Medifacts International
Address: 2101 Gaither Rd, Rockville, MD 20850 Phone: (301) 795-2500: Category: : : Place name: : : Website: :
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Medifacts International Employees
BioClinica March 2013 - Present
CoreLab Partners, Inc. February 2012 - March 2013
CoreLab Partners, Inc. May 2010 - February 2012
Medifacts International, Inc. October 2008 - May 2010
Medifacts International February 2008 - October 2008
Skills
CRO, Clinical Trials, Clinical Development, CTMS, Pharmaceutical Industry, GCP, Drug Development, EDC, 21 CFR Part 11, Clinical Data Management, Regulatory Affairs, Protocol, Biotechnology, FDA, Oncology, ICH-GCP, Infectious Diseases, Data Management, Medical Devices, Sop, Clinical Monitoring, Therapeutic Areas, Pharmacovigilance, Lifesciences, Cardiology, Regulatory Submissions, Biopharmaceuticals, Validation, Medical Writing, Clinical Research, GLP, Computer System..., Proposal Writing
Education
Salisbury University 2005 — 2007
KPMG February 2007 - Present
KPMG June 2006 - August 2006
Medifacts International June 2005 - August 2005
Medifacts International June 2004 - August 2004
Skills
IT Audit, Internal Controls, Risk Assessment, Auditing, Business Process..., SAS70, Federal Government, Requirements Gathering, Risk Management, Physical Inventory, Document Review, FISCAM, NIST 800-53, Audit Support, Controls, Status Tracking, DoD, Metrics Reporting, SSAE 16
Education
University of Maryland - Robert H. Smith School of Business 2002 — 2006
B.S., Information Systems and Logistics, Transportation, and Supply Chain Management
Clinical Research Management, Inc. (ClinicalRM) September 2014 - Present
PAREXEL July 2012 - Present
PAREXEL March 2012 - September 2012
PAREXEL 2006 - March 2012
CONRAD/Eastern Virginia Medical School 2004 - 2006
Medifacts International 2001 - 2004
Roche 1998 - 2001
PAREXEL 1995 - 1998
COROMED 1994 - 1995
Skills
CRO, Clinical Development, CTMS, EDC, Clinical Trials, Pharmaceutical Industry, Clinical Monitoring, GCP, ICH-GCP, Oncology, Lifesciences
Education
Trinity College-Hartford 1989 — 1993
BS, Biology
General Dynamics Information Technology August 2014 - Present
Clinical Research Management August 2011 - August 2014
Your Task Master, LLC August 2010 - November 2012
Dell Services October 2010 - August 2011
Medifacts International June 2009 - August 2010
GenVec September 2008 - June 2009
Lonza January 2008 - September 2008
Southern Research Institute August 2002 - January 2008
SAIC 2000 - 2002
Skills
Program Management, Process Improvement, Proposal Writing, Biotechnology, Strategic Planning, Contract Management, Team Building, GMP, GLP, Human Resources, Lifesciences, Resource Management, Risk Management, Government Contracting, Budget Analysis, Cross Functional Team..., Business Process..., Budgets, Cross-functional Team..., Management, Project Management, Project Planning, Strategy, Life Sciences, Leadership, Analysis
Education
Mt. St. Mary's University 2012 — 2014
Masters Certificate, Organizational Development
Hood College 2004 — 2007
BA, Business Management - Finance Focus
Frederick Community College
AAS, Business Management
Rigel Pharmaceuticals Inc. February 2015 - Present
Medtronic May 2012 - May 2014
Concentric-Medical August 2011 - May 2012
St. Jude Medical January 2010 - May 2011
Actelion January 2008 - January 2010
PAREXEL October 2007 - July 2009
Medifacts International 2005 - 2006
Medifacts International 2005 - 2006
Skills
Clinical Trials, Clinical Research, Clinical Research..., Osteoporosis, CTMS, Clinical Monitoring, GCP, EDC, ICH-GCP, Clinical Development, CRO, Oncology, Clinical Data Management, Cardiology, Regulatory Submissions, FDA, Medical Devices, Protocol, Neurology, Regulatory Affairs
Education
University of Maryland Baltimore 1985 — 1987
BSN, Nursing
PPD February 2014 - Present
PPD July 2010 - February 2014
Peachtree Bioresearch Solutions January 2009 - July 2010
UCB Pharma 2005 - January 2009
Medifacts International 2001 - 2005
Otsuka 2000 - 2001
N.I.H - National Cancer Institute 1999 - 2000
Skills
Global Management, Clinical Data Management, Project Management, Clinical Trial..., Training & Development, Training Delivery, Virtual Training, Oracle Clinical Remote..., Oracle Clinical, Medidata Rave, TMS, Oracle Inform, SQL, EDC, Clinical Development, GCP, CTMS, Medidata, Clinical Research, CRO, Data Management, Clinical Trials, Employee Training, Tape Management, Clinical Data, Oncology
Education
Louisiana State University 1992 — 1996
B.S., Zoology
INFECTIOUS DISEASE CLINICAL RESEARCH PROGRAM, UNIFORM SERVICES UNIVERSITY OF THE HEALTH SCIENCES July 2012 - Present
Medstar Montgomery Medical Center March 2012 - June 2012
Accelovance October 2008 - October 2011
Medifacts International October 2005 - January 2007
