Premier Research Group
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Premier Research Group Employees
Optimal Research September 2015 - Present
Premier Research Group January 2005 - August 2015
Premier Research August 2004 - July 2005
Radiant Research 2003 - 2004
Radiant Research 1998 - 2003
Skills
CTMS, CRO, Clinical Trials, Clinical Development, Pharmaceutical Industry, GCP, ICH-GCP, Clinical Research, EDC, FDA, Oncology, Clinical Monitoring, Regulatory Submissions, Biotechnology, Clinical Data Management, Protocol, Medical Devices, Sop, Regulatory Affairs, Lifesciences, Vaccines
Education
McGill University
Bachelor of Science (BSc)
The Princeton Review May 2013 - Present
Learning corporation 2013 - Present
Global Leadership Academy Charter School 2014 - 2015
Altec May 2012 - May 2013
WyzAnt Tutoring April 2008 - May 2013
Rosemont College January 2011 - December 2011
Delta T Group January 2007 - February 2010
BROOKGLEN BEHAVIORAL HOSPITAL February 2007 - December 2007
Commonwealth of Pennsylvania November 2006 - December 2007
Premier Research Group March 2007 - July 2007
Skills
Interviews, Staff Development, Research, Psychology, Employee Relations, Microsoft Office, Public Speaking, PowerPoint, Training, Teaching, Mental Health, Tutoring, Adolescents, Higher Education, Program Development, Curriculum Design, K-12, Classroom Management, Lesson Planning, Differentiated..., Instructional Design, Technology Integration
Education
Gwynedd-Mercy College 2012 — 2013
M.Ed, Elementary Education and Teaching
2001 — 2005
B.A., Psychology
PENNSYLVANIA STATE UNIVERSITY University 2001 — 2005
Bachelor of Arts, Psychology 2005
DataCeutics September 2014 - Present
PAREXEL March 2012 - July 2014
Quintiles July 2011 - February 2012
Premier Research Group June 2007 - July 2011
Premier Research Group June 2006 - May 2007
New England Research Institutes October 2005 - March 2006
New England Research Institutes, Inc. (NERI) June 2004 - October 2005
Brandeis University September 2003 - June 2004
Institute for Community Inclusion June 2003 - September 2003
Skills
CDISC, Clinical Data Management, Statistics, Biostatistics, Oracle Clinical, SAS, SDTM, Pharmaceutical Industry, CRO, SAS programming, Statistical Programming, ICH-GCP, 21 CFR Part 11, Clinical Trials, Data Management, Clinical Research, Clinical Development, GCP, Therapeutic Areas, Oncology, Inform, CTMS, Software Documentation, EDC, Databases, Quality Assurance, Sop, Biotechnology, Drug Development, FDA, Protocol, Pharmacovigilance, Validation, Infectious Diseases, CRF design, Regulatory Submissions, SAS Programming, SOP
Education
Brandeis University 2000 — 2004
BA, English
Harvard University 2005 — 2005
Statistics Courses
Premier Research February 2014 - Present
Premier Research Group May 2012 - February 2014
Premier Research May 2009 - May 2012
Premier Research Group September 2009 - May 2011
Premier Research August 2008 - May 2009
Pottery Barn May 2008 - August 2008
Skills
Data Management, Oracle Clinical, Clinical Data Management, CRO, GCP, Clinical Trials, CTMS, EDC, Inform, Clinical Research, ICH-GCP, SOP
Education
Assumption College 2004 — 2008
Bachelors, Art History
Premier Research September 2013 - Present
Premier Research Group April 2012 - Present
PPD January 2010 - May 2012
PPD January 2007 - October 2010
Signature Science, LLC October 1997 - January 2007
JJT 1995 - 1997
Skills
SAS, Biostatistics, Clinical Trials, Regression, Survival Analysis, CDISC, Data Analysis, Clinical Data Management, Pharmaceutical Industry, Statistics, CRO, Clinical Research, EDC, Regression Testing, Clinical Development, Statistical Modeling, Data Management, Statistical Programming, SDTM
Education
New Mexico State University 1992 — 1994
M.S., Biostatistics
Kansas State University 1987 — 1992
B.A., Statistics
JobAnts.com August 2013 - Present
Bodhi Global Solutions LLC July 2009 - Present
InClin, Inc November 2014 - June 2015
Roche Molecular Systems March 2014 - October 2014
Premier Research Group October 2011 - November 2013
Galderma April 2011 - September 2011
Baxter Healthcare August 2010 - March 2011
Friendly Consultants July 2006 - June 2009
Skills
Startup Development, entrepreneur, SAS, CDISC, Clinical Data Management, Clinical Trials, Data Mining, Data Management, Predictive Modeling, Statistics, Analytics, SQL, 21 CFR Part 11, Validation, FDA, Clinical Research, CRO, Data Integration, Data Analysis, SDTM, Oracle Clinical, Biostatistics, Programming, Statistical Programming, Pharmaceutical Industry, SAS programming, ADAM, TLF, SAS Clinical Toolkit, Define.xml, Medidata RAVE, MS Office Suite, Clinical, Pharmaceuticals, EDC, Clinical Development, CTMS, Lifesciences, Analysis, Database Design, Life Sciences, Clinical Trial..., Microsoft Office, Database Marketing, Regulatory Submissions, SAS Programming
Education
Oklahoma State University 2003 — 2005
MS, MIS
Bharati Vidyapeeth 1998 — 2002
Production Engineering, 2002
Apple April 2015 - Present
Charles Schwab August 2014 - April 2015
Hemming Morse, LLP March 2014 - August 2014
Ernst & Young October 2010 - March 2014
Premier Research Group February 2009 - August 2010
Vertical Screen, Inc March 2005 - February 2009
Skills
Auditing, Internal Controls, Accounting, Fraud, Sarbanes-Oxley Act, Due Diligence, Financial Audits, Financial Analysis, Assurance, Financial Reporting, Finance, US GAAP, Certified Fraud Examiner, AML, Anti-corruption, FCPA, External Audit, Financial Accounting, Compliance, Sarbanes-Oxley, Corporate Fraud..., Certified Anti-Money..., General Ledger, Fraud Detection, Big 4, Anti-bribery, Data Analysis, Data Analytics
Education
Drexel University - College of Business and Administration 2009 — 2011
Accounting, Accounting
Medtronic January 2014 - Present
Covidien October 2011 - January 2014
Covidien October 2010 - October 2011
Covidien January 2010 - October 2010
Premier Research Group May 2009 - January 2010
Premier Research December 2007 - May 2009
Premier Research Group June 2007 - December 2007
Feeley's Co. Inc. June 2005 - June 2007
Department of Social Services March 2006 - June 2006
Skills
Oracle Clinical, CRF design, Data Management, Database Management, Databases, Clinical Trials, Vendor Management, Process Development, Business Process..., Cross-functional Team..., SQL*Plus, Siebel, Database Design, Data Integration, Database Admin, EDC, PL/SQL, CDISC, Pharmaceutical Industry, Oracle, Sop, Clinical Data Management, ICH-GCP, Integration, Software Documentation, Validation, 21 CFR Part 11, GCP, Process Simulation, Clinical Research, Medical Devices, CRO, Clinical Development, FDA, Clinical Study Design, Computer System...
Education
Connecticut College 2001 — 2005
B.A., Zoology
Northeastern University 2004 — 2004
E.M.T., Emergency Medicine
American Red Cross 2005 — 2011
Certification, Disaster Services Team
Hingham High School 1997 — 2001
High School
eClinical Solutions October 2014 - Present
Premier Research Group November 2011 - September 2014
Premier Research November 2008 - November 2011
Premier Research Group November 2007 - November 2008
Premier Research August 2007 - November 2007
ARS Clinical June 2007 - August 2007
Skills
Data Management, Oracle Clinical, Clinical Data Management, Clinical Trials, CRO, EDC, GCP, Software Documentation, SAE Reconciliation, Oncology, Medical Devices, Data Labs, Rare Diseases, Third Party Vendor..., Safety Management..., Medidata, J Review
Education
Bridgewater State University 2003 — 2007
Bachelors of Science, Psychology
Randstad Pharma April 2014 - Present
Mallinckrodt Pharmaceuticals August 2013 - February 2014
INC Research August 2012 - August 2013
Synchrogenix March 2012 - September 2012
Synchrogenix October 2010 - February 2012
Premier Research Group July 2010 - September 2010
Premier Research Group March 2007 - June 2010
Anita Frijhoff Freelance Medical Writer and Editor January 2006 - February 2007
UT MD Anderson Cancer Center December 2001 - December 2005
UT MD Anderson Cancer Center December 1997 - August 2001
Skills
Protocol, Medical Writing, Clinical Research, Regulatory Submissions, Biochemistry, Manuscript, Editing
Education
Leiden University
PhD, Medicine
University of Amsterdam
MS, Medical Biology
Premier Research Group 2012 - Present
Skills
Strategic IT Management, Infrastructure..., Cloud Vendor Management, Cloud Applications, ITIL Certified, SaaS, PaaS, IaaS, FDA, Pharmaceutical Industry, Global Implementations, Business Continuity, Validation, SDLC, System Development, CRO, Clinical Trials, Testing, GCP, Sop, EDC, Data Management, Clinical Data Management, Change Management, Document Management, System Testing, 21 CFR Part 11, Strategic Planning, Process Improvement, Risk Analysis, Risk Management, Service Delivery, Regulatory Compliance, Management Reporting, Vendor Selection, Vendor Management, Project Management, Team Leadership, SOP
Education
Cornell University 1991 — 1993
Bachelor of Science, Biology
Bain Capital September 2012 - Present
Premier Research Group September 2010 - September 2012
Big Y Foods October 2002 - September 2010
Big Y Foods June 2009 - September 2009
Westfield State College September 2008 - May 2009
Westfield State College Computer Lab December 2007 - May 2008
Skills
Helpdesk experience, Wireless Networking, Oracle, Active Directory, Windows Server 2003, Crystal Reports, Microsoft Office, Lotus Notes, Computer Hardware, Troubleshooting, Quality Assurance, Windows Server, Help Desk Support, Databases, Software Documentation, Outlook, Customer Service, Security, Technical Support, Servers, SharePoint, Project Management, Networking, VMware
Education
Westfield State College 2007 — 2009
Bachelor of Science, Computer Information Systems
Westfield State University 2007 — 2009
Bachelor of Science, Computer and Information Systems Security/Information Assurance
Holyoke Community College 2004 — 2007
Associate in Science, Information Security & Assurance
Holyoke Community College 2004 — 2007
Associate, Science; Information Security &
Premier Research Group March 2006 - Present
China Shipping (Group) Company May 1999 - April 2004
Skills
Oracle, PL/SQL, RMAN, Oracle Clinical, Clinical Data Management, Data Standards, Java, JSP, Applets, JavaBeans, Microsoft Servers, Windows Network..., Database Servers, Microsoft Infrastructure, Application Optimization, Database Optimization, SAS, GCP, Data Management, 21 CFR Part 11, CRO
Education
