Theorem Clinical Research
Industry: Company
DescriptionFounded: 1985 Parent organization: Chiltern International Group Limited Subsidiaries: Omnicare Investigaciones Clinicas Limitada, Clinimetrics Research Associates Inc
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Theorem Clinical Research Employees
Theorem Clinical Research April 2015 - Present
Allergan August 2009 - March 2015
Allergan January 2006 - August 2009
Allergan January 2004 - January 2006
Promedica International November 2003 - January 2004
Western Clinical Research, Inc. August 2002 - November 2003
Paragon Biomedical June 1998 - April 2002
Skills
Clinical Data Management, Clinical Research, CRF design, Inform, 21 CFR Part 11, CRO, Clinical Trials, Data Analysis, Oracle Clinical, ICH-GCP, Clinical Development, Data Reconciliation, Data Cleaning, Discrepancy Resolution, PowerPoint, Problem Solving, CTMS, GCP
Education
California State University-Chico 1994 — 1997
Bachelor of Arts (B.A.), Political Science and Government
Fremont College 1999 — 2000
Associate of Arts (A.A.), Legal Assistant/Paralegal
Cognizant Technology Solutions September 2011 - Present
TAKE Solutions Global LLP March 2010 - September 2011
Theorem Clinical Research April 2007 - March 2010
Ecron Acunova 2006 - 2007
Skills
Oracle Clinical, Clinical Data Management, CDISC, EDC, GCP, Clinical Trials, ICH-GCP, CTMS, 21 CFR Part 11, Data Management, Inform, Pharmacovigilance, Validation, MedDRA, CRO, Computer System..., Clinical Development, Oncology, Clinical Monitoring, Clinical Research, Pharmaceutical Industry, Regulatory Affairs
Education
Amity Business School
Master of Business Administration (MBA), Information Technology
Bangalore University
Bachelor in Pharmacy, Pharmacy
Theorem Clinical Research July 2013 - Present
DataCeutics, Inc. August 2008 - July 2013
Targanta Therapeutics 2007 - 2008
B2S Consulting 2005 - 2007
Roche Diagnostics 2003 - 2004
Elanco 2001 - 2003
Eli Lilly and Company 1998 - 2000
Anthem 1989 - 1997
Skills
Clinical Research, SAS programming, Clinical Data Management, Statistical Programming, CRO, Biostatistics, CDISC, Clinical Trials, EDC, Data Management, 21 CFR Part 11, GCP, Clinical Development
Education
Purdue University 1986 — 1988
Master of Science (MS), Economics
Bowling Green State University 1981 — 1985
Bachelor of Arts (B.A.), Mathematics
ASH Legal Consulting March 2014 - Present
Theorem Clinical Research May 2013 - February 2014
Quintiles November 2012 - May 2013
INC Research July 2007 - October 2012
Schwarz Biosciences April 2005 - July 2007
INC Research April 2002 - April 2005
SpectraSite Communications September 2000 - March 2002
YMCA of Greater Cleveland June 1990 - September 1995
Skills
Clinical Development, Contract Management, Legal Writing, Lifesciences, Mergers, Employment Law, Risk Management, Negotiation, Corporate Law, Process Improvement, Legal Research, Licensing, Regulatory Requirements, Litigation, Ethics, FCPA, Data Privacy, Research, Team Building, ICH-GCP, Contract Law, Mergers, Pharmaceutical Industry
Education
Wake Forest University School of Law 1996 — 1999
Doctor of Law (JD), Law
Case Western Reserve University 1989 — 1994
Bachelor of Arts (B.A.), Psychology
KVS Title December 2014 - Present
AvalonBay Communities February 2014 - December 2014
AvalonBay Communities September 2013 - February 2014
Theorem Clinical Research June 2012 - August 2012
Skills
Spanish, Foreign Languages, Management, Microsoft Office, Chinese, Translation, Social Networking, Microsoft Excel, Facebook, Customer Service, Interpretation, Copy Editing, Stylistic Editing, Revision, Salesforce.com, MRI Software
Education
James Madison University 2009 — 2013
Bachelor of Arts, Spanish Language and Literature
Universitat Rovira i Virgili 2012 — 2012
Shire Pharmaceuticals November 2014 - Present
Theorem Clinical Research February 2007 - November 2014
Arcadia University September 2004 - May 2008
Skills
CDISC, XML, ODM, Global Macro, Macro, Standards Development, SDTM
Education
Arcadia University 2004 — 2008
Bachelor, Computer Science
Theorem Clinical Research June 2014 - Present
Theorem Clinical Research February 2013 - June 2014
Theorem Clinical Research (formerly Omnicare Clinical Research) February 2010 - February 2013
Clinimetrics November 2008 - February 2010
Kalypsys, Inc. January 2007 - November 2008
Neurocrine Biosciences, Inc. July 2004 - May 2006
Abbott Vascular Devices 2006 - 2006
Neurocrine Biosciences, Inc. July 2003 - July 2004
Skills
CRO, CTMS, Clinical Trials, Clinical Research, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Regulatory Affairs, Clinical Development, GCP, Validation, Medical Writing, FDA, IND
Education
Houston Community College 2003 — 2003
General
Pennfield High School 1987 — 1989
PRA International November 2013 - Present
Theorem Clinical Research October 2010 - Present
Omnicare Clinical Research February 2007 - November 2010
Synarc January 2006 - January 2007
Clinimetrics October 2002 - May 2004
Universidade de São Paulo January 1998 - March 1999
Skills
GCP, CTMS, EDC, CRO, Clinical Trials, Clinical Monitoring, Clinical Data Management, Clinical Development, Oncology, Oracle Clinical, Pharmaceutical Industry, Clinical Research, Sop, Regulatory Submissions, Biotechnology, FDA
Education
San Diego State University-California State University 1994 — 1997
MSc, Nutritional Sciences
Universidade de São Paulo 1988 — 1992
BS, Nutrition
Universidade de Santo Amaro 1987 — 1991
BS, Physical Education
Sungard Availability Services August 2014 - Present
Valley Forge Benefit Administrators February 2011 - August 2014
Theorem Clinical Research January 2012 - August 2013
Elk Valley Health Services a wholly owned subsidiary of Critical Homecare Solutions, Inc. June 2009 - May 2010
Trion September 2007 - September 2008
Skills
Insurance, Employee Benefits, Disability Insurance, Human Resources, Benefits Administration, Claim, Open Enrollment, Microsoft Excel, Customer Service, Onboarding, Employee Relations, Analysis
Education
Bryant University
Bachelor of Science (BS), Human Resources Management/Personnel Administration, General
BARC Global Central Laboratory December 2014 - Present
Theorem Clinical Research May 2013 - October 2014
Singleton Moms April 2011 - March 2014
BARC Global Central Laboratory 2008 - May 2013
OneAccord Partners 2007 - 2008
EXACT Sciences, Inc. 2003 - 2007
Sensys Medical 2002 - 2003
Ventana Medical Systems, Inc 2000 - 2002
Veracel (formerly Morphometrix) 1996 - 2000
Quest Diagnostics 1986 - 1996
Skills
Global Business..., Strategic Partnerships, Contract Negotiation, Market Development, Cross-functional Team..., Strategic Planning, Biotechnology, Sales Management, Molecular Diagnostics, Molecular Oncology, Alzheimer's disease, Global Drug Development, Oncology, Market Analysis, Infectious Diseases, Pharmaceutical Industry, Clinical Research, Leadership, CRO, Drug Development, Clinical Development, Business Development, Clinical Trials, Commercialization, CTMS, Lifesciences, Biopharmaceuticals, GCP, Drug Discovery, Regulatory Affairs, FDA, Vaccines, Immunology, Regulatory Submissions, Global Marketing, Life Sciences
Education
Arizona State University
Bachelor of Science, Marketing
Romer Labs September 2013 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2013 - July 2013
Villanova University August 2011 - June 2012
Thomas Jefferson University Hospitals March 2011 - August 2011
Centocor November 2006 - January 2007
Theorem Clinical Research July 2006 - October 2006
WuXi AppTec February 2005 - November 2005
Wyeth March 2001 - November 2002
Pennsylvania Department of Environmental Protection May 1999 - August 1999
Skills
Training, Biochemistry, Biotechnology, Validation, ELISA, Cell Culture, PCR, GLP, Assay Development, GMP, SDS-PAGE, Western Blotting, Flow Cytometry, Aseptic Technique, Teaching, Immunology, Microscopy, Microbiology, Molecular Biology, Immunoassays, Cell Biology, Life Sciences, Genomics
Education
Villanova University 2007 — 2013
Advanced Graduate Certificate, Biology, concentration in cell and molecular
Lebanon Valley College 1996 — 2000
Bachelor of Science (B.S.), Biology
Novella Clinical, Inc. March 2013 - Present
Theorem Clinical Research June 2012 - February 2013
Covance November 2011 - June 2012
PRA International September 2010 - March 2011
Hoffmann-La Roche May 2009 - March 2011
Boehringer Ingelheim 2010 - 2010
Purdue Pharma October 2007 - February 2009
PAREXEL May 2007 - October 2007
Paragon September 2006 - May 2007
PPD November 2005 - September 2006
Skills
Clinical Monitoring, EDC, CRO, Clinical Trials, GCP, Medidata, CTMS, Cardiovascular, Respiratory Disease, Phase Forward InForm, Documentum, JReview, Drug Accountability, Drug Distribution, Mentoring, Oncology, Remote Monitoring
Education
John Jay College of Criminal Justice
None, Criminalistics and Criminal Science
Fave CRC enr. (Clinical Research Consultancy) May 2015 - Present
Theorem Clinical Research April 2013 - April 2015
PRA International December 2011 - April 2013
Ste-Justine Hospital, Paediatrics Teaching Hospital May 2010 - August 2010
MedQualis January 2007 - January 2010
MethylGene Inc. May 2006 - December 2006
Bioniche Life Sciences June 2005 - May 2006
Bellus Health March 2002 - June 2005
Pfizer June 2000 - January 2002
CroMedica (Integrated to PRA International in 2001) 1998 - 2000
Skills
CRO, Phase Forward InForm, Oracle RDC, Biopharmaceuticals, Medical Devices, Phototherapy, inhaled insulin, CTMS, IMPACT system, Anthropometrics, CRA Management, Neurology, Cardiology, Oncology, Biotechnology, GCP, Diabetes, Endocrinology, Clinical Trials
Education
McGill University - Macdonald Campus
B.Sc, Human Nutrition and Dietetics
CEGEP-Edouard-Montpetit 1984 — 1987
DEC sc., Health sc/Pure and Applied
College Francais 1979 — 1984
high school, DES Général sciences
CEGEP
DEC, Nursing
HEC Montréal
Certificate (30 cr.), Human Resources Management/Personnel Administration, General
Theorem Clinical Research April 2015 - Present
Foster Jewelers October 2003 - Present
Theorem Clinical Research January 2014 - April 2015
Theorem Clinical Research February 2013 - January 2014
Theorem Clinical Research October 2012 - February 2013
Skills
Microsoft Office 2007, Time Management, Efficiency, Multi Tasking, Personality, Building Relationships, Marketing, Advertising, Small Events, Email Marketing, Facebook Marketing, Oral & Written..., Teamwork, Work Well Independently, Motivated self-starter, Superior Work Ethic, Dependable Team Player, Clinical Trials, CRO, Therapeutic Areas, ICH-GCP, Account Management, Regulatory Submissions, Pharmaceutical Industry, Sop, Data Management, Clinical Research, Dermatology, Healthcare, Protocol, Respiration, Cardiology, Neurology, GCP, Clinical Development, Drug Development, Regulatory Requirements, Biopharmaceuticals, Clinical Operations, Sales, Cardiovascular Disease, Clinical Pharmacology, Pharmaceutical Sales, Clinical Data Management, Oncology, Pharmacovigilance, Infectious Diseases, Patient Recruitment, Trial Management, Urology
Education
DeSales University 2009 — 2010
Bachelor of Science (B.S.), Pharmaceutical Marketing
Cedar Crest College 2005 — 2008
Registered Nursing/Registered Nurse
Theorem Clinical Research June 2015 - Present
Theorem Clinical Research 2006 - 2015
MaxisIT Inc. 2002 - 2006
Crompton Greaves 1999 - 2001
Skills
Biostatistics, Clinical Trials, Cross-functional Team..., Data Management, SAS programming, Validation, Integration, SAS, Pharmaceutical Industry, CDISC, 21 CFR Part 11, Clinical Data Management, SDTM, Business Analysis, Oracle Clinical, SAS Programming
Education
Drexel University 2000 — 2002
Master of Business Administration (MBA)
Birla Institute of Technology 1995 — 1999
Bachelor of Engineering (BE), Mechanical Engineering
Theorem Clinical Research May 2015 - Present
DrugDev June 2014 - May 2015
Accenture March 2013 - May 2014
Accenture/Octagon Research Solutions November 2011 - March 2013
IMS Health August 2006 - November 2011
IMS Health May 2004 - August 2006
UHS July 2002 - March 2003
Skills
Business Planning, CRM, Leadership, Management, Project Management, Strategic Planning, Operations Management, Budgets, Process Improvement, Competitive Analysis, Market Research, Sales, Analytics, Cross-functional Team...