Medifacts International July 2004 - September 2005
Medifacts International June 2003 - July 2004
Medifacts International November 2001 - June 2003
Medifacts International April 2000 - October 2001
Medifacts International June 1998 - March 2000
Medifacts International June 1998 - December 1998
Skills
Clinical Trials, Clinical Data Management, CDISC, Clinical Research, GCP, Data Management, Sop, FDA, EDC, CRO, Pharmaceutical Industry, CTMS, Clinical Development, 21 CFR Part 11, Biostatistics, SAS, ICH-GCP, Epi Info, Epidemiology, Data Analysis, Relational Databases, SQL, MedDRA, Personnel Management, Department Budgeting, Proposal Generation, Strategic Planning, Mentoring Of Staff, Process Improvement, Medidata
Education
University of Maryland Baltimore 2001 — 2003
Master of Science (M.Sc.), Epidemiology and Preventive Medicine
Eastern Connecticut State University 1981 — 1985
Bachelor of Science (B.Sc.), Biology/Biological Sciences, General
McGladrey May 2013 - Present
Argus Management Corp 2010 - April 2013
RAS Management Advisors, LLC January 2009 - April 2013
CFO Systems LLC 2012 - 2012
Monarch Holdings September 2008 - March 2010
Medifacts International November 2006 - April 2008
Nuvex Ingredients March 2003 - October 2006
Pella Plastics October 2001 - March 2003
GMT Corporation December 1994 - October 2001
Skills
Restructuring, Crisis Management, Cost Management, Manufacturing, Management Consulting, Business Strategy, Change Management, Turn Around Management, Mergers & Acquisitions, Management, Private Equity, Leadership, Strategic Planning, Finance, Venture Capital, Process Improvement, Accounting, Strategy, Financial Analysis, Executive Management, Marketing
Education
University of Nebraska-Lincoln 1979 — 1989
BS, Business Admin / Accounting
Doane College 1977 — 1980
LITMUS Clinical Research Group September 2010 - Present
Knopp Biosciences June 2008 - July 2012
Theravance July 2006 - July 2008
Johnson & Johnson October 2005 - July 2006
Medifacts International May 2004 - October 2005
Kos Pharmaceuticals May 2001 - May 2004
The SEARLE Company Ltd. May 1994 - May 2001
Skills
Infectious Diseases, CRO, Therapeutic Areas, EDC, Clinical Development, Clinical Trials, Neurology, Clinical Research, CTMS, Drug Development, Pharmaceutical Industry, Gastroenterology, Oncology, Clinical Study Design, Pharmacokinetics, GCP, FDA, Medical Writing, Regulatory Submissions, Clinical Monitoring, Diabetes, Clinical Operations, ICH-GCP, Clinical Data Management, Hypertension, IND, Biotechnology, Pharmacovigilance, Medical Affairs, Protocol, Pharmacology, Oracle Clinical, Lifesciences, CRF design, Regulatory Affairs, Drug Discovery, Neuroscience, Rheumatoid Arthritis, Clinical Pharmacology, Cardiology, Life Sciences
Education
University of Illinois at Chicago 1989 — 1993
MSPH, Epidemiology and Biostatistics, 5.0/5.0
Illinois Wesleyan University 1983 — 1987
BA, Biological Sciences, 3.85/4.00
Ricoh Americas Corporation February 2013 - June 2015
Medifacts International November 2010 - February 2011
JBS International Inc September 2008 - June 2010
JBS International. Inc May 2005 - September 2008
Skills
Software Documentation, Management, Training, Team Building, Security, Technical Support, Event Management, Shipping, Start-ups, Lotus Notes, Process Improvement, Recruiting
Education
Montgomery College 2007 — 2007
Largo High School 1997 — 1997
High School Diploma - GED
Dovel Technologies August 2013 - Present
Social & Scientific Systems February 2012 - August 2013
CoreLab Partners, Inc. February 2011 - February 2012
CoreLab Partners, Inc. January 2008 - February 2011
Medifacts International January 2007 - January 2008
Medifacts International February 2004 - January 2007
Skills
Clinical Research, Clinical Trials, Clinical Trial..., CRO, GCP, Leadership, Pharmaceutical Industry, ICH-GCP, CTMS, Business Development, Clinical Development, Infectious Diseases, Medical Devices, Biotechnology, Oncology, Clinical Monitoring, EDC, Healthcare, Drug Development, Lifesciences, Clinical Data Management, FDA, Sop, Regulatory Affairs, Protocol, Regulatory Submissions, Diabetes, 21 CFR Part 11, Data Management, Cardiology
Education
American University 1999 — 2000
MS, Exercise Physiology
BAO Systems January 2013 - Present
Blackbarn Media January 2009 - Present
Social & Scientific Systems January 2009 - January 2013
Blackbarn Media June 2001 - January 2009
Econometrica July 2006 - October 2007
TranTech, Inc September 2001 - January 2003
Medifacts International 2002 - 2003
Etensity July 2000 - March 2001
Cobalt January 2000 - July 2000
Computer Sciences Corporation (CSC) June 1994 - November 1998
Skills