Bentley University 2004 — 2005
Master of Science (MS), Information Technology
Dalian Maritime University 1995 — 1999
Bachelor of Engineering (B.E.), Transportation and Materials Moving
Sanofi, U.S. July 2013 - Present
Sanofi U.S. September 2005 - July 2013
Centocor (J&J) November 1998 - August 2005
Premier Research Group May 1997 - November 1998
Novo Nordisk Pharmaceuticals April 1995 - May 1997
Novo Nordisk Inc 1994 - 1997
Janssen-Cilag June 1988 - April 1994
Skills
Planisware..., Clinical Research, Project Planning, Pharmaceuticals, SharePoint, Access, OPX2, Project Management, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Project Portfolio..., CRO, MS Project, Clinical Data Management, Oncology, Programming, Healthcare, Change Management, Drug Development, CTMS, Biotechnology, R&D, Biopharmaceuticals, Six Sigma, FDA, Cross-functional Team..., IND, Regulatory Submissions, Validation, Change Control, EDC, Microsoft Project
Education
Rutgers University-New Brunswick 1986 — 1988
none, Behavioral Neuroscience-Ph.D Progam
University of Alabama at Birmingham 1984 — 1985
none, Behavioral Neuroscience - Ph.D Program
City University of New York-Hunter College 1982 — 1984
none, Pre-Med 2nd B.A. Program
Skidmore College 1977 — 1980
BA, Psychology with minor in Dance
Bennington College 1976 — 1977
Undergrad (Dance and Psychology)
Applied Clinical Intelligence June 2012 - Present
United Biosource Corporation March 2006 - May 2012
Premier Research Group June 2001 - March 2007
Skills
EDC, Data Management, CRO, Clinical Trials, Inform, Oncology, Clinical Data Management, CDISC, CTMS, Viedoc EDC, ICH-GCP
Education
John Jay College of Criminal Justice 1994 — 1997
B.A., Criminal Justice
Premier Research Group February 2012 - Present
Thomas A. Laage, MD, MPH July 2009 - April 2012
Harvard School of Public Health 2010 - 2011
Private Practice July 1990 - January 2009
McLean Hospital July 1982 - July 1990
Brigham and Women's Hospital 1977 - 1979
Skills
Biostatistics, SAS programming, Sanskrit language, Clinical Trials, Clinical Study Design, Clinical Development, Oncology, Medical Writing, Biotechnology, Lifesciences, Pharmaceutical Industry, Infectious Diseases, FDA, Regulatory Affairs, Clinical Research, Public Health, Protocol, GCP, Medical Devices
Education
Harvard School of Public Health 2010 — 2011
MPH 2011, Quantitative Methods
McLean Hospital 1979 — 1982
NA, Psychiatry Residency
Brigham and Women's Hospital 1976 — 1979
NA, Internal Medicine
Albert Einstein College of Medicine of Yeshiva University 1973 — 1976
MD, Medicine
Harvard University 1969 — 1973
AB, Biochemical Sciences
University of Southern California 1968 — 1969
CVS Caremark Corporation February 2013 - Present
Jabil November 2011 - February 2013
Kingman Regional Medical Center June 2011 - November 2011
Premier Research Group February 2008 - May 2011
AHLSTROM LLC March 2002 - February 2008
Ernst & Young July 2000 - October 2001
Ernst & Young January 1998 - June 2000
SCHNEIDER NATIONAL CARRIERS INCORPORATED November 1996 - December 1997
US Navy January 1994 - November 1996
Naval Propulsion Examing Board (PEB) May 1992 - January 1994
Skills
Microsoft SQL Server, VB.NET, C# 4.0, ASP.NET AJAX, ASP.NET, CSS3, SDLC, Public Speaking, Process Automation, Software Development, Software Documentation, Software Project..., Systems Analysis, Microsoft Office, JavaScript, AJAX Toolkit, Oracle SQL, Crystal Reports, Photoshop, Illustrator, Flash, Adobe Fireworks, Dreamweaver, HTML, HTML 5, Lotus Notes, Lotus Domino, LotusScript, XML, Web Services, Web Development, Web Design, Web Analytics, Google Analytics, C# 2.0, SQL, C#, .NET, CSS
Education
National University 1993 — 1996
Master of Business Administration (MBA), Finance, General, 3.6
Miami University 1984 — 1988
BS, Marketing
Wayne High School 1980 — 1984
High School Diploma
H.M.Hillman Brass & Copper Inc January 2015 - Present
Premier Research Group March 2005 - January 2015
Office of the Comptroller of the Currency September 2002 - March 2005
Skills
Cash Management, Finance, Accounting, Financial Accounting, Banking, Internal Controls, Management, Sarbanes-Oxley Act, Human Resources, Budgets, Auditing, Clinical Trials, Financial Reporting, Analysis, Pharmaceutical Industry, Financial Analysis
Education
La Salle University 1998 — 2002
Bachelor of Arts, Accounting
Greenteaspoon April 2012 - Present
Azumio Inc. July 2011 - Present
Innovative Clinical Financing (ICF) September 2008 - March 2011
Latin American Clinical Research Sites May 2004 - 2011
Premier Research Group 2009 - 2010
MD Physicians' Research Network January 2001 - December 2003
Intermedics Orthopedics January 1993 - December 1997
Skills
Pharmaceutical Industry, Clinical Trials, CRO, Biotechnology, Clinical Research, Entrepreneurship, Project Management, Sales, Business Development, Hospitals, Lifesciences, Regulatory Affairs, Medical Devices, Data Analysis, Clinical Development, Life Sciences, Healthcare, Start-ups
Education
Medical College of Ohio 1998 — 2000
MSBS, Biomedical Research
University of South Carolina-Columbia 1991 — 1993
MS, Public Health/Epidemiology
Clemson University 1984 — 1987
BA, Psychology
Boehringer Ingelheim RCV GmbH & Co KG June 2012 - Present
Aptiv Solutions September 2010 - May 2012
Averion International April 2008 - September 2010
Premier Research Group June 2004 - June 2008
Skills
Clinical Monitoring, ICH-GCP, Clinical Trial..., CRO, GCP, Study Start-Up, Pharmacovigilance, Regulatory Requirements, Oracle Clinical, Oncology, CTMS, Regulatory Submissions, Infectious Diseases, EDC, Clinical Research, Neurology, Clinical Trials, Regulatory Affairs, Clinical Operations, Sop, Clinical Study Design, Drug Development, Cardiology, Rheumatology, Medical Writing, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Medical Affairs, Hematology, Diabetes, Clinical Development, Vaccines, Protocol, Inform, Clinical Research..., Endocrinology, Dermatology
Education
National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky 1996 — 2002
Ph.D, Pulmonology
Kyiv Medical Institute 1995 — 2001
MD, Pulmonology
Late Phase Research February 2014 - Present
Mapi - Real World Evidence April 2012 - January 2014
Atlantic Research Group March 2010 - April 2012
Encorium Group November 2007 - August 2009
Premier Research Group May 2004 - October 2007
IMPATH Predictive Oncology March 2001 - March 2003
Skills
Clinical Trials, Immunology, Business Strategy, Marketing, Leadership, CRO, Clinical Development, CTMS, GCP, Oncology, Pharmaceutical Industry, EDC
Education
La Salle University
B.S., Marketing
Valley Forge Military Academy & College
AA, Business Administration & Military Science
ICON plc September 2011 - Present
Premier Research Group June 2006 - September 2011
BioMarin 2004 - 2006
Corixa Corporation 2003 - 2004
Chiron Corporation 2002 - 2003
Abgenix 2000 - 2002
Stanford University 1997 - 2000
Skills
CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, GCP, EDC, Oncology, Pharmaceutical Industry, Biotechnology, Drug Development, ICH-GCP, Clinical Data Management
Education
Illinois State University
The Hartford February 2015 - Present
Premier Research Group February 2009 - Present
Aetna November 2004 - November 2008
United Bank Card 2003 - 2004
Drew University August 2001 - May 2002
Aetna May 2001 - January 2002
Skills
SQL, Data Analysis, Team Leadership, Process Improvement, Data Management, Crystal Reports, Java, Software Documentation, Databases, PL/SQL, Visual Basic, Testing, Troubleshooting, Project Management, Oracle, Database Design
Education
The University of Connecticut School of Business 2009 — 2014
Master of Business Administration (M.B.A.), Management; Management of Technology
Drew University 1998 — 2002
BA, Major: Computer Science Minor: Psychology
Gilead Sciences 2013 - Present
Summit Analytical, LLC September 2010 - Present
Premier Research Group June 2007 - April 2010
Skills
Clinical Trials, Pharmaceutical Industry, Biotechnology, Clinical Research, Clinical Development, Medical Devices, EDC, Clinical Data Management, CRO, Biopharmaceuticals, Oncology, GCP, CTMS, Sop, FDA, Regulatory Affairs
Education
DePaul University
BSc, Biochemistry
North Shore Country Day School
University of Illinois at Chicago
Biopharmaceutical Sciences
CTI Clinical Trial and Consulting Services November 2013 - Present
CTI Clinical Trial and Consulting Services November 2013 - Present
Premier Research Group November 2011 - November 2013
Duke University Clinical Research Unit November 2010 - December 2011
Louisiana Research Associates March 2010 - November 2010
Cetero Research August 2009 - March 2010
Centurion Clinical Research, LLC August 2008 - August 2009
New Orleans Center for Clinical Research January 2008 - August 2008
MDS Pharma Services October 2001 - December 2006
NJ Dept of Health/OEMS February 1991 - September 2001
Skills
Hypertension, Phase I, Clinical Trials, CRO, Diabetes, Clinical Monitoring, Clinical Development, GCP, EDC, Protocol, CTMS, Clinical Research, Medical Writing, ICH-GCP, Clinical Data Management, CRF design, Infectious Diseases, Sop, Therapeutic Areas, Drug Development, Regulatory Submissions, Clinical Study Design, Oncology, Clinical Operations, Patient Recruitment, Regulatory Affairs, Pharmacology, Pharmacovigilance, FDA, Medical Devices, Lifesciences, Biotechnology, Oracle Clinical, Cardiology, Vaccines, Trial Management, Inform, IND, Pharmaceutical Research, Pharmaceutical Industry, IRB, Clinical Pharmacology, Immunology, Medicine, GMP, Neurology, Pediatrics, Validation, Healthcare, 21 CFR Part 11
Education
Essex County College 1982 — 1984
AAS, Biology, Emergency Medical Services
University of Medicine and Dentistry of NJ 1984 — 1986
Certificate of Completion, Mobile Intensive Care Unit Paramedic
AKF Medical Language Services 2003 - Present
Premier Research Group February 2008 - December 2008
Vancouver Cancer Center July 2000 - December 2001
Pacific Clinical Trials, Vancouver, Canada November 1999 - May 2000
Stoke Mandeville Hospital, Aylesbury, UK January 1977 - February 1998
ASTA Medica AG, Frankfurt, Germany April 1991 - December 1996
Immuno AG, Vienna, Austria August 1978 - August 1990
Maschinenfabrik Andritz AG, Graz, Austria January 1977 - July 1978
Skills
Translation, Editing, Medical Writing, Project Management, Pharmaceutical Industry, Clinical Trials
Education
Ashridge Business School
Master of Business Administration (M.B.A.)