Education
Saint Joseph's University 1995 — 1997
Master's Degree, Elementary Education and Teaching
La Salle University 1990 — 1994
Bachelor's Degree, Psychology
Astellas Pharma May 2015 - Present
Theorem Clinical Research July 2014 - April 2015
Theorem Clinical Research February 2013 - July 2014
Clinipace Worldwide July 2010 - February 2013
PharPoint Research, Inc. April 2009 - July 2010
Clinsys Clinical Research February 2008 - April 2009
Hill's Pet Nutrition May 2006 - August 2006
US Army May 1998 - November 2003
Skills
Clinical Trials, SAS, Biostatistics, Clinical Research, Statistics, Clinical Data Management, Statistical Programming, Data Management, Clinical Development, CDISC, CRO, CTMS, EDC, GCP, Protocol, SAS programming, Professional Mentoring, SAS Programming
Education
North Carolina State University 2006 — 2016
PhD, Statistics
Kansas State University 2004 — 2006
MS, Statistics
United States Military Academy at West Point 1994 — 1998
BS, Mathematics
ARI June 2014 - Present
ARI November 2012 - June 2014
Theorem Clinical Research August 2011 - November 2012
Radian October 2010 - August 2011
Radian November 2009 - September 2010
EMCOR Facilities Services March 2008 - November 2009
Sodexo 2005 - 2008
Temple University 2005 - 2008
Veterans Administration May 2007 - August 2007
Skills
HRIS, Analytics, Employee Relations, Metrics, Performance Management, Performance Analysis, Performance Metrics, Business Intelligence, Metrics Analysis, System Administration, Project Implementation, Technology..., SharePoint, ADP, Ceridian, Cognos, ADP Payroll, Human Resources, Employee Benefits, Applicant Tracking..., Process Improvement, Project Management, Analysis, Employee Training, Management, Motivation, New Hire Orientations, Organizational..., Payroll, Personnel Management, Succession Planning, Workforce Planning, Creative Strategy, Employment Law, Strategy, Leadership
Education
University of Michigan - Stephen M. Ross School of Business 2015 — 2015
Advanced Human Resources Executive Program with David Ulrich, Business
Villanova University 2010 — 2011
MS, Human Resources Development
Temple University 2004 — 2009
BA Business Admin., Human Resource Management
Cornell University 2008 — 2008
Certificate in Human Resources, Employee Relations
Cedar Crest High School 2000 — 2004
HS diploma, General Studies
Baron Clinical Research, LLC. March 2002 - Present
Theorem Clinical Research 2014 - 2014
Outcome Sciences / Medtronics April 2006 - March 2009
inVentiv Clinical Solutions 2008 - 2008
Genta 2006 - 2008
Otsuka America Pharmaceutical, Inc. April 2005 - December 2006
Schering-Plough Research Institute January 1997 - January 2000
Skills
Clinical Trials, GCP, Pharmaceutical Industry, Clinical Research, Clinical Monitoring, CTMS, CRO, Regulatory Affairs, Oncology, Vaccines, Clinical Development, EDC, Pharmacovigilance, ICH-GCP, FDA, Clinical Study Design, Infectious Diseases, Sop, Validation, Diabetes, Cardiology, Biotechnology, Regulatory Submissions, Medical Devices, Clinical Data Management, Pharmaceutical Sales, Protocol, Pharmaceutics, Lifesciences, Dermatology, Neurology, Drug Development, Software Documentation, Data Management, CRF design, GMP, 21 CFR Part 11, Hardware Diagnostics, Therapeutic Areas, Gastroenterology, Ophthalmology, Immunology, Managed Care, Biopharmaceuticals, Product Launch, R&D, Oracle Clinical, Quality Assurance, Healthcare, Pain Management
Education
New York Medical College 1998 — 2003
MSc., Clinical Research Administration
Immaculata University 1981 — 1984
BA, Sociology/Biology
Villa Walsh Academy 1976 — 1979
High School Diploma, College Prep
Takeda Pharmaceuticals June 2015 - Present
Theorem Clinical Research March 2014 - June 2015
Baxter Healthcare October 2012 - March 2014
Grifols May 2012 - September 2012
Grifols October 2011 - May 2012
Grifols (formerly Talecris Biotherapeutics) July 2008 - October 2011
Talecris Biotherapeutics, Inc. August 2006 - July 2008
Schering Plough Animal Health June 2001 - August 2002
Skills
Technical Writing, Presentation, Supervisory Skills, Research Study..., Problem Solving, Regulatory Affairs, FDA, Biopharmaceuticals, Clinical Research, Cell, Validation, Microbiology, GxP, GMP, Aseptic Processing, 21 CFR Part 11, Assay Development, Biotechnology, CAPA, Change Control, Clinical Development, GLP, Pharmaceutical Industry, Pharmaceutics, Regulatory Requirements, Regulatory Submissions, Sop, Technology Transfer, V&V, Computer System..., LIMS, Vaccines, CRO, Clinical Trials, GCP, Quality System, SOP
Education
Kansas State University 2002 — 2006
PhD, Animal Physiology
Kansas State University 1999 — 2001
MS, Animal Physiology
University of Wisconsin-La Crosse 1990 — 1994
BS, Biology
BioPrecision Group, LLC August 2015 - Present
Theorem Clinical Research January 2014 - July 2015
Oracle 2011 - May 2013
BioClinica May 2010 - December 2010
Bioclinica, Inc. (formerly Phoenix Data Systems) January 2005 - December 2010
Therakos, Inc. 2004 - 2005
Cephalon 2003 - 2004
Discovery Labs 2002 - 2003
Centocor 2000 - 2002
Rhone-Poulenc Rorer (Aventis) 1995 - 2000
Skills
21 CFR Part 11, CTMS, Vendor Management, Clinical Trials, EDC, Sop, Management, Data Management, Databases, Clinical Operations, Clinical Research, Clinical Data Management, Quality Assurance, Oncology, ICH-GCP, Cross-functional Team..., SOP
Education
Harcum College
BioMarin Pharmaceutical Inc. April 2015 - Present
Theorem Clinical Research March 2004 - March 2015
MedImmune Vaccines 2002 - 2004
Roche 1995 - 2001
Syntex Research 1991 - 1995
Skills
Clinical Data Management, EDC, Oracle Clinical, CRO, Quality Assurance, Biostatistics, Clinical Trials, Clinical Development, CTMS, Medical Writing, Statistical Programming, Oncology, MedDRA, SAS, GCP, SAS programming, Therapeutic Areas, Computer System..., Data Management, Clinical Operations, Protocol, Clinical Study Design, Clinical Research, Clinical Monitoring, Vaccines, Infectious Diseases, SDTM, Lifesciences, Regulatory Affairs, Pharmaceutical Industry, ICH-GCP, Inform, CRF design, Medidata, Medical Devices, Phase I, Pharmacovigilance, FDA, 21 CFR Part 11, Change Control, Regulatory Submissions, Endocrinology, Biotechnology, Sop, Validation, Drug Development, CDISC, Cardiology, Neurology, Medical Affairs
Education
California Polytechnic State University-San Luis Obispo 1985 — 1990
BS, Statistics
PRA Health Sciences January 2015 - Present
Theorem Clinical Research July 2012 - January 2015
Novo Nordisk March 2010 - July 2012
Skills
EDC, ICH-GCP, Drug Safety, Clinical Monitoring, Clinical Research, GCP, Pharmacovigilance, Sop, CRO, Clinical Study Design, FDA, Protocol, Software Documentation, Clinical Trials, Infectious Diseases, Oncology, Medidata, Medical Devices, SOP
Education
James Madison University 2005 — 2009
Bachelor of Business Administration (BBA), Human Resources Management/Personnel Administration, General
Theorem Clinical Research May 2014 - Present
East Penn Rheumatology April 2012 - May 2014
Siemens Healthcare November 2011 - April 2012
Lehigh Valley Health Network April 2011 - October 2011
East Penn Rheumatology October 2008 - March 2011
Skills
Rheumatology, Clinical Trials, Cardiology, Nursing Care, Clinical Development, GCP, Organization &..., Oncology, Regulatory Submissions
Education
Drexel University 2008 — 2013
Master of Science (M.S.), Clinical Research
Alvernia College 2003 — 2006
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
Chiltern September 2015 - Present
Theorem Clinical Research July 2015 - September 2015
Theorem Clinical Research May 2013 - July 2015
Theorem Clinical Research May 2012 - May 2013
Arcadia University January 2012 - January 2013
Skills
SAS, Statistics, Data Analysis, SAS programming, Statistical Programming, Programming, Databases, SPSS, Java, HTML, Analysis
Education
West Chester University of Pennsylvania 2013 — 2015
Master of Science (M.S.), Statistics
Arcadia University 2009 — 2013
Bachelor of Science (B.S.), Mathematics
Chiltern September 2015 - Present
Theorem Clinical Research September 2014 - September 2015
Theorem Clinical Research June 2011 - August 2014
Omnicare Clinical Research 2010 - June 2011
Clinimetrics Research Associates, Inc. 2006 - 2010
Clinimetrics Research Associates, Inc. 2006 - 2006
Clinimetrics Research Associates, Inc. 2004 - 2005
Clinimetrics 2000 - 2004
Clinimetrics Research Associates, Inc. 1997 - 2000
Clinimetrics Research Associates, Inc. 1995 - 1997
Skills
GCP, EDC, CTMS, CRO, Clinical Data Management, Clinical Development, Clinical Operations, Clinical Trials, Clinical Monitoring, Infectious Diseases, Oracle Clinical, Oncology, Pharmaceutical Industry, FDA, 21 CFR Part 11, Clinical Research, ICH-GCP, Sop, Therapeutic Areas, Endocrinology, Medical Writing, Regulatory Submissions, Drug Development, SOP, Cross-functional Team...