Drupal, Microsoft Dynamics CRM, Information Architecture, Web Development, CMS, .NET, SQL Server, HTML5, EC2, Cloud hosting, NoSQL, Agile Development, DHIS2, CMMI, Kentico, Cloud Computing, HTML 5, Microsoft SQL Server, Agile Methodologies, Web Design, Healthcare Information..., Information Technology, Public Health, Microsoft CRM, Business Development, Software Development, E-commerce, SaaS, PHP, Enterprise Software, XML, User Experience, Open Source, Architectures, jQuery, ASP.NET
Education
George Mason University
Bachelor of Science, Decision Sciences and Management Information Systems
Novavax May 2014 - Present
PAREXEL March 2013 - May 2014
Human Genome Sciences August 2005 - March 2013
Medifacts International June 2004 - August 2005
Shire Pharmaceuticals June 2003 - June 2004
LIQUENT 2000 - 2003
Nabi Biopharmaceutical Company 1999 - 2000
Otsuka America Pharmaceutical, Inc. 1994 - 1999
Skills
Regulatory Submissions, Regulatory Affairs, IND, Clinical Research, eCTD, Regulatory Requirements, Change Control, GMP, Quality Assurance, Clinical Study Design, GLP, Biotechnology, Biologics, Protocol, Regulatory Filings, EDC, Vaccines, Clinical Trials, CRO, Regulatory Operations, NDA, Lifesciences, Drug Development, FDA, Validation, Medical Writing, Pharmacovigilance, Pharmaceutical Industry, 21 CFR Part 11, Clinical Development, CTMS, Regulations, GCP, Biopharmaceuticals, Medical Devices, CMC, Oncology, Sop, Liquent InSight •..., Project Management, Document Management, CAPA, GxP, Technology Transfer, Computer System..., Clinical Data Management, Pharmaceutics, Life Sciences, SOP
Education
University of Maryland Baltimore 1991 — 1994
MSW, Social Work, Clinical
University of Maryland Baltimore County 1985 — 1989
BA, Social Work, Psychology
ICON plc September 2010 - July 2013
Han Al Americano January 2008 - September 2010
Medifacts International July 2007 - January 2008
Skills
Informed Consent, Clinical Research, Clinical Trials, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Research Ethics, Pharmaceutical Industry, Human Subjects Research, Teaching English as a..., Teaching, Teaching Adults, Training, Infectious Diseases
Education
KYCOM 2013 — 2017
D.O., Medicine
Des Moines University-Osteopathic Medical Center 2011 — 2014
Master's degree, Public Health
Liberty University 2003 — 2007
Bachelor of Science (BS), Biology, General
Top To Bottom Services, LLC May 2013 - Present
Changing the Lives of Children With Autism May 2011 - December 2013
The Inn at Brookeville Farms September 2011 - January 2012
Medifacts International November 2009 - February 2011
Skills
Organizing, Planning, Teamwork, Customer Service, Microsoft Office, Management, Invoicing, Sales, Event Planning, Time Management, Public Speaking, Microsoft Excel, Research, Data Analysis, Social Networking, Team Leadership, Strategic Planning, Editing, Social Media Marketing, Project Planning
Education
Towson University 2007 — 2011
Bachelor of Science (BS), Business Administration and Management, General
AST Clinical Solutions 2011 - Present
Consultant May 2002 - Present
Medifacts International April 2005 - July 2006
PRA International September 2003 - April 2005
Abbott Laboratories September 2001 - May 2002
Neurochem September 1999 - August 2001
Skills
Central Nervous System, Clinical Trials, CRO, Infection, GI, Clinical Development, Clinical Research, Oncology, CTMS, Therapeutic Areas, Neurology, EDC, Pharmaceutical Industry, GCP, ICH-GCP, Regulatory Submissions, Clinical Monitoring, Protocol, Inform, Drug Development, Clinical Data Management, Biotechnology, Cardiology
Education
Université de Montréal 2001 — 2003
M.Sc., Pharmaceutical Sciences
Université du Québec à Trois-Rivières 1995 — 1999
B.Sc., Medical Biology
Eurofins August 2012 - Present
CoreLab Partners, Inc. September 2008 - August 2012
CoreLab Partners, Inc. April 2011 - October 2011
Medifacts International September 2008 - April 2011
Taylor Technologies, Inc. October 2005 - October 2007
Skills
Software Documentation, Project Management, Training, 21 CFR Part 11, FDA, Management, Quality Assurance, Public Speaking, Motivation, People Skills, Creative Problem Solving, Operating Budgets, Healthcare Consulting, Capital Campaigns, New Business Development, Marketing Strategy, Long-term Customer..., Leadership, Clinical Research, CRO, Clinical Development, Pharmaceutical Industry, Protocol, Biotechnology, Medical Devices, Cross-functional Team..., Process Improvement, Customer Service, Cardiology, Quality System, Proposal Writing, Team Leadership
Education
Keller Graduate School of Management of DeVry University
Masters of Business Administration, Business
Montclair State University
Bachelor of Science, Biology
JJD Consulting 2011 - Present
Medifacts International 2008 - 2011
Bilcare, Inc. 2006 - 2008
Dendrite International 2001 - 2006
Skills