Universität Alma Mater Rudolphina Wien
Bachelor of Arts (B.A.), Translation (French>German)
Karl-Franzens-Universität Graz
Master of Arts (M.A.), Translation/Interpretation (English<>German)
Self employed - e Marketing Consulting January 2011 - Present
Pre-Paid Legal Services, Inc. March 2010 - April 2012
MetLife Financial Services June 2008 - December 2009
Premier Research Group June 1994 - November 2007
Skills
Clinical Data Management, Mergers, Marketing Materials, Financial Advisory, EDC, Due Diligence, CDISC, CRF design, Restructuring, Private Equity, Clinical Trial..., Data Validation, Online Marketing, Acquisition Integration, Oracle Clinical, Research, Customer Relations, Data Management, Mentoring, Operations Management, SEO, E-commerce, Languages, Creative Writing, Entrepreneurship, Marketing, Advertising, Mergers & Acquisitions, Email Marketing, CTMS, Business Development, Sales, Management, Small Business, Social Networking, Strategic Partnerships
Education
Jagiellonian University 1972 — 1977
MA, German Literature
Premier Research July 2012 - Present
Premier Research Group October 2011 - July 2012
Premier Research Group July 2011 - October 2011
Premier Research Group August 2009 - July 2011
Premier Research Group August 2007 - August 2009
Abraxis BioScience June 2006 - August 2007
Campbell University August 2005 - December 2006
Abraxis BioScience August 2005 - June 2006
Campbell University August 2004 - May 2006
Abraxis BioScience August 2004 - August 2005
Skills
Clinical Data Management, Clinical Trials, CRO, Oncology, Data Management, Oracle Clinical, Clinical Research, Project Management, Pharmaceutical Industry, CRF design, EDC, Rheumatoid Arthritis, Medical Coding, Cross-functional Team..., Medical Devices, Protocol, Pharmaceuticals, DataLabs, Oncology Clinical..., Medical Device Research, Remote Data Capture, Sop, SOP, Validation
Education
Campbell University 2002 — 2003
Master's of Science, Clinical Research
Campbell University 1998 — 2002
Bachelor's of Science, Clinical Research
North Forsyth High School 1994 — 1998
Premier Research January 2014 - Present
Premier Research Group February 2008 - Present
Skills
Microsoft Office, Photoshop, Time Management, Microsoft Word, Outlook, Data Entry, GCP, Microsoft Excel, CRO, Software Documentation, Pharmaceutical Industry, Access, Clinical Trials, Project Management, PowerPoint, Data Analysis, Visio, Customer Service, Team Leadership
Education
Community College of Philadelphia 2000 — 2003
Associates, Liberal Arts
Takeda March 2014 - Present
AbbVie March 2010 - March 2014
Premier Research Group 2008 - 2009
University of Illinois at Chicago September 1998 - June 2008
Skills
SAS, Clinical Trials, Pharmaceuticals, Statistics, Programming, Pharmaceutical Industry, Biostatistics
Education
University of Illinois at Chicago 2006 — 2008
Master of Sciences, Mathematical Statistics
Peking University 1995 — 1998
PhD, Biochemistry
China Agricultural University 1988 — 1992
Bachelor of Science (BS), Animal Genetics
AbbVie February 2013 - June 2015
PPD 2012 - 2013
Johnson & Johnson 2011 - 2012
Shire Pharmaceuticals 2009 - 2010
Shire Pharmaceuticals 2004 - 2009
Premier Research Group 2001 - 2004
Medex Clinical Trials 1999 - 2001
Acute and Outpatient Care Facilities 1990 - 1999
Skills
Pharmacovigilance, Team Leadership, Quality Assurance, Regulatory Requirements, CAPA, Auditing, Drug Safety, Operations Management, Change Management, Process Improvement, GCP, Compliance, Clinical Trials
Education
Pennsylvania State University-Great Valley Graduate Center
MBA, Healthcare and Biotech Management
Richard Stockton College of New Jersey
BSN, Nursing
Hahnemann University Hospital
Critical Care Nursing Course, Nursing-Critical Care
Bucks County Community College
Associate Degree in Nursing
Quintiles January 2012 - Present
2008 -Premier Research Group January 2008 - December 2010
Premier Research Group June 2007 - January 2008
Emory University School of Medicine Winship Cancer Institute July 2004 - June 2007
Emory Univeristy School of Medicine Winship Cancer Institute October 2002 - June 2004
Skills
Pharmaceutical Industry, CRO, Clinical Research, Cancer, Protocol, EDC, FDA, Clinical Data Management, Clinical Trials, Data Management, GCP, ICH-GCP, Medical Writing, Oncology, Therapeutic Areas, Validation
Education
Georgia State University 2000 — 2002
MS, Biochemistry and Molecular Genetics
Georgia State University
B.S, Biology; Pre-Med
eClinical Solutions April 2013 - Present
Pfizer November 2007 - December 2012
Premier Research Group February 2006 - November 2007
EMD Serono, Inc. 2001 - 2005
PAREXEL 1994 - 2000
Skills
Clinical Data Management, EDC, Oracle Clinical, CRF design, CRO, CTMS, Clinical Trials, GCP, ICH-GCP, 21 CFR Part 11, Clinical Development, Data Management, Oncology, Therapeutic Areas, Pharmaceutical Industry, Clinical Monitoring, Clinical Research, Inform, CDISC, Sop, Clinical Operations, Protocol, Pharmacovigilance, Drug Development, Infectious Diseases, FDA, Validation, Clinical Study Design
Education
University of Massachusetts Lowell 1989 — 1993
Master of Science, Health Services Administration
Framingham State University 1982 — 1986
Bachelor of Science, Medical Technology
Premier Research September 2013 - Present
Just Joan Clinical Research, LLC April 2013 - Present
Enzon Pharmaceuticals February 2011 - April 2013
NicOx January 2007 - February 2011
Premier Research Group 2006 - 2007
PRA International 2005 - 2006
Covance 1994 - 2004
Hoechst Roussel Pharmacueticals 1990 - 1994
Berlex Laboratories 1988 - 1990
Skills
Clinical Development, CRO, Clinical Trials, Clinical Research, Management, CTMS, Medical Devices, Sop, Pharmaceutical Industry, Medical Affairs, Oncology, Lifesciences, Contract Negotiation, Drug Development, Clinical Operations, ICH-GCP, Clinical Monitoring, Regulatory Submissions, Budgets, FDA, Therapeutic Areas, Biotechnology, Data Management, Medical Writing, Protocol, SOP
Education
Cedar Crest College 1978 — 1982
BS, Nursing
OM Pharm Associates, Inc. April 2010 - Present
Self employed January 2000 - Present
Medtronic Spine & Biologics April 2010 - February 2012
Center Orthopedic & Neurosurgery - Bend 2010 - 2011
Premier Research Group 2007 - 2008
MAP Pharmaceuticals 2006 - 2008
Point Therapeutics 2006 - 2008
Javelin Pharmaceuticals 2006 - 2008
Atlantic Research Group 2005 - 2007
InGenium Research, Inc. 2005 - 2006
Skills
TV Commercial actor, Radio voice over actor, Cardiology, Clinical Trials, GCP, Vaccines, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, FDA, Oncology, Protocol, Project Management
Education
Gonzaga University
Pre-Med; Biology / Chemistry
San Francisco State University
BA, Pre-Med
Premier Research Group February 2012 - Present
Shire Pharmaceuticals April 2010 - February 2012
United BioSource Corporation September 2005 - April 2010
Bristol-Myers Squibb January 2003 - September 2005
Berlex Laboratories (Bayer/Schering AG) August 2001 - January 2003
PAREXEL International February 1993 - May 2000
Skills
Therapeutic Areas, Oncology, Medical Writing, Clinical Trials, Clinical Research, Medicine, Central Nervous System, Clinical Development, Pharmaceutical Industry, Neurology, CRO, Regulatory Submissions, Software Documentation, GCP, Diabetes, ICH-GCP, CTMS, Pharmaceutics, Drug Development, Clinical Data Management, Pharmacovigilance
Education
Northeastern University 2011 — 2015
Master's degree, Regulatory Affairs for Drugs, Biologics, and Devices
Florida State University 1983 — 1985
BA, English, International Affairs
Gettysburg College 1981 — 1983
English, Political Science
High school
Premier Research Group August 2005 - Present
PharmData, Inc. February 1996 - July 2005
Skills
Protocol, Biotechnology, General Awesomeness, Clinical Trials, Research, Medical Writing, Pharmaceutics, FDA, CRO, Clinical Research, Clinical Development, Clinical Study Design
Education
Georgia State University 1991 — 1995
MA
UCLA 1987 — 1991
BA
Loara
Independence Blue Cross March 2014 - Present
Premier Research Group February 2012 - February 2014
Florida State University April 2010 - December 2011
Florida State University 2008 - 2010
Solution Skills Inc. 2002 - 2006
McKesson Provider Technologies May 2005 - August 2005
Skills
Statistics, Data Analysis, SAS, Mathematics, Data Management, Analysis, Programming, Research, Project Management, Predictive Modeling, Predictive Analytics, Big Data Analytics, Analytics, Maple, University Teaching, Mathematica, Mentoring, Fortran, LaTeX, Management, R, Mathematical Modeling, Statistical Modeling, Technical Writing, GAP, SPSS, WebAssign, e-Grade, Microsoft Excel, Matlab, Microsoft Office, Science, Teaching, Public Speaking, SQL, Higher Education
Education
Florida State University 2009 — 2012
Doctor of Philosophy (Ph.D.), Mathematics
Florida State University 2006 — 2009
Master's Degree, Mathematics
Florida State University 2002 — 2006
Bachelor's Degree, Mathematics, Statistics (Double Major)
Venice High School 1998 — 2002
High School Diploma
PAREXEL February 2013 - Present
Premier Research Group July 2010 - January 2013
Kforce Clinical Research, Inc. 2008 - July 2010
PPD February 2007 - February 2008
PPD January 2006 - February 2007
Oncology Alliance 2003 - 2006
Aurora Health Care 1996 - 2003
St LukesMedical Center December 1989 - January 1996
Skills
Oncology, GI, CTMS, Clinical Monitoring, Clinical Trials, ICH-GCP, GCP, EDC, CRO, Clinical Research, Dermatology, Therapeutic Areas, Medicine, Clinical Operations, Clinical Development, Infectious Diseases, Pharmaceutical Industry
Education
Alverno College 1990 — 1994
Bachelors of Science, Nursing
John C. Lincoln Health Network June 2015 - Present
Oasis Hospital November 2012 - Present
Premier Research Group January 2008 - June 2015
Pulmonary Associates, Phoenix, AZ June 2003 - January 2008
Northwest Valley Health Associates, Sun City, AZ April 2001 - June 2003
Skills
Clinical Research, Health Assessments, critical thinking, wound care, Venipuncture, IV placement and therapy, Pulmonary Function..., EKG, Vitals, triage, Surgical Prep, sterile techniques, scheduling, GCP & ICH guidelines, Health Assessment, PFT, IV, Temporary Placement, Therapists, Critical Thinking, Vital Signs, Wound Care, Triage, Surgery, ICU, Nursing, ICH-GCP, Healthcare Management, EMR, BLS, Acute Care, Hospitals, Critical Care, Patient Education, Phlebotomy, Patient Advocacy, Healthcare Information..., Direct Patient Care, Process Scheduler, ACLS, Patient Safety, Medical Terminology, HIPAA, CRO
Education
Chamberlain College of Nursing-Phoenix Campus 2009 — 2012
Bachelor of Science (BS) Nursing, BSN
Long Technical College, Phoenix, AZ 2000 — 2001
Sports Medicine/Orthopedics & Medical Assistant
PRA Health Sciences July 2015 - Present
PRA Health Sciences November 2012 - July 2015
PRA International March 2011 - November 2012
PRA International May 2010 - March 2011
Premier Research Group May 2009 - April 2010
Premier Research Group April 2005 - April 2009
Covance 2003 - 2005
Mercer County Community College 2004 - 2004
Community College of Philadelphia 2003 - 2003
SCIREX Corporation 2001 - 2003
Skills
Clinical Trials, Protocol, Data Management, Statistics, CRO, Oncology, Clinical Research, GCP, CTMS, EDC, ICH-GCP, Pharmaceutical Industry, Drug Development, Vaccines, Clinical Development, Clinical Data Management, Clinical Monitoring, Regulatory Submissions, FDA, Therapeutic Areas, Regulatory Affairs, 21 CFR Part 11, Clinical Operations, Infectious Diseases, Sop, SOP
Education
Villanova University 2001 — 2003
MS, Applied Statistics
Willowbrook High School 1979 — 1982
Loyola University Chicago
BS, Psychology
Accenture March 2015 - Present