Education
California State University-Sacramento 1983 — 1987
B.A., Biological Sciences
Chiltern (formerly Theorem) September 2015 - Present
Theorem Clinical Research January 2010 - Present
PSPS: Philadelphia Society of People & Strategy January 2014 - Present
INC Research (via acquisition of MDS Pharma Services) July 2009 - November 2009
MDS Pharma Services July 2007 - July 2009
GlaxoSmithKline August 1997 - February 2007
CIGNA Healthcare August 1985 - August 1997
Skills
HR Metrics, Talent Management, Leadership Development, Mergers, Team Building, Strategy, Management, Personnel Management, Leadership, Strategic Planning, Culture Change, Employee Training, Business Planning, Executive Management, HR Transformation, Interviews, Program Management, Employment Law, Sourcing, Mergers & Acquisitions
Education
Cornell University 2012 — 2012
Certificate in Executive Leadership
LaSalle University
BA,, Psychology, Labor Relations
University of Pennsylvania
coursework at UPenn, Masters Program in Organizational Dynamics
Batherson Casting December 2010 - Present
Theorem Clinical Research April 2015 - Present
Hollywood Talent Associates October 2011 - Present
Central Casting March 2012 - Present
ICON plc 2000 - 2005
Skills
ARISg, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Research, GCP, Television, Sop, Feature Films, Music Videos, Regulatory Affairs, Oncology, Film, Videography, Clinical Data Management, Acting, Voice Over, Dance, FDA, EDC, Theatre, Commercials, Music, Entertainment, Casting, Video Editing, Narrative, Sound, Short Films
Education
Gwynedd-Mercy College 1990 — 1994
BSN, Nursing
Chiltern June 2015 - Present
Theorem Clinical Research August 2013 - Present
ICON Clinical Research July 2011 - August 2013
ICON Clinical Research July 2010 - August 2011
ISS Solutions November 2005 - January 2009
General Healthcare Resources 2005 - 2005
Reimbursement Technologies, Inc. 2000 - 2005
Advanta National Bank March 2000 - June 2000
Snelling Personnel Services October 1999 - January 2000
Kelly Services March 1998 - October 1999
Skills
E-Verify, Affirmative Action..., Recruitment, Staffing Services, Payroll, Ad Hoc Reporting, Employee Relations, Recruiting, New Hire Orientations, Training, Interviews, Human Resources, Sourcing, Personnel Management, Talent Acquisition, Applicant Tracking..., Employee Benefits, Deferred Compensation, Benefits Administration, Screening, Hiring, PeopleSoft, Temporary Staffing, Leadership
Education
DeSales University 2011 — 2015
MBA
Villanova University in conjunction with SHRM 2010 — 2010
Certificate, Human Resources Management
Philadelphia University 2003 — 2005
Bachelor of Science, Human Resources
Montgomery County Community College 2001 — 2004
AA, Business Administration and Management, General
New York University 1991 — 1996
Aeris Communications June 2013 - Present
Better Place, Inc. September 2011 - April 2013
Theorem Clinical Research April 2010 - July 2011
Clinimetrics Research Associates, Inc October 2008 - April 2010
Clinimetrics Research Associates, Inc. May 2004 - October 2008
Clinimetrics Research Associates, Inc February 2002 - May 2004
PricewaterhouseCoopers September 2000 - February 2002
PricewaterhouseCoopers June 2000 - August 2000
PricewaterhouseCoopers January 2000 - May 2000
PricewaterhouseCoopers September 1997 - December 1999
Skills
Financial Modeling, Budgeting and..., US and International..., M&A due diligence, Valuations, Financial Integration, ERP Implementation, US GAAP, IFRS, Excel (including macros..., Internal Controls, Budgets, Start-ups, Strategy, Finance, Due Diligence, Accounting, ERP, Valuation, Microsoft Excel, Sarbanes-Oxley Act, Forecasting, Visual Basic, Financial Reporting, Mergers & Acquisitions, Process Improvement, Revenue Recognition, Analysis, Restructuring
Education
University of California, Berkeley - Walter A. Haas School of Business 2006 — 2010
MBA
American University in Bulgaria 1992 — 1996
BA
Theorem Clinical Research July 2014 - Present
PRA International April 2013 - June 2014
Aptiv Solutions September 2010 - April 2013
sanofi-aventis April 2008 - March 2010
sanofi-aventis July 2007 - April 2008
ICON Clinical Research November 2000 - July 2007
Skills
Clinical Trials, Oncology, Infectious Diseases, Vaccines, Endocrinology, Clinical Operations, Hypertension, In Vitro, Assay Development, CTMS, CRO, GCP, Clinical Monitoring, EDC, Clinical Development, Phase I, Clinical Research, ICH-GCP
Education
Eastern Illinois University 1994 — 1998
Bachelor of Science, Zoology
Theorem Clinical Research October 2014 - Present
Accenture April 2013 - October 2014
DSG, Inc. January 2012 - February 2013
Quantason March 2011 - December 2011
Crozer Chester Medical Center May 2010 - July 2010
Temple University January 2009 - July 2010
Temple University January 2009 - July 2010
Northwestern Human Services June 2008 - February 2009
MacroStat, Inc. July 2008 - December 2008
Center for Obesity Research and Education February 2008 - October 2008
Skills
SAS programming, statistical analysis, grant applications, clinical writing, Oncology, Technical Writing, Statistical Data..., Statistics, Clinical Trials, Clinical Research, SAS, Data Analysis, Clinical Development, Lifesciences, Biotechnology, Medical Devices, EDC, FDA, Quality Assurance, Data Management, SAS Programming
Education
Villanova University 2014 — 2016
Master of Science (M.S.), Applied Statistics
Temple University 2006 — 2010
M.Ed., Counseling Psychology
Cornell University 2002 — 2006
B.A., Neurobiology
Lannett Company September 2014 - Present
Theorem Clinical Research November 2013 - September 2014
GlaxoSmithKline January 2012 - June 2013
Skills
SAS programming, Statistics, Analysis, ANOVA, Biostatistics, SAS, Statistical Modeling, Data Analysis, Segmentation, Predictive Modeling, Logistic Regression, Mathematical Modeling, Minitab, SPSS, Variance Analysis, Experimental Design, Quantitative Research, R, Survival Analysis
Education
West Chester University of Pennsylvania 2011 — 2013
Master of Science (M.S.), Applied Statistics
Arcadia University 2009 — 2011
Bachelor of Science (B.S.), Mathematics
Theorem Clinical Research June 2013 - Present
Research Pharmaceutical Services July 2011 - May 2013
American College of Radiology December 2010 - July 2011
Octagon Research Solutions June 2010 - December 2010
MERCK & CO., INC August 2006 - August 2009
MERCK & CO., INC August 2003 - August 2006
MERCK & CO., INC August 2000 - August 2003
Omnicare Clinical Research January 1999 - August 2000
Childrens Hospital of Philadelphia 1993 - 1999
Temple University Hospital 1992 - 1999
Skills
Clinical Research, CRO, Clinical Trials, EDC, Data Management, Oracle Clinical, CRF design, Therapeutic Areas, Clinical Data Management, Neurology, GCP, Oncology, CTMS, Managed Care, ICH-GCP, Inform
Education
Gwynedd-Mercy College 1998 — 2003
2003BS, Health Information Administration
Theorem Clinical Research November 2014 - Present
Theorem Clinical Research October 2011 - Present
Covance 2009 - 2011
Hospira 2007 - 2009
Baxter Healthcare September 2000 - March 2007
Baxter Healthcare - Anesthesia, Critical Care & Oncology 2000 - 2004
Kendle International 1998 - 2000
Medex 1994 - 1998
Skills
Pharmacovigilance, Regulatory Affairs, FDA, Medical Devices, Clinical Research, GCP, Clinical Development, Regulatory Requirements, Regulatory Submissions, Oncology, Clinical Trials, Pharmaceuticals, Biotechnology, Advisory Boards, Therapeutic areas, Risk Management, Diabetes, CRO, Cardiac, Protocol Development, Internal Medicine, Pain Management, Pain, ICU, Outcomes Research, Product Development, Pharmaceutical Industry, Cardiology, CTMS, Biopharmaceuticals, EDC, Pharmaceutics, Clinical Monitoring, Neurology, Data Management, Infectious Diseases, Endocrinology, Medical Writing, Drug Development, Protocol, Therapeutic Areas, Medicine
Education
University of Wales, Cardiff 1988 — 1991
Diploma of Pharmaceutical Medicine, Pharmaceutical Medicine
AUC School of Medicine
Doctor of Medicine (MD)
Emory University
Bachelor's Degree, Psychology, Pre-Med
Amgen June 2015 - Present
Onyx Pharmaceuticals March 2015 - June 2015
Onyx Pharmaceuticals May 2013 - March 2015
Theorem Clinical Research June 2011 - May 2013
Quintiles Transnational March 2010 - June 2011
PRA International November 2007 - February 2010
Skills
Healthcare, SDTM, SAS programming, SAS, Relational Databases, Statistical Programming, Clinical Research, Statistics, Oncology, Survival Analysis, Clinical Trials, CDISC, Data Analysis, Regulatory Submissions, Analysis, Biostatistics, Clinical Data Management, Pharmaceutical Industry, EDC, SAS Programming
Education
Texas Tech University
MS, Statistics
Concordia College 2000 — 2003
BA, Computer Science
Theorem Clinical Research January 2010 - Present
Clinimetrics Research Associates, Inc. September 2002 - January 2010
Education
University of California, Los Angeles 2004 — 2013
Ph.D Candidate, History
University of California, Los Angeles - School of Law 1999 — 2002
JD, Law
Boston College 1995 — 1998
BA, History
Theorem Clinical Research May 2014 - Present
Covance February 2013 - Present
United BioSource Corporation March 2012 - November 2012
Actelion October 2011 - March 2012
Merck July 2008 - December 2010
Pharmanet April 2007 - October 2007
Johnson & Johnson December 2006 - April 2007
MERCK & Co February 2001 - November 2006
Wyeth - Ayerst September 1999 - January 2001
Skills
Clinical Development, Clinical Trials, Clinical Data Management, Sop, Validation, Protocol, Oracle Clinical, Oncology, Infectious Diseases, EDC, Data Management
Education
Drexel University 1988 — 1992
BSMT, Medical Technology
Drexel University
Graduate classes, Adult Education
Theorem Clinical Research June 2014 - Present
PRA International August 2012 - May 2014
CRI Worldwide September 2008 - August 2012
CRI Worldwide September 2008 - September 2010
CRI Worldwide September 2008 - March 2009
Bucknell University September 2006 - August 2008
Skills
Clinical Trials, Research, EDC, GCP, Clinical Research, SPSS, Clinical Development, Psychology, Oncology, Pharmaceutical Industry, Gel Electrophoresis, Healthcare, FDA, Protocol
Education
Bucknell University 2006 — 2008
M.S., Experimental Psychology
Rider University 2002 — 2006
B.A., Psychology
Theorem Clinical Research January 2013 - Present
Theorem Clinical Research November 1996 - Present
Abington Memorial Hospital June 1990 - May 1997
Polyclinic Medical Center 1989 - 1991
Carlisle Hospital 1986 - 1989
Hershey Medical Center 1983 - 1985
Holy Spirit Hospital 1983 - 1984
UPMC Mercy Hospital 1980 - 1983
Skills
Oracle Clinical, Clinical Data Management, EDC, CRO, Clinical Trial...