Pharmaceutical Industry, Strategic Planning, Cross-functional Team..., Mergers, Clinical Trials, Process Improvement, Mergers & Acquisitions, Managerial Finance, Analysis, Finance, Forecasting, Strategy, Start-ups, Business Development, Business Strategy, CRO, Business Planning, Management, Due Diligence, Business Process..., Financial Analysis, Budgets, Financial Reporting, Project Management, Business Analysis, Vendor Management
Education
James Madison College at Michigan State University
BA, International Relations
University of Michigan - Stephen M. Ross School of Business
MBA, International Finance, Summa Cum Laude
Fairfax High School August 2013 - Present
Loudoun County Public Schools April 2013 - June 2013
Loudoun County Public Schools April 2013 - May 2013
Helios HR November 2011 - December 2012
Lanmark Technology, Inc. December 2010 - November 2011
Medifacts International February 2009 - July 2010
Skills
Employee Training, Compensation & Benefit, Student Engagement, Employee Relations, Onboarding, Classroom Management, Instructional Design, Human Resources, Talent Acquisition, Employee Benefits, Performance Management, Presentations, Collaboration, Curriculum Development, Student Counseling, Marketing
Education
Shenandoah University 2013 — 2013
Career Switcher Program for Provisional Teaching License
Virginia Tech 1979 — 1983
BS, Marketing Management
Mallinckrodt Pharmaceuticals July 2012 - Present
ICON Development Solutions October 2006 - July 2012
Medifacts International February 2004 - July 2006
Maryland Digestive Disease Research September 2002 - February 2004
Skills
CRO, FDA, CTMS, Drug Development, Clinical Trials
Education
University of Maryland University College 2011 — 2013
MBA
University of Maryland Baltimore County 2002 — 2004
Bachelor of Science, Emergency Health Services Administration
PAREXEL December 2013 - Present
PAREXEL September 2012 - December 2013
PAREXEL November 2010 - September 2012
PAREXEL October 2008 - November 2010
PAREXEL November 2006 - October 2008
Medifacts International October 2004 - November 2006
3M Pharmaceuticals 2000 - 2001
Searle September 1999 - September 2000
Clinical Cardiovascular Research 1997 - 1999
Skills
Project Management, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, CRO, GCP, EDC, Oncology
Education
University of Minnesota - Carlson School of Management 1992 — 1993
BS, Business
University of Minnesota-Duluth 1988 — 1992
BS, Business
BioClinica August 2009 - November 2014
Medifacts International August 2008 - August 2009
Algorithme Pharma January 2008 - August 2008
Geisinger Health Systems/One Source Staffing Solutions August 2007 - January 2008
Skills
CRO, GCP, Clinical Trials, Biotechnology, ICH-GCP, Clinical Development, CTMS, EDC, Clinical Data Management, 21 CFR Part 11, SOP, Project Management, Process Improvement, Pharmaceutical Industry, Budget Management, Vendor Management
Education
Penn State University
Biology
Chiltern January 2012 - Present
Chiltern 2010 - 2012
Clearstone Central Laboratories (formerly MDS Global Central Lab) 2009 - 2010
MDS Pharma Services, Global Central Lab and Centralized Cardiac Services 2007 - 2009
AAIPharma 2005 - 2007
Medifacts International 2004 - 2005
PAREXEL International 1999 - 2004
MDS Clinical Trial Services (Central Lab) 1997 - 1999
Med-Chem 1986 - 1997
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Biotechnology, Account Management, Biopharmaceuticals, Business Development, Lifesciences, New Business Development, Oncology, Pharmaceutics, R, Strategic Planning, Cross-functional Team..., Clinical Research, Drug Development, EDC, Clinical Development, Life Sciences
Education
Ivey Business School at Western University 1998 — 2000
MBA
Fanshawe College
MLT, Medical Laboratory Technology
Western University
BSc, Biology
George Washington University August 2011 - Present
American University May 2009 - August 2011
University of Maryland, College Park July 2007 - May 2009
Medifacts International 2004 - 2007
American University 2002 - 2007
AOL 1999 - 2003
Skills
Public Speaking
Education
University of South Alabama 1989 — 1994
Bachelor of Science (BS), International Business
Indiana University Kelley School of Business August 2015 - Present
Medtronic October 2014 - August 2015
Covidien October 2012 - September 2014
Cardinal Health December 2010 - December 2012
Arizona Molecular Imaging Center September 2008 - December 2010
Medifacts International September 2007 - April 2008
Skills
Healthcare, Management, Biotechnology, Capital Equipment, Sales, Project Management, Pharmaceutical Industry, Medical Devices, Budgets, Sales Operations, Cold Calling, Urology, Operating Room, Sales Management, Product Launch, Market Development, Surgical Instruments, Cardiology, Surgery, Pharmaceutical Sales, Selling, Leadership, Cross-functional Team..., Strategic Planning, Surgeons
Education
Indiana University - Kelley School of Business 2015 — 2017
Master of Business Administration (M.B.A.)
