical Development, Clinical Research, Clinical Trials, Oncology, Dermatology, Aesthetics, Cardiovascular, Diabetes, Infectious Diseases, Preclincal Research /..., Electronic Data Capture, Clinical Data Management, Clinical Events..., Drug Development, Medical Devices, Clinical Study Design, Inform, Oracle Clinical, Protocol, Sop, Medical Writing, GCP, Endocrinology, Regulatory Submissions, Cardiology, Biotechnology, FDA, ICH-GCP, Medical Affairs, CRO, CTMS, Pharmaceutical Industry, Therapeutic Areas, EDC, Clinical Monitoring, Regulatory Affairs, Neurology, 21 CFR Part 11, Lifesciences, IND, Pharmacovigilance, Trial Management, Data Management, Regulatory Requirements, CRF design, Drug Safety
Education
Regis University 2004 — 2006
MBA, Health Care Management
Bellevue University, Bellevue Nebraska
Bachelor of Science, Health Care Administration
W. Chadd Charles W. Chadd Charles's Integrium Experience March 2003 - October 2007
Job Senior Clinical Research Consultant with MedPace, Inc.
Industry Research
Experience
MedPace, Inc. Project Manager/Director, Clinical Affairs, DC2 Healthcare - President, NRIOM
Senior Regional Site Manager, Forest Labs March 2009 - November 2011
ClinForce for Allergan Medical 2007 - July 2009
Integrium March 2003 - October 2007
Integrium March 2004 - August 2006
Skills
Clinical Trials, GCP, Clinical Monitoring, Healthcare, Oncology, New Business Development, CRO, CTMS, Protocol, Pharmaceutical Industry, Clinical Development, Biotechnology, EDC, Strategic Planning, Clinical Research, Therapeutic Areas, ICH-GCP, ICH guidelines, Clinical Data Management, Clinical Operations, Cardiology, Infectious Diseases, Dermatology, Pharmacovigilance, Medical Writing, Rheumatology, Regulatory Submissions, Medical Devices, Neurology, Drug Development, Vaccines, Sop, Diabetes, FDA, Clinical Study Design, Immunology, Regulatory Affairs
Education
Eastern Mennonite University 1993 — 1997
Biology/Chemistry/Biochemistry
MedPace, Inc. Project Manager/Director, Clinical Affairs, DC2 Healthcare - President, NRIOM
Senior Regional Site Manager, Forest Labs March 2009 - November 2011
ClinForce for Allergan Medical 2007 - July 2009
Integrium March 2003 - October 2007
Integrium March 2004 - August 2006
Skills
Clinical Trials, GCP, Clinical Monitoring, Healthcare, Oncology, New Business Development, CRO, CTMS, Protocol, Pharmaceutical Industry, Clinical Development, Biotechnology, EDC, Strategic Planning, Clinical Research, Therapeutic Areas, ICH-GCP, ICH guidelines, Clinical Data Management, Clinical Operations, Cardiology, Infectious Diseases, Dermatology, Pharmacovigilance, Medical Writing, Rheumatology, Regulatory Submissions, Medical Devices, Neurology, Drug Development, Vaccines, Sop, Diabetes, FDA, Clinical Study Design, Immunology, Regulatory Affairs
Education
Eastern Mennonite University 1993 — 1997
Biology/Chemistry/Biochemistry
Dorene Doherty Dorene Doherty's Integrium Experience August 2014 - Present
Job Project Leader at Integrium
Industry Pharmaceuticals
Experience
Integrium August 2014 - Present
Doherty Consulting March 2013 - August 2014
TRIMED Clinical Trials June 2009 - August 2013
Irvine Center For Clinical Research October 2005 - May 2009
Radiant Research 2000 - 2005
California Clinical Trials 1998 - 2000
Skills
CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Clinical Research, GCP, Infectious Diseases, ICH-GCP, Clinical Operations, EDC, Clinical Monitoring, CRFs, CRF design, IRB, Quality Assurance, FDA, 21 CFR Part 11, HIPAA, IATA, Belmont Report, Declaration of Helsinki, Therapeutic Areas, Protocol, Sop, SOP development, Patient Recruitment, Psychometrician, Drug Development, Medical Terminology, Trial Management, Neuroscience, Cardiology, Neurology, Diabetes, Hypertension, Medical Writing, Endocrinology, Clinical Development, SOP
Education
University of California, Los Angeles 1999 — 2000
Forensics Science
California State Polytechnic University-Pomona 1991 — 1997
BA, Psychology
California State Polytechnic University-Pomona 1991 — 1997
Minor, Criminal Justice and Corrections
Integrium August 2014 - Present
Doherty Consulting March 2013 - August 2014
TRIMED Clinical Trials June 2009 - August 2013
Irvine Center For Clinical Research October 2005 - May 2009
Radiant Research 2000 - 2005
California Clinical Trials 1998 - 2000
Skills
CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Clinical Research, GCP, Infectious Diseases, ICH-GCP, Clinical Operations, EDC, Clinical Monitoring, CRFs, CRF design, IRB, Quality Assurance, FDA, 21 CFR Part 11, HIPAA, IATA, Belmont Report, Declaration of Helsinki, Therapeutic Areas, Protocol, Sop, SOP development, Patient Recruitment, Psychometrician, Drug Development, Medical Terminology, Trial Management, Neuroscience, Cardiology, Neurology, Diabetes, Hypertension, Medical Writing, Endocrinology, Clinical Development, SOP
Education
University of California, Los Angeles 1999 — 2000
Forensics Science
California State Polytechnic University-Pomona 1991 — 1997
BA, Psychology
California State Polytechnic University-Pomona 1991 — 1997
Minor, Criminal Justice and Corrections
Ellen Goldberg, CCDM Ellen Goldberg, CCDM's Integrium Experience March 2008 - December 2008
Job Clinical Data Management Professional
Industry Pharmaceuticals
Experience
self-employed December 2013 - Present
Writeresult LLC January 2009 - November 2013
Integrium March 2008 - December 2008
ClinPro Inc. June 1987 - March 2008
Skills
Sop, Computer System..., SAS, Medical Devices, Cardiology, ePRO, EDC, Medical Coding, Data Management, CRO, Team Building, Forms Development, Patient Reported..., Digital Pen Data Capture, Project Management, Clinical Development, SAS programming, Biotechnology, Drug Development, Therapeutic Areas, Clinical Monitoring, Oracle Clinical, Software Documentation, CDISC, GxP, Medical Writing, Databases, Process Improvement, CTMS, ICH-GCP, Cross-functional Team..., Quality Assurance, e-PRO, Regulatory Submissions, Biostatistics, Oncology, Neurology, Clinical Operations, Inform, Biopharmaceuticals, MedDRA, Protocol, CRF design, Diabetes, Immunology, Endocrinology, Pharmaceutics, Rheumatology, Data Validation, Infectious Diseases
Education
Raritan Valley Community College 1978 — 1979
AA, Business Administration
self-employed December 2013 - Present
Writeresult LLC January 2009 - November 2013
Integrium March 2008 - December 2008
ClinPro Inc. June 1987 - March 2008
Skills
Sop, Computer System..., SAS, Medical Devices, Cardiology, ePRO, EDC, Medical Coding, Data Management, CRO, Team Building, Forms Development, Patient Reported..., Digital Pen Data Capture, Project Management, Clinical Development, SAS programming, Biotechnology, Drug Development, Therapeutic Areas, Clinical Monitoring, Oracle Clinical, Software Documentation, CDISC, GxP, Medical Writing, Databases, Process Improvement, CTMS, ICH-GCP, Cross-functional Team..., Quality Assurance, e-PRO, Regulatory Submissions, Biostatistics, Oncology, Neurology, Clinical Operations, Inform, Biopharmaceuticals, MedDRA, Protocol, CRF design, Diabetes, Immunology, Endocrinology, Pharmaceutics, Rheumatology, Data Validation, Infectious Diseases
Education
Raritan Valley Community College 1978 — 1979
AA, Business Administration
Will Tilton's Integrium Experience June 2006 - October 2008
Job Web Dev Extraordinaire
Industry Computer Software
Experience
CSC October 2008 - April 2011
Integrium June 2006 - October 2008
Sparta Inc March 2004 - June 2006
Document Solutions Group April 2002 - December 2003
Mantech International December 1999 - July 2002
Skills
Process Improvement, Program Management, Software Documentation, Microsoft SQL Server, Agile Methodologies, .NET, Software Development, Disaster Recovery, SDLC, Technical Leadership, SQL, Microsoft Excel, JavaScript, C#
Education
Colorado State University-Pueblo 1997 — 2001
CSC October 2008 - April 2011
Integrium June 2006 - October 2008
Sparta Inc March 2004 - June 2006
Document Solutions Group April 2002 - December 2003
Mantech International December 1999 - July 2002
Skills
