SCDM Company
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SCDM Employees
EPM CPM/ Biopharmaceutics CP&E, Eli Lilly and Company September 2008 - Present
Eli Lilly and Company September 1997 - Present
SCDM 2006 - 2010
Eli Lilly and Company February 2007 - September 2008
Early Phase, Eli Lilly and Company October 2002 - February 2007
Eli Lilly and Company March 2001 - October 2002
Eli Lilly and Company November 1999 - March 2001
Eli Lilly and Company September 1997 - October 1999
Medi-Span Inc April 1990 - September 1997
Medi-Span 1989 - 1997
Skills
Clinical Data Management, CDISC, EDC, Clinical Trials, CRO, Clinical Development, CTMS, GCP, Computer System..., 21 CFR Part 11, Oracle Clinical, Data Management, Pharmaceutical Industry, Oncology, Pharmacovigilance, Regulatory Submissions, Drug Development, GxP, Clinical Research, Sop, FDA, Protocol, Biostatistics, SDTM, Regulatory Affairs, Cross-functional Team..., Validation, Pharmaceutics, Leadership, Supervisory Skills, SOP
Education
Ball State University 1980 — 1982
Bachelor of Science, Computer Science
Ball State University 1980 — 1982
B.S, Computer Science
PAREXEL April 2010 - Present
Accenture June 2007 - March 2010
Siemens Medical Solutions January 2005 - April 2007
Aventis Pharmaceuticals February 1998 - December 2004
SCDM 2000 - 2003
Hoechst Marion Roussel 1998 - 1999
Amgen 1995 - 1997
Synergen 1992 - 1994
GD Searle 1988 - 1992
GD Searle 1981 - 1988
Skills
Clinical Trials, Clinical Development, CRO, Clinical Data Management, CTMS, Pharmaceutical Industry, SAS, GCP, 21 CFR Part 11, Drug Development, Data Management, EDC, Oncology, Pharmacovigilance, Biotechnology, Sop, Regulatory Submissions, Biopharmaceuticals, FDA
Education
University College London, U. of London 1972 — 1975
B. Sc., Statistics
King Edward VI, Southampton 1965 — 1972
Quintiles August 2013 - Present
Quintiles March 2011 - August 2013
i3 Statprobe May 2009 - March 2011
C Dark Consulting November 2008 - May 2009
Clarkston Consulting January 2008 - November 2008
Statistics and Data Corporation July 2006 - January 2008
SCDM January 2005 - December 2007
Omnicare July 2005 - April 2006
Constella Group July 2001 - July 2005
Constella Group June 2001 - June 2005
Skills
Data Management, Project Management, CRM, Relationship Management, Continuous Improvement, Biostatistics, Organizational..., Regulations, Quality Improvement, Income Statement, Clinical Trials, CRO, Pharmaceutical Industry, EDC, Clinical Development, GCP, Clinical Data Management, Inform, Strategy, Drug Development, Clinical Research, Leadership, Global Client Management, CTMS, Business Process..., Cross-functional Team..., 21 CFR Part 11, Validation, Management, FDA, Program Management, Sop, CRF design, CDISC, Oracle Clinical, Business Development, ICH-GCP, Regulatory Affairs, Regulatory Submissions, Lifesciences, SAS, Oncology, Biotechnology, Infectious Diseases, Manage Client..., Clinical Study Design, Operations Management, Life Sciences, Strategic Planning, Consulting
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2006 — 2007
Masters, Business Administration
North Carolina State University 1990 — 1995
BS, Statistics
North Carolina State University 1991 — 1994
Bachelors of Science, Statistics
INC Research March 2012 - Present
SCDM November 2010 - Present
StatWorks, a Pharm-Olam company October 2010 - February 2012
Abraxis BioScience March 2010 - October 2010
Rho, Inc. September 2008 - February 2010
SCDM October 2008 - December 2009
i3Statprobe December 2006 - July 2008
PPD September 1999 - November 2006
InSite Clinical 1996 - 1999
University of North Carolina at Chapel Hill, Hospitals 1994 - 1996
Skills
Clinical Data Management, Clinical Trials, Oracle Clinical, CRO, EDC, CDISC, GCP, Clinical Development, Data Management, Oncology, ICH-GCP, Clinical Research, Therapeutic Areas, CRF design, Pharmaceutical Industry, CTMS, Sop, Regulatory Submissions, Inform, 21 CFR Part 11, Clinical Monitoring, SOP
Education
Ithaca College 1982 — 1984
BS, Health Information Management
Broome Community College 1980 — 1982
AAS, Medical Information Technology
Sprout Social, Inc. August 2015 - Present
Nutshell January 2015 - June 2015
Seat Side Service May 2014 - August 2014
University of Michigan September 2012 - May 2014
SCDM June 2013 - July 2013
Social Media Link May 2012 - August 2012
Skills
HTML, CSS, JavaScript, Social Media, Photoshop, Social Media Marketing, Python, Database Administration, AngularJS, jQuery, Node.js, PHP, MySQL, Web Development, Front-end Development, User Experience, Software Engineering, Graphic Design, User Interface Design, Human Computer...