Knowledgent September 2013 - March 2015
Accenture February 2013 - August 2013
Revenue Solutions, Inc. March 2012 - August 2013
Premier Research Group December 2011 - March 2012
Skills
PL/SQL, IBM Rational Tools, Oracle Clinical, IBM BPM, BPMN, IBM Process Designer, Cognos 8 Report Studio, Cognos 8 Framework..., Requirements Gathering, Use Case, Activity Diagrams, JAD, Relational Databases, Database Design, Visio, Business Intelligence..., ERD, Oracle SQL, Data Mining, Query Optimization, Data Analysis, SQL*Plus, SQL Tuning, Oracle Discoverer, Integrated Review, JReview, SQL Navigator, TOAD, SQL, Cognos
Education
Boston University 2010 — 2012
M.S., Computer Information Systems
Vanderbilt University 2004 — 2008
B.S., Human and Organizational Development
Sanofi October 2014 - Present
AbbVie May 2013 - October 2014
ReSearch Pharmaceutical Services February 2010 - May 2013
Premier Research Group November 2004 - October 2009
Skills
ICH-GCP, Clinical Trials, Clinical Research, CRO, CTMS, EDC, Clinical Development, Therapeutic Areas, GCP, Clinical Monitoring, IRB, Oncology, Infectious Diseases, Inform, Medical Writing, Pharmaceutical Industry
Education
Charter Oak State College
BS- psychology, AS- General; Bachelor's of Science- Psychology
Charter Oak State College
Associates of Science, general
Santa Barbara City College
University of Hawaii-West Oahu
PRA Health Sciences June 2015 - Present
PRA International July 2013 - June 2015
Premier Research Group July 2012 - July 2013
University of Pennsylvania Health System January 2009 - June 2012
Children's Hospital of Philadelphia September 2010 - January 2012
University of Pennsylvania Presbyterian Hospital December 2008 - May 2010
Saint Joseph's University August 2005 - May 2009
Skills
Team Leadership, Attention To Detail, Statistics, Psychology, Clinical Research, Clinical Trials, Organizational Structure, Clinical Trial Associate, Regulatory Submissions, Regulatory Documentation, ICH-GCP, Communication Skills, Biotechnology, Protocol, CRO, Pharmaceutical Industry, Clinical Data Management, EDC, Oncology, CTMS, Microsoft Office, Clinical Development, GCP, Research
Education
Drexel University College of Medicine 2013 — 2014
Masters of Science, Clinical Research Organization and Management, 3.95
University of Pennsylvania 2009 — 2011
Post-Baccalaureate Certificate, Pre-Health Studies, 3.55
Graduate of Saint Joseph's University 2005 — 2009
B.S, Psychology; Experimental, 3.5
Bishop Eustace Preparatory School 2001 — 2005
High School Diploma, General High School Education, 3.85
RiverCity Research Organization November 2010 - Present
Southeast Renal Research Institute September 2009 - Present
Premier Research Group September 2006 - May 2009
SCIREX Corporation November 2004 - September 2006
SCIREX Corporation October 2003 - November 2004
SCIREX Corporation March 2002 - October 2003
Chiltern International 1999 - 2002
Skills
CRO, CTMS, Oncology, Therapeutic Areas, Clinical Monitoring, Diabetes, Clinical Research, Medical Devices, Nephrology, Pain Management, GCP, Clinical Trials, EDC, Clinical Development, ICH-GCP, Clinical Data Management, Protocol, Sop, Pharmaceutical Industry, Trial Management, Clinical Operations, Regulatory Submissions, Patient Recruitment, CRF design, Drug Development, Vaccines, Dermatology, Data Management, Pharmaceutical Research, Clinical Study Design, Pharmaceutics, Medical Research, Infectious Diseases, Pharmacovigilance, Medical Writing, IND, Neurology, Biotechnology, Cardiology, FDA, Lifesciences, Oracle Clinical, Phase I, Regulatory Affairs
Education
East Tennessee State University 1999 — 2000
Graduate Studies, Healthcare Management
East Tennessee State University 1995 — 1999
B.S., Public Relations and Clinical Psychology
AbbVie October 2014 - Present
Scoping By Angela, LLC June 2004 - December 2014
Avella Specialty Pharmacy September 2013 - October 2014
Premier Research Group July 2011 - September 2013
Serenity Hospice & Palliative Care March 2013 - August 2013
West Valley Hospital January 2011 - July 2011
Rush University Medical Center June 1994 - May 1998
Skills
Biopharmaceuticals, Drug Development, Immunology, Patient Safety, Presentations, Clinical Analytics, Clinical Research, Nursing, Healthcare, Hospitals, Clinical Trials, Acute Care, Hematology, IV, GCP, ICH-GCP, Phase I, Informed Consent, Proofreading, Copy Editing, Laboratory Medicine, CRFs, ACLS, BLS, Clinical, Health, Nurses, Stylistic Editing, Medicine
Education
Chamberlain College of Nursing 2008 — 2010
BSN, Nursing
Gateway Community College 2005 — 2006
Certificate of Diploma, Clinical Research Coordinating, A
Indiana State University 1990 — 1993
BS, Medical Technology
Manulife Asset Management January 2013 - Present
John Hancock Life Insurance Company (U.S.A.) June 2011 - December 2012
Premier Research Group June 2009 - May 2011
ABC MT September 2008 - May 2010
Horizon Capital Realty June 2008 - August 2008
Joslin Diabetes Center Through the OfficeTeam June 2007 - August 2007
BSI International June 2006 - August 2006
Skills
Business Analysis, Database Design, PL/SQL, SQL, Oracle, Databases, Microsoft SQL Server, Integration, VBA, Crystal Reports, Portia, Client Reporting, Agile, Iterations, Project Management, Project Coordination, CRM, Requirements Analysis, Data Mining, Data Analysis, XML, Requirements Gathering, Quality Assurance
Education
University of Massachusetts, Amherst 2004 — 2008
Bachelors, Economics and Management Information Systems
Boston Latin School 1998 — 2004
Teva Pharmaceuticals July 2015 - Present
Genentech May 2012 - May 2015
PRA International January 2011 - May 2012
ICON plc January 2008 - December 2010
ICON plc September 2006 - December 2007
ICON plc August 2004 - September 2006
Covance November 2002 - August 2004
Covance September 2001 - November 2002
Covance October 1999 - October 2001
Premier Research Group March 1999 - October 1999
Skills
Data Management, Clinical Trial..., Clinical Data Management, EDC, Clinical Research, Oracle Clinical, Medidata, CRO, GCP, Validation, CRF design, SAS, ICH-GCP, Access, Excel, PowerPoint, Mentoring, Microsoft Office, CTMS, Phase I, Phase 2, Phase 3, Phase 4, Query Management, Vendor Management, Oncology Clinical..., Cardiology, Oncology
Education
Temple University - School of Pharmacy 1995 — 1998
BS, Pharmacy
Delaware County Community College 1991 — 1994
Associates, Natural Science
Cardinal O'Hara High School 1987 — 1991
High School Diploma, Academic
Saint Kevin 1978 — 1987
Academic (K-8)
CRO Clinical Research Associate IIQuintilesJune 2014 - Present
Repros Therapeutics August 2012 - October 2013
Premier Research Group February 2012 - June 2012
Baylor College of Medicine/VA Medical Center August 2009 - January 2012
Harris County Hospital District- Ben Taub County Hospital November 2007 - November 2011
MD Anderson Cancer Center February 2006 - August 2009
Intercontinental Fragances ( Symrise) 2004 - 2006
Skills
MS Office Suite, Clinical Research, Clinical Trials, Oncology, Biotechnology, CRO, GCP, Clinical Monitoring, EDC, Protocol, IRB, Patient Recruitment, CTMS, Research, ICH-GCP, Lifesciences, CRF design, Regulatory Affairs, Healthcare, FDA, Therapeutic Areas, Pharmacology, Cancer, Gastroenterology, Data Analysis, Microsoft Office, Life Sciences
Education
Texas A&M University 2001 — 2004
Bachelors of Science, Biology
Blinn College 1999 — 2001
Applied Science
Dayco October 2014 - Present
Dayco Products November 2011 - October 2014
Premier Research Group February 2010 - November 2011
New York Life Retirement Plan Services July 2006 - February 2010
Skills
Oracle Clinical, Clinical Trials, Clinical Research, Therapeutic areas, Clinical, Oncology, CRO, Data Management, Clinical Data Management, EDC, SOP, Pharmaceuticals, Salesforce.com, Outlook, Lotus Notes, Microsoft Excel, PowerPoint, Microsoft Word, Program Management, Sop, Sales, Quality Assurance, Data Analysis, Management, Pharmaceutical Industry
Education
Bryant University 2001 — 2005
Bachelor of Science, Business Administration; Marketing
Family Service Association June 2013 - Present
The Wedge Recovery Center January 2013 - Present
PeopleRUs August 2012 - January 2013
Social Work Connections September 2011 - May 2012
The Center For Family Services September 2010 - May 2011
Premier Research Group October 2006 - May 2009
Pfizer 2004 - 2006
Skills
CBT, Case Managment, Clinical Data Management, Clinical Research, Crisis Intervention, Group Therapy, Mental Health, Mental Health Counseling, Adolescents, Behavioral Health, Case Management, Clinical Supervision, Clinical Trials, Community Outreach, Counseling Psychology, Customer Service, Family Therapy, Event Planning, Grant Writing, Non-profits, Program Development, Microsoft Office, Fundraising, Psychology, Psychotherapy, Public Speaking, Research, School Social Work, Social Services, Treatment
Education
Fordham University 2009 — 2012
Masters, Clinical Social Work/Law
State University of New York College at Buffalo 1998 — 2002
Bachelor of Arts (B.A.), Psychology
Drexel University
Masters, Clinical Research
Maryvale Senior High School
Ansun Biopharma, Inc. July 2014 - Present
Rebecca N. Schiller Consulting April 2006 - Present
Accelovance, Inc. April 2014 - January 2015
ICON plc April 2013 - March 2014
Cell Therapeutics, Inc. October 2012 - April 2013
Covance February 2012 - September 2012
Novella Clinical December 2008 - January 2012
Aptium Oncology May 2011 - November 2011
Premier Research Group January 2008 - February 2009
Kendle International October 2005 - December 2008
Skills
Clinical Monitoring, ICH-GCP, Phase 1 - 4 Clinical..., Site Managment, EDC, Auditing, Oncology, Infectious Diseases, Hematology, CNS/Psychiatry, Endocrinology, Diabetes, Respiratory, Pharmacokinetics, Pharmacodynamics, Regulatory Documentation, Pharmaceutical Industry, Clinical Trials, Protocol, Respiration, Management, CTMS, GCP, Clinical Research, Cancer, Therapeutic Areas, Lifesciences, FDA, Phase 1, Clinical Development, Immunology, Medical Writing, Phase I, Neurology, Pharmacovigilance, Drug Development, Biotechnology
Education
National Cancer Institute 1998 — 1999
Research Fellow
Bastyr University 1996 — 1998
MS
University of Wisconsin-Madison 1987 — 1991
BA
Northwest Yeshiva High School
Northwest Yeshiva High School
Pfizer, Inc November 2009 - Present
Premier Research Group June 2005 - November 2009
PRA International 2004 - 2005
Smith Hanley Consulting Group 2001 - 2004
Allergan June 2003 - December 2003
Amgen November 2001 - June 2003
Quintiles 1999 - 2000
Skills
Clinical Data Management, Oracle Clinical, Clinical Trials, Validation, SOP, Clinical Research, Pharmaceuticals, GCP, 21 CFR Part 11, Mentoring, Microsoft Office, Computer System..., Supervisory Skills, Customer Relations, Budgeting, Problem Solving, ICH-GCP, Performance Management, Vendor Management, Hiring, CAPA, Internal Communications, Regulatory Requirements, Randomization, Sop, Pharmaceutical Industry, Clinical Data
Education
Boston University 2011 — 2014
Master's of Science, Health Communications
Central Missouri State University 1994 — 1996
Business Administration, Marketing
AT&T Mobility April 2013 - Present
The Exchange, Georgia State University July 2010 - April 2013
Georgia State University August 2009 - May 2010
Premier Research Group May 2008 - December 2008
Solvay Pharmaceuticals October 2007 - May 2008
Citysam AG February 2006 - July 2006
Skills
Instructional Design, Camtasia, SnagIt, Captivate, Photoshop, eLearing, Final Cut Pro, Wordpress, Microsoft Office, PowerPoint, Word, RedDot, CMS, German, Teaching, Editing, Problem Solving, Training Delivery, Technical Training, Microsoft Word, Distance Learning, Learning Management..., WordPress, HTML, E-Learning, Training, Staff Development, Instructional Technology