American University 2004 — 2008
BS, Health Promotion
Accelovance, Inc. September 2013 - Present
GridPoint, Inc. September 2011 - September 2013
Affiliated Computer Services November 2009 - September 2011
Bridge Laboratories October 2007 - November 2009
Amarex Clinical Research September 2006 - October 2007
Medifacts International March 2002 - September 2006
GE Global Exchange Services August 1996 - March 2002
GE Global Exchange Services August 1996 - September 2000
General Electric Information Services 1991 - 1996
Skills
Global Marketing, Proposal..., Marketing & Proposal..., Editing, Cross-Functional Team..., Six Sigma/Lean Six..., Proposal Writing, Marketing, Cross-functional Team..., Marketing Communications, Strategy, Salesforce.com, Strategic Planning, Program Management, Budgets, Advertising, Leadership, Lead Generation, Management, New Business Development, Sales, Integration, E-commerce, Public Relations, Online Advertising, Negotiation, Sales Management, Business Development, Product Management, Six Sigma, Integrated Marketing, Competitive Analysis, Product Marketing, Start-ups, SaaS, Strategic Partnerships, Pricing, Account Management, Project Management, Business Strategy, Market Research, CRM, Enterprise Software, Contract Negotiation, Process Improvement, Marketing Strategy, Solution Selling, Sales Operations, Selling
Education
University of Maryland University College
B.S.
Montgomery College 1976 — 1978
A.A.
A-Team Onsite April 2010 - Present
2004 -2010 May 2004 - April 2010
Medifacts International May 2004 - April 2010
Global Research Services Worldwide March 2004 - April 2010
Dr. Chris Serlo, DPM March 2000 - April 2004
Paychex Payroll Services January 1997 - January 1999
Brinker International January 1996 - January 1998
Skills
Strategic Planning, Human Resources, Management, Clinical Research, Lifesciences, Biotechnology, Public Speaking, Microsoft Excel, Data Management, Pharmaceutical Industry, Microsoft Office, Project Management
Education
Huntington Beach High School 1994 — 1997
General, Basic Studies
Orange Coast College
of Liberal Arts Degree; Diploma, inpersuit
Special CRO Training / Certified
Superior Vision Services 2014 - Present
Cornerstone Records Management, LLC 2009 - 2014
RWD Technologies 2008 - 2009
GLOBAL RESEARCH SERVICES 2007 - 2008
MEDIFACTS INTERNATIONAL 2002 - 2007
PHYSICIANS PRACTICE INC. 2000 - 2002
AMERIX CORPORATION 1996 - 2000
LB&B ASSOCIATES, INC. 1995 - 1996
MOBILEMEDIA COMUNICATIONS, A Southwestern Bell Company 1991 - 1995
Skills
Human Resources, Performance Management, Talent Acquisition, Program Management, Talent Management, Change Management, Employee Relations, Leadership, Process Improvement, Organizational..., Deferred Compensation, Recruiting, Succession Planning, Employee Engagement, Employee Benefits, Personnel Management, HRIS, Training, Workforce Planning, HR Consulting, Strategy, Management, Benefits Administration, Strategic Planning, Team Building, Leadership Development, Coaching, Organizational..., Payroll
Education
Florida State University 1979 — 1983
Bachelors, Business Administration and Management
National Institute of Standards and Technology September 2014 - Present
IT Coalition March 2013 - September 2014
Chainbridge Technologies 2007 - 2013
Medifacts International March 2004 - January 2007
Skills
C#, SQL, Microsoft SQL Server, ASP.NET, Silverlight, jQuery, HTML 5, AJAX, ADO.NET, Web Services, HTML5
Education
Towson University 2001 — 2003
BS, Computer Science
University of Maryland College Park 1998 — 2001
Computer Science
Boy Scouts of America January 2007 - Present
Sigma-Tau Pharmaceuticals, Inc. September 2010 - June 2013
Accelovance June 2009 - September 2010
Dynport Vaccine Company, LLC November 2008 - June 2009
W K Lohr, LLC April 2007 - August 2008
MedImmune, Inc. March 2005 - April 2007
Otsuka 2007 - 2007
Medifacts International August 2003 - March 2005
Skills
Clinical Research, Clinical Trials, Vaccines, CRO, Clinical Trial..., Clinical Development, Cardiology, Lupus
Education
Virginia Commonwealth University School of Medicine 1994 — 1999
Biochemistry
Milligan College 1985 — 1989
BS, Chemistry
Social and Scientific Systems November 2008 - Present
Medifacts International November 2004 - August 2008
Skills
Clinical Trials, Clinical Development, Clinical Monitoring, Vaccines, Clinical Research, ICH-GCP, Pharmaceutical Industry, GCP, CTMS, CRO, Biotechnology, Lifesciences, Infectious Diseases, Clinical Pharmacology, Internal Medicine, Pharmacology, Protocol, Oncology, Medical Writing, Regulatory Submissions, Regulatory Affairs, Epidemiology, Pharmacovigilance, EDC, Drug Development
Education
University of Geneva 1970 — 1977
Doctor of Medicine (MD)
Halloran Consulting Group August 2013 - Present
Otsuka Pharmaceutical Research & Commercialization, Inc. May 2010 - August 2013
Sucampo Pharmaceuticals, Inc. February 2007 - April 2010
MedImmune May 2005 - January 2007