Process Improvement, Program Management, Software Documentation, Microsoft SQL Server, Agile Methodologies, .NET, Software Development, Disaster Recovery, SDLC, Technical Leadership, SQL, Microsoft Excel, JavaScript, C#
Education
Colorado State University-Pueblo 1997 — 2001
Andrea Tucker's Integrium Experience April 2004 - April 2006
Job Product Marketing / Product Management
Industry Marketing and Advertising
Experience
Alchemy Systems July 2014 - Present
NWP Services Corporation November 2012 - July 2014
NWP Services Corporation February 2008 - October 2012
NWP Services Corporation April 2006 - February 2008
Integrium April 2004 - April 2006
Integrium April 2003 - April 2006
Integrium September 2002 - April 2003
Ultimate Staffing Services March 2002 - September 2002
Better Buildings Interactive December 2000 - March 2002
Mosler, Inc. 1999 - 2000
Skills
Marketing, Customer Service, Networking, Team Building, Outlook, Project Management, Training, Strategic Planning, PowerPoint, Budget, Microsoft Excel, Microsoft Office, Software Documentation, Process Improvement, New Business Development, Contract Negotiation, Account Management, Team Leadership, Program Management, Healthcare, Budgets, Leadership, Employee Relations, Strategy, Cross-functional Team..., Competitive Analysis, Sales, Management, Email Marketing, Human Resources, Selling, Sales Management, Recruiting, Business Development, Salesforce.com, Time Management, Marketing Strategy, Strategic Partnerships, Customer Retention, Negotiation, Start-ups, Marketing Communications, CRM, Product Management, Product Marketing
Education
American Intercontinental University
Bachelor's Degree, Human Resource Management, 4.0
Belmont University
Music Business
Gruver High School
High School
Alchemy Systems July 2014 - Present
NWP Services Corporation November 2012 - July 2014
NWP Services Corporation February 2008 - October 2012
NWP Services Corporation April 2006 - February 2008
Integrium April 2004 - April 2006
Integrium April 2003 - April 2006
Integrium September 2002 - April 2003
Ultimate Staffing Services March 2002 - September 2002
Better Buildings Interactive December 2000 - March 2002
Mosler, Inc. 1999 - 2000
Skills
Marketing, Customer Service, Networking, Team Building, Outlook, Project Management, Training, Strategic Planning, PowerPoint, Budget, Microsoft Excel, Microsoft Office, Software Documentation, Process Improvement, New Business Development, Contract Negotiation, Account Management, Team Leadership, Program Management, Healthcare, Budgets, Leadership, Employee Relations, Strategy, Cross-functional Team..., Competitive Analysis, Sales, Management, Email Marketing, Human Resources, Selling, Sales Management, Recruiting, Business Development, Salesforce.com, Time Management, Marketing Strategy, Strategic Partnerships, Customer Retention, Negotiation, Start-ups, Marketing Communications, CRM, Product Management, Product Marketing
Education
American Intercontinental University
Bachelor's Degree, Human Resource Management, 4.0
Belmont University
Music Business
Gruver High School
High School
Jeff Cottonaro's Integrium Experience November 2008 - March 2010
Job Lead Clinical Operations Manager at Amgen
Industry Pharmaceuticals
Experience
Amgen January 2014 - Present
Amgen June 2012 - January 2014
AMGEN / RPS June 2010 - June 2012
Integrium November 2008 - March 2010
ClinAssure, Inc. July 2006 - November 2008
Valeant Pharmaceuticals August 2004 - July 2006
Parexel International November 1999 - August 2004
Skills
Clinical Operations, Clinical Monitoring, Data Management, Clinical Trials, Project Management, Line Management, CRO, CTMS, EDC, ICH-GCP, Drug Development, Pharmacovigilance, Regulatory Affairs, Clinical Research, GCP, Clinical Development, Oncology
Education
University of California, Los Angeles 1994 — 1998
BS, Biochemistry
Amgen January 2014 - Present
Amgen June 2012 - January 2014
AMGEN / RPS June 2010 - June 2012
Integrium November 2008 - March 2010
ClinAssure, Inc. July 2006 - November 2008
Valeant Pharmaceuticals August 2004 - July 2006
Parexel International November 1999 - August 2004
Skills
Clinical Operations, Clinical Monitoring, Data Management, Clinical Trials, Project Management, Line Management, CRO, CTMS, EDC, ICH-GCP, Drug Development, Pharmacovigilance, Regulatory Affairs, Clinical Research, GCP, Clinical Development, Oncology
Education
University of California, Los Angeles 1994 — 1998
BS, Biochemistry
Kevin Vernarec's Integrium Experience July 2004 - December 2005
Job Vice President, Operational Excellence at TKL Research
Industry Pharmaceuticals
Experience
TKL Research May 2011 - Present
Vernarec Consulting, LLC April 2009 - Present
ICON Clinical Research August 2008 - March 2009
ICON Clinical Research December 2005 - July 2008
Integrium July 2004 - December 2005
Symbiance October 2002 - July 2004
Pfizer October 2001 - September 2002
Nexigent April 1999 - August 2001
Covance April 1998 - August 2001
ACER/Excel 1993 - 1998
Skills
Clinical Trial..., Process Development, Clinical Research, CRO, EDC, CTMS, Project Planning, Clinical Trials, Clinical Monitoring, Strategic Planning, Pharmaceutics, GCP, Process Simulation, Pharmaceutical Industry, Clinical Operations, Clinical Data Management, CTMS Integrations, Clinical Development, Drug Development
Education
Penn State University 1976 — 1980
Bachelor of Science (B.S.), Biology, General
TKL Research May 2011 - Present
Vernarec Consulting, LLC April 2009 - Present
ICON Clinical Research August 2008 - March 2009
ICON Clinical Research December 2005 - July 2008
Integrium July 2004 - December 2005
Symbiance October 2002 - July 2004
Pfizer October 2001 - September 2002
Nexigent April 1999 - August 2001
Covance April 1998 - August 2001
ACER/Excel 1993 - 1998
Skills
Clinical Trial..., Process Development, Clinical Research, CRO, EDC, CTMS, Project Planning, Clinical Trials, Clinical Monitoring, Strategic Planning, Pharmaceutics, GCP, Process Simulation, Pharmaceutical Industry, Clinical Operations, Clinical Data Management, CTMS Integrations, Clinical Development, Drug Development
Education
Penn State University 1976 — 1980
Bachelor of Science (B.S.), Biology, General
Christine Somogyi's Integrium Experience 1994 - 2005
Job Sr Director Dermatology Clinical Research and Development at Allergan
Industry Pharmaceuticals
Experience
Allergan September 2005 - Present
Integrium 1994 - 2005
St Joseph Hospital 1990 - 1994
Biola University 1982 - 1984
Skills
Dermatology, Aesthetics, Cardiology, Biotechnology, Sop, Lifesciences, Medical Devices, ICH-GCP, Regulatory Submissions, Pharmacology, Global Drug Development, FDA Interactions, Global Clinical and..., Business Development, Corporate Development, Clinical Development, Cross-functional Team..., Cardiovascular Research, Patient Advocacy, Research, Team Building, Leadership Development, Nursing Education, Education and Training
Education
Biola University
Registered Nursing/Registered Nurse
CSU Long Beach
Nursing / Research
Allergan September 2005 - Present
Integrium 1994 - 2005
St Joseph Hospital 1990 - 1994
Biola University 1982 - 1984
Skills
Dermatology, Aesthetics, Cardiology, Biotechnology, Sop, Lifesciences, Medical Devices, ICH-GCP, Regulatory Submissions, Pharmacology, Global Drug Development, FDA Interactions, Global Clinical and..., Business Development, Corporate Development, Clinical Development, Cross-functional Team..., Cardiovascular Research, Patient Advocacy, Research, Team Building, Leadership Development, Nursing Education, Education and Training
Education
Biola University
Registered Nursing/Registered Nurse
CSU Long Beach
Nursing / Research
Eileen McAuley's Integrium Experience November 2005 - April 2014
Job Senior Vice President, Clinical Operations at Frontage Laboratories, Inc
Industry Pharmaceuticals
Experience
Frontage Laboratories, Inc May 2014 - Present
Integrium November 2005 - April 2014
Alteon May 2004 - October 2005
Target Research Associates, Inc. October 2003 - April 2004
The Phoenix March 1998 - September 2003
Zambon 1990 - 1996
Skills