Education
Georgia State University 2009 — 2010
MA, German Literature
University of Potsdam 2003 — 2007
BA, English and American Literature and Language, Minor: Spanish Philology
Vector Oncology April 2015 - Present
PAREXEL International, LLC-PACE NA July 2010 - April 2015
Premier Research Group June 2006 - June 2010
BARD Peripheralvascular, Inc. September 2005 - May 2006
Ingenix/i3 Research, Inc. September 2003 - December 2004
MDS Pharma Services, Inc. July 1998 - September 2003
Organon Pharmaceuticals 2001 - 2002
Barrow Neurological Group January 1995 - July 1998
Barrow Neurological Institute July 1993 - January 1995
Maricopa Medical Center June 1991 - July 1993
Skills
Multi-Tasking / Project..., Analysis & Investigation, Continuous Process..., Expense Planning &..., Scientific..., Software Utilization /..., Interpersonal..., Original Content..., Complex Problem Solving, Root Cause Analysis, Project Planning and..., Project Leadership..., Risk Management, Project Scope Management, Meeting Planning and..., Clinical Research, Clinical Trials, Neurology, GCP, Clinical Monitoring, Nursing, Medical Devices, CTMS, Clinical Development, ICH-GCP, Neuroscience, Scope Management, Lifesciences, Clinical Operations, EDC, CRO, Clinical Data Management, Therapeutic Areas, Clinical Study Design, Regulatory Submissions, Drug Development, Oncology, CRF design, Infectious Diseases, Oracle Clinical, Medical Writing, Sop, Regulatory Affairs, Pharmacovigilance, Inform, FDA, Continuous Improvement, Content Development, Diabetes, 21 CFR Part 11
Education
The George Washington University School of Medicine and Health Sciences 2004 — 2006
MSHS, Clinical Research Administration
Nazareth College 1988 — 1991
BA, Psychology
Genesee Community College 1975 — 1977
AAS, Registered Professional Nursing
Medpace January 2010 - Present
Camargo Pharmaceutical Services 2009 - March 2010
Premier Research Group 2005 - 2009
PRA International January 2004 - June 2005
Skills
Neurology, Autoimmune Diseases, Biosimilars, Orphan Indications, Pain Management, Analgesia product..., Clinical Development, 505(b)2 regulations, Neuroscience, Drug Development, Regulatory Submissions, CRO, Biotechnology, Pharmacovigilance, Regulatory Affairs, Oncology, Multiple Sclerosis, neuro-oncology, Medical Affairs, Clinical Trials, FDA, Biologics
Education
State University of New York at Buffalo 1989 — 1994
MD, Neurology Residency Program
Damascus University
Pentair August 2013 - Present
Wipfli LLP October 2011 - August 2013
Premier Research Group June 2001 - December 2009
Thermo Fisher Scientific June 1991 - March 2001
Skills
PowerPoint, Administrative..., Microsoft Word, Outlook, Microsoft Excel, Office Management, Microsoft Publisher, Caseview, STAR, Executive Calendar..., Event Planning, Management, Microsoft Office, Accounting, Recruiting, Administrative..., Customer Service, Nonprofits, Travel Arrangements, Human Resources, Administration, Training
Education
Elgin Community College 1989 — 1991
Legal Secretary
Hyland, creator of OnBase March 2015 - Present
North Carolina Department of Health and Human Services July 2014 - December 2014
Westerly Ambulance Corps, Inc. January 2006 - December 2012
Westerly Ambulance Corps, Inc. June 2008 - December 2010
Premier Research Group November 2009 - May 2010
COMSYS November 2006 - November 2009
Telltale Consultants January 2002 - December 2008
COMSYS March 2004 - September 2005
TMP Worldwide November 2000 - June 2002
EVAS May 1999 - November 2000
Skills
Databases, EDC, Oracle Clinical, Troubleshooting, Operating Systems, Windows, Windows Server, Clinical Trials, XP, Integration, Training, Management, Software Documentation, Networking, Data Management, Microsoft Office, Database Design, Visio, CTMS, SharePoint, Healthcare Information..., Sop, Protocol, SDLC, SAS programming, GCP, 21 CFR Part 11, SAS, Quality Assurance, Validation, Pharmaceutical Industry, Software Installation, FDA, Help Desk Support, Data Analysis, CRO, Testing, Clinical Development, Clinical Data Management, Windows XP
Education
Stony Brook University 1980 — 1982
MS, Marine Environmental Science
Boston University 1977 — 1980
BA, Biology
SEA
Sea Education Association
Massachusetts General Hospital October 2013 - Present
Massachusetts General Hospital December 2011 - Present
Premier Research Group June 2010 - December 2011
Skills
Clinical Data Management, GCP, Clinical Trials
Education
Fairfield University 2006 — 2010
BS, Biology
Notre Dame Academy 2002 — 2006
Celgene January 2013 - Present
Celgene October 2007 - Present
Celgene October 2007 - January 2013
Premier Research Group January 2007 - October 2007
Mile High Oncology April 2006 - January 2007
Ortho Biotech/Johnson and Johnson January 2005 - April 2006
Eli Lilly and Company May 2001 - December 2004
US Oncology, Rocky Mountain Cancer Center January 2000 - May 2001
US Oncology, Rocky Mountain Cancer Center February 1998 - January 2000
Rocky Mountain Cancer Center March 1991 - February 1998
Skills
Clinical Trials, Oncology, GCP, CRO, Clinical Research, Regulatory Affairs, Sop, Clinical Operations, Protocol, Data Management, Healthcare, Medical Affairs
Education
Clarke University 1985 — 1987
Bachelor of Science, Nursing
University of Iowa; Clarke College 1982 — 1987
BSN, Nursing
Iowa 1981 — 1985
Bachelor of Science, Nursing
University of Iowa
BSN, Nursing
BioBridges March 2015 - Present
Consultant at Johnson and Johnson November 2014 - February 2015
BioBridges 2015 - 2015
CSL Behring January 2013 - November 2014
Endo Pharmaceuticals January 2010 - January 2013
Premier Research Group November 2007 - November 2009
AstraZeneca Pharmaceuticals August 2006 - November 2007
Glaxo Smith Kline January 2006 - September 2006
Glaxo SmithKline (GSK outsource group May 2006 - August 2006
Glaxo Smith Kline May 2005 - January 2006
Skills
Clinical Data Management, EDC, CRO, Clinical Trials, CTMS, Data Management, FDA, Oncology, Clinical Development, Oracle Clinical, Pharmaceutical Industry, Therapeutic Areas, Clinical Research, GCP, CDISC, CRF design, Sop, 21 CFR Part 11, ICH-GCP, Regulatory Affairs, Drug Development, Cross-functional Team..., Biotechnology, Protocol, Validation, Inform, Infectious Diseases, Clinical Study Design, Clinical Monitoring, Regulatory Submissions, Pharmacovigilance, Life Sciences, Lifesciences, Quality Assurance, Medical Writing, Computer System..., Biopharmaceuticals, IND, GxP, Project Management, SOP
Education
Project Management Institute 2014 — 2014
Project Management Professional, Project Management
CCDM: Society For Clinical data Management 2009 — 2009
CCDM, Clinical data management certification
Campbell University 1999 — 2002
Clinical Research
Coe College 1989 — 1993
BA, Biology and Material Science
Coe College 1989 — 1992
BA, Biology
Visva-Bharati 1985 — 1989
Mathematics and
Wake Forest University
Panorama MedWriters Group, Inc. 2005 - Present
Premier Research Group July 2008 - June 2010
BIOGEN IDEC 2004 - 2005
Alliance Pharmaceutical 1998 - 2001
CITICORP DINERS CLUB INTERNATIONAL 1995 - 1998
Technical Information Associates 1995 - 1996
Steri-Oss, Inc. (now NobelBiocare) 1992 - 1994
Skills
Protocol, Annual Reports, Medical Writing, Oncology, Infectious Diseases, Clinical Trials, Regulatory Submissions, Therapeutic Areas, Clinical Development, eCTD, Clinical Research, Drug Development, GCP, Medical Devices, Lifesciences, Diabetes, FDA, Biotechnology, Pharmaceutical Industry, Life Sciences
Education
University of Colorado Denver 1994 — 1997
MS
California State University-Fullerton
BA
Philadelphia Zoo January 2013 - Present
JoAnn Fabrics August 2012 - January 2013
St. James School 2011 - 2012
St. Malachy's School August 2007 - February 2010
Premier Research Group 2007 - 2007
Kaplan Professional Schools July 2004 - August 2006
California Labor Federation May 2002 - June 2004
San Francisco School to Career Partnership April 2000 - May 2002
San Francisco Hotel Partnership Project January 1996 - April 2000
San Francisco Art Institute January 1994 - October 1994
Skills
Community Outreach, Training, Editing, Non-profits, Office Management, Microsoft Excel, Management, Payroll, Recruiting, Public Speaking, Social Media, Event Planning, Fine Art, Human Resources, Databases, Process Scheduler, Nonprofits, Microsoft Office, Marketing Strategy, Research, Program Development, Social Networking
Education
California College of the Arts 1982 — 1985
BFA
Bucks County Community College 1981 — 1982
Johnson & Johnson May 2015 - Present
Johnson & Johnson November 2012 - May 2015
DePuy Orthopaedics June 2011 - November 2012
RQMIS Inc. May 2010 - June 2011
Premier Research Group May 2008 - May 2010
D-TARGET / Premier Research Group July 2007 - June 2008
D-TARGET SA January 2006 - July 2007
D-TARGET SA May 2005 - December 2005
BioControl Medical May 2002 - May 2005
Magen David Adom (Israel National Emergency Response services - Part of the Red Cross organisation) 1989 - May 2005
Skills
Medical Devices, Nephrology, Clinical Trials, CTMS, Clinical Research, FDA, CRO, Regulatory Affairs, Biotechnology, Clinical Monitoring, Clinical Study Design, Clinical Operations, Quality System, Lifesciences, Neurology, Pharmaceutical Industry, GCP, Regulatory Submissions, ISO 13485, Cardiology, Clinical Data Management, Quality Assurance, Clinical Development, EDC, ICH-GCP, Cross-functional Team..., Sop, Therapeutic Areas, Protocol, Oncology, 21 CFR Part 11, Medical Affairs, Medical Writing, Regulatory Requirements, Orthopedic, Dermatology, Validation, Diabetes, Life Sciences, SOP, Orthopedics, Regulatory Compliance
Education
Johnson and Johnson 2011 — 2015
Different Leadership programs
Different Clinical and Regulatory courses and meetings 2000 — 2015
Harvard Business School 2014 — 2014
Executive Program, RnD Leadership
Derby University 2000 — 2002
MBA
Ben-Gurion University of the Negev 1997 — 2000
B.EMS, Emergency Medicine
Ben-Gurion University of the Negev 1996 — 1997
None, Psychology
Immucor, Inc. September 2013 - Present
Premier Research Group January 2012 - 2013
Pfizer 1998 - 2009
Skills
Databases, Data Management, Automation, SQL Server, HLA, Java, VBA, Validation, Oracle, Integration, 21 CFR Part 11, Quality Assurance, Oracle Clinical, GLP, Process Improvement, Visual Basic, GMP, Oracle SQL, Oracle Discoverer, GCP, Integrated Review, Tecan Robotics
Education
Quinnipiac University
DeVry University
Computer Science
Premier Research April 2012 - Present
Premier Research Group December 2011 - February 2013
Premier Research Group January 2010 - December 2011
Premier Research Group July 2008 - January 2010
Premier Research Group August 2007 - July 2008
Skills
PL/SQL, Oracle Clinical, Databases, SQL, XML, SAS, C#, ASP, Programming, CDISC, SDTM, ADaM, Java, JavaScript, C/C++, PHP, VBScript
Education
Boston University 2002 — 2007
Bachelor of Arts, Computer Science
Premier Research OwnerVision 21 ProductionsJanuary 2007 - Present
Premier Research Group 2007 - Present
Education
Joseph Business School 2006 — 2007
Certificate, Business and Entreprenuership
Alverno College 1999 — 2003
B.S., Molecular Biology
Barbara G. Miller, MS December 2010 - Present
Synchrogenix Information Strategies March 2010 - November 2010
Premier Research Group October 2008 - February 2010
Barbara G. Miller, MS, LLC March 1996 - September 2008
Skills
CRO, Clinical Development, Pharmaceutical Industry, Medical Writing, Oncology, GCP
Education
University of Pittsburgh 1981 — 1983
MS, Biostatistics
Bucknell University 1974 — 1978
BA
Premier Research January 2014 - Present
ReSearch Pharmaceutical Services September 2012 - January 2014