Medifacts International 2004 - 2005
Oxigene 1998 - 2000
Skills
Pharmaceutical..., Pharmaceutical..., Biotechnology, CRO, CTMS, Clinical Development, Clinical Research, Clinical Trials, Drug Development, Infectious Diseases, Oncology, Pharmaceutical Industry
Education
Harvard University 1989 — 1993
Bachelor of Arts (BA)
CoreLab Partners, Inc. September 2008 - Present
BioClinica August 2004 - Present
Medifacts International August 2004 - September 2008
Skills
Medical Devices, GCP, Clinical Trials, Clinical Trial..., Data Management, 21 CFR Part 11, CTMS, CRO, Clinical Development, EDC, Clinical Monitoring, Drug Development, ICH-GCP, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Sop, Oncology, Protocol, FDA, Clinical Research, Clinical Operations, Regulatory Submissions, Validation, Regulatory Affairs, Pharmacovigilance, Lifesciences, GMP, Cardiology, Biotechnology, Infectious Diseases, GLP, Diabetes, Vaccines, Computer System..., Quality Assurance
Education
Pennsylvania State University- Main Campus 1992 — 1996
Bachelor of Science (BS), Management
Knopp Biosciences LLC 2007 - 2012
Theravance May 2006 - November 2007
Medifacts International 2005 - 2006
Wyeth Pharmaceuticals 2000 - 2005
Astra USA 1996 - 1999
Pharmaco Ltd. 1992 - 1996
PACT /G.H. Besselaar 1990 - 1992
Temple University Hospital 1988 - 1990
Skills
Clinical Research, Infectious Diseases, Clinical Development, Clinical Trial..., Drug Safety Management, Clinical Quality..., Cardiovascular Medicine, Neurology, Women's Health, Medicine, CTMS, Clinical Monitoring, Clinical Trials, CRO, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Pharmacovigilance, Drug Development, Lifesciences, GCP, Medical Writing, Pharmacology, Vaccines, Medical Affairs, Regulatory Submissions, Drug Discovery, Therapeutic Areas, ICH-GCP, FDA, Biopharmaceuticals, EDC, IND, Clinical Data Management, Clinical Operations
Education
Drexel University School of Public Health 2011 — 2013
Master of Public Health (M.P.H.)
University of Pennsylvania 1981 — 1986
Bachelor of Arts (B.A.), Biology
Willingboro High School 1978 — 1981
Otsuka Pharmaceutical Development & Commercialization, Inc February 2012 - Present
Otsuka Pharmaceutical Development & Commercialization, Inc December 2008 - February 2012
Prestwick Pharmaceuticals, Inc 2005 - 2008
Medifacts International 2002 - 2005
Education
James Madison University
BS, Integrated Science and Technology
PRA International 2012 - 2012
Contract 2009 - 2010
Medifacts 2004 - 2007
Medifacts International 2004 - 2007
Entropin 1999 - 2000
Rhone Poulenc Rorer 1990 - 1992
RPR 1987 - 1992
Serono 1985 - 1987
Physicians Health Study 1984 - 1985
Skills
CRO, CTMS, Clinical Development, Clinical Trials, ICH-GCP, Clinical Monitoring, Pharmaceutical Industry, Clinical Research...
Education
University of Virginia 1980 — 1992
Bowdoin College
Madeira
Global Research Services, LLC March 2007 - Present
Medifacts International April 2005 - March 2007
First Health Corporation March 2000 - April 2005
Skills
General Ledger, GAAP, Journal Entries, Account Reconciliation, Fixed Assets, Accounting, Financial Reporting, Tax Preparation, Microsoft Office, Financial Accounting, Financial Statements, Tax
Education
Indiana University - Kelley School of Business 1990 — 1994
Bachelor's degree, Accounting
Biomedical Systems October 2012 - Present
Biomedical Systems January 2012 - October 2012
Biomedical Systems March 2006 - January 2012
Biomedical Systems November 2004 - March 2006
Biomedical Systems February 1994 - November 2004
Biomedical Systems February 1992 - February 1994
Medifacts International February 1989 - December 1991
Skills
Oncology, GCP, FDA, Clinical Research, Cross-functional Team..., Medical Devices, Clinical Trials, CRO, Clinical Development, Pharmaceutical Industry, Biotechnology, Management, Lifesciences, Drug Development, CTMS, Cardiology, Data Management, Healthcare, Regulatory Affairs, Sop, Regulatory Submissions, Life Sciences
Education
Missouri State University 1985 — 1988
BS, Biology, Psychology
Emergent BioSolutions January 2015 - Present
Goldbelt Raven 2012 - 2014
PharmAthene August 2011 - February 2012
Foundation for the National Institutes of Health September 2010 - April 2011
PRTM Management Consultants August 2009 - June 2010
Panacos Pharmaceuticals 2005 - 2008
Social & Scientific Systems 2002 - 2005
Medifacts International 2001 - 2002
Life Technologies 2000 - 2001
Edge BioSystems 2000 - 2001
Skills
Biotechnology, Lifesciences, Clinical Trials, Infectious Diseases
Education
The Johns Hopkins University 2001 — 2003
MS, Biotechnology
UMBC 1995 — 1999
BS, Biochemistry
Sigma-Tau Pharmaceuticals, Inc. July 2014 - Present
Sigma-Tau Pharmaceuticals, Inc July 2010 - July 2014
SGS Life Science Services June 2005 - July 2010
MedImmune August 2004 - June 2005
NIH/NIAID/DMID/Office of Clinical Research Affairs April 2003 - August 2004
Medifacts International 2000 - 2003
Skills