CRO, Clinical Trials, GCP, CTMS, Pharmaceutical Industry, FDA, Clinical Research, EDC, Nursing, Sop, Clinical Operations, 21 CFR Part 11, Process Improvement, Infectious Diseases, Clinical Monitoring, Quality Assurance, Clinical Development, Medical Writing, Regulatory Affairs, CAPA, Regulatory Requirements, Lifesciences, Oncology, Pharmacovigilance, Ophthalmology, Validation, Phase I, Regulatory Submissions, Oracle Clinical, Endocrinology, Protocol, Vaccines, Diabetes, Biopharmaceuticals, Dermatology, Therapeutic Areas, Neurology, Cardiology, Biotechnology, GMP, Drug Discovery, Clinical Data Management, Data Management, ICH-GCP, Drug Development, Clinical Study Design, Leadership, Immunology
Education
Felician College 1981 — 1983
AAS, Nursing
Montclair State University
BS
Seton Hall University
MPH, Health Care
Frontage Laboratories, Inc May 2014 - Present
Integrium November 2005 - April 2014
Alteon May 2004 - October 2005
Target Research Associates, Inc. October 2003 - April 2004
The Phoenix March 1998 - September 2003
Zambon 1990 - 1996
Skills
CRO, Clinical Trials, GCP, CTMS, Pharmaceutical Industry, FDA, Clinical Research, EDC, Nursing, Sop, Clinical Operations, 21 CFR Part 11, Process Improvement, Infectious Diseases, Clinical Monitoring, Quality Assurance, Clinical Development, Medical Writing, Regulatory Affairs, CAPA, Regulatory Requirements, Lifesciences, Oncology, Pharmacovigilance, Ophthalmology, Validation, Phase I, Regulatory Submissions, Oracle Clinical, Endocrinology, Protocol, Vaccines, Diabetes, Biopharmaceuticals, Dermatology, Therapeutic Areas, Neurology, Cardiology, Biotechnology, GMP, Drug Discovery, Clinical Data Management, Data Management, ICH-GCP, Drug Development, Clinical Study Design, Leadership, Immunology
Education
Felician College 1981 — 1983
AAS, Nursing
Montclair State University
BS
Seton Hall University
MPH, Health Care
Karen M. Le, MSHS, CCRA's Integrium Experience 2002 - 2003
Job Senior CRA / Site Manager, Consultant
Industry Pharmaceuticals
Experience
Klinical Logics Consulting 2006 - Present
New York University February 2013 - January 2015
ReSearch Pharmaceutical Services 2007 - 2011
Quintiles 2004 - 2006
Advanced Bionics 2003 - 2004
Integrium 2002 - 2003
Skills
EDC, Oncology, Endocrinology, Dermatology, Neurology, Medical Devices, Urology, Central Nervous System, Pediatrics, Nuclear Medicine, CTMS, Clinical Monitoring, Clinical Trials, Cardiology, Study Monitoring, GCP, SOP development, Clinical Development
Education
The George Washington University 2006 — 2008
MSHS, Health Sciences
University of California, Irvine 1999 — 2002
BS, Biology, emphasis on Molecular Biology
Klinical Logics Consulting 2006 - Present
New York University February 2013 - January 2015
ReSearch Pharmaceutical Services 2007 - 2011
Quintiles 2004 - 2006
Advanced Bionics 2003 - 2004
Integrium 2002 - 2003
Skills
EDC, Oncology, Endocrinology, Dermatology, Neurology, Medical Devices, Urology, Central Nervous System, Pediatrics, Nuclear Medicine, CTMS, Clinical Monitoring, Clinical Trials, Cardiology, Study Monitoring, GCP, SOP development, Clinical Development
Education
The George Washington University 2006 — 2008
MSHS, Health Sciences
University of California, Irvine 1999 — 2002
BS, Biology, emphasis on Molecular Biology
Pierre Devesly's Integrium Experience 2008 - September 2009
Job Project Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2010 - Present
Integrium 2008 - September 2009
QualoPro Services March 2008 - May 2008
Kendle International August 2005 - March 2008
Kendle 2005 - 2008
Quintiles May 2003 - March 2005
Eisai March 2000 - June 2002
Forest Laboratories November 1996 - March 2000
Skills
Oncology, Clinical Development, CRO, Pharmaceutical Industry, Clinical Trials, Medical Writing, Drug Development, Regulatory Submissions, Clinical Monitoring, Clinical Research, Therapeutic Areas, Pharmacovigilance, Sop, Regulatory Affairs
Education
Binghamton University 1984 — 1987
cours rene descartes 1968 — 1980
terminal d
PAREXEL March 2010 - Present
Integrium 2008 - September 2009
QualoPro Services March 2008 - May 2008
Kendle International August 2005 - March 2008
Kendle 2005 - 2008
Quintiles May 2003 - March 2005
Eisai March 2000 - June 2002
Forest Laboratories November 1996 - March 2000
Skills
Oncology, Clinical Development, CRO, Pharmaceutical Industry, Clinical Trials, Medical Writing, Drug Development, Regulatory Submissions, Clinical Monitoring, Clinical Research, Therapeutic Areas, Pharmacovigilance, Sop, Regulatory Affairs
Education
Binghamton University 1984 — 1987
cours rene descartes 1968 — 1980
terminal d
Vernon Hackworth's Integrium Experience January 2005 - Present
Job Sr. CRA at Integrium
Industry Pharmaceuticals
Experience
Integrium January 2005 - Present
Schering-Plough Research Institute 1998 - January 2005
Covance 1997 - 1998
Skills
CRO, GCP, ICH-GCP, Therapeutic Areas, Clinical Trials, Clinical Development, Oncology, Clinical Operations, Clinical Data Management, Medidata, Endocrinology, Regulatory Submissions
Education
University of Kentucky
Bachelor's degree
Integrium January 2005 - Present
Schering-Plough Research Institute 1998 - January 2005
Covance 1997 - 1998
Skills
CRO, GCP, ICH-GCP, Therapeutic Areas, Clinical Trials, Clinical Development, Oncology, Clinical Operations, Clinical Data Management, Medidata, Endocrinology, Regulatory Submissions
Education
University of Kentucky
Bachelor's degree
Julie (Broadley) Tobin's Integrium Experience March 2008 - May 2012
Job Clinical Operations Manager at Amgen
Industry Pharmaceuticals
Experience
Amgen January 2013 - Present
RPS, Inc. (on assignment for Amgen) April 2012 - January 2013
Integrium March 2008 - May 2012
OrthoLogic July 2000 - February 2008
PRA International October 1999 - June 2000
MDS Pharma Services February 1997 - September 1999
Skills
Clinical Trials, EDC, Clinical Monitoring, CTMS, CRO, Medical Writing, Clinical Operations, Oracle Clinical, Clinical Research, Process Improvement, Cardiology, Project Management, Neuroscience, IND, FDA, Sop, Oncology, Neurology, Data Management, Clinical Development, ICH-GCP, Computer System..., Pharmacovigilance, Clinical Data Management, Pharmaceutical Industry, Regulatory Affairs, Lifesciences, GCP, Patient Recruitment, 21 CFR Part 11, Dermatology, Therapeutic Areas, Biotechnology, Diabetes, Quality Assurance, Validation, Protocol, Drug Development, Central Nervous System, R&D, CAPA, Endocrinology, Regulatory Submissions, Medical Affairs, Biopharmaceuticals, Cancer, Line Management, Gastroenterology, Vaccines, SOP
Education
University of Colorado at Boulder 1989 — 1993
BA, International Affairs
Amgen January 2013 - Present
RPS, Inc. (on assignment for Amgen) April 2012 - January 2013
Integrium March 2008 - May 2012
OrthoLogic July 2000 - February 2008
PRA International October 1999 - June 2000
MDS Pharma Services February 1997 - September 1999
Skills
Clinical Trials, EDC, Clinical Monitoring, CTMS, CRO, Medical Writing, Clinical Operations, Oracle Clinical, Clinical Research, Process Improvement, Cardiology, Project Management, Neuroscience, IND, FDA, Sop, Oncology, Neurology, Data Management, Clinical Development, ICH-GCP, Computer System..., Pharmacovigilance, Clinical Data Management, Pharmaceutical Industry, Regulatory Affairs, Lifesciences, GCP, Patient Recruitment, 21 CFR Part 11, Dermatology, Therapeutic Areas, Biotechnology, Diabetes, Quality Assurance, Validation, Protocol, Drug Development, Central Nervous System, R&D, CAPA, Endocrinology, Regulatory Submissions, Medical Affairs, Biopharmaceuticals, Cancer, Line Management, Gastroenterology, Vaccines, SOP
Education
University of Colorado at Boulder 1989 — 1993
BA, International Affairs
Pame' Sawyer-Smith, BBA, MTID's Integrium Experience July 2002 - February 2004
Job Clinical Research Consultant
Industry Pharmaceuticals
Experience
Clinical Monitoring Services Group, LLC May 2005 - Present
Discovery Life Coaching Center May 2010 - Present
Minority Clinical Research Center of Atlanta January 2008 - May 2012
Kforce August 2004 - July 2005