Education
HACC, Central Pennsylvania's Community College 1986 — 1988
ASN, Nursing
Duquesne University 1980 — 1983
Registered Nursing/Registered Nurse
Jazz Pharmaceuticals April 2015 - Present
Theorem Clinical Research October 2013 - April 2015
JANSSEN Alzheimer Immunotherapy September 2011 - September 2013
Teikoku Pharma USA February 2011 - August 2011
ClinOps, formerly Pacific Data Designs September 2009 - January 2011
The Nielsen Company May 2009 - September 2009
Skills
SAS, SQL, Clinical Trials, GCP, Statistics, CDISC, Data Analysis, SAS/SQL, Biostatistics, Survival Analysis, Logistic Regression, Statistical Modeling, SAS programming, Statistical Programming, Analysis, Data Mining, Pharmaceutical Industry, SAS Macro, Software Documentation, CRO, ICH-GCP, SAS Certified Base..., SDTM, ANOVA, Validation, Oncology, Clinical Data Management, Therapeutic Areas, EDC, Drug Development, Data Management, Clinical Study Design, CRF design, SAS Programming
Education
California State University-East Bay 2005 — 2008
Master of Science, Statistics
Chiltern July 2015 - Present
Theorem Clinical Research December 2013 - June 2015
inVentiv Health Clinical July 2011 - December 2013
R. P.Chiacchierini & Associates, LLC April 2010 - July 2011
Virginia Tech August 2008 - April 2010
Minitab September 2006 - August 2008
Minitab July 2001 - August 2006
Skills
Clinical Trials, Statistics, Data Analysis, Minitab, SAS, Design of Experiments, Statistical Modeling, Cross-functional Team..., Technical Writing, R, Six Sigma, Project Management, Data Management, Microsoft Office, SAS programming, SAS Programming, Pharmaceutical Industry, Management
Education
Virginia Polytechnic Institute and State University 2008 — 2010
MS, Statistics
Penn State University 2002 — 2006
MAS, Applied Statistics
Bloomsburg University of Pennsylvania 1999 — 2001
BS, Mathematics with Statistics
Pennsylvania College of Technology 1997 — 1999
AAS, General Studies
PPD August 2015 - Present
ACI Clin April 2014 - July 2015
Theorem Clinical Research March 2013 - April 2014
PharmaNet/i3 October 2010 - March 2013
i3 October 2009 - September 2010
i3 March 2007 - September 2009
i3 March 2005 - March 2007
i3 August 2001 - March 2005
Skills
Clinical Data Management, Clinical Trials, CDISC, CRO, SAS, Data Management, Pharmaceutical Industry, SAS programming, Biostatistics, Oracle Clinical, Oncology, 21 CFR Part 11, Clinical Research, GCP, FDA, EDC, Statistical Programming, Strategic Leadership, Clinical Development, ICH-GCP, Validation, Regulatory Submissions, Pharmacovigilance, CTMS, Protocol, SAS Programming, Management
Education
Kaplan University
MBA, Management
Andhra University 1988 — 1992
BE, Electronics and Communications
Dr. B.R.Ambedkar college, Hyderabad 1985 — 1987
Mathematics
Credit Suisse July 2015 - Present
RQG-LLC June 2015 - Present
INC Research November 2013 - June 2015
Theorem Clinical Research June 2013 - November 2013
ICON plc February 2012 - June 2013
Novella Clinical, Inc. June 2009 - October 2011
PPD October 2005 - June 2010
Skills
Clinical Trials, Forecasting, Pharmaceutical Industry, FDA, Financial Reporting, Six Sigma, Finance, CRO, Cross-functional Team..., Biotechnology, Clinical Research, Process Improvement, Lifesciences, Microsoft Excel, Microsoft Office, Clinical Development, Leadership, CTMS, Oncology, SOP, Data Analysis, Budgets, Team Building, Customer Service, PowerPoint, Management
Education
North Carolina State University 2014 — 2014
Lean Six Sigma Black Belt
Campbell University 2008 — 2009
MBA
North Carolina State University 2001 — 2003
Bachelor, Science Agricultural Business Management
PRA Health Sciences September 2015 - Present
Theorem Clinical Research April 2015 - September 2015
Theorem Clinical Research May 2013 - April 2015
Villanova University August 2013 - February 2015
Theorem Clinical Research June 2011 - May 2013
James Madison University January 2013 - April 2013
James Madison University August 2012 - December 2012
James Madison University August 2012 - December 2012
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Teaching, SPSS, Data Analysis, Management, Program Management, Leadership, Social Media, Public Speaking, Social Networking
Education
James Madison University 2009 — 2013
Bachelor of Arts (B.A.) with honors, Psychology (Pre-Law concentration)
Lorenzo de' Medici: Italian International Institute 2011 — 2011
Theorem Clinical Research July 2012 - Present
Case Western Reserve University May 2012 - July 2012
Case Western Reserve University November 2008 - May 2012
Case Western Reserve University November 2005 - November 2008
Case Western Reserve University November 2004 - November 2005
Skills
CCRP, IRB, Clinical Research, Clinical Trials, Neuroscience, Mental Health, Data Analysis, EDC, Protocol, Research, GCP, Clinical Development, Clinical Study Design, CTMS, Data Management, Medical Writing, FDA, Oncology, CRO, Clinical Data Management
Education
Walden University 2010 — 2011
Master of Science, Clinical Research Administration
Cuyahoga Community College 2009 — 2010
Certificate, Medical Laboratory Technology
The University of Akron 1999 — 2003
Bachelor of Arts, Psychology
Theorem Clinical Research April 2009 - Present
Omnicare Clinical Research December 2006 - April 2009
Omnicare Clinical Research March 2004 - December 2006
Omnicare Clinical Research July 2001 - March 2004
Omnicare Clinical Research December 2000 - June 2001
IBAH, Inc. June 1999 - April 2000
SmithKline Beecham May 1996 - June 1999
Skills
Lifesciences, Biotechnology, Program Management, Change Management, Clinical Data Management, SharePoint, Medical Devices, Integration, Clinical Development, Outsourcing, Business Intelligence, Strategy, Enterprise Architecture, Clinical Research, Healthcare, Business Process..., Quality Assurance, Healthcare Information..., Oncology, Data Center, Information Technology, Software Documentation, Management, 21 CFR Part 11, Clinical Trials, Pharmaceutical Industry, Vendor Management, Cross-functional Team..., Process Improvement, IT Management, Project Management, Business Analysis
Education
Villanova University 2000 — 2002
MBA
La Salle University - School of Business Administration 1995 — 1999
Bachelor of Science, Management Information Systems and Marketing
Williamstown High School 1991 — 1995
Chiltern September 2014 - Present
Theorem Clinical Research 2014 - 2015
Quintiles July 2010 - September 2014
Quintiles July 2010 - June 2012
Copernicus Group IRB January 2007 - November 2009
PPD January 2007 - December 2007
BCBSNC 2003 - 2005
BCBSNC 2003 - 2005
Skills
Clinical Research..., Clinical Trials, Pharmacovigilance, FDA, Clinical Research, Sop, CTMS, CRO, ICH-GCP, Clinical Monitoring, GCP, IRB, Software Documentation, Protocol, Clinical Data Management, EDC, Regulatory Submissions, Clinical Development, Therapeutic Areas, Inform, Clinical Operations, SOP
Education
Ashford 2007 — 2009
Fayetteville State University 1986 — 1988
Hillside High School 1980 — 1984
TruHealth Asset Development Partners, LLC July 2015 - Present
Bilger Health Consulting September 2014 - August 2015
Theorem Clinical Research August 2011 - September 2014
Fisher Clinical Services January 2010 - June 2011
PPL Corporation 2007 - February 2009
PPL Corporation 1998 - 2007
Skills
Access, Leadership, Process Improvement, Software Documentation, Risk Management, Contract Negotiation, Regulations, Pharmaceutical Industry, Project Management, Contract Management, Budgets, Negotiation, Training, Strategic Planning
Education
Muhlenberg College 2000 — 2004
Bachelor's, Business Administration
Penn State University 1999 — 2000
Paralegal Certificate
Lehigh Carbon Community College
Independent Coursework
Chiltern September 2015 - Present
Theorem Clinical Research July 2015 - Present
Theorem Clinical Research November 2014 - Present
Villanova University August 2013 - May 2015
Source One Management Services July 2014 - November 2014
Integnol LLC April 2013 - August 2013
East Stroudsburg University January 2013 - May 2013
Skills
Mathematics, Mathematical Modeling, Algebra, Differential Equations, Maple, Mathematica, Matlab, Calculus, Numerical Analysis, Statistics, Academic Tutoring, Microsoft Excel, Physics, Scientific Computing, LaTeX, Applied Mathematics, Probability, Algorithms, Critical Thinking, Linear Algebra, Tutoring, Close Attention to..., Microsoft Word, Research, Microsoft Office, PowerPoint
Education
Villanova University 2013 — 2015
Master of Arts (MA), Mathematics
East Stroudsburg University of Pennsylvania 2011 — 2013
Bachelor of Arts (BA), Mathematics, Summa Cum Laude
Chiltern (formerly Theorem Clinical Research) April 2015 - Present
Theorem Clinical Research October 2014 - April 2015
Rho July 2013 - April 2014
ClinStar November 2011 - July 2013
INC Research September 2010 - November 2011
INC Research July 2009 - September 2010
INC Research June 2006 - July 2009
INC Research January 2006 - July 2006
INC Research September 2004 - January 2006
Quintiles July 1999 - September 2004
Skills
Clinical Data Management, Project Management, Strategic Planning, Personnel Management, ERP, Programming, Trial Management, Operational Support, CRO, Clinical Trials, Clinical Development, Pharmaceutical Industry, CTMS, GCP, Clinical Research, EDC, Regulatory Affairs, Thought Leadership, Public Speaking, Sop
Education
Long Island University, C.W. Post Campus 1982 — 1984
MPA, Public Administration and Health Care
LIU Post 1977 — 1981
BA cum laude, Political Science
National Defense University 1996 — 1998
Certificate, DoD Advanced Management Program
Army Management Staff College 1991 — 1993
Sewanhaka 1974 — 1977
Theorem Clinical Research April 2015 - Present
Allergan, Inc. November 2012 - March 2015
PAREXEL - PERCEPTIVE INFORMATICS July 2010 - November 2012
VERIZON COMMUNICATIONS - Ajilon Consulting September 2006 - July 2010
VERIZON COMMUNICATIONS - Volt Information Services January 2004 - September 2006
Skills
Clinical Systems:..., Systems Testing &..., Vendor Oversight, Requirement Gathering &..., FDA Compliance: 21 CFR..., Project Planning, Public Speaking, Programming Languages: ..., Microsoft Office Tools:..., Operating Systems: ..., Software and Servers: ..., Problem Analysis, Project Team &..., Quality and..., Schedule Coordination, Timeline Development, Technical Documentation, Agile Methodologies, SDLC, Contract Review, Notary Public, Databases, Quality Assurance, Validation, CRO, EDC
Education
Baylor University 1999 — 2003
Bachelor of Arts, Business Administration
Theorem Clinical Research January 2015 - Present
Inventiv Health Clinical July 2012 - December 2014
Ockham Development Group July 2008 - May 2012
Quintiles November 2007 - June 2008
Quintiles July 2007 - October 2007
Skills
Statistical Programming, CDISC, Biostatistics, Oracle Clinical, EDC, Oncology, Clinical Data Management, SAS, SAS programming, Pharmaceutical Industry, SDTM, Clinical Trials, Clinical Development, CRO, Biotechnology, GCP, Data Management, ICH-GCP
Education