Certified Project..., Certified CRA, Vaccines, Cardiology, Infectious Diseases, Clinical Research, Oncology, Healthcare, Biologics, Dermatology, Nephrology, Clinical Development, GCP, CRO, Project Management, Sop, Clinical Monitoring, Quality Assurance, FDA, Medical Writing, Biopharmaceuticals, Medical Devices, Clinical Data Management, Hematology, Data Management, Molecular Biology, Clinical Trials, Drug Development, Pharmaceutical Industry, CTMS, Biotechnology, SOP
Education
Louisiana State University 1996 — 1998
MS, Veterinary Sciences
Shepherd University 1992 — 1996
Bachelor's Degree, Biology and Chemistry
Boonsboro High 1988 — 1992
Medifacts International October 2008 - Present
MAPS Applied Research Center February 2008 - October 2008
Minneapolis VA Medical Center October 2006 - October 2007
MN Veterans Research Institute / Minneapolis VA Medical Center June 2005 - July 2006
Education
Saint Mary's University of Minnesota 2006 — 2010
MA, Human Development
Texas A&M University 2008 — 2008
MPH, Public Health
Colorado Christian University 2001 — 2004
BS, Biology
The Palmer Law Group January 2012 - Present
The Brickman Group March 2011 - January 2012
Unknown November 2010 - July 2011
Covance October 2006 - November 2010
COVANCE MARKET ACCESS SERVICES October 2006 - November 2010
Medifacts International August 2004 - September 2006
Medifacts International October 2004 - August 2006
Jai Medical Systems, MCO 1998 - 2004
Education
Catonsville Community College
business administration studies
Tufts University School of Dental Medicine September 2011 - Present
Medifacts International August 2008 - August 2010
Education
Tufts University School of Dental Medicine 2011 — 2015
DMD, Dentistry
Virginia Polytechnic Institute and State University 2004 — 2008
B.S. Biological Sciences
MOD Mission Critical June 2012 - Present
Sirius Telecommuncations January 2010 - June 2014
Trans World Internet Exchange 2004 - 2011
Medifacts International 2005 - 2007
Neovera October 2001 - December 2003
Exodus Communications August 1999 - October 2001
UUNET August 1996 - August 1999
Bayer March 1989 - August 1996
Skills
Managed Services, MPLS, IP, BGP, Network Security, Network Design, Internet Product..., Cisco Routers, Cloud Computing, VoIP, Unified Communications, Network Administration, Cisco IOS, Cisco IP Telephony..., Juniper Technologies, DNS Management, Internet Strategy, Red Hat Linux, Embedded Linux, FreeBSD, FreeBSD Administration, MySQL, Apache, CGI/Perl, Object Oriented Perl, C++, C, ASP.NET, x86 Assembly, 68k Assembly, DEC Alpha, DEC VAX, Mac OS X Server, Shell Scripting, IT Hardware Support, CPU design, Asterisk, Freeswitch, Ekinops, E-commerce, Operating System..., Electrical Engineering, Mechanical Engineering, Strategic Partnerships, PHP, Data Center..., Hybrid Cloud, CentOS, Data Center, Network Architecture
Education
Duquesne University 1990 — 1992
Bachelor's Degree, Mechanical Engineering
Pittsburgh Technical Institute 1986 — 1988
Associate's Degree, Specialized Technology, 4.0
PPD November 2005 - Present
Medifacts International May 2003 - October 2005
Quintiles September 1998 - May 2003
Skills
CTMS, Clinical Development, CRO, Biotechnology, EDC, Pharmacovigilance, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Trials, Clinical Research, Therapeutic Areas, ICH-GCP, GCP, Clinical Monitoring, Protocol, Clinical Operations, Oncology, Clinical Data Management
Education
University of Dayton 1993 — 1998
MA, Clinical Psychology
University of North Carolina at Chapel Hill 1988 — 1990
BA, Psychology
East Carolina University 1986 — 1988
N/A, Psychology
SAIC-Frederick September 2011 - Present
SAIC-Frederick November 2009 - September 2011
SAIC-Frederick July 2009 - November 2009
Clinilabs, Inc. August 2008 - February 2009
Medifacts International January 2008 - August 2008
Medifacts International October 2005 - January 2008
Medifacts International March 2004 - October 2005
Skills
Clinical Trials, Cross-functional Team..., Clinical Development, Pharmaceutical Industry, Project Management, Clinical Research, GCP, Biotechnology, CRO
Education
The George Washington University 1994 — 1996
MFS, Forensic Science
The University of Georgia 1991 — 1994
BS, Biochemistry
Social & Scientific Systems August 2011 - Present
Social & Scientific Systems November 2010 - September 2011
Social & Scientific Systems June 2008 - November 2010
Medifacts International 2004 - 2008
Talisman Programs 1999 - 1999
Education
University of North Carolina at Chapel Hill 1997 — 2001
B.S., Biology
Financial Industry Regulatory Authority August 2013 - Present
Westat 2007 - August 2013
Medifacts International 2002 - 2007
Medifacts International (Shanghai Office) 1998 - 2002
Skills
WCF, ASP.NET MVC, WPF, OOP, Silverlight, MVVM, Architecture, SAS, Data Management, SQL, SharePoint, Agile Methodologies, SDLC, Software Development, Microsoft SQL Server, Database Design, Oracle, Software Project...