Education
University of Michigan 2011 — 2015
Bachelor of Arts (B.A.), Informatics
SCDM March 2003 - Present
SDS July 2002 - February 2003
Erstebank January 2001 - June 2002
Education
University of Pennsylvania - The Wharton School 2007 — 2007
Essentials of Marketing
University of Liverpool 2005 — 2007
MBA
University of Pennsylvania - The Wharton School 2006 — 2006
Leading and Managing People
HTL 1991 — 1996
United BioSource Corporation April 2012 - Present
SCDM 2014 - 2015
PAREXEL 2010 - 2012
Gilead Sciences January 2006 - July 2010
Gilead Sciences January 2002 - January 2006
Quintiles May 1999 - January 2002
Skills
Clinical Data Management, Clinical Operations, EDC, Data Management, CRF design, Validation, Clinical Trials, IND, Clinical Research, Phase I, Oracle Clinical, CTMS, Clinical Study Design, FDA, CDISC, Sop, Protocol, Clinical Development, CRO, GCP, ICH-GCP, SAS, MedDRA, SDTM, Clinical Pharmacology, Data Validation, SOP development, Pharmacology, Regulatory Requirements, Pharmacokinetics, Clinical Monitoring, Therapeutic Areas, 21 CFR Part 11, Infectious Diseases, Inform, Medidata, Pharmaceutical Industry, SAS programming, Software Documentation, Clinical Research..., Trial Management, NDA, Medical Devices, Laboratory, Outcomes Research, Databases, Regulatory Submissions, Medical Writing, Oncology, Pharmacovigilance
Education
Campbell University 2007 — 2010
Bachelors of Applied Science Degree Program, Clinical Trials Research
Durham Technical Community College 1998 — 2002
Diplomas: Associate of Applied Science, Clinical Trials Research; A.A.S in General Ed., Clinical Trials Research; General Education
North Carolina State University 1997 — 1998
Biological Sciences
Wake Technical Community College 1996 — 1997
Associates of Applied Science Nursing Program; Diploma: AAS, General Occupational Technology, Nursing
Methodist Hospital School of Nursing 1992 — 1994
Non-Diplomacy Program, Nursing
Society for Clinical Data Management January 2015 - Present
Astellas Pharma March 2012 - Present
Pfizer November 1998 - March 2012
SCDM 2005 - 2008
Eli Lilly January 1995 - November 1998
Eli Lilly and Company July 1990 - December 1994
Skills
Clinical Data Management, Clinical Development, Clinical Trials, EDC, CDISC
Education
Purdue University 1992 — 1995
Bachelor of Science, Organizational Leadership & Supervision
Pfizer November 2013 - Present
SCDM 2010 - Present
Pfizer August 2012 - November 2013
Pfizer January 2006 - July 2012
Pfizer Global Research & Development February 2004 - January 2006
Pfizer February 1999 - February 2004
Maryland State Health Department January 1998 - January 1999
Skills
Six Sigma, Continuous Improvement, Process Improvement, Process Engineering, Team Building, Budgeting, Change Management, Coaching, Data Analysis, Forecasting, Kaizen, Team Leadership, Program Management, Outsourcing, Organizational..., Optimization, Strategic Planning, Quality Management, Research, Problem Solving, Yellow Belt..., Clinical Data Management, Budgets, Clinical Trials, EDC, Training, Clinical Development, CRO, Management, Clinical Research, Cross-functional Team..., Sop, Pharmaceutical Industry, Data Management, 21 CFR Part 11, Regulatory Submissions, Quality Assurance, GCP, Validation
Education
The Johns Hopkins University
Master's degree, Microbiology and Immunology
Towson University
Bachelor's degree, Political Science and Government
Bucks County Community College August 2006 - Present
ASTD 2003 - Present
Merck & Company March 2000 - November 2013
SCDM 2005 - 2008
Skills
Training, Instructional Design, E-Learning, Clinical Research, Instructor-led Training, Adult Education, Clinical Trials, Pharmaceutical Industry, Laboratory Medicine, Leadership Development, ADDIE, Learning Management..., Project Management, Blended Learning, Change Management, Management, Blood Bank, Medicine, Curriculum Development, Clinical Development
Education
Saint Joseph's University
M.S., Training & Organization Development, 3.77
University of Pennsylvania
B.S., Medical Technology
Self employed 2011 - Present
PhaseForward 2005 - 2010
CDISC 1999 - 2010
SCDM 2003 - 2003
PHT Corporation 2000 - 2002
Belmont Research 1997 - 2000