Eastern Michigan University 2004 — 2006
Master's degree, Bioinformatics
Acharya N.G. Ranga Agricultural University 2001 — 2003
Master's degree
Theorem Clinical Research January 2015 - Present
Allergan, Inc. 2012 - 2014
Skills
Sales Tax, CRO, Clinical Trials, Pharmaceutical Industry, Income Tax, Bookkeeping, Tax Returns, GCP, Tax Preparation, Clinical Development, Data Management, ICH-GCP, Clinical Research, 21 CFR Part 11, Oracle Clinical, SOP, Biotechnology, FDA, EDC
Education
Grand Canyon University 2013 — 2015
Master's degree, Public Health
California State University San Marcos 1991 — 1992
Bachelor of Arts (B.A.), English
Chiltern September 2015 - Present
Theorem Clinical Research July 2014 - September 2015
Theorem Clinical Research December 2010 - July 2014
Octagon Research Solutions April 2010 - December 2010
Accenture (Wyeth-Pfizer) May 2005 - April 2010
Accenture (Wyeth) April 2003 - November 2006
Wyeth Pharmaceuticals December 2002 - April 2003
Wyeth Pharmaceuticals July 2001 - December 2002
Omnicare Clinical Research June 2000 - July 2001
Rhone-Poulenc Rorer Pharmaceuticals, Inc May 1999 - June 2000
Skills
Clinical Data Management, CRO, Therapeutic Areas, Data Management, Oracle Clinical, Software Documentation, Clinical Trials, CDISC, Process Improvement, Project Management, Clinical Development, Sop, SDTM, Medidata, Protocol, EDC, Clinical Research, Validation, CTMS, CRF design, 21 CFR Part 11, GCP, ICH-GCP
Education
Edinboro University of Pennsylvania 1989 — 1994
BS, Biology
Theorem Clinical Research April 2014 - Present
inVentiv Health Clinical October 2013 - April 2014
ICON Clinical Research April 2011 - October 2013
ICON Clinical Research January 2008 - April 2011
Covance November 2005 - November 2007
LabCorp September 2004 - November 2005
Lockheed Martin Information Technology June 2003 - July 2004
Skills
Process Improvement, Contract Negotiation, Time Management, Organization, Financial Analysis, Change Orders, Contract Management, Clinical Research, Microsoft Office, Proposal Writing, Budgets, Management, Clinical Development, Biotechnology, CRO, Pharmaceutical Industry, Negotiation, Software Documentation, Clinical Data Management, Start-ups, CTMS, GCP, Clinical Trials, Pharmacovigilance, ICH-GCP, EDC, Finance, Analysis, Regulatory Submissions
Education
American University 1998 — 2002
BA, Justice
LiquidHub June 2014 - Present
SEI November 2013 - Present
Apprenda 2015 - 2015
LiquidHub February 2013 - May 2014
Apprenda 2014 - 2014
Liquidhub India Pvt. Ltd. February 2011 - February 2013
ABIM Foundation 2012 - 2013
LiquidHub February 2009 - February 2011
Theorem Clinical Research 2008 - 2010
LiquidHub July 2007 - February 2009
Skills
ASP.NET, ASP.NET MVC, Informatica, .NET, MVC Architecture, WCF Services, Angular JS, BizTalk, LINQ, ADO.NET, Sitecore, C# 2.0, SOA, C# 3.0, c# 4.0, ColdFusion, Actuate Report, Actuate Reporting, Business Rule, Clinical Development, SSRS, SSIS, Web Services, TDD, VB.NET, Microsoft SQL Server..., C#, Agile Methodologies, SDLC, SOA Governance, Microsoft SQL Server, Mule ESB, Requirements Analysis, WCF, Web Applications, T-SQL, Visual Studio, XML
Education
Jawaharlal Nehru Technological University 2000 — 2004
Bachelor of Technology (B.Tech.), Computer Science
DAV Public School, Ukkunagaram, Visakhapatnam 1988 — 1998
10, High School Equivalence Certificate Program
Theorem Clinical Research January 2015 - Present
PRA International October 2012 - Present
inVentiv Health May 2005 - October 2011
The Medicines Company May 2005 - October 2011
Skills
Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, English, Windows, Research, Outlook, Photoshop, Teaching, HTML, Budgets, Public Speaking, C++
Education
Highline Community College 1987 — 1989
DOCS June 2015 - Present
Theorem Clinical Research February 2012 - June 2015
PRA International June 2008 - February 2012
Skills
CRO, SAS programming, Clinical Trials, CDISC, SAS, Biostatistics, SDTM, Clinical Research, Pharmaceutical Industry, ICH-GCP, Oncology, Statistics
Education
East Carolina University 2015 — 2018
Master of Business Administration (M.B.A.)
East Carolina University 2007 — 2008
MS, Economics
East Carolina University 2002 — 2007
BS, Economics; Minor in Business Administration
Theorem Clinical Research July 2015 - Present
INC Research June 2012 - July 2015
INC Research January 2006 - June 2012
University of Virginia Health System June 2005 - January 2006
PRA June 2001 - June 2005
Skills
CTMS, Clinical Trials, CRO, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, EDC, GCP, ICH-GCP, Protocol, Therapeutic Areas, Oncology, Regulatory Submissions
Education
James Madison University
Bachelor of Science (B.S.), Psychology
Wincere Inc. September 2013 - Present
Theorem Clinical Research July 2012 - September 2013
Theorem Clinical Research May 2009 - June 2012
Cognizant Technology Solutions 2007 - 2009
Novartis Pharma Limited 2007 - 2007
Quintiles Transnational 2005 - 2007
Skills
Clinical Data Management, EDC, Oracle Clinical, Data Management, CTMS, Clinical Trials, 21 CFR Part 11, GCP, CRO, Validation, SAS, CDISC, Medidata, Quality Assurance, Pharmaceutical Industry, Clinical Development, Lifesciences, Clinical Research, Protocol, ICH-GCP, Pharmacovigilance, Computer System..., Sop, Oncology
Education
Bharathidasan University
M.Sc, Information Technology
University of Madras
B.Sc, Computer Science
Chiltern International February 2014 - Present
INC Research August 2013 - February 2014
Theorem Clinical Research October 2012 - July 2013
PAREXEL August 2011 - October 2012
Array BioPharma November 2009 - June 2011
Eliassen Group February 2008 - August 2009
Medidata Solutions January 2007 - January 2008
Eisai Pharmaceuticals 2002 - 2007
US Army 1987 - 1990
Skills
EDC, Clinical Trials, CTMS, Validation, CRO, Sop, Data Management, Computer System..., Medidata, Clinical Data Management, GCP, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Clinical Research, FDA, Product Demonstration, Oncology, Clinical Development, Software Documentation, Change Control, Protocol, Regulatory Submissions, Technical Training, Oracle Clinical, Integration, ICH-GCP, Inform, GxP, Lifesciences, SAS programming, Clinical Monitoring, Regulatory Affairs, Drug Development, Medical Devices, Therapeutic Areas, Pharmacovigilance, GMP, Life Sciences, Merge eClinicalOS, SOP
Education
Georgetown University
BS Foreign Service, STIA: Science Technology and International Affairs
Webster University
MA, Management
Intercept Pharmaceuticals March 2015 - Present
Intercept Pharmaceuticals September 2013 - March 2015
Theorem Clinical Research August 2012 - September 2013
Synteract, Inc. June 2012 - August 2012
Synteract, Inc June 2010 - June 2012
Synteract, Inc. June 2008 - June 2010
Synteract, Inc. June 2006 - June 2008
Elan Pharmaceuticals 2004 - 2006
Bristol-Myers Squibb January 2004 - October 2004
Skills
CRO, Clinical Data Management, EDC, CDISC, Medidata, SDTM, Randomization, ANCOVA, Mixed Model, Bayesian inference, Bayesian, Statistical Analysis..., Clinical Protocols, Study Reports, WinNonlin, PK, Pharmacodynamics, Pharmacokinetics, R, Bayesian statistics, Categorical Data..., Statistical Consulting, Logistic Regression, Clinical Trials, Clinical Trial Analysis, Survival Analysis, Biostatistics, Protocol Review, SAS programming, GLM, Pharmaceutical Industry, NDA, eCTD, FDA, ICH guidelines, MHRA, EMA, Clinical Development, Statistical Programming, SAS, Drug Development, Data Management, DMC, Biotechnology, ADaM, ISE, ISS, Management, Clinical Study Design, GCP
Education
University of California, Los Angeles 1999 — 2004
DrPH, Biostatistics
Georgetown University 1997 — 1999
MS, Biostatistics & Epidemiology
University of Oregon 1993 — 1997
BS, Math and Biology
Chiltern July 2015 - Present
Theorem Clinical Research September 2013 - July 2015
inVentiv Health Clinical April 2013 - September 2013
Clinical Solutions Group (CSG, Inc.) May 2012 - March 2013
PPD June 2011 - May 2012
PPD December 2009 - June 2011
i3 StatProbe February 2009 - March 2010
PPD Inc. June 2005 - February 2009
Parke-Davis / Pfizer 2000 - 2005
Skills
SDTM, Oracle Clinical, EDC, Clinical Data Management, CRO, Clinical Trials, Inform, GCP, 21 CFR Part 11, Biostatistics, SAS programming, Data Management, Pharmaceutical Industry, Validation, SAS, Clinical Research, CTMS, MedDRA, Therapeutic Areas, Regulatory Affairs, SAS Programming, Clinical Development, Oncology, Statistical Programming
Education
Grand Valley State University 1992 — 1994
BS, Mathematics
Chiltern January 2015 - Present
Theorem Clinical Research September 2011 - Present
Theorem Clinical Research January 2015 - Present
Qivana March 2012 - January 2014
Univera LifeSciences 2007 - March 2012
INC Research March 2010 - June 2011
CRMi January 2009 - April 2010
PRA International July 2008 - January 2009
ResearchPoint May 2002 - July 2008
Clinical Research Center July 2001 - February 2002
Skills
CRO, EDC, Clinical Trials, Oncology, GCP, Pharmaceutical Industry, CTMS, Neurology, Clinical Data Management, Clinical Research, Clinical Development, Infectious Diseases, Clinical Monitoring, Lifesciences, Medical Writing, Cardiology, Regulatory Affairs, Pharmacovigilance, Biotechnology, Regulatory Submissions, Endocrinology, Data Management, Dermatology, Diabetes, Gastroenterology, Therapeutic Areas, ICH-GCP, FDA, Drug Development, Sop, Medical Devices, Vaccines, Protocol, Pharmaceutics, 21 CFR Part 11, Biopharmaceuticals, Neuroscience
Education
Santa Barbara College of Oriental Medicine 1996 — 1999
MTCM, Acupuncture, Traditional Chinese Medicine
University of New Orleans 1993 — 1996
Theorem Clinical Research April 2015 - Present
Allergan November 2011 - April 2015
Array BioPharma 2008 - 2011
Amgen Inc. 1992 - 2007
Skills
Clinical Data Management, Medidata, Data Management, EDC, Clinical Trials, CRF design, CRO, GCP, ICH-GCP, Inform, Biotechnology, Clinical Development, Oncology, Clinical Research, CTMS
Education
Drexel University 2014 — 2017
Bachelor's Degree, Health Sciences Administration
Delta College 1981 — 1984
Associate's Degree, General Secretarial Science
CSC January 2013 - Present
Theorem Clinical Research August 2012 - December 2012
Prudential Financial October 2009 - August 2012
Dudnyk Healthcare Group February 2007 - February 2009
EMC Outdoor 2004 - 2007
Skills
Project Management
Education
Arcadia University
West Chester University of Pennsylvania
Marketing
INC Research 2015 - Present
Theorem Clinical Research August 2014 - April 2015
Abbott 2011 - August 2014
i3 Statprobe, United Healthcare 2006 - 2011
Millennium Medical Management, Inc. 2005 - 2006
Limited Brands 2004 - 2005
Prologue Research International, Inc.: An Oncology CRO 2002 - 2004
Merck 2001 - 2002
Merck 2000 - 2001
Skills