PRA International March 2004 - August 2004
Integrium July 2002 - February 2004
Quintiles August 1999 - July 2002
PAREXEL November 1996 - August 1998
Duke Clinical Research Institute November 1996 - August 1998
Duke Clinical Research Institute November 1994 - November 1996
Skills
Rheumatology, Inform, Clinical Research, Ophthalmology, Infectious Diseases, ICH-GCP, Gastroenterology, Vaccines, Sop, Cardiovascular Disease, Cardiovascular Devices, CNS disorders, Pain Management, Endocrinology, Orthopedic, Respiratory Disease, Women's Health, Pediatric Research, EDC - Inform, Medidata,..., Certified Life Coach, Clinical Trials, CTMS, Clinical Monitoring, CRO, FDA, EDC, Life Coaching, GCP, Neurology, SOP, Therapeutic Areas
Education
American Institute of Holistic Theology - PhD 2009 — 2016
PhD, Holistic Health
North Carolina State University 1995 — 1998
MTID, Master of Technology for International Development
North Carolina Central University 1986 — 1990
BBA, Marketing
Clinical Monitoring Services Group, LLC May 2005 - Present
Discovery Life Coaching Center May 2010 - Present
Minority Clinical Research Center of Atlanta January 2008 - May 2012
Kforce August 2004 - July 2005
PRA International March 2004 - August 2004
Integrium July 2002 - February 2004
Quintiles August 1999 - July 2002
PAREXEL November 1996 - August 1998
Duke Clinical Research Institute November 1996 - August 1998
Duke Clinical Research Institute November 1994 - November 1996
Skills
Rheumatology, Inform, Clinical Research, Ophthalmology, Infectious Diseases, ICH-GCP, Gastroenterology, Vaccines, Sop, Cardiovascular Disease, Cardiovascular Devices, CNS disorders, Pain Management, Endocrinology, Orthopedic, Respiratory Disease, Women's Health, Pediatric Research, EDC - Inform, Medidata,..., Certified Life Coach, Clinical Trials, CTMS, Clinical Monitoring, CRO, FDA, EDC, Life Coaching, GCP, Neurology, SOP, Therapeutic Areas
Education
American Institute of Holistic Theology - PhD 2009 — 2016
PhD, Holistic Health
North Carolina State University 1995 — 1998
MTID, Master of Technology for International Development
North Carolina Central University 1986 — 1990
BBA, Marketing
Gretchen Haig's Integrium Experience September 2003 - October 2006
Job Director, Clinical Research at Ivantis, Inc.
Industry Medical Devices
Experience
Ivantis, Inc. August 2013 - Present
Glaukos August 2011 - August 2013
ISTA Pharmaceuticals October 2006 - August 2010
Integrium September 2003 - October 2006
The PHOENIX January 1999 - August 2003
PRA International March 1997 - January 1999
Allergan October 1987 - March 1997
Education
California State University-Long Beach
Bachelor of Science (BS), Chemical Engineering
University of California, Irvine
Master of Business Administration (MBA)
Ivantis, Inc. August 2013 - Present
Glaukos August 2011 - August 2013
ISTA Pharmaceuticals October 2006 - August 2010
Integrium September 2003 - October 2006
The PHOENIX January 1999 - August 2003
PRA International March 1997 - January 1999
Allergan October 1987 - March 1997
Education
California State University-Long Beach
Bachelor of Science (BS), Chemical Engineering
University of California, Irvine
Master of Business Administration (MBA)
Marjory Kadash, PMP's Integrium Experience 2006 - 2008
Job Director, Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization
Industry Pharmaceuticals
Experience
Otsuka March 2010 - January 2013
Integrium 2006 - 2008
Galderma 2000 - 2006
Bristol-Myers Squibb 1998 - 2000
Bristol-Myers Squibb 1989 - 1998
Skills
Clinical Development, Operations Management, Project Management, CRO, Quality Assurance, Drug Development, Cross-functional Team..., Medical Devices, Management, Program Management, Biotechnology, Product Development, Business Strategy, Project Planning, Quality System, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, Process Improvement, IND, Biopharmaceuticals, FDA, R&D, SDLC, Clinical Trials, GCP
Education
University of Maryland College Park
MS
University of Maryland College Park
BS
Otsuka March 2010 - January 2013
Integrium 2006 - 2008
Galderma 2000 - 2006
Bristol-Myers Squibb 1998 - 2000
Bristol-Myers Squibb 1989 - 1998
Skills
Clinical Development, Operations Management, Project Management, CRO, Quality Assurance, Drug Development, Cross-functional Team..., Medical Devices, Management, Program Management, Biotechnology, Product Development, Business Strategy, Project Planning, Quality System, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, Process Improvement, IND, Biopharmaceuticals, FDA, R&D, SDLC, Clinical Trials, GCP
Education
University of Maryland College Park
MS
University of Maryland College Park
BS
Tsai Lan-Feng's Integrium Experience November 2004 - July 2005
Job Sr. Biostatistician at Otsuka Pharmaceutical Companies (U.S.)
Industry Biotechnology
Experience
Otsuka Pharmaceutical Companies (U.S.) March 2013 - Present
Human Genome Sciences May 2011 - January 2013
Human Genome Sciences November 2007 - May 2011
University of Maryland 2006 - June 2007
Integrium November 2004 - July 2005
Edwards Lifesciences June 2000 - November 2004
Center for Community Health, UCLA November 1998 - June 2000
Skills
SAS, Statistical Analysis, Phase I-IV clinical..., Project Management
Education
UCLA 1996 — 1998
Master of Science (MS), Biostatistics
Tamkang University 1990 — 1994
Bachelor of Science (BS), Mathematical Statistics
Otsuka Pharmaceutical Companies (U.S.) March 2013 - Present
Human Genome Sciences May 2011 - January 2013
Human Genome Sciences November 2007 - May 2011
University of Maryland 2006 - June 2007
Integrium November 2004 - July 2005
Edwards Lifesciences June 2000 - November 2004
Center for Community Health, UCLA November 1998 - June 2000
Skills
SAS, Statistical Analysis, Phase I-IV clinical..., Project Management
Education
UCLA 1996 — 1998
Master of Science (MS), Biostatistics
Tamkang University 1990 — 1994
Bachelor of Science (BS), Mathematical Statistics
Jessica Droge's Integrium Experience 2002 - 2002
Job Executive Director, Business Development at Amgen
Industry Biotechnology
Experience
Amgen November 2014 - Present
Amgen 2011 - November 2014
Amgen 2007 - 2011
Integrium 2002 - 2002
TheraCardia 1999 - 2002
UCLA Center for Vaccine Research (LABiomed) 1996 - 1998
Los Angeles Department of Health and Human Services 1993 - 1996
Centers for Disease Control and Prevention 1992 - 1996
Skills
Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Life Sciences, Clinical Development, Oncology, Technology Transfer, Drug Discovery, Drug Development, Clinical Trials, FDA, Validation, Commercialization, CRO, Immunology, SOP, Medical Devices, Molecular Biology
Education
University of California, Los Angeles,
Doctor of Philosophy (PhD)
University of California, San Diego
Bachelor's degree, Biochemistry and Cell Biology
Amgen November 2014 - Present
Amgen 2011 - November 2014
Amgen 2007 - 2011
Integrium 2002 - 2002
TheraCardia 1999 - 2002
UCLA Center for Vaccine Research (LABiomed) 1996 - 1998
Los Angeles Department of Health and Human Services 1993 - 1996
Centers for Disease Control and Prevention 1992 - 1996
Skills
Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Life Sciences, Clinical Development, Oncology, Technology Transfer, Drug Discovery, Drug Development, Clinical Trials, FDA, Validation, Commercialization, CRO, Immunology, SOP, Medical Devices, Molecular Biology
Education
University of California, Los Angeles,
Doctor of Philosophy (PhD)
University of California, San Diego
Bachelor's degree, Biochemistry and Cell Biology
Helen Schwartz's Integrium Experience Clinical Trial Coordinatorsanofi-aventisDecember 2004 - May 2006
Job Project Management Coordinator at Integrium
Industry Pharmaceuticals
Experience
Integrium Clinical Trial Coordinatorsanofi-aventisDecember 2004 - May 2006
sanofi-aventis 2004 - 2006
Essex Institutional Review Board 1997 - 2004
Education
Raritan Valley Community College
Business Administration
Integrium Clinical Trial Coordinatorsanofi-aventisDecember 2004 - May 2006
sanofi-aventis 2004 - 2006