BBN 1985 - 1997
Skills
CDISC, Clinical Trials, Pharmaceuticals, Software Design, XML Tools, Databases, Bayesian statistics, Drug Development
Education
Harvard School of Public Health
SM, Biostatistics
McGill University
BS, Mathematics
Amgen April 2015 - Present
Amgen March 2012 - Present
SCDM 2005 - 2014
Amgen March 2009 - March 2012
Clinimetrics September 2008 - March 2009
Allergan August 2007 - September 2008
Amgen 2005 - 2007
Eli Lilly 2002 - 2005
Education
University of California, Santa Barbara
Bachelor of Science (BS), Biopsychology
University of Phoenix
Master of Arts (M.A.), Organizational Management
Chiltern International January 2014 - Present
SCDM January 2013 - Present
Chiltern International February 2005 - December 2013
SCDM 2007 - 2010
CB Technologies 2001 - 2005
Skills
Clinical Trials, CRO, Pharmaceutical Industry, Clinical Data Management, Data Management, Clinical Development, EDC, CTMS, GCP, ICH-GCP, Oncology, Regulatory Affairs, Clinical Research, 21 CFR Part 11, Regulatory Submissions, Biotechnology, FDA, Lifesciences, Pharmacovigilance, Sop
Education
Bentley University 1982 — 1986
BS, Computer Information Systems
CDISC May 2009 - Present
etera solutions, LLC 2008 - Present
SCDM April 2011 - 2012
Vertex Pharmaceuticals 2007 - 2008
EMD Serono April 2004 - September 2007
Millennium Pharmaceuticals August 2002 - March 2004
Self-employed August 1997 - July 2002
PAREXEL 1994 - 1997
Skills
Pharmaceutical Industry, Standards Adoption and..., CDISC Modelling, CDISC Conversions, Metadata Repository..., CDASH, ODM, SDTM, ADaM, define.xml, define.pdf, Statistical Programming, SAS, 21 CRF Part 11, XML, Clinical Data Management, Data Management, CDISC, 21 CFR Part 11
Education
University of Massachusetts, Amherst 1991 — 1993
Computer Studies and Comparative Literature
Northeastern University 1985 — 1987
Computer Science
Jazz Pharmaceuticals August 2015 - Present
CDISC 2007 - Present
FibroGen, Inc. October 2014 - August 2015
Onyx Pharmaceuticals April 2013 - September 2014
Affymax, Inc. February 2010 - April 2013
Exelixis July 2008 - January 2010
Independent Consultant July 2007 - July 2008
CV Therapeutics 2002 - 2007
SCDM 2002 - 2004
PPD November 2000 - April 2002
Skills
Clinical Trials, SOP, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Data Management, CDM, CRO, Regulatory Affairs, 21 CFR Part 11, CDISC, SAS, Drug Development, Biotechnology, Sop, CTMS, SDTM, CRF design, Data Management, EDC, GCP, Clinical Development, Clinical Study Design, Regulatory Submissions, ICH-GCP, Computer System..., Therapeutic Areas, Oracle Clinical, FDA, SAS programming, Biostatistics, Infectious Diseases, Lifesciences, Validation, Pharmacovigilance, Medical Writing, Vaccines, Inform, Protocol, SAS Programming, Life Sciences
Education
The University of Edinburgh 1971 — 1973
MPhil, Statistics
Portsmouth University 1968 — 1971
BSc, Mathematics
Statistics & Data Corporation (SDC) April 2013 - Present
CDISC 2008 - Present
SCDM 2003 - Present
Gilead Sciences September 2003 - March 2013
Chiron Corporation 2000 - 2003
ASG, Inc. 1999 - 2002
McGhan Medical Corp 1994 - 1999
Skills
Clinical Data Management, EDC, CRF design, CDISC, CRO, GCP, Oncology, Clinical Trials, Clinical Development, Clinical Research, CTMS, ICH-GCP, Data Management, Protocol, Sop, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11
Education
University of California, Santa Barbara
B.A., English
Merrimack Pharmaceuticals January 2015 - Present
Merrimack Pharmaceuticals January 2013 - December 2014
SCDM 2010 - 2014
Genzyme June 2012 - January 2013
Veristat, Inc. October 2011 - April 2012
Harvard Clinical Research Institute November 2010 - October 2011
New England Research Institutes, Inc. (NERI) January 2010 - September 2010
New England Research Institutes, Inc. (NERI) August 2008 - January 2010
Skills
Data Management, Inform, GCP, Clinical Research, EDC, Clinical Trials, Oncology, CRO, Clinical Data Management, FDA, Sop, CRF design, Biostatistics, Protocol, Pharmaceutical Industry
Education
Drexel University 2010 — 2011
Certificate, Epidemiology & Biostatistics
California State University-Stanislaus
Cognitive Studies, Theatre
College of Charleston
BA, Theatre