Clinical Trials, GCP, CRO, Oncology, Pharmaceutical Industry, Clinical Research, Quality Assurance, Data Management, Program Management, Project Management, Data Analysis, FDA, Clinical Data Management, Portfolio Management, Oncology Clinical..., Contract Negotiation, MS Project, Contract Management, Clinical Development, 21 CFR Part 11, Infectious Diseases, Regulatory Submissions, Drug Development, Protocol, Clinical Study Design, Cross-functional Team..., Regulatory Affairs, Diabetes, SAS, Change Control, Process Improvement, Biostatistics, Healthcare, CRF design, R, Statistics, Vendor Management, Project Portfolio..., Business Process..., Clinical Operations, Resource Management, IND, Analysis, Hematology, Change Management
Education
Yale University 1998 — 2000
MPH, Public Health
Boston University 1997 — 1998
MA, Medical Sciences
Wellesley College 1992 — 1996
Bachelor of Arts (B.A.), Biological Chemistry
Chiltern September 2015 - Present
Theorem Clinical Research (now Chiltern) August 2014 - September 2015
Theorem Clinical Research August 2012 - August 2014
TKL Research July 2011 - August 2012
Jubilant Clinsys (formerly Clinsys Clinical Research) February 2007 - July 2011
INC Research April 2005 - February 2007
Inveresk Research, a Charles River Company December 2000 - April 2005
Tek Solutions, Inc. April 1998 - December 2000
Lockheed Martin Information Technology January 1990 - April 1998
Heart of Carolina Aerial Surveys August 1988 - December 1989
Skills
CRO, GCP, Clinical Trials, Clinical Development, EDC, CTMS, Oncology, Therapeutic Areas, Clinical Monitoring, ICH-GCP, Clinical Research, Biotechnology, Clinical Data Management, Infectious Diseases, Sop, Regulatory Affairs, Regulatory Submissions, Drug Development, Protocol, FDA, Pharmacovigilance, Neurology, Medical Writing, Clinical Operations, Regulatory Requirements, Data Management, 21 CFR Part 11, Lifesciences, Oracle Clinical, Inform, CRF design
Education
Meredith College 1994 — 1997
MBA
Florida Atlantic University 1982 — 1985
BA, Management Science and Systems
Navigate Corporation August 2006 - Present
Theorem Clinical Research 1999 - 2010
NHS Human Services January 2004 - May 2006
Citadel Information Technology Services January 2003 - January 2004
IDC Partners January 1999 - August 2003
Skills
Vendor Management, Project Management, Process Improvement, Program Management, Business Analysis, Project Planning, SQL, ERP, EDC, Microsoft Excel, Management Consulting, Microsoft Office, PowerPoint, ITIL Certified, MCSE, Windows 7 Migration, SCCM, Active Directory, Business Process, Business Process..., Change Management, Consulting, Data Analysis, Disaster Recovery, Governance, IT Management, IT Operations, IT Service Management, IT Strategy, Information Technology, ITIL, Leadership, MS Project, Management, Microsoft Certified..., PMP, Operations Management, Project Delivery, Networking, Risk Management, Servers, Software Documentation, Strategy, Troubleshooting, Visio, Data Warehousing, Integration, System Administration, SharePoint
Education
Delaware County Community College 2002 — 2006
The Chubb Institute 1998 — 1999
Diploma in Computer Technical Support, Information Technology
Chiltern September 2015 - Present
Theorem Clinical Research, Inc. April 2013 - Present
PA Army National Guard February 2012 - May 2015
Theorem Clinical Research, Inc. January 2012 - April 2013
Theorem Clinical Research January 2011 - December 2011
PA ARMY National Guard July 1997 - July 2011
Omnicare Clinical Research, Inc. June 2006 - January 2011
Lancaster Laboratories March 2002 - June 2006
US Navy June 1994 - July 1997
Skills
Clinical Trials, Pharmaceutical Industry, Contract Management, Oncology, Contract Negotiation, Clinical Research, FDA, Legal Documents, ICH-GCP, CRO, Clinical Development, GCP, Contract Law, Vendor Management, Strategic Partnerships, Contract Writing
Education
Villanova University 2005 — 2006
Certificate, Commercial Contract Management
Academy of Medical Arts and Business 2000 — 2002
Associates in Specialized Business, Paralegal Studies
Harrisburg Area Community College 1992 — 1993
Business Management
California University of Pennsylvania 1991 — 1992
Elementary/Special Education and Business Management
US Military
Chiltern September 2015 - Present
Theorem Clinical Research 2012 - September 2015
Theorem Clinical Research November 2003 - September 2015
PRA International August 2000 - November 2003
Skills
Clinical Research, Proposal Writing, Budgeting, Negotiation, Pricing, RFP, CRO, Marketing, Management, Process Improvement, Training, New Business Development, Budgets, CTMS, Pharmaceutical Industry, Contract Negotiation, Clinical Trials, Strategic Planning, Clinical Development, Cross-functional Team..., Contract Management, Business Development
Education
Rutgers, The State University of New Jersey-Newark 1998 — 2003
Master’s Degree
Fairleigh Dickinson University 1984 — 1988
BS, Business
Theorem Clinical Research August 2013 - Present
PharmaNet November 2004 - July 2013
Quintiles December 1986 - August 1999
Skills
CDISC, CRO, Clinical Data Management, EDC, Clinical Trials, GCP, Clinical Development, Biostatistics, Pharmaceutical Industry, 21 CFR Part 11, SAS programming, ICH-GCP
Education
Duke University 1978 — 1981
TriWorth September 2015 - Present
Theorem Clinical Research September 2014 - July 2015
NexGen RxMarketing, LLC February 2013 - January 2014
ICON Clinical Research April 2008 - January 2009
ICON Clinical Research May 2005 - April 2008
Kenexa May 2004 - May 2005
Education
Immaculata University 1999 — 2002
Masters, Counseling Psychology
University of Delaware 1993 — 1997
Bachelors, Criminal Justice
Theorem Clinical Research November 2013 - Present
PPD April 2013 - October 2013
Comprehensive Clinical Development September 2012 - January 2013
CATO Research April 2012 - September 2012
Pharmaceutical Companies September 2005 - April 2012
Skills
Clinical Trials, SAS, Biostatistics, Statistical Programming, CDISC, CRO
Education
University of North Texas Health Science Center at Fort Worth
Auburn University
Theorem Clinical Research December 2012 - Present
Lockheed Martin Aeronautics October 2010 - 2012
Almac Group November 2007 - July 2010
Skills
Test Planning, Software Quality..., Quality Assurance, Testing, System Testing, ClearQuest, Configuration Management, Quality Center, Test Automation, Regression Testing, CMMI, User Acceptance Testing, Test Management, Requirements Analysis, Manual Testing, Defect Tracking, Quality System, Computer System..., SDLC, Requirements Management, Relational Databases
Education
Drexel University 2004 — 2007
Bachelor of Science (BS), Computer Information System
Carnegie Mellon University - Tepper School of Business
MBA, Management
Theorem Clinical Research May 2015 - Present
Theorem Clinical Research May 2012 - Present
ICON plc November 2011 - April 2012
MDS Pharma Services April 2008 - September 2010
Covidien (Tyco Heathcare Retail Group) December 2001 - April 2008
Education
Kutztown University of Pennsylvania 1994 — 1996
Self Employed November 2013 - Present
Theorem Clinical Research July 2011 - November 2013
Otsuka January 2010 - August 2011
PAREXEL 2007 - February 2010
The EMMES Corporation 2006 - 2007
Mathematica Policy Research 2005 - 2006
University of Maryland, Joint Program in Survey Methodology 2003 - 2005
U.S. Department of Agriculture, National Agricultural Statistics Service (NASS) June 2004 - August 2004
Rainforest Reforestation Program, School for Field Studies, Boston University July 2003 - August 2003
U.S. Department of Energy, Energy Information Administration (EIA) June 2002 - August 2002
Skills
CDISC, SAS, SAS programming, Clinical Trials, Project Management, Clinical Data Management, CRO, Data Warehousing, Clinical Research, EDC, SAS Base, Pharmaceutical Industry, Data Management
Education
University of Maryland College Park 2003 — 2005
M.S., Survey Statistics
Smith College 2001 — 2003
B.A., Economics, Mathematics with Concentration in Statistics
Bryn Mawr College
Chiltern September 2015 - Present
Theorem Clinical Research August 2008 - Present
Omnicare Clinical Research October 1998 - March 2005
InSite Clinical Trials October 1997 - October 1998
GlaxoWellcome January 1996 - December 1996
Duke University 1991 - 1995
Skills
Diabetes, Asthma, Heart Failure, CTMS, Clinical Monitoring, CRO, EDC, Clinical Trials, GCP, Therapeutic Areas, Clinical Development, ICH-GCP, Oncology, Clinical Data Management, Clinical Research, Phase I, Pharmaceutical Industry, Endocrinology, Regulatory Submissions, Infectious Diseases, Certified Project..., Urology, Stem Cell Transplant, Phase II-IV Clinical..., Cystic Fibrosis, Protocol, Drug Development, Clinical Operations
Education
Duke University 1991 — 1995
MS, Chemistry/Toxicology
Carleton College 1987 — 1991
Bachelor of Arts (BA), Chemistry
Theorem Clinical Research October 2014 - Present
Pharm-Olam International August 2011 - October 2014
Theorem Clinical Research (formerly Omnicare Clinical Research) June 2010 - August 2011
AAI Pharma 2005 - 2010
CCL Custom Manufacturing, Toronto, Ontario October 2001 - February 2003
Fundeni Hospital, Bucharest, Romania April 1997 - March 2001
Sf. Spiridon Hospital, Braila, Romania January 1996 - March 1997
Skills
Medical Writing, Clinical Data Management
Education
M.D., General Medicine
Theorem Clinical Research September 2010 - Present
Amgen September 2010 - Present
Omnicare Clinical Research November 1995 - September 2010
Skills
CDISC
Education
Rensselaer Polytechnic Institute 1998 — 2000
ME, Operations Research and Statistics
Clarkson University 1989 — 1993
BS, Mathematics
Merck September 2015 - Present
PRA Health Sciences February 2015 - September 2015
Theorem Clinical Research October 2014 - January 2015
PRA Health Sciences July 2013 - September 2014
PRA Health Sciences February 2012 - September 2014
Merck 2011 - September 2014
ReSearch Pharmaceutical Services October 2009 - February 2012
sanofi-aventis July 2006 - October 2009
Cephalon May 2005 - June 2006
Covance August 2000 - May 2005
Skills
EDC, Clinical Data Management, Oracle Clinical, CRO, CTMS, MS Project, InForm, Spectrum, Therapeutic Areas, Clinical Trials, Clinical Development, Clinical Monitoring, Inform, ICH-GCP, GCP, CRF design, CDISC, Data Management, 21 CFR Part 11, Oncology, Sop, Pharmaceutical Industry, Protocol, Clinical Research, Pharmacovigilance, SOP
Education
Thomas Jefferson University 1996 — 1998
MS OTR/L, Occupational Therapy
Ithaca College 1989 — 1993
BS, Sociology, Gender Studies
ICON plc July 2015 - Present
Theorem Clinical Research October 2014 - June 2015
inVentiv Health Clinical June 2011 - October 2014
i3 Research May 2006 - June 2011
Allphase Clinical Research September 2005 - May 2006
PRA International October 2000 - August 2005
University of Ottawa Heart Institute 1998 - 2000
Skills
Lifesciences, Clinical Trials, Pharmaceutical Industry, EDC, CRO, Neurology, Oncology, Business Development, Biotechnology, Clinical Monitoring, CRM, Marketing, GCP, Medical Devices, Start-ups, CTMS, Global Business..., Drug Development, Clinical Data Management, Infectious Diseases, Cross-functional Team..., Regulatory Affairs, Clinical Research, Clinical Development, Protocol, Therapeutic Areas, Life Sciences, Biopharmaceuticals