Essex Institutional Review Board 1997 - 2004
Education
Raritan Valley Community College
Business Administration
Trish Kuper, RN, CCRA's Integrium Experience April 2008 - December 2008
Job Senior Clinical Research Associate at Theorem Clinical Research
Industry Research
Experience
Chiltern September 2015 - Present
Theorem Clinical Research May 2014 - Present
Abbott Vascular Structural Heart October 2009 - May 2014
Evalve, Inc. March 2009 - May 2014
Self Employed December 2008 - March 2009
Integrium April 2008 - December 2008
Bailer Research February 2002 - April 2008
Mid Carolina Cardiology September 2001 - February 2003
Skills
CCRA, EDC, Clinical Research, FDA, Clinical Trials, Clinical Monitoring, Medical Devices, CTMS, GCP, Cardiology, CRO, Clinical Development, ICH-GCP, Regulatory Affairs
Education
Carolinas College of Health Sciences 1992 — 1994
ADN, Nursing
University of North Carolina at Charlotte 1981 — 1983
Bachelor of Arts (BA), English
Chiltern September 2015 - Present
Theorem Clinical Research May 2014 - Present
Abbott Vascular Structural Heart October 2009 - May 2014
Evalve, Inc. March 2009 - May 2014
Self Employed December 2008 - March 2009
Integrium April 2008 - December 2008
Bailer Research February 2002 - April 2008
Mid Carolina Cardiology September 2001 - February 2003
Skills
CCRA, EDC, Clinical Research, FDA, Clinical Trials, Clinical Monitoring, Medical Devices, CTMS, GCP, Cardiology, CRO, Clinical Development, ICH-GCP, Regulatory Affairs
Education
Carolinas College of Health Sciences 1992 — 1994
ADN, Nursing
University of North Carolina at Charlotte 1981 — 1983
Bachelor of Arts (BA), English
Silke Thode's Integrium Experience February 2004 - May 2007
Job Director, Clinical Research at Advanced Bionics
Industry Pharmaceuticals
Experience
Advanced Bionics June 2015 - Present
Glaukos Corporation July 2012 - June 2015
Aptiv Solutions September 2009 - July 2012
Averion International (now part of Aptiv Solutions) June 2007 - September 2009
Integrium February 2004 - May 2007
Iconix Biosciences August 1999 - February 2004
Signal Pharmaceuticals November 1996 - July 1999
Skills
Clinical Trials, CRO, CTMS, GCP, Clinical Development, Clinical Operations, Clinical Monitoring, Clinical Research, Regulatory Submissions, FDA, ICH-GCP, Clinical Data Management, Sop, Drug Development
Education
University of Cologne 1980 — 1992
PhD, Biology
Advanced Bionics June 2015 - Present
Glaukos Corporation July 2012 - June 2015
Aptiv Solutions September 2009 - July 2012
Averion International (now part of Aptiv Solutions) June 2007 - September 2009
Integrium February 2004 - May 2007
Iconix Biosciences August 1999 - February 2004
Signal Pharmaceuticals November 1996 - July 1999
Skills
Clinical Trials, CRO, CTMS, GCP, Clinical Development, Clinical Operations, Clinical Monitoring, Clinical Research, Regulatory Submissions, FDA, ICH-GCP, Clinical Data Management, Sop, Drug Development
Education
University of Cologne 1980 — 1992
PhD, Biology
Jeff Xia's Integrium Experience February 2007 - November 2011
Job Technical Manager at Galderma
Industry Pharmaceuticals
Experience
Galderma March 2013 - Present
Integrium February 2007 - November 2011
Merck May 2005 - February 2007
Meta Solutions February 2004 - February 2005
T-synergy March 2002 - May 2003
Skills
EDC, SAS, Data Management, Clinical Data Management, GxP, Databases, GCP, SAS programming, Clinical Trials, Clinical Development, Computer System..., Lifesciences, SDTM, CRO, Statistical Programming, CDISC, Biostatistics, CRF design, Sop, 21 CFR Part 11, SAS Programming, Oracle Clinical, SOP, Life Sciences
Education
New Jersey Institute of Technology 2002 — 2003
master, Computer Information Science
Galderma March 2013 - Present
Integrium February 2007 - November 2011
Merck May 2005 - February 2007
Meta Solutions February 2004 - February 2005
T-synergy March 2002 - May 2003
Skills
EDC, SAS, Data Management, Clinical Data Management, GxP, Databases, GCP, SAS programming, Clinical Trials, Clinical Development, Computer System..., Lifesciences, SDTM, CRO, Statistical Programming, CDISC, Biostatistics, CRF design, Sop, 21 CFR Part 11, SAS Programming, Oracle Clinical, SOP, Life Sciences
Education
New Jersey Institute of Technology 2002 — 2003
master, Computer Information Science
Scott Wieland's Integrium Experience 2003 - 2004
Job SVP, Drug Development, CytRx Corporation
Industry Pharmaceuticals
Experience
CytRx Corporation 2005 - Present
BrainCells, Inc. 2006 - 2007
Accera 2004 - 2005
SW Pharma Management 2002 - 2005
Integrium 2003 - 2004
NeoTherapeutics 1997 - 2002
CoCensys 1990 - 1997
Skills
Regulatory Affairs, Clinical Research, Clinical Trials, Pharmaceuticals, Oncology, Drug Discovery, Clinical Development, FDA, Life Sciences, GCP, Clinical Trial..., Clinical, CRO, Pharmacology, R&D, Neuroscience, Regulatory Submissions, SOP, Neurology, Due Diligence, Start-ups, Cross-functional Team..., Toxicology, Competitive Intelligence, Biopharmaceuticals, Pharmaceutical Industry, Lifesciences, Biotechnology, Drug Development, Infectious Diseases, Immunology, Technology Transfer, Therapeutic Areas
Education
Webster University 1996 — 1998
MBA, Management
University of Pennsylvania 1987 — 1990
Neuropsychopharmacology
University of Arizona 1982 — 1987
PhD, Physiological Psychology
University of California, Santa Barbara 1977 — 1981
BS, Physiological Psychology
CytRx Corporation 2005 - Present
BrainCells, Inc. 2006 - 2007
Accera 2004 - 2005
SW Pharma Management 2002 - 2005
Integrium 2003 - 2004
NeoTherapeutics 1997 - 2002
CoCensys 1990 - 1997
Skills
Regulatory Affairs, Clinical Research, Clinical Trials, Pharmaceuticals, Oncology, Drug Discovery, Clinical Development, FDA, Life Sciences, GCP, Clinical Trial..., Clinical, CRO, Pharmacology, R&D, Neuroscience, Regulatory Submissions, SOP, Neurology, Due Diligence, Start-ups, Cross-functional Team..., Toxicology, Competitive Intelligence, Biopharmaceuticals, Pharmaceutical Industry, Lifesciences, Biotechnology, Drug Development, Infectious Diseases, Immunology, Technology Transfer, Therapeutic Areas
Education
Webster University 1996 — 1998
MBA, Management
University of Pennsylvania 1987 — 1990
Neuropsychopharmacology
University of Arizona 1982 — 1987
PhD, Physiological Psychology
University of California, Santa Barbara 1977 — 1981
BS, Physiological Psychology
Shelda Maier's Integrium Experience May 2008 - March 2012
Job Quality Assurance Consultant
Industry Pharmaceuticals
Experience
Novartis August 2014 - Present
Novartis Pharmaceuticals through META Solutions, Inc. October 2012 - November 2014
Trifecta Multimedia through META Solutions, Inc. November 2013 - August 2014
Overlook Foundation; Atlantic Health System May 2012 - August 2013
Integrium May 2008 - March 2012
Clinsys Clinical Research, Inc. June 2005 - May 2008
Clinsys Clinical Research, Inc. September 2004 - June 2005
META Solutions, Inc. July 1998 - March 2004
Genta, Inc. 2003 - 2004
META Solutions, Inc. July 1996 - June 1998
Skills
GLP, 21 CFR Part 11, Clinical Trials, GCP, CRO, Sop, FDA, Validation, Quality System, CAPA, Oncology, GxP, Computer System..., Regulatory Submissions, Quality Assurance, Software Documentation, IND, Pharmacovigilance, Therapeutic Areas, Regulatory Affairs, Pharmaceutical Industry, Clinical Research, Pharmaceutics, Biopharmaceuticals, ICH-GCP, CTMS, Clinical Study Design, EDC, Clinical Data Management, Biotechnology, Clinical Development, SOP
Education
The University of Montana
B.A., Cum laude
Novartis August 2014 - Present
Novartis Pharmaceuticals through META Solutions, Inc. October 2012 - November 2014
Trifecta Multimedia through META Solutions, Inc. November 2013 - August 2014
Overlook Foundation; Atlantic Health System May 2012 - August 2013
Integrium May 2008 - March 2012
Clinsys Clinical Research, Inc. June 2005 - May 2008
Clinsys Clinical Research, Inc. September 2004 - June 2005
META Solutions, Inc. July 1998 - March 2004
Genta, Inc. 2003 - 2004
META Solutions, Inc. July 1996 - June 1998
Skills