Pfizer November 2009 - August 2012
Premier Research Group Ltm December 2008 - November 2009
ICON Clinical Research May 2008 - December 2008
PharmaNet August 2004 - May 2008
Advanced Biologics January 2002 - August 2004
Covance March 2001 - January 2002
Premier Research Group May 2000 - February 2001
Neose Technologies 1996 - 1999
Skills
Project Management, Clinical Data Management, Oncology, Data Management, Clinical Trials, Clinical Research, CRO, Oracle Clinical, EDC, Central Nervous System, CTMS, GCP, Protocol, ICH-GCP, Validation, Clinical Development
Education
Temple University 2003 — 2006
MS, Quality Assurance / Regulatory Affairs
La Salle University - School of Business Administration 1997 — 2000
MBA, General Business Administration
University of Rochester 1989 — 1993
BS, Biochemistry
William Tennent 1986 — 1989
Accenture August 2012 - Present
PhUSE 2012 - 2015
Octagon Research Solutions March 2006 - August 2012
Premier Research Group February 2004 - March 2006
Scp communications July 2000 - January 2004
American Tower April 2000 - July 2000
eResearch Technology June 1998 - April 2000
County of Chester December 1995 - June 1998
First Data Corporation October 1994 - December 1995
Skills
Database Administration, Unix Administration, Perl, SAS, PL/SQL, CDISC, XML, Linux, HTML, JavaScript, AIX, CSS, XSL, Ksh, eCTD, Unix, MDR, Life Science Industry, SDLC, SDTM, Microsoft SQL Server, Data Warehousing, Clinical Trials, Data Modeling, Solaris, Integration, Data Management, Testing, IBM AIX
Education
The Ohio State University 1991 — 1994
MCRP
Central China Normal University 1984 — 1986
Master's Degree
Hubei University 1978 — 1982
Bachelor's Degree
Lundbeck May 2013 - Present
Lundbeck June 2011 - May 2013
Lundbeck Inc. September 2009 - July 2011
Lundbeck October 2006 - September 2009
Premier Research Group 2005 - 2006
Scirex 1999 - 2005
Skills
Validation, CTMS, Database Design, Project Management, Data Management, Data Warehousing, PL/SQL, SAS programming, Business Intelligence, Databases, Master Data Management, ETL, SDLC, Clinical Systems..., SQL, Data Modeling, Data Analysis, Pharmaceutical Industry, Data Integration, Clinical Trials, SAS, T-SQL, EDC, Clinical Data Management, CRO, GCP, OLAP
Education
National Louis University 2009 — 2011
Management of Information Systems
Illinois State University 1997 — 1999
History, Political Science
College of DuPage 1995 — 1997
Westmont High School 1991 — 1994
PPD 2010 - Present
Heart & Vascular Institute of Florida January 2010 - April 2010
Premier Research Group March 2007 - October 2009
Premier Research Group (incorporating SCIREX) April 2005 - March 2007
SCIREX Corporation March 2002 - April 2005
CNS Research August 2001 - February 2002
Rheumatology, PC January 1988 - January 2001
Education
Henry Ford Community College
Associate Degree, Nursing
Premier Research Group July 2010 - Present
PPD March 2006 - November 2009
MDS Pharma Services 2004 - 2006
Education
Clarion University of Pennsylvania 1997 — 2001
Premier Research Group August 2011 - Present
CliniRx Research Pvt. Ltd. November 2009 - August 2010
Premier Research Group January 2008 - October 2009
Education
Carthage College 1972 — 1976
BA, Biology/Medical Technology
Premier Research April 2008 - Present
Premier Research Group 1999 - Present
Premier Research 1999 - 2008
Education
La Salle University
Premier Research Group February 2005 - Present
Skills
Financial Forecasting, Financial Modeling, Financial Reporting, Budgets, Compensation Structures, Employee Benefits, Financial Analysis, Deferred Compensation, HRIS, HR Policies, Business Planning, Benefits Administration, Performance Management, Accounting, Rewards Programs, Workers Compensation, FMLA, Succession Planning, Onboarding, Talent Management, Employee Relations, Human Resources, Workforce Planning, Employee Engagement, Internal Controls, Compensation Strategies, Interviews, Talent Acquisition, Biotechnology, CRO, Pharmaceutical Industry, Clinical Trials, Managerial Finance, Clinical Development, CTMS, Clinical Research, Leadership, Management, GCP
Education
Drexel University - LeBow College of Business
Medtronic February 2015 - Present
Covidien June 2013 - January 2015
Premier Research Group April 2012 - June 2013
Premier Research Group July 2011 - April 2012
Premier Research Group May 2010 - July 2011
Kohl's Department Stores October 2008 - May 2010
Clay Chevrolet/Hyundai September 2006 - May 2010
Rainbow Studios January 2008 - April 2008
Clay Chevrolet/Hyundai March 2002 - September 2006
Bristol Community College January 2005 - June 2006
Skills
Oracle Clinical, Video Game Development, Digital Art, 3D animation, Motion Analysis, Multimedia, Data Analysis, Database Development, PL/SQL, Photoshop, 3D Studio Max, Dreamweaver, Maya, Zbrush, HTML, CSS, Web Design, Character Studio, Java, C, Programming, Animation, C++, Texturing, SQL, Visual Basic, Motionbuilder, Rigging, Art, Illustrator, Modeling, UML, 3D, Databases, Data Management, eClinicalOS, Corel Painter, C#, Oracle, Teamwork, Game Development, CDISC, SDTM, Project Management, Analysis, TOAD, Conceptual Art, Problem Solving, Oracle RDC, SDLC
Education
University of Advancing Technology 2006 — 2008
Bachelor, Digital Animation
Bristol Community College 2004 — 2006
Associate, Computer Science
Merck August 2014 - Present
Merck August 2012 - Present
Merck July 2010 - August 2012
Merck Research Labs November 2008 - June 2010
Merck November 2007 - November 2008
Doylestown Hospital 2001 - 2007
Healthexchange 1999 - 2001
Premier Research Group 1998 - 1999
Premier Research Group 1997 - 1998
Thomas Jefferson University 1988 - 1998
Skills
Infectious Diseases, Oncology, Clinical Research, GCP, Biotechnology, CRO, Pharmaceutical Industry, Clinical Development, Clinical Trials, CTMS, Lifesciences, EDC, Cardiology, Clinical Monitoring, Drug Development, Therapeutic Areas, ICH-GCP, Pharmacology, Protocol, Sop, Diabetes, Neurology, Patient Recruitment, Regulatory Affairs, Medical Writing, Pharmacovigilance, Regulatory Submissions, Medical Affairs, Clinical Data Management, Neuroscience, Biomarkers, Immunology, Hematology, Clinical Study Design, Drug Discovery, Translational Medicine, FDA, Cancer, Clinical Pharmacology, Clinical Operations, Endocrinology, Biostatistics, Dermatology, Cardiovascular Disease, Biopharmaceuticals, Rheumatology, Vaccines, Phase I, Hypertension
Education
Drexel University 2011 — 2015
MSN
Drexel University
Bloomsburg University of Pennsylvania 1984 — 1988
BSN
Pennridge High School 1980 — 1984
Sanofi Pasteur January 2015 - Present
Sanofi Pasteur June 2010 - December 2014
Sanofi Pasteur January 2008 - July 2010
Sanofi Pasteur July 2007 - December 2007
ICON Clinical Research January 2007 - July 2007
ICON Clinical Research July 2005 - December 2006
ICON Clinical Research July 2004 - July 2005
ICON Clinical Research January 2002 - June 2004
Premier Research Group March 2001 - December 2001
Premier Research Group July 2000 - March 2001
Skills
CRO, Vaccines, Clinical Trials, GCP, EDC, Clinical Data Management, Pharmaceutical Industry, Sop, Phase Forward InForm, Quality Procedures, Compliance, Compliance Support, Regulatory Affairs, 21 CFR Part 11, Infectious Diseases, Data Management, Clinical Research, Clinical Development, SOP
Education
Indiana University Bloomington 1996 — 2000
M.A., Ecology & Evolutionary Biology
Lafayette College 1992 — 1996
A.B., Psychobiology
ReSearch Pharmaceutical Services November 2009 - Present
Premier Research Group August 2008 - October 2009
Education
Cumberland College 1978 — 1982
Premier Research Group June 2007 - Present
Education
Lehigh University 2003 — 2005
Master of Education (MEd), Counseling Psychology
Lehigh University 1998 — 2002
Bachelor of Arts, Psychology
Premier Research Group December 1999 - Present
SCIREX 1999 - 2006
Covance December 1998 - December 1999
Skills
CRO, CTMS, Proposal Writing, Clinical Trials, Pharmaceutical Industry, Clinical Research, Lifesciences, Medical Devices, Management, Cross-functional Team..., Team Building, Team Management, Team Leadership, Process Improvement, Business Development, Data Management
Education
Drexel University 1978 — 1983
Bachelor of Science (B.S.), Business, Management, Marketing, and Related Support Services
Premier Research Group December 2011 - Present
Roche 1995 - 1996
Skills
CRO, Clinical Trials, GCP, Clinical Development, Sop, Oncology, CTMS, EDC, Regulatory Affairs, 21 CFR Part 11, Validation, Clinical Data Management, Regulatory Submissions, FDA, Biotechnology, Clinical Research, Data Management, Pharmacovigilance, Medical Devices
Education
Bryn Mawr College 1985 — 1989
BA
Lexington Catholic High School 1982 — 1985
NA
ReSearch Pharmaceutical Services November 2009 - Present
Premier Research Group August 2008 - October 2009
INC Research December 2006 - July 2008
Quintiles September 2005 - December 2006
Resurgens Orthopaedics October 2004 - September 2005
Emory Unversity December 2001 - July 2004
Education
Clark Atlanta University 1991 — 1997
B.S., Biology
AbbVie April 2012 - Present
Rose Marys Pecan Pralines, LLC November 2009 - Present
sanofi-aventis September 2010 - January 2011
Premier Research Group 2004 - 2009
dddition Technology (KeraVision, Inc) 2001 - 2003
Addition Technology, Inc. 2000 - 2003
Skills
Clinical Trials, Medical Devices, CRO, Biotechnology, Pharmaceutical Industry, Oncology, Lifesciences, Data Management, Quality Assurance, Protocol, Clinical Development, Clinical Research, Regulatory Affairs, CTMS, FDA, Life Sciences, Management, GCP
Education
Howard University 1979 — 1984
Bachelor of Science, Zoology
Loyola High School
Premier Research Group Limited January 2012 - Present
Premier Research Group May 2009 - January 2012
Premier Research Group September 2007 - May 2009
PPD, Inc. July 2005 - September 2007
Target Research Group 2002 - 2005
Education
Doane College 1992 — 1995
BA, Education
Private Practice Owner October 2011 - Present
Synexus LTD May 2009 - July 2010
Averion Clinical Research GmbH January 2007 - May 2008
Premier Research Group January 2006 - December 2006
Imform GmbH March 2001 - December 2005
Janssen-Cilag October 1999 - February 2001
Skills
Clinical Research, Clinical Trials, Clinical Development, Medicine, ICH-GCP, Cancer, Infectious Diseases, GCP, Oncology, Pharmacovigilance, Pharmaindustrie, Gute klinische Praxis, Klinische Entwicklung, CRO, Klinische Forschung, CTMS, EDC, Onkologie, Klinische Studien
Education
Medizinische Universität Wien
MD, Medicine
Pluris Marketing February 2014 - Present
Premier Research Group April 2012 - January 2014
Premier Research Group January 2011 - April 2012
Premier Research Group May 2009 - January 2011
Starbucks Coffee Company November 2008 - May 2009
Connecticut College August 2006 - May 2008
McCarter & English, LLP January 2008 - January 2008
Gboat May 2006 - September 2006
Gadsby Hannah LLP June 2005 - August 2005
Acura of Peabody May 2004 - August 2004
Skills
Clinical Trials, Data Analysis, Oracle Clinical, Databases, Microsoft SQL Server, SQL, Social Media, Customer Service, Troubleshooting, Training, Data Management, Toad, Analysis, Microsoft Office, Management, Microsoft Excel, Research, Event Planning, Marketing, Social Media Marketing
Education
Connecticut College 2004 — 2008
Sociology, Sociology
Connecticut College 2004 — 2008
Bachelor of Sociology, Sociology
Premier Research Group 2006 - Present
SCIREX Corporation 1998 - 2006
Hartford Life 1996 - 1998
Eagle Innovations, Inc. 1993 - 1995
Skills