Education
Carleton University 1996 — 1999
BPA - Honours, Public Administration
INC Research November 2011 - Present
THEOREM Clinical Research August 2010 - October 2011
THEOREM Clinical Research (previously Omnicare Clinical Research) 2001 - 2011
Omnicare Clinical Research 2008 - 2010
Omnicare Clinical Research October 2007 - 2010
Omnicare Clinical Research 2005 - 2008
Pfizer Pharmaceuticals 1994 - 1995
Skills
Oncology, Clinical Trials, Management, Clinical Monitoring, CRO, Clinical Development, Pharmacovigilance, CTMS, Pharmaceutical Industry, ICH-GCP, Clinical Research, Drug Safety, GCP, EDC, Therapeutic Areas, Drug Development, Life Sciences, Clinical Operations
Education
Semmelweis Egyetem 1983 — 1989
MD, General Medicine
Hungarian Academy of Science
PhD, Neuropharmacology
Budapesti Corvinus Egyetem 1998 — 2000
MBA
Theorem Clinical Research October 2014 - March 2015
Clementi & Associates November 2013 - January 2014
Merck September 2012 - November 2012
Covance April 2011 - January 2012
Merck November 2007 - October 2008
inVentiv Health 2007 - 2008
GlaxoSmithKline July 2007 - October 2007
Merck July 2006 - June 2007
Bristol-Myers Squibb November 2005 - June 2006
wyeth 2004 - 2005
Education
Gwynedd-Mercy College 2010 — 2011
MSM, management
Gwynedd Mercy University 2005 — 2008
BS, BA
Drexel University
AS, laboratory sciences
overbrook high
Theorem Clinical Research June 2015 - Present
inVentiv Health Clinical July 2012 - June 2015
BJC HealthCare February 2009 - June 2012
Genentech July 2002 - April 2008
NESUG 1988 - 2008
The Hartford 1995 - 2002
consultant at BMS 2000 - 2001
GE Capital 1995 - February 1997
Skills
SAS, Data Analysis, SAS programming, Analytics, Data Mining, Statistics, Data Management, SQL, Visio, Business Analysis
Education
The Graduate Center, City University of New York 1971 — 1980
Ph.D., Neuropsychology
City University of New York City College 1963 — 1968
BME, Mechanical Engineering
HTH Worldwide September 2012 - Present
HTH Worldwide September 2012 - Present
Theorem Clinical Research 2008 - 2010
Skills
Social Networking, Strategic Planning, Customer Service, Microsoft Excel, Research, Process Improvement, Marketing, Microsoft Office, Vendor Management, Team Building, Event Planning, Social Media, Fundraising, Contract Management, Government, Training
Education
Ashford University 2013 — 2014
Bachelor's degree, Communications
Ashford University 2011 — 2013
Associates Degree, Business
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
Chiltern September 2015 - Present
Arcadia University August 2014 - Present
Theorem Clinical Research July 2015 - September 2015
ICON plc June 2013 - July 2015
Merck October 2000 - June 2012
Kimberly-Clark 2009 - 2010
Merck 2000 - 2009
Synteract 1998 - 2000
iBRD 1997 - 1998
Skills
Data Warehousing, Clinical Data Management, 21 CFR Part 11, Oncology, Data Analysis, Market Analysis, SAS, Lifesciences, Business Analysis, Project Management, Vendor Management, Sop, Clinical Trials, Pharmaceutical Industry, Clinical Development, Data Management, Pharmaceutical Sales, Validation, Strategy, CRO, Microsoft SQL Server, Computer System..., Analytics, Market Research, EDC, Change Management, Cross-functional Team..., GLP, GCP, SAS programming, ICH-GCP, Statistical Programming, Regulatory Submissions, SDTM, SAS Programming, Teaching, SOP
Education
Arcadia University
Arcadia University
Montgomery County Community College
Theorem Clinical Research June 2001 - Present
Omnicare Clinical Research 2001 - June 2011
CIBER 1998 - 2001
Education
Drexel University 1992 — 1995
MS, Electrical & Computer Engineering
Theorem Clinical Research 2013 - Present
inVentiv Health 2011 - 2013
University Of Alberta, Department of Medicine, EPICORE center January 2007 - August 2011
University Of Alberta, Department of Public Health Sciences September 2006 - January 2007
University Of Alberta, Department of Public Health Sciences September 2006 - December 2006
Dalhousie University, Department of Mathematics and Statistics September 2005 - August 2006
Spielo, A GTECH Company October 2003 - August 2005
Mount Allison University May 2003 - September 2003
Mount Allison University August 2001 - April 2003
Mount Allison University, Department of Mathematics and Computer Science December 2000 - April 2003
Skills
Stata, SAS, Analysis, Data Mining, Statistical Modeling, R, SPSS, Matlab, Data Analysis, Statistics, Research
Education
University of Alberta 2006 — 2007
Graduate courses in Epidemiology
Dalhousie University 2005 — 2006
Masters Of Science, Statistics
Mount Allison University 2003 — 2003
Bachelor of Arts, Bachelor of Arts with distinction, Major in Math and minors in Computer Science and Economics
Theorem Clinical Research April 2013 - Present
Quintiles July 2009 - April 2013
ICON Clinical Research March 2004 - April 2009
Clinimetrics February 2000 - March 2004
Skills
EDC, Clinical Trials, Oracle Clinical
Education
De Anza College 1998 — 1999
AS, GE
Theorem Clinical Research Senior Statistical ProgrammerClinForceFebruary 2011 - December 2012
Ockham Development Group (an ASG Company) June 2010 - February 2011
Forest Labs May 2009 - June 2010
StatWorks November 2008 - May 2009
ClinForce August 2006 - October 2008
PPD April 2005 - August 2006
Skills
CDISC, Statistical Programming, SAS, EDC, Drug Development, Biostatistics, Clinical Trials, Programming, CRO, Clinical Data Management, SDTM, GCP, Clinical Development, CRF design, 21 CFR Part 11, ICH-GCP, Inform, CTMS, Data Management, SAS programming, Regulatory Submissions, Therapeutic Areas, SAS Programming
Education
North Carolina State University 2003 — 2005
MS, Statistics / BioMedical Concentration
East Carolina University 1996 — 1998
MS, Analytical Chemistry
Theorem Clinical Research March 2014 - Present
Covance Inc. October 2012 - March 2014
ReSearch Pharmaceutical Services January 2011 - October 2012
Icon Clinical Research (ICON) November 2006 - January 2011
Digestive Healthcare of Georgia 2003 - 2006
Skills
Grants, Clinical Research, Budgeting, Clinical Trials, CRO, CTMS, GCP, EDC, Therapeutic Areas, ICH-GCP, Clinical Development, Oncology, Pharmaceutical Industry, Sop, Regulatory Affairs, FDA, Infectious Diseases, Protocol, Pharmacovigilance, Vaccines, Contract Negotiation, Gastroenterology, Cardiology, Microsoft Excel, Microsoft Office, Budgets
Education
Augusta State University 1988 — 1992
BS, Mathematics
Theorem Clinical Research December 2012 - Present
Quality Data Services September 2008 - December 2012
The Children's Hospital of Philadelphia June 2006 - September 2008
Skills
CRO, CDISC, SAS, Clinical Trials, Statistical Programming
Education
Temple University - Fox School of Business and Management 2008 — 2010
M.S., Statistics
Rutgers University-New Brunswick 2004 — 2006
B.A., Statistics
Camden County College 2001 — 2004
A.S., Mathematics
Theorem Clinical Research August 2013 - September 2013
Theorem Clinical Research January 2010 - July 2013
Omnicare Clinical Research March 2008 - December 2009
Ugam Solutions January 2006 - February 2007
Skills
Oracle Clinical, Clinical Data Management, CDISC, Clinical Trials, CRO, EDC, Clinical Research, CRF design, Medidata, GCP, CTMS, 21 CFR Part 11, SDTM, MedDRA, SAS programming, Clinical Development, Clinical Study Design, Data Management, ICH-GCP, Biostatistics, Clinical Data, Clinical Monitoring, Clinical Operations, Computer System..., Data Standards, Data Validation, Drug Development, FDA, Lifesciences, Line Management, Macro, Medical Devices, Oncology, Pharmaceutical Industry, Pharmacovigilance, Phase I, Protocol, Regulatory Affairs, Regulatory Submissions, SAE Reconciliation, SAS, SOP development, Sop, Therapeutic Areas, Vaccines, Validation, eCRF, Statistical Programming, Biotechnology
Education
Anna University
Bachelor of Science (BS)
Theorem Clinical Research January 2011 - Present
Octagon Research Solutions July 2010 - January 2011
Accenture April 2003 - June 2010
Wyeth March 1996 - April 2003
Various hospitals June 1987 - March 1996
Sacred Heart Hospital 1989 - 1994
Education
Gwynedd-Mercy College 1987 — 1994
Bachelor's degree, Health Sciences
Gwynedd-Mercy College 1985 — 1987
Associate's degree, Medical Laboratory Technology
PRA Health Sciences July 2014 - Present
Theorem Clinical Research May 2013 - July 2014
Execupharm August 2011 - May 2013
Dr. Amy Sheffield October 2010 - August 2011
Drexel Against Cancer September 2007 - June 2009
Skills
Clinical Trials, Clinical Development, Clinical Data Management, Cell Culture, Western Blotting, Microbiology, Pharmacokinetics, Clinical Study Design, CTMS, DNA extraction, Microsoft Office, SPSS, DNA electrophoresis, Clinical Research, CRO, Languages, Microsoft Excel, Microsoft Word, Adobe Acrobat, R, Pipetting, Northern Blotting, Southern Blot, Assay Development, Molecular Genetics, Public Relations, Confidentiality, Cell Fractionation, Primary Cell Isolation, Health Insurance, Clinical Operations, IRB, Informed Consent
Education
Drexel University 2011 — 2013
M.S., Interdisciplinary Sciences - Clinical Regulations
Drexel University 2006 — 2009
B.S., Biology
J Renee LLC May 2015 - Present
Theorem Clinical Research August 2013 - April 2015
RPS January 2006 - March 2007
Kforce Inc September 2004 - January 2006
GlaxoSmithKline May 1999 - September 2004
Searle March 1997 - May 1999
Searle March 1995 - March 1997
Searle March 1993 - March 1995
Lorex Pharmaceuticals (Searle & Synthelabo joint venture) March 1990 - March 1993
Searle March 1987 - March 1990
Skills
Clinical Trials, Oncology, Pharmaceutical Industry, CTMS, GCP, Clinical Monitoring, Clinical Development, ICH-GCP, EDC, Therapeutic Areas, Clinical Data Management, Infectious Diseases, CRO, Sop, Patient Recruitment, Regulatory Submissions, 21 CFR Part 11, Drug Development, Clinical Research, Regulatory Affairs, SOP
Education
University of Wisconsin-Milwaukee 1981 — 1982
Bachelor of Science (BS), Microbiology, General
Concordia University-River Forest 1976 — 1978
Bachelor’s Degree, Elementary/Secondary Education - Life Sciences Major
Concordia College, Ann Arbor, MI 1974 — 1976
Associate’s Degree, Education
Novo Nordisk September 2015 - Present
Theorem Clinical Research December 2014 - August 2015
Quintiles May 2012 - December 2014
Kforce Inc. December 2010 - May 2012
INC Research July 2009 - December 2010
MDS Pharma Services June 2007 - June 2009
BJC HealthCare October 1997 - June 2009
Arch Medical Services July 2001 - June 2007
Skills
Clinical, Oncology, Clinical Research, Clinical Monitoring, Nursing, Transplantation, Cholesterol, Hematology, Rheumatology, Clinical Trials, Clinical Research..., EDC, ICH-GCP, CTMS, GCP, CRO
Education
Jewish Hospital College of Nursing and Allied Health 1995 — 1997
RN, Nursing
University of Missouri-Saint Louis 1982 — 1987
BS, Marketing
Theorem Clinical Research 2013 - Present
Theorem Clinical Research 2011 - 2013
Omnicare Clinical Research 2002 - 2011
Neighborhood Visiting Nurse Association 2001 - 2002