GLP, 21 CFR Part 11, Clinical Trials, GCP, CRO, Sop, FDA, Validation, Quality System, CAPA, Oncology, GxP, Computer System..., Regulatory Submissions, Quality Assurance, Software Documentation, IND, Pharmacovigilance, Therapeutic Areas, Regulatory Affairs, Pharmaceutical Industry, Clinical Research, Pharmaceutics, Biopharmaceuticals, ICH-GCP, CTMS, Clinical Study Design, EDC, Clinical Data Management, Biotechnology, Clinical Development, SOP
Education
The University of Montana
B.A., Cum laude
Jessica Crane's Integrium Experience July 2007 - November 2007
Job Clinical Trials Manager at Spectrum Pharmaceuticals
Industry Biotechnology
Experience
Spectrum Pharmaceuticals May 2014 - Present
Aptiv Solutions November 2007 - April 2014
Integrium July 2007 - November 2007
UCI Comprehensive Cancer Center February 2007 - July 2007
UPMC June 2005 - January 2007
Skills
GCP, Oncology, Clinical Research, CRO, EDC, Clinical Study Design, Clinical Development, Therapeutic Areas, Clinical Trials, CTMS, ICH-GCP, Pharmaceutical Industry, Clinical Operations, Clinical Monitoring, Clinical Data Management, Data Management
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2010
MS, Health Sciences
University of Pittsburgh 2000 — 2005
BS, Health and Rehabilitation Sciences
Spectrum Pharmaceuticals May 2014 - Present
Aptiv Solutions November 2007 - April 2014
Integrium July 2007 - November 2007
UCI Comprehensive Cancer Center February 2007 - July 2007
UPMC June 2005 - January 2007
Skills
GCP, Oncology, Clinical Research, CRO, EDC, Clinical Study Design, Clinical Development, Therapeutic Areas, Clinical Trials, CTMS, ICH-GCP, Pharmaceutical Industry, Clinical Operations, Clinical Monitoring, Clinical Data Management, Data Management
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2010
MS, Health Sciences
University of Pittsburgh 2000 — 2005
BS, Health and Rehabilitation Sciences
Merynda Fuellhart, BS, RN, LNC's Integrium Experience 2005 - 2006
Job Manager, Trials Safety at Celgene
Industry Pharmaceuticals
Experience
Celgene March 2007 - Present
Celgene Corp 2007 - Present
Daiichi Pharamceutical May 2005 - April 2006
Integrium 2005 - 2006
Abbott Pharmaceutical January 2003 - December 2003
Schering Plough 1998 - 2003
Skills
Clinical Trials, Oncology, CTMS, Clinical Research, Phase I, Clinical Development, Trial Management, Pharmaceutical Industry, EDC, Infectious Diseases, Therapeutic Areas, CRO, Clinical Monitoring, ICH-GCP, Regulatory Submissions, GCP, Pharmacovigilance, Sop, Investigator Initiated..., Early Drug developement, SOP, Drug Development, Cooking, Clinical Data Management
Education
Fairleigh Dickinson University 1997 — 1999
Certification, Legal Nurse Consultant, Certificate as LNC
Bethany College 1969 — 1973
BS, Experimental Psych
County College of Morris
Associate's Degree, Registered Nursing/Registered Nurse
Celgene March 2007 - Present
Celgene Corp 2007 - Present
Daiichi Pharamceutical May 2005 - April 2006
Integrium 2005 - 2006
Abbott Pharmaceutical January 2003 - December 2003
Schering Plough 1998 - 2003
Skills
Clinical Trials, Oncology, CTMS, Clinical Research, Phase I, Clinical Development, Trial Management, Pharmaceutical Industry, EDC, Infectious Diseases, Therapeutic Areas, CRO, Clinical Monitoring, ICH-GCP, Regulatory Submissions, GCP, Pharmacovigilance, Sop, Investigator Initiated..., Early Drug developement, SOP, Drug Development, Cooking, Clinical Data Management
Education
Fairleigh Dickinson University 1997 — 1999
Certification, Legal Nurse Consultant, Certificate as LNC
Bethany College 1969 — 1973
BS, Experimental Psych
County College of Morris
Associate's Degree, Registered Nursing/Registered Nurse
Scott Rosenberger's Integrium Experience June 2009 - November 2011
Job Sr. Director, Clinical Monitoring Operations, Chiltern International
Industry Pharmaceuticals
Experience
Covance April 2012 - March 2015
Integrium June 2009 - November 2011
Clinsys Clinical Research August 1998 - June 2009
Wyeth September 1989 - August 1998
Skills
Clinical Trial..., CTMS, EDC, CRO, GCP, Clinical Research, Clinical Trials, Therapeutic areas, Clinical Development, Endocrinology, Dermatology, Clinical, Nephrology, Cardiology, Diabetes, Clinical Monitoring, Pharmaceuticals, Pediatrics, Data Management, Clinical Data Management, Protocol Development, Phase I, Asthma, Gastroenterology, SOP, Allergy, Research, Protocol
Education
University of Delaware 1985 — 1989
BS, Medical Technology (ASCP)
Covance April 2012 - March 2015
Integrium June 2009 - November 2011
Clinsys Clinical Research August 1998 - June 2009
Wyeth September 1989 - August 1998
Skills
Clinical Trial..., CTMS, EDC, CRO, GCP, Clinical Research, Clinical Trials, Therapeutic areas, Clinical Development, Endocrinology, Dermatology, Clinical, Nephrology, Cardiology, Diabetes, Clinical Monitoring, Pharmaceuticals, Pediatrics, Data Management, Clinical Data Management, Protocol Development, Phase I, Asthma, Gastroenterology, SOP, Allergy, Research, Protocol
Education
University of Delaware 1985 — 1989
BS, Medical Technology (ASCP)
Bernadette Farrell's Integrium Experience October 2006 - April 2007
Job DM Project Leader at Chiltern International
Industry Research
Experience
Chiltern International August 2014 - Present
Novartis July 2013 - November 2013
Bayer HealthCare February 2011 - May 2013
NORDIC Research - St Luke's - Roosevelt Hospital July 2009 - August 2010
Cmed June 2007 - November 2008
Integrium October 2006 - April 2007
Novartis November 2003 - August 2006
ViroPharma Incorporated March 2001 - June 2003
GSK 1993 - 1999
Skills
CRO, Clinical Trials, Clinical Data Management, GCP, EDC, CTMS, Oracle Clinical, Clinical Development, ICH-GCP, Therapeutic Areas, CRF design, Pharmacovigilance, Oncology, Infectious Diseases
Education
The George Washington University
Master's degree, Health Services/Allied Health/Health Sciences, Minor Clinical Research
Holy Family University 1987 — 1991
BSN, Nursing
James Martin Trade School 1982 — 1983
LPN, Nursing
Chiltern International August 2014 - Present
Novartis July 2013 - November 2013
Bayer HealthCare February 2011 - May 2013
NORDIC Research - St Luke's - Roosevelt Hospital July 2009 - August 2010
Cmed June 2007 - November 2008
Integrium October 2006 - April 2007
Novartis November 2003 - August 2006
ViroPharma Incorporated March 2001 - June 2003
GSK 1993 - 1999
Skills
CRO, Clinical Trials, Clinical Data Management, GCP, EDC, CTMS, Oracle Clinical, Clinical Development, ICH-GCP, Therapeutic Areas, CRF design, Pharmacovigilance, Oncology, Infectious Diseases
Education
The George Washington University
Master's degree, Health Services/Allied Health/Health Sciences, Minor Clinical Research
Holy Family University 1987 — 1991
BSN, Nursing
James Martin Trade School 1982 — 1983
LPN, Nursing
C. Curtis Clifton's Integrium Experience May 2013 - September 2013
Job Sr. CRA at Allergan R&D
Industry Pharmaceuticals
Experience
Allergan January 2014 - Present
Allergan January 2014 - Present
Integrium May 2013 - September 2013
Integrium Pharmaceuticals April 2013 - September 2013
Skills
Clinical Trials, Clinical Monitoring, CTMS, CRO, Clinical Development, Pharmaceutical Industry, EDC, Dermatology, ICH-GCP, Oncology, Endocrinology, Regulatory Affairs, Infectious Diseases, Sop, FDA, Clinical Research, Clinical Data Management, Regulatory Submissions, Cardiology, GCP, Therapeutic Areas, Neurology, Medical Devices, Pharmacovigilance, Diabetes, Biotechnology, Drug Development, Data Management, Clinical Operations, Immunology, Vaccines, Oracle Clinical, Medical Writing, Rheumatology, Protocol, Urology, Gastroenterology, Hematology, Clinical Study Design, Inform, Validation, Regulatory Requirements, Lifesciences, Clinical Research..., Psychiatry
Education
University of Phoenix
Master's degree, Business Administration and Management, General
Allergan January 2014 - Present
Allergan January 2014 - Present
Integrium May 2013 - September 2013
Integrium Pharmaceuticals April 2013 - September 2013
Skills