.NET, ASP.NET, Oracle, Data Management, Management, Clinical Data Management, Databases, Analysis, SharePoint, VB.NET, CTMS, Clinical Research, Project Management, Oracle Clinical, Microsoft SQL Server, SQL, ICH-GCP, CRO, Process Improvement, Software Development, Software Documentation, FDA, Clinical Trials, Database Design, EDC, Business Intelligence, PL/SQL, Medical Devices, Business Analysis
Education
Eastern Connecticut State University 1980 — 1982
Business & Computer Science
Porter & Chester Institute
Computer Electronics
Premier Research Group August 2007 - January 2010
Bio-Imaging Technologies, Inc. February 2007 - June 2007
Geisinger Health System September 2006 - December 2006
Education
Montgomery County Community College 2009 — 2011
A.S., Nursing
Bloomsburg University of Pennsylvania 2001 — 2006
B.S., Exercise Science with Minor in Cardiac Rehab
AbbVie January 2013 - Present
Abbott Laboratories April 2009 - December 2012
TimePoint Clinical Research May 2005 - April 2009
Premier Research Group May 2007 - April 2008
SCIREX Corporation January 2003 - May 2005
SCIREX Corporation August 2001 - December 2002
SCIREX Corporation February 1999 - July 2001
SCIREX Corporation November 1997 - February 1999
PPD October 1995 - November 1997
Education
Florida State University 1988 — 1990
BS, Economics
SynteractHCR July 2014 - Present
Boehringer Ingelheim March 2009 - April 2013
Premier Research Group June 2008 - November 2008
Baxter BioScience March 2007 - April 2008
Grünenthal May 2000 - February 2007
Skills
Clinical Trials, GCP, Clinical Development, Clinical Research, CTMS, ICH-GCP, Clinical Monitoring
Education
Technische Hochschule Mittelhessen 1995 — 2000
Dipl.-Ing. (FH), Biotechnologie
TFS Trial Form Support April 2015 - Present
PRA Health Sciences March 2010 - April 2015
REGISTRAT, Inc. October 2008 - April 2010
Premier Research Group (formerly SCIREX Corporation) November 2005 - October 2008
Premier Research Group 2000 - 2008
Monitorforhire.com 2001 - 2005
Skills
CRO, Management, Neurology, Infectious Diseases, Clinical Trials, CTMS, Oncology, Pharmaceutical Industry, GCP, Clinical Development, Drug Development, Medical Devices, Cross-functional Team..., Lifesciences, Clinical Research, Clinical Monitoring, Biotechnology, Regulatory Affairs, EDC, Sop, ICH-GCP, Data Management, Life Sciences, SOP
Education
Bucks County Community College 1996 — 1998
Criminal Justice
Archishop Wood 1981 — 1985
Business, Business
ICON plc July 2012 - Present
MD Anderson Cancer Center January 2012 - July 2012
Premier Research Group November 2011 - January 2012
Premier Research Group November 2008 - November 2011
Encysive Pharmaceuticals 2005 - 2008
US Oncology June 2000 - December 2005
Intermedics, Inc. April 1981 - May 1999
Skills
Clinical Data Management, CRO, Clinical Trials, GCP, Data Management, FDA, Protocol, EDC, CTMS, Oracle Clinical, Clinical Development, Oncology, Sop, Clinical Research, 21 CFR Part 11, Regulatory Submissions, Validation, SAS, Database Design, CRF design, Pharmaceutical Industry, Medical Devices, Cardiology
Education
Alvin Community College 1997 — 2000
AAS, Computer Science
Premont Hight School 1977 — 1981
PRA Health Sciences June 2014 - Present
ReSearch Pharmaceutical Services, Inc (RPS) February 2010 - May 2014
Premier Research Group July 2006 - February 2010
SCIREX Corporation March 1996 - July 2006
Skills
EDC, Clinical Development, Patient Recruitment, Clinical Data Management, Drug Development, Oncology, Vaccines, Pharmacovigilance, Endocrinology, Infectious Diseases, Rheumatology, Pharmaceutical Industry, Hypertension, Neurology, Clinical Research, Protocol, Team Leadership, ICH-GCP, Project Management
Education
Chestnut Hill College 1984 — 1988
BS, Chemistry
BMO Financial Group September 2014 - Present
Capital One May 2011 - September 2014
BlueCross BlueShield of Tennessee December 2008 - May 2011
Premier Research Group June 2008 - August 2008
Skills
SAS, SAS programming, Data Analysis, Statistics, Predictive Modeling, Analytics, Data Mining, Predictive Analytics, CRO, Unix, SAS Certified Base..., Biostatistics, DB2, Microsoft Excel, Program Evaluation, Time Series Analysis, Microsoft SQL Server, SAS E-Miner, Angoss knowledge seeker
Education
Georgia Institute of Technology 2007 — 2008
M.S., Statistics
Chengdu University of Technology 2003 — 2006
M.S, Computer Science
Chengdu University of Technology 1999 — 2003
B.S, Information Engineering
Premier Research Group August 2010 - Present
Advanced Career Technologies December 2007 - November 2008
A+ Mobile PC Doctors June 2007 - November 2007
US Army April 1983 - April 2003
Skills
Database Development, Business Intelligence, Oracle PL/SLQ, Microsoft T-SQL, Java, VBA, JavaScript, C#, VB
Education
Setfocus LLC 2008 — 2009
Microsoft Business Intelligence
Clark University 2006 — 2007
Enterprise Software Development
Defense Language Institute 1992 — 1993
Russian Studies
Novo Nordisk May 2014 - Present
Inventiv Health contracted to Novo Nordisk October 2013 - May 2014
PAREXEL October 2012 - October 2013
Theorem Clinical Research February 2012 - October 2012
KForce Clinical Research contracted to Sanofi-Aventis July 2010 - February 2012
Chiltern International March 2009 - February 2011
KForce contracted to Sanofi-Aventis June 2007 - December 2008
Medtronic/Diabetes September 2006 - June 2007
Premier Research Group January 2005 - September 2006
Skills
Osteoporosis, Epilepsy, Breast, Migraine, Metabolic Syndrome, Clinical Monitoring, Clinical Research, Clinical Trials, Diabetes, Neurology, Oncology, CTMS
Education
Adelphi University 1971 — 1974
BSN, Nursing
Thermo Fisher Scientific (Life Technologies) 2013 - Present
McDonough Consultancy 2012 - May 2013
Premier Research Group 2012 - November 2012
Gen-Probe Incorporated 2011 - 2012
Gen-Probe Incorporated 2008 - 2010
Gen-Probe Incorporated 2007 - 2007
Gen-Probe Incorporated 2004 - 2007
Gen-Probe Incorporated 1998 - 2004
Skills
Biotechnology, FDA, Assay Development, Medical Devices, Clinical Trials, Design Control, Molecular Biology, Cross-functional Team..., Lifesciences, Program Management, Molecular Diagnostics, Commercialization, Validation, Infectious Diseases, Technology Transfer, Clinical Development, R&D, Genomics, Clinical Research, Team Management, Teamwork, Biomarkers, In Vitro, DNA sequencing, V&V, Hardware Diagnostics, Sop, Life Sciences, GLP, Oncology, Drug Development, GMP, Cancer, Biochemistry, PCR, Microbiology, Regulatory Submissions, GCP
Education
University of California, San Diego 2008 — 2013
Certificate, Clinical Trials Design and Management
University of California, San Diego 1978 — 1985
PhD, Biology (Molecular Biology, Virology)
California State Polytechnic University-Pomona 1974 — 1978
B.S., Microbiology
PPD February 2013 - September 2014
Premier Research Group May 2008 - October 2009
Skills
CRO, GCP, CTMS, Clinical Trials, EDC, ICH-GCP, Clinical Monitoring, Clinical Development, Oncology, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Sop, Regulatory Submissions, Clinical Research, Oracle Clinical, Regulatory Affairs, Pharmacovigilance, Biotechnology, Drug Development
Education
University of California, Santa Cruz 2001 — 2004
Bachelor of Arts (BA), English Language and Literature, General
Cuesta College
Novella Clinical Resourcing May 2009 - Present
Clinipace Worldwide August 2013 - August 2014
Premier Research Group January 2008 - March 2009
Nexus Oncology, Ltd August 2008 - February 2009
Quintiles June 2007 - January 2008
Theradex July 2004 - May 2007
Quintiles 2000 - 2001
Skills
Clinical Monitoring, EDC, Oncology, Phase I, CRO, Clinical Trials, Data Management, Inform, Hematology, Oracle Clinical, ICH-GCP, GCP, CTMS, Therapeutic Areas, Clinical Research..., Clinical Development, Validation, Clinical Operations, Regulatory Submissions
Education
Campbell University 2001 — 2003
MS, Coursework in Clinical Research
Norfolk State University 1990 — 1995
BS, Chemistry
Dyad Systems August 2013 - Present
Pharmaceutical and Medical Device assignments 2013 - Present
Pfizer, Inc 2009 - 2013
Premier Research Group 2006 - 2009
BattelleCRO (formerly CareStat) 2006 - 2006
Millennium Pharmaceuticals 2003 - 2006
PAREXEL 1991 - 2002
Baxter Healthcare Corporation 1988 - 1991
Skills
Clinical Data Management, Oracle Clinical, CRO, EDC, CRF design, Data Management, Clinical Trials, Oncology, Sop, Clinical Development, Infectious Diseases, Therapeutic Areas, CTMS, GCP, Pharmaceutical Industry, ICH-GCP, Regulatory Submissions, 21 CFR Part 11, Validation, Cardiology, Immunology, Drug Development, FDA, Pharmacovigilance, Protocol, Pharmaceutics, Computer System..., Clinical Monitoring, Biotechnology, Regulatory Affairs, Endocrinology, Lifesciences, Vaccines
Education
Framingham State College
Bachelor of Science (B.S.), Biology
PRA Health Sciences December 2009 - Present
Premier Research Group May 2008 - December 2009
ReSearch Pharmaceutical Services 2007 - 2008
PharmaNet Development Group, Inc. August 2000 - September 2005
Encorium Oy/Ltd September 1999 - August 2000
SmithKline Beecham September 1997 - September 1998
Frankford Hospital 1991 - 1997
Skills
ICH-GCP, GCP, CRF design, Pharmaceutical Industry, Oncology, Oracle Clinical, CTMS, CRO, Clinical Development, EDC, Data Management, Clinical Trials, Clinical Data Management, 21 CFR Part 11, Therapeutic Areas, Infectious Diseases, Sop, Clinical Monitoring, SOP
Education
Arcadia University 1995 — 1998
Bachelor, Biology
Manor Jr. College 1991 — 1993
Associate, Science, Medical Laboratory Technology
Vinfen Corporation June 2010 - Present
Cornerstone Mitubishi Associate Buisness Process SpecialistPremier Research GroupJuly 2009 - May 2010
Premier Research Group 2009 - 2010
Education
Framingham State University 2005 — 2009
Bachelors of Science, Computer Software Engineering
Prosoft Clinical October 2006 - Present
Premier Research Group 1997 - 1998
AstraZeneca 1996 - 1996
Skills
CRO, Clinical Research, Clinical Development, CTMS, Clinical Trials, Oncology, GCP, Dermatology, EDC, ICH-GCP, Pharmaceutical Industry, Biotechnology, Pharmacovigilance, Clinical Data Management, Infectious Diseases, Drug Development, Life Sciences
Education
Tulane University School of Medicine 1991 — 1996
Doctor of Medicine (M.D.), Medicine
Massachusetts Institute of Technology 1986 — 1990
Bachelor's degree, Molecular Biology
Premier Research Group March 2010 - Present
New York Life Insurance Company July 2006 - March 2010
Education
Bryant University 2001 — 2005
BS, Marketing/Communications
inVentiv Health November 2014 - Present
AstraZeneca / RPS November 2013 - November 2014
Quintiles April 2012 - October 2013
PharmaNet/i3 October 2009 - April 2012
Paragon Biomedical February 2008 - June 2009
Premier Research Group November 2006 - February 2008
INC Research September 2005 - November 2006
ICON Clinical Research January 2003 - September 2005
Skills
Endocrinology, Neurology, Rheumatology, Gastroenterology, Urology, CTMS, Clinical Monitoring, EDC, ICH-GCP, GCP, CRO, Clinical Trials, Neonatology
Education
Hampton University 1996 — 2000
B. S., Biology
University of California @ San Diego (UCSD) August 2012 - April 2013
N/A - Currently Self Employed July 2011 - June 2012
PAREXEL February 2011 - June 2011
Premier Research Group April 2008 - May 2009
Pharmaceutical Product Developement, Inc. (PPDI) June 2004 - April 2008
Quintiles December 1996 - January 2004
Tri-City Medical Center January 1994 - November 1996
Hoag Hospital April 1972 - January 1975
Skills
Data Management, Clinical, Documentation, Pediatrics, EDC, Clinical Research, Clinical Monitoring, GCP, Clinical Trials, FDA, Infectious Diseases, ICH-GCP, Inform, CRO
Education
MiraCosta College 1987 — 1990
AA, General studies to SDSU
Golden West College 1970 — 1972
VN, Nursing (LVN)
Cigna Pharmacy Management September 2012 - Present