Professional Home Health Services 2000 - 2001
Immaculate Mary Home 1990 - 2000
Paoli Memorial Hospital 1988 - 1989
Skills
Pharmaceutical Industry, Clinical Trials, CRO, EDC, GCP, Clinical Data Management, ICH-GCP, Data Management, Oncology, Sop, 21 CFR Part 11, Validation, Clinical Research
Education
Gwynedd-Mercy College 1986 — 1988
Associate of Science (AS), Registered Nursing/Registered Nurse
Self Employed January 2014 - Present
Beardsworth Consulting Group 2012 - 2013
Theorem Clinical Research 2011 - 2012
Endocyte 2008 - 2011
Med Institute 2002 - 2008
Skills
CTMS, GCP, Clinical Trials, EDC, CRO, ICH-GCP, Oncology, Clinical Development, Clinical Data Management, Therapeutic Areas, Clinical Research, Medical Writing, Biotechnology, Infectious Diseases, Oncology Clinical..., Regulatory Submissions, Pharmaceutical Industry, Immunology, Regulatory Affairs, Lifesciences, Medical Devices
Education
Indiana Wesleyan University
Master of Business Administration (MBA), Registered Nursing/Registered Nurse
Indiana Wesleyan University
BSN
Theorem Clinical Research 2002 - April 2012
PAREXEL International 1994 - 1999
PAREXEL International 1993 - 1994
Education
City University of New York-Brooklyn College
BS, Biology
Northeastern University
Certificate Health Information Administration, Health Information Administration
PPD September 2015 - Present
PPD September 2014 - June 2015
Theorem Clinical Research January 2008 - September 2014
Client Associated Businesses, Inc. October 2005 - January 2008
Skills
Data Management, Oracle Clinical, EDC, Medidata, Clinical Research, Clinical Data, 21 CFR Part 11, Clinical Data Management, Validation, Pharmaceutical Industry
Education
Fairleigh Dickinson University 2000 — 2004
BS, Mathematics, Computer Science
Theorem Clinical Research July 2015 - Present
Theorem Clinical Research August 2013 - June 2015
Theorem Clinical Research 2010 - July 2013
Omnicare Clinical Research 2006 - 2010
Omnicare Clinical Research 2005 - 2006
Omnicare Clinical Research 2004 - 2005
University of Pennsylvania School of Medicine 1999 - 2004
Skills
CRO, Pharmaceutical Industry, GCP, Clinical Research, Clinical Trials, Sop, CTMS, 21 CFR Part 11, FDA, ICH-GCP, Clinical Development
Education
Immaculata University 2001 — 2003
MA
Bloomsburg University of Pennsylvania 1992 — 1997
BA
Insight Pharmaceuticals October 2011 - Present
Theorem Clinical Research 2010 - 2011
Bristol-Myers Squibb April 2010 - October 2010
BTG October 2009 - April 2010
MedImmune February 2007 - July 2009
National Institutes of Health May 2005 - December 2006
Skills
Medical Devices
Education
Temple University Beasley School of Law 1998 — 2002
JD, Law
Drexel University
Bachelor's Degree, Biology/Biological Sciences, General
Theorem Clinical Research May 2011 - Present
Accenture April 2003 - April 2011
Weth Research 1988 - 2003
Skills
Clinical Data Management, Project Management, Data Management, User Acceptance Testing, Process Improvement, Vendor Management, Quality Assurance, Pharmaceutical Industry, Database Design, Data Analysis, Clinical Trials, Databases, Microsoft Office
Education
Immaculata College
Theorem Clinical Research November 2014 - Present
Quintiles February 2012 - October 2014
Blue Ridge Cancer Care / U.S. Oncology 2008 - December 2011
Carilion IRB 2004 - 2008
Androscoggin Cardiology 2000 - 2003
Skills
Clinical Monitoring, CTMS, ICH-GCP, Clinical Research, CRO, GCP, EDC, Clinical Trials, Oncology
Education
Central Maine Medical Center School of Nursing 1990 — 1993
ASN, Registered Nurse
Liberty University
MA, Human Services - Health and Wellness
University of Maine
BA, Psychology
Theorem Clinical Research February 2002 - Present
Education
Georgia State University 1992 — 1995
MS, Physiology
Penn State University 1984 — 1989
BS, Health Administration
Helen of Troy February 2012 - Present
Theorem Clinical Research June 2011 - February 2012
TransMedics, Inc. May 2010 - June 2011
research fellow March 2005 - May 2010
Education
University of Cambridge 2001 — 2005
Doctor of Philosophy (Ph.D.), Pharmacology
Shenyang Medical College 1992 — 1998
Doctor of Medicine (M.D.), clinical medicine
DOCS May 2015 - Present
Theorem Clinical Research January 2012 - May 2015
PRA International June 2008 - January 2012
Education
East Carolina University 2007 — 2008
MS, Applied and Resource Economics; Business Administration
University of North Carolina at Wilmington 2003 — 2007
BS Business Administration, Business Economics
Pfizer August 2015 - Present
inVentiv Health Clinical March 2015 - August 2015
Theorem Clinical Research January 2013 - February 2015
Theorem Clinical Research September 2012 - September 2013
PRA International April 2012 - September 2012
Pfizer, Inc. March 2011 - April 2012
Kforce Clinical Research, Inc. January 2011 - March 2011
Kforce Clinical Research, Inc. March 2007 - January 2011
Duke University Medical Center July 2003 - March 2007
Skills
Clinical Monitoring, EDC, CTMS, GCP, ICH-GCP, Therapeutic Areas, CRO, Endocrinology, Clinical Trials, Clinical Development, Oncology, Phase I, Clinical Operations, Oracle Clinical, Infectious Diseases, Protocol, Clinical Research, CRF design, Sop, Trial Management, Oncology Clinical..., Medical Devices, Hematology, Patient Recruitment, Urology, Pharmaceutical Industry, Clinical Study Design, Clinical Data Management, Drug Development, Inform, Regulatory Submissions, Cardiology, Pediatrics, 21 CFR Part 11, Medidata, Pharmacology, IRB, Clinical Pharmacology, SOP
Education
Eastern Illinois University 1999 — 1999
Master of Science, Exercise Science
Millikin University 1994 — 1998
Bachelor of Science, Athletic Training/Secondary Education
Clinical Research Management, Inc. (ClinicalRM) August 2015 - Present
Clinical Research Management, Inc. (ClinicalRM) August 2014 - Present
Theorem Clinical Research March 2013 - August 2014
PAREXEL March 2011 - March 2013
SPRI Clinical Trials February 2007 - December 2010
Duke Clinical Rese March 2003 - June 2005
Pfizer April 1991 - February 2003
Skills
Black Belt Six Sigma, Business Plan..., Product Development, Managment of Clinical..., CRO, CTMS, Clinical Research, GCP, Oncology, Clinical Development, Drug Development, Biotechnology, ICH-GCP, Protocol, Lifesciences, Pharmaceutical Industry, Cross-functional Team..., FDA, Validation, EDC, Clinical Data Management, Process Improvement, Mergers, Data Management, Regulatory Submissions, Mergers, Management, Leadership, Infectious Diseases, Life Sciences
Education
Rutgers University 1985 — 1989
Bachelor's degree, Molecular Biology
Fairleigh Dickinson University
Theorem Clinical Research December 2013 - Present
Omnicare January 2007 - January 2008
Omnicare June 2002 - August 2005
Bristol-Myers Squibb 2001 - 2002
Aurora Health Care December 1998 - June 2001
Abbott October 1997 - November 1998
Abbott July 1995 - October 1997
Skills
Clinical Data Management, Clinical Decision..., Clinical Trials, Oracle Clinical, Pharmaceutical Industry, CRO, Data Management, Clinical Research, Medidata, GCP, Databases, Quality Assurance, EDC, Oncology, CTMS, Clinical Development, ICH-GCP, 21 CFR Part 11, Document Management, SAS, SOP
Education
Illinois State University
Bachelor of Science (BS), Health Information Management
University of Illinois at Urbana-Champaign
Bachelor of Science (BS), Political Science and Government
Theorem Clinical Research April 2011 - Present
Theorem Clinical Research April 2010 - Present
Ciber Inc December 2009 - September 2010
Shriners Hospital for Children January 2006 - January 2009
Cananwill Inc January 2001 - January 2006
Delaware Investments, Inc January 1990 - January 2001
Skills
Software Documentation, Quality Assurance, Process Improvement, Active Directory, Disaster Recovery, SharePoint, Vendor Management, Outlook, Project Management, Troubleshooting, Data Analysis, CRO, Servers, Microsoft Office, Training, Customer Service, Team Leadership, Access, EDC, Data Entry
Education
Community College of Philadelphia 1988 — 1989
West Catholic High School 1982 — 1986
PSI CRO AG May 2015 - Present
inVentive Health August 2014 - April 2015
Theorem Clinical Research July 2012 - February 2014
Theorem Clinical Research September 2011 - July 2012
Omnicare Clinical Research June 2002 - May 2011
StarComm June 2000 - July 2001
Healthcare Liability Group October 1998 - March 2000
Skills
CRO, Project Management, Clinical Monitoring, GCP, Multiple Project..., Clinical Trials, CTMS, Clinical Development, Clinical Data Management, ICH-GCP, EDC, Regulatory Submissions, Therapeutic Areas, Drug Development, Inform, Pharmacovigilance, Protocol, Oncology, Medical Writing, Regulatory Affairs, 21 CFR Part 11, Sop, SOP
Education
Framingham State College 1981 — 1987
Bachelor of Arts (B.A.), Economics
Framingham State College
BA Economics
Clinipace Worldwide June 2014 - Present
Theorem Clinical Research January 2014 - April 2014
Quintiles August 1999 - December 2013
Skills
SAS programming, Clinical Trials, Oracle Clinical, Oracle, PL/SQL
Education
Iowa State University 1995 — 1999
Bachelor of Science (BSc), Management Information Systems, General
INC Research January 2015 - Present
Theorem Clinical Research August 2014 - December 2014
INC Research August 2013 - July 2014
INC Research February 2007 - August 2013
INC Research June 2006 - February 2007
INC Research April 2001 - June 2006
Skills
Clinical Research, Project Management, Proposal Writing, Microsoft Excel, CRO, Therapeutic Areas, Pharmaceutical Industry, Clinical Trials, Clinical Development, Clinical Monitoring, FDA, ICH-GCP, SOP
Education
The University of Texas at Austin 1998 — 2001
Child Development
Huston-Tillotson University
Theorem Clinical Research July 2006 - Present
Schiffrin & Barroway June 2004 - April 2006
GMAC Commercial Mortgage November 2003 - December 2003
Delaware County Court House 2002 - 2002
Law Firm of Allen L. Rothenberg 2001 - 2001
PFPC (PNC Bank) January 1999 - June 2000
Upland Mortgage Corporation December 1997 - December 1998
Arneg, USA Inc. February 1996 - December 1997
Skills
Pharmaceutical Industry, Clinical Trials, CRO, Microsoft Excel, Microsoft Word, Contract Negotiation
Education
Widener University School of Law 2000 — 2003
Doctor of Law (JD)
La Salle University 1991 — 1995
Bachelor's degree, Finance, General
Theorem Clinical Research April 2012 - Present
PRA Health Sciences September 2008 - April 2012
Kendle International May 2007 - September 2008
PRA Health Sciences May 2005 - May 2007
Quintiles February 2001 - May 2005
Quintiles Laboratory June 1997 - February 2001
Education
Drexel University
Ottawa University
Theorem Clinical Research 2007 - Present
Education
Arcadia University
Theorem Clinical Research April 2000 - July 2013
Nycomed Amersham Imaging 1995 - 1999
Sterling Winthrop, Inc. September 1989 - January 1995
Glaxo Smith Kline Pharmaceuticals 1988 - 1989
Education
Immaculata University 1983 — 1988
Bachelor’s Degree, Biology/Biological Sciences, General
Penn State Dunmore, PA 1969 — 1970
Retail Merchandising
Immaculata University