Clinical Trials, Clinical Monitoring, CTMS, CRO, Clinical Development, Pharmaceutical Industry, EDC, Dermatology, ICH-GCP, Oncology, Endocrinology, Regulatory Affairs, Infectious Diseases, Sop, FDA, Clinical Research, Clinical Data Management, Regulatory Submissions, Cardiology, GCP, Therapeutic Areas, Neurology, Medical Devices, Pharmacovigilance, Diabetes, Biotechnology, Drug Development, Data Management, Clinical Operations, Immunology, Vaccines, Oracle Clinical, Medical Writing, Rheumatology, Protocol, Urology, Gastroenterology, Hematology, Clinical Study Design, Inform, Validation, Regulatory Requirements, Lifesciences, Clinical Research..., Psychiatry
Education
University of Phoenix
Master's degree, Business Administration and Management, General
A.J. Leyco's Integrium Experience April 2002 - June 2003
Job Associate Director, Clinical Affairs at Peregrine Pharmaceuticals
Industry Biotechnology
Experience
Peregrine Pharmaceuticals January 2009 - Present
Valeant Pharmaceuticals April 2006 - January 2009
Cardiogenesis Corporation October 2004 - April 2006
Sicor June 2003 - October 2004
Integrium April 2002 - June 2003
BMR Healthquest January 2000 - April 2002
Affiliated Research Institute May 1999 - January 2000
Affiliated Research Institute November 1997 - May 1999
Education
Maric College
Nursing
San Diego State University-California State University
Nursing
St. Joseph's Highschool
Sweetwater Union Highschool
Peregrine Pharmaceuticals January 2009 - Present
Valeant Pharmaceuticals April 2006 - January 2009
Cardiogenesis Corporation October 2004 - April 2006
Sicor June 2003 - October 2004
Integrium April 2002 - June 2003
BMR Healthquest January 2000 - April 2002
Affiliated Research Institute May 1999 - January 2000
Affiliated Research Institute November 1997 - May 1999
Education
Maric College
Nursing
San Diego State University-California State University
Nursing
St. Joseph's Highschool
Sweetwater Union Highschool
Nora Phetcharat's Integrium Experience February 2005 - August 2005
Job Allergan
Industry Pharmaceuticals
Experience
Allergan February 2015 - Present
Allergan January 2012 - Present
Allergan September 2007 - December 2011
Amgen August 2006 - August 2007
Allergan (contractor) August 2005 - August 2006
Integrium February 2005 - August 2005
Paragon Biomedical August 2001 - June 2003
Skills
Clinical Monitoring, EDC, CTMS, GCP, CRO, Clinical Trials, ICH-GCP, Oncology, Clinical Development, Therapeutic Areas, Oracle Clinical, Ophthalmology, Regulatory Submissions, Clinical Operations, Clinical Data Management
Education
University of California, Irvine
Allergan February 2015 - Present
Allergan January 2012 - Present
Allergan September 2007 - December 2011
Amgen August 2006 - August 2007
Allergan (contractor) August 2005 - August 2006
Integrium February 2005 - August 2005
Paragon Biomedical August 2001 - June 2003
Skills
Clinical Monitoring, EDC, CTMS, GCP, CRO, Clinical Trials, ICH-GCP, Oncology, Clinical Development, Therapeutic Areas, Oracle Clinical, Ophthalmology, Regulatory Submissions, Clinical Operations, Clinical Data Management
Education
University of California, Irvine
Ashley Tripi's Integrium Experience April 2013 - April 2015
Job CPL On Assignment with Sanofi CSU
Industry Research
Experience
PRA Health Sciences April 2015 - Present
Integrium April 2013 - April 2015
Medicis January 2011 - December 2012
Phoenix Heart, PLLC May 2010 - December 2010
Phoenix Heart, PLLC March 2009 - December 2010
Arizona Heart Institute September 2007 - February 2009
Paradise Valley Hospital September 2003 - March 2007
Skills
Pharmaceutical Industry, Clinical Trials, Medical Devices, Clinical Development, FDA, Drug Development, GCP, Biotechnology, CTMS, Oncology, Clinical Research, Lifesciences, Program Management, Project Management, Cardiology, Dermatology, Aesthetics, GMP, 21 CFR Part 11, Budgets, Quality Assurance, Sop, Regulatory Submissions, Protocol, CRO, Regulatory Affairs, SOP, Life Sciences
Education
University of Phoenix 2007 — 2009
Master of Business Administration (MBA), Health/Health Care Administration/Management
Arizona State University 2003 — 2007
Bachelor of Science (BS), Cell Biology and Physiology
PRA Health Sciences April 2015 - Present
Integrium April 2013 - April 2015
Medicis January 2011 - December 2012
Phoenix Heart, PLLC May 2010 - December 2010
Phoenix Heart, PLLC March 2009 - December 2010
Arizona Heart Institute September 2007 - February 2009
Paradise Valley Hospital September 2003 - March 2007
Skills
Pharmaceutical Industry, Clinical Trials, Medical Devices, Clinical Development, FDA, Drug Development, GCP, Biotechnology, CTMS, Oncology, Clinical Research, Lifesciences, Program Management, Project Management, Cardiology, Dermatology, Aesthetics, GMP, 21 CFR Part 11, Budgets, Quality Assurance, Sop, Regulatory Submissions, Protocol, CRO, Regulatory Affairs, SOP, Life Sciences
Education
University of Phoenix 2007 — 2009
Master of Business Administration (MBA), Health/Health Care Administration/Management
Arizona State University 2003 — 2007
Bachelor of Science (BS), Cell Biology and Physiology
Daniele Tompkins's Integrium Experience 2012 - 2013
Job Clinical Trial Manager at Pearl Therapeutics
Industry Pharmaceuticals
Experience
Pearl Therapeutics July 2014 - Present
Novartis May 2013 - June 2014
Integrium 2012 - 2013
Roche Pharmaceuticals November 2006 - July 2012
Skills
CTMS, Clinical Development, GCP, Clinical Trials, EDC, CRO, ICH-GCP, Therapeutic Areas, Clinical Operations, Clinical Monitoring, Clinical Data Management, Protocol, Oncology, Drug Development, Clinical Research
Education
Montclair State University 2006 — 2011
MA, Health Education
Rutgers University-New Brunswick 2002 — 2006
BA, Biology
Pearl Therapeutics July 2014 - Present
Novartis May 2013 - June 2014
Integrium 2012 - 2013
Roche Pharmaceuticals November 2006 - July 2012
Skills
CTMS, Clinical Development, GCP, Clinical Trials, EDC, CRO, ICH-GCP, Therapeutic Areas, Clinical Operations, Clinical Monitoring, Clinical Data Management, Protocol, Oncology, Drug Development, Clinical Research
Education
Montclair State University 2006 — 2011
MA, Health Education
Rutgers University-New Brunswick 2002 — 2006
BA, Biology
Kenneth Homer's Integrium Experience September 2011 - Present
Job Director, Biostatistics and Data Management at Integrium
Industry Pharmaceuticals
Experience
Integrium September 2011 - Present
Eisai January 2007 - September 2011
TKL Research February 2002 - January 2007
Blue Wizard Software, LLC April 1999 - January 2002
Kendle International March 1998 - April 1999
ACER/Excel October 1992 - March 1998
Skills
CRO, Clinical Trials, Clinical Development, Statistical Programming, Biostatistics
Education
University of Iowa 1990 — 1992
MS, Statistics
California Polytechnic State University-San Luis Obispo 1986 — 1989
BS, Statistics
Integrium September 2011 - Present
Eisai January 2007 - September 2011
TKL Research February 2002 - January 2007
Blue Wizard Software, LLC April 1999 - January 2002
Kendle International March 1998 - April 1999
ACER/Excel October 1992 - March 1998
Skills
CRO, Clinical Trials, Clinical Development, Statistical Programming, Biostatistics
Education
University of Iowa 1990 — 1992
MS, Statistics
California Polytechnic State University-San Luis Obispo 1986 — 1989
BS, Statistics
Taryn Smith's Integrium Experience June 2013 - June 2014
Job Youth Justice Education Clinic at Center for Juvenile Law and Policy
Industry Law Practice
Experience
Center for Juvenile Law and Policy August 2015 - Present
Legal Aid Foundation of Los Angeles June 2015 - July 2015
Integrium June 2013 - June 2014
Integrium September 2009 - June 2013
CASA of Orange County January 2013 - May 2013
Chapman Student Government Association May 2012 - April 2013
Athletic Republic of Orange County July 2012 - October 2012
Kappa Alpha Theta January 2011 - December 2011
Integrium June 2011 - August 2011
Professional Development Institute May 2010 - July 2010
Skills
Online Research, Microsoft Office, Time Management, Microsoft Excel, PowerPoint, Event Planning, Research, Social Media, Marketing
Education
Loyola Law School, Los Angeles 2014 — 2017
Doctor of Law (J.D.)