Education
Fudan University 1994 — 1998
Bachelor of Science (BS)
Congregation Beth El Synagogue September 2008 - Present
GameStop June 2009 - November 2011
Congregation Beth El September 2008 - June 2010
Congregation Beth El Synagogue September 2007 - June 2010
Greenwich Reform Synagogue September 2005 - May 2009
Morton's The Steakhouse May 2007 - February 2008
Medifacts International January 2004 - May 2005
ACNielsen 2000 - 2001
Skills
Non-profits, Public Speaking, Counseling, Teaching, Writing, People Management, Sales Management, Direct Sales
Education
Central Connecticut State University 2005 — 2008
BA, Political Science, Economics
Central Connecticut State University 2005 — 2008
Bachelor of Arts, Political Science; Economics
Southern Connecticut State University 2001 — 2003
N/A, Political Science, Economics
Roche/ADECCO January 2013 - July 2014
Biomedical Systems,Cardiology Division January 2011 - January 2012
Medifacts International 2007 - 2009
Skills
Clinical Development, CRO, CTMS, Clinical Trials, GCP, Oncology, Therapeutic Areas, Infectious Diseases, Neurology, Biopharmaceuticals, Biotechnology, Lifesciences, Hardware Diagnostics, Hematology, EDC, Pharmaceutical Industry, Vaccines, Medical Devices, Pharmacovigilance, Endocrinology, Gastroenterology, Clinical Research, Regulatory Affairs, Pharmaceutical Sales, Clinical Monitoring, Cardiology, Dermatology, Diabetes, ICH-GCP, FDA, Pharmaceutics, Sop, Immunology, Interventional..., Genomics, Lab Products, Life Sciences
Education
Roche/Adecco Diabetes Education/Onboarding requirements 2013 — 2015
Diabetes Education;Pharmacy Science;Cardiovascular sales and technical service;Lab Medicine
Central Piedmont Community College 2012 — 2013
National Certification Pharmacy Technician, Pharmacy Technician/Assistant, 4.0
University of Maryland University College 2008 — 2010
BA, Science, Pharmacy, Business Adm.
Southern College of Pharmacy 1969 — 1971
Pharmacy Science
Youth For Understanding USA August 2007 - Present
Medifacts International March 2004 - August 2007
eko systems, inc. November 1996 - January 2004
Skills
HTML, Program Management, Cloud Computing, Programming, .NET, Java, PHP, W3C, AS400, Linux, OSX, Windows, JavaServer Faces, Process Improvement, Project Management, Web Development, Integration, JavaScript, Software Development, Software Project..., OS X, Management, Security, Enterprise Software, SaaS, Networking, Leadership
Education
The George Washington University 1986 — 1989
MS, Information Management
Washington University in St. Louis 1980 — 1984
BS, Chemistry
Cognizant March 2015 - Present
LifeLogics January 2007 - March 2015
National Cancer Institute August 2004 - January 2007
Medifacts International January 2004 - August 2004
National Cancer Institute July 2002 - January 2004
Kaiser Permanente July 2000 - July 2002
Skills
Clinical Research, Healthcare, Leadership, Management, PMP, Project Management, Program Management, Nonprofits, EHR, Policy, Process Improvement, Proposal Writing, Quality Assurance
Education
James Madison University 1996 — 2000
Bachelor of Science (BS), Health Science/Health Info Sys
Project Management Institute
PMP
Children's National Medical Center
Paramedic (NREMT-Paramedic)
PAREXEL March 2014 - Present
Sanofi Pasteur May 2011 - March 2014
Sanofi Pasteur January 2007 - May 2011
Medifacts International May 2005 - January 2007
Medifacts International May 2004 - May 2005
UPS February 2001 - October 2004
BBI Biotech Research June 2003 - May 2004
BBI Biotech Research June 2002 - June 2003
Skills
Clinical Trials, Clinical Research, GCP, CTMS, Vaccines, Pharmaceutical Industry, Clinical Development, CRO, Sop, Protocol, EDC, ICH-GCP, Therapeutic Areas, Clinical Monitoring, Infectious Diseases, Regulatory Submissions, Drug Development
Education
St. Francis University 1995 — 2000
Physician Assistant Sciences
EU Services September 2007 - Present
Medifacts International January 2003 - September 2007
IGEN International December 1996 - February 2002
Skills
Business Planning, Revenue Recognition, Strategic Planning, Business Strategy, International Accounting, Analysis, SEC filings, Public Companies, Banking Relationships, Working Capital..., Corporate Budgeting, Cash Flow Forecasting, Treasury, Business Process..., People Skills, Financial Reporting, Cost Management, Cost Accounting, Internal Controls, Manufacturing..., Production Budgeting
Education
University of Maryland College Park 1978 — 1982
Bachelor of Science (BS), Accounting
Triangle Clinical Trial Mgmt September 2006 - Present
Rho 2009 - 2012
Omeros Corporation 2008 - 2011
Averion International 2007 - 2009
Medifacts International 2004 - 2006
Inveresk Research 2000 - 2004
Duke University Medical Center July 1996 - May 2000
Education
University of North Carolina at Chapel Hill 1994 — 1996
Bachelor's degree, Registered Nursing/Registered Nurse
University of North Carolina at Chapel Hill 1988 — 1992
Bachelor's degree, Biology, General