CIGNA Tel-Drug March 2004 - August 2012
Premier Research Labs 2000 - 2002
Premier Research Group 2000 - 2002
Premier Research 2000 - 2002
McNeil Consumer Healthcare 1999 - 2000
Skills
Excel, Pharmaceuticals, Microsoft Office, Healthcare, Problem Solving
Education
University of the Sciences in Philadelphia 1995 — 1999
BS, Pharmacy
Widener University School of Law 1989 — 1993
JD, Law
La Salle University 1985 — 1989
BA, Political Science
Premier Research May 2015 - Present
Premier Research September 2013 - Present
Premier Research Group July 2012 - September 2013
Premier Research Group 2009 - July 2012
Skills
CTMS, Regulatory Submissions, EDC, Clinical Trials, Oncology, Therapeutic Areas, CRO, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, ICH-GCP
Education
Western Governors University 2013 — 2015
Bachelor of Science (BS), Business Administration and Management, General
Austin Community College
Ongoing, Biology
INC Research November 2013 - Present
Premier Research Group 2001 - November 2013
CTMS, Inc (now operating as Chiltern) 1999 - 2001
Skills
CRO, Clinical Trials, Therapeutic Areas, Clinical Research, Rheumatology, Gastroenterology, Dermatology, CTMS, EDC, GCP, Clinical Monitoring, ICH-GCP, Clinical Data Management, Pharmaceutical Industry, Psychiatry, Protocol, Clinical Operations, Regulatory Submissions, Patient Recruitment, Drug Development
Education
Colorado Technical University 2004 — 2005
Project Management, Masters Program
Virginia Intermont College 1995 — 1999
BS, Organizational Management
Covance July 2011 - Present
Premier Research Group March 2008 - October 2009
PPD 2007 - 2008
PRA International 2003 - 2006
Advanced Biologics 2001 - 2003
North Texas Clinical Research 1999 - 2001
Skills
Therapeutic Areas, Clinical Development, FDA, Clinical Research, ICH-GCP, Pharmaceutical Industry, Protocol, Clinical Data Management, CRO, Medical Writing, CTMS, Clinical Trials, GCP, EDC, Cardiology, Clinical Monitoring, Infectious Diseases, CRF design
Education
Columbia University College of Physicians and Surgeons 1992 — 1996
MA, Genetics
San Diego State University-California State University 1988 — 1992
B.A., Psychology
Baxter International Inc. August 2015 - Present
ForeignExchange Translations December 1999 - Present
Astellas Pharma February 2013 - July 2015
inVentiv Health August 2012 - February 2013
Advanced Clinical Services December 2010 - 2012
Translation Link, Inc. 2000 - 2012
Lundbeck January 2010 - December 2010
Premier Research Group August 2001 - December 2009
Skills
Inform, I-Review, OC, RDC, eDM,..., Oracle Discoverer, Hematology, Cardiology, Immunology, Central Nervous System, Endocrinology, Urology, Psychiatry, Pain Management, Gynecology, Medical Devices, Medicine, Databases, Business Objects, SAE Reconciliation, Vendor Management, Mentoring, Work Allocation, Clinical Trials, CRO, Clinical Data Management, Clinical Research, Pharmaceutical Industry, Clinical Development, Protocol, ICH-GCP, Medical Writing, GCP, Data Management, FDA, EDC
Education
SCDM 2011 — 2011
CCDM - Certifed Clinical Data Manager
CDRH - Center for Devices and Radiological Health
Uniwersytet Jagielloński w Krakowie
MA, English
Quintiles May 2010 - January 2014
Premier Research Group December 2008 - October 2009
Peachtree Dermatology Associates September 2008 - December 2008
UCB May 2007 - September 2008
Altea Therapeutics March 2007 - November 2007
AtheroGenics, Inc. March 2005 - March 2007
PharmChem 2001 - 2004
Skills
Clinical Research, Clinical Trials, ICH-GCP, CRO, IRB, GCP, Data Review, Data Management, CTMS, Inform, EDC, Clinical Study Design, FDA
Education
Walden University 2008 — 2010
Master of Science (M.S.), Clininical Research Administration
Clark Atlanta University 1996 — 2000
Bachelor of Science (BS), Community Health Education
Averion International 2008 - 2010
Averion International 2006 - 2008
Premier Research Group July 2006 - September 2006
Averion International 2002 - 2006
Heart & Vascular Institute of Florida 1998 - 2002
Education
Florida State University 1972 — 1975
BSN
US Department of Veterans Affairs June 2010 - Present
COMSYS part of Manpower Inc. April 2010 - July 2010
Premier Research Group September 2007 - March 2010
US Department of Veterans Affairs July 1992 - December 2007
E.F Wonderlic December 1991 - July 1992
Skills
SAS, Clinical Trials, CDISC, CRO, Statistics, Clinical Data Management, SAS programming, Testing, VBA, Pharmaceutical Industry, Databases, Oracle Clinical, Data Management, Biostatistics, SQL, Data Analysis, Clinical Research, Clinical Development, FDA, EDC, ICH-GCP
Education
Illinois Institute of Technology 1990 — 1991
MS, Computer Science
University of Illinois at Chicago 1984 — 1989
BS, Mechanical Engineering
UC San Diego Health System July 2008 - Present
Sharp HealthCare January 2004 - January 2014
Premier Research Group March 2008 - July 2008
Cosmo Bioscience, Inc. April 2004 - June 2007
UC San Diego Health System January 1999 - December 2002
Skills
Clinical Research, Nursing, Clinical Trials, Accreditation, Non-profits, Healthcare
Education
Grossmont College
Nursing
The University of Texas at Austin
Nursing
Cleveland State University
Music
The Ohio State University
Music
Endo Pharmaceuticals February 2011 - September 2013
INC Research July 2009 - November 2010
MDS Pharma Services May 2007 - June 2009
Encorium / Covalent Group November 2005 - May 2007
Covalent Group June 2001 - October 2005
Covalent Group February 1999 - June 2001
Premier Research Group 1996 - 1999
Premier Research Group 1993 - 1996
Skills
EDC, Clinical Data Management, CRO, Clinical Trials, Clinical Research, Data Management, Oncology, CTMS, GCP, Oracle Clinical, Quality Assurance, Clinical Development, ICH-GCP, CDISC, Medidata, MedDRA, Medical Coding, WhoDrug, Pharmaceutical Industry
Education
Hahnemann University
M.S., Medical Science
Gannon University 1985 — 1988
B.S., Biology
Franlie Consultant, LLC October 2013 - Present
Premier Research Group October 2013 - June 2014
Covance September 2011 - February 2013
PRA International October 2010 - August 2011
Quintiles October 2007 - August 2010
University of Miami, Miller School of Medicine August 2002 - April 2007
Skills
Infectious Diseases, Oncology, Clinical Monitoring, ICH-GCP, Vaccines, Rheumatology, Clinical Research, Gastroenterology, Allergy, Sop, Ophthalmology, Respiration, Protocol, Autoimmune Diseases, CTMS, Cardiovascular Disease, Gastrointestinal..., Women's Health, Medical Devices, CNS disorders, Endocrinology, Psychiatry, Neurology, Immunology, Liaison, Respiratory Disease, Reproductive Health, Musculoskeletal, HIV, Asthma
Education
Nova Southeastern University 2010 — 2012
Doctorate, Health Services/Allied Health/Health Sciences, General
Barry University 2001 — 2002
MS, Health Services Administration
Barry University 1997 — 2000
BS, Biology
Universidad Nacional Pedro Henríquez Ureña 1993 — 1996
Health Science, Health Sciences
Haitian American Academy
PPD August 2004 - Present
Premier Research Group 2008 - 2010
Skills
Clinical Research, Clinical Monitoring, Clinical Trials, CRO, ICH-GCP, EDC, Inform, CTMS, Oncology, Oracle Clinical, Hematology, IRB, 21 CFR Part 11, Cancer, Oncology Clinical..., Medidata
Education
Armstrong State University 1981 — 1987
BS, Chemistry
Gun safety class
INC Research November 2011 - Present
Premier Research Group April 2002 - November 2011
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, Clinical Development, EDC, Oncology, Clinical Data Management, Clinical Research
Education
Miami University 1991 — 1996
BS, Marketing, Psychology
PAREXEL International November 2014 - Present
PAREXEL International May 2013 - October 2014
PAREXEL International October 2011 - May 2013
Premier Research Group September 2008 - October 2011
Self Employed Service Provider February 2002 - December 2010
UCB Pharma June 2007 - September 2008
UCB Pharma January 2006 - June 2007
UCB Pharma January 2004 - January 2006
UCB Pharma September 2003 - January 2004
BodyBlitz January 2000 - January 2002
Skills
Clinical Development, CRO, Clinical Research, Clinical Trials, Oracle Clinical, Clinical Data Management, Oncology
Education
University of Southern Mississippi 1997 — 1999
Master of Science, Exercise Physiology
Millsaps College 1992 — 1994
Bachelor of Arts, English
Novartis June 2014 - Present
Various contract positions June 2010 - July 2014
Premier Research Group May 2009 - October 2010
i3 Research January 2008 - February 2010
Smith Hanley Consulting Group November 2006 - December 2007
Skills
Database Management, Clinical database..., Microsoft Excel, Word,..., Database Admin, EDC, Microsoft Excel, Oncology, Oracle Clinical, Inform, Data Management, CRO, Clinical Trials
Education
Campbell University 1993 — 1996
Psychology
Wake Technical Community College 1992 — 1993
Transfer student
Cigna December 2014 - Present
TicketNetwork.com August 2013 - June 2014
COMPLETE HEALTHCARE SOLUTIONS, INC. October 2012 - April 2013
Premier Research Group May 2010 - September 2012
Skills
Microsoft SQL Server, Oracle Database, MongoDB, SSIS, System Migration, Clinical Trials, EDC, Clinical Data Management, CTMS, Data Management, CRO, Pharmaceutical Industry, GCP, Clinical Development, ICH-GCP, Oncology, Sop, SSAS 2008, SSRS, Powershell, Database Engine Tuning..., SQL, Troubleshooting, SQL Tuning, Customer Service, Databases, Software Development, Leadership, Microsoft Excel, Software Documentation, Networking, Outlook, Training, Social Media, Management, SharePoint, Microsoft Office
Education
Westfield State College 2007 — 2010
Bachelor of Computer Information Systems, Computer Information Systems with a minor in Business
Holyoke Community College 2004 — 2007
Associate of Arts and Sciences (A.A.S.), Networking/Programming
Finnell Properties August 2011 - Present
Premier Research Group August 2010 - May 2011
Lindenmeyr Munroe April 2007 - June 2009
Skills
Advertising, Marketing Communications, Direct Marketing, Marketing, Marketing Strategy, Social Media Marketing, Direct Mail, Social Media, Digital Marketing, Copywriting, Market Research, Email Marketing
Education
Bryant University 2003 — 2007
Bachelor's degree, Marketing
Milton High School 1999 — 2003
Premier Research Group July 2010 - Present
Quintiles June 2004 - April 2010
University of Texas at Austin April 1994 - June 1998
University of Texas at Austin August 1995 - February 1998
Skills
EDC, Clinical Monitoring, GCP, CRO, CTMS, IVRS/IWRS, IRB, QA, SAE, Laboratory Research, Labview, Clinical Trials, Clinical Research, Evaluation, MS Project, MS Office Suite
Education
California State University-Chico 1985 — 1989
BA, Psychology
California Polytechnic State University-San Luis Obispo 1987 — 1987
MAXISIT Inc/PPD Inc July 2012 - Present
Covance October 2010 - July 2012
Genzyme 2010 - 2010
Premier Research Group 2008 - 2010
Skills
CDISC, Clinical Data Management, CRO, SAS, SAS programming, SDTM, Infectious Diseases, Clinical Trials, Biostatistics, Clinical Research, Databases, Data Analysis, 21 CFR Part 11, Pharmaceutical Industry, GCP, Validation, Biotechnology, Data Management, Statistical Programming, EDC, Clinical Development, Oracle Clinical, Oncology, CTMS, Sop, FDA, ICH-GCP, CRF design, SAS Base, Pharmacovigilance, Regulatory Submissions, CDISC Standards, ADaM Standards/Analysis..., SDTM datasets..., Statistical tables,..., Late phase clinical..., Early phase AME studies, Oncology studies, Cardiovascular studies, Define XML/Metadata..., ISS - Integrated..., ISE - Integrated...
Education
University of New Haven
Master of Science (MS), Molecular Biology (Biostats/Bioinformatics)
Jawaharlal Nehru Technological University
Bachelor of Technology (B.Tech.), Biotechnology