Chapman University 2009 — 2013
Bachelor of Arts (B.A.), History
Center for Juvenile Law and Policy August 2015 - Present
Legal Aid Foundation of Los Angeles June 2015 - July 2015
Integrium June 2013 - June 2014
Integrium September 2009 - June 2013
CASA of Orange County January 2013 - May 2013
Chapman Student Government Association May 2012 - April 2013
Athletic Republic of Orange County July 2012 - October 2012
Kappa Alpha Theta January 2011 - December 2011
Integrium June 2011 - August 2011
Professional Development Institute May 2010 - July 2010
Skills
Online Research, Microsoft Office, Time Management, Microsoft Excel, PowerPoint, Event Planning, Research, Social Media, Marketing
Education
Loyola Law School, Los Angeles 2014 — 2017
Doctor of Law (J.D.)
Chapman University 2009 — 2013
Bachelor of Arts (B.A.), History
Jennifer Soh's Integrium Experience June 2013 - August 2013
Job COO and Project Manager at Monimus, LLC
Industry Information Technology and Services
Experience
Anthiem Ventures February 2014 - Present
Monimus, LLC February 2014 - Present
Web Content Administrator at Heidi Daus Designs via Creative Group September 2013 - January 2014
Episolve LLC July 2013 - September 2013
Integrium June 2013 - August 2013
CreativeWell Inc., Literary and Lecture Agency September 2010 - May 2012
GEO Net Pages – Randolph, NJ January 2010 - September 2010
White Box Ltd. July 2009 - March 2010
Shootart.com (Christopher Burke Studio) May 2009 - June 2009
Skills
SEO, Web Development, Web Design, Photoshop, HTML, Dreamweaver, Office Administration, Office Management, Illustrator, InDesign, CSS, JavaScript, jQuery, Java, HTML 5, PHP, MySQL, LAMP, CSS3, WordPress, Drupal, Magento, Eclipse, Responsive design, Microsoft Excel, Microsoft Word, Quark, Microsoft Office, Microsoft Access, PowerPoint, Project Coordination, QuickBooks, Event Planning, User Experience Design, JazzMaster
Education
New Jersey Institute of Technology 2012 — 2014
Bachelor of Applied Science (B.A.Sc.), Web and Information Systems
Montclair State University 1999 — 2005
Bachelor of Fine Arts (BFA), Sculpture
Anthiem Ventures February 2014 - Present
Monimus, LLC February 2014 - Present
Web Content Administrator at Heidi Daus Designs via Creative Group September 2013 - January 2014
Episolve LLC July 2013 - September 2013
Integrium June 2013 - August 2013
CreativeWell Inc., Literary and Lecture Agency September 2010 - May 2012
GEO Net Pages – Randolph, NJ January 2010 - September 2010
White Box Ltd. July 2009 - March 2010
Shootart.com (Christopher Burke Studio) May 2009 - June 2009
Skills
SEO, Web Development, Web Design, Photoshop, HTML, Dreamweaver, Office Administration, Office Management, Illustrator, InDesign, CSS, JavaScript, jQuery, Java, HTML 5, PHP, MySQL, LAMP, CSS3, WordPress, Drupal, Magento, Eclipse, Responsive design, Microsoft Excel, Microsoft Word, Quark, Microsoft Office, Microsoft Access, PowerPoint, Project Coordination, QuickBooks, Event Planning, User Experience Design, JazzMaster
Education
New Jersey Institute of Technology 2012 — 2014
Bachelor of Applied Science (B.A.Sc.), Web and Information Systems
Montclair State University 1999 — 2005
Bachelor of Fine Arts (BFA), Sculpture
Kent Kashiwai's Integrium Experience November 2001 - April 2004
Job Sr. QA Associate II at Dendreon
Industry Biotechnology
Experience
Dendreon August 2010 - Present
Teva Pharmaceuticals April 2004 - August 2010
Integrium November 2001 - April 2004
Harbor UCLA Med Center, Research and Education Institute November 1993 - June 2001
Skills
GMP, CAPA, FDA, Validation, Sop, 21 CFR Part 11, Change Control, GLP, Pharmaceutical Industry, Biotechnology, V&V, LIMS
Education
UC Santa Barbara 1987 — 1992
Bachelor of Science (BS), Pharmacology
Dendreon August 2010 - Present
Teva Pharmaceuticals April 2004 - August 2010
Integrium November 2001 - April 2004
Harbor UCLA Med Center, Research and Education Institute November 1993 - June 2001
Skills
GMP, CAPA, FDA, Validation, Sop, 21 CFR Part 11, Change Control, GLP, Pharmaceutical Industry, Biotechnology, V&V, LIMS
Education
UC Santa Barbara 1987 — 1992
Bachelor of Science (BS), Pharmacology
Charlotte Hallow's Integrium Experience February 2013 - Present
Job Associate Director, Field Operations & Project Leader at Integrium
Industry Pharmaceuticals
Experience
Integrium February 2013 - Present
Integrium October 2008 - February 2013
Integrium October 2008 - July 2009
PAREXEL July 2006 - June 2008
PRA International June 2002 - July 2006
PRA International June 2002 - December 2002
PRA International June 2002 - October 2002
CroMedica October 2000 - June 2002
Quintiles May 1998 - October 2000
Quintiles May 1998 - September 1999
Skills
Clinical Research, CTMS, CRO, EDC, Clinical Monitoring, Clinical Trials, Clinical Development, Clinical Data Management, Regulatory Affairs, Regulatory Submissions, GCP, ICH-GCP, Pharmaceutical Industry, Sop, Medical Writing, Biotechnology, Endocrinology, Diabetes, Project Management, Cardiovascular Disease, Gene Therapy, Sleep Disorders, CNS disorders
Education
East Carolina University 1991 — 1996
Bachelor of Science (B.S.), Nutrition/Dietetics
North Carolina State University 1996 — 1998
Master of Science (M.S.), Food Science
Integrium February 2013 - Present
Integrium October 2008 - February 2013
Integrium October 2008 - July 2009
PAREXEL July 2006 - June 2008
PRA International June 2002 - July 2006
PRA International June 2002 - December 2002
PRA International June 2002 - October 2002
CroMedica October 2000 - June 2002
Quintiles May 1998 - October 2000
Quintiles May 1998 - September 1999
Skills
Clinical Research, CTMS, CRO, EDC, Clinical Monitoring, Clinical Trials, Clinical Development, Clinical Data Management, Regulatory Affairs, Regulatory Submissions, GCP, ICH-GCP, Pharmaceutical Industry, Sop, Medical Writing, Biotechnology, Endocrinology, Diabetes, Project Management, Cardiovascular Disease, Gene Therapy, Sleep Disorders, CNS disorders
Education
East Carolina University 1991 — 1996
Bachelor of Science (B.S.), Nutrition/Dietetics
North Carolina State University 1996 — 1998
Master of Science (M.S.), Food Science
Sagar Wagh's Integrium Experience 2004 - 2006
Job Associate Clinical Data Manager
Industry Pharmaceuticals
Experience
AstraZeneca 2011 - Present
GSK 2008 - 2011
Quintiles 2006 - 2008
Integrium 2004 - 2006
Skills
Project Management, Lean Six Sigma, PMP, Business Analysis, Oracle Clinical, SQL, Windows, SAS Programming
Education
Long Island University 2002 — 2004
Master of Science (MS), Biomedical Sciences, General
University of Mumbai 1999 — 2002
Bachelor of Science (B.Sc.), Molecular Biology
AstraZeneca 2011 - Present
GSK 2008 - 2011
Quintiles 2006 - 2008
Integrium 2004 - 2006
Skills
Project Management, Lean Six Sigma, PMP, Business Analysis, Oracle Clinical, SQL, Windows, SAS Programming
Education
Long Island University 2002 — 2004
Master of Science (MS), Biomedical Sciences, General
University of Mumbai 1999 — 2002
Bachelor of Science (B.Sc.), Molecular Biology