Aptiv Solutions, an ICON plc company
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Aptiv Solutions, an ICON plc company Employees
Leidos Health/NIH September 2014 - Present
Aptiv Solutions, an ICON plc company November 2013 - September 2014
Clinical Research Management, Inc. (ClinicalRM) at USAMRIID April 2013 - November 2013
Center for Digestive and Liver Diseases, Inc. August 2012 - April 2013
The University of Kansas Cancer Center April 2012 - August 2012
Chevy Chase Clinical Research October 2011 - April 2012
Chevy Chase Clinical Research April 2010 - October 2011
Chevy Chase Clinical Research February 2007 - April 2010
Johns Hopkins University December 2002 - February 2007
St Agnes Hospital August 2000 - December 2002
Skills
IRB, Systematic Reviews, Epidemiology, Literature Reviews, Health Research, Public Health, Health Services Research, Qualitative Research, Research Management, Medical Research, Research Design, Clinical Research, Clinical Study Design, Nursing, CRO, Oncology, GCP, Healthcare, Clinical Trials, FDA, Infectious Diseases, Medicine, Sop, Vaccines, CTMS, Cancer, Clinical Data Management, ICH-GCP, Clinical Monitoring, Protocol, Medical Writing, EDC, Hematology, Immunology, Clinical Development, Pharmaceutical Industry, Biotechnology, Inform, Phlebotomy, Drug Development, Regulatory Affairs, Pharmacology, Data Management, Regulatory Submissions
Education
The George Washington University School of Medicine and Health Sciences 2015 — 2017
Master’s Degree, Clinical Research Administration
Howard Community College
Associate of Arts, Nursing RN
Howard Community College
Associate of Arts, International Business
University of Baltimore
Bachelor of Science, Business Management; Marketing
PRA Health Sciences June 2014 - Present
Aptiv Solutions, an ICON plc company July 2013 - May 2014
PPD March 2012 - July 2013
PRA International October 2010 - March 2012
PRA International April 2007 - October 2010
PRA International December 2004 - April 2007
Skills
ICH-GCP, CTMS, Clinical Monitoring, Clinical Research, GCP, Sop, Protocol, EDC, FDA
Education
Northwest Missouri State University 1984 — 1990
B.S., Technical Theatre/Theatre Design and Technology
Michael B. Bless, Quality Consulting Services LLC September 2013 - Present
Aptiv Solutions, an ICON plc company September 2013 - May 2014
Aptiv Solutions April 2011 - July 2013
Averion International April 2008 - March 2011
ICON plc November 1996 - March 2008
Career break July 1995 - October 1996
Gesellschaft für wissenschaftliche Datenverarbeitung + Didaktik mbH (GWD) January 1990 - June 1995
Skills
CRO, GCP, Pharmaceutical Industry, Clinical Trials, EDC, Auditing, SOP development, CAPA, External Audit, Data Privacy, Supplier Quality..., Oncology, SOP, Quality Assurance, ICH-GCP, Clinical Development, Risk Management, Records Management, Clinical Research, Clinical Monitoring, Pharmacovigilance, Regulatory Affairs
Education
Johann Wolfgang Goethe-Universität Frankfurt am Main 1984 — 1992
University Diploma (MA equivalent)
ICON plc December 2013 - Present
Aptiv Solutions, an ICON plc company June 2011 - December 2013
Aptiv Solutions, an ICON plc company March 2009 - June 2011
Aptiv Solutions, an ICON plc company August 2007 - February 2009
MDS Pharma Services February 2006 - August 2007
Integrium September 2005 - February 2006
Leigh Ann Buydos, DDS, MS January 1999 - September 2005
Integrium October 2002 - February 2004
Integrium April 2001 - October 2002
Integrium October 2000 - April 2001
Skills
CRO, EDC, CTMS, Clinical Trials, Clinical Data Management, Data Management, Project Management, 21 CFR Part 11
Education
California State University-Fullerton
BA, Business Administration / Management Information Systems
Shire Pharmaceuticals 2012 - Present
Covidien 2011 - 2012
Brigham and Women's Hospital 2010 - 2011
The Boston Cecilia 2008 - 2010
Aptiv Solutions, an ICON plc company 2007 - 2010
Boston Blades Rowing Club 2001 - 2008
PAREXEL 2005 - 2007
Quintiles / Outcome Sciences 2004 - 2005
Quintiles, Verispan Health Care Data Informatics Division. 2001 - 2004
Novation 1996 - 2000
Skills
Budgets, Oncology, Clinical Trials, Central Nervous System, Medical Devices, Pharmaceutical Industry, CRO, Biotechnology, CTMS, Healthcare, EDC, Therapeutic Areas, Clinical Research, Informatics, Clinical Development, FDA, Managed Care, GCP, Regulatory Submissions, Clinical Monitoring, Pharmacovigilance, Regulatory Affairs, Drug Development, Pharmaceutics, Sop, Clinical Data Management, Lifesciences, Cardiology, Protocol, Dermatology, Diabetes, Infectious Diseases, 21 CFR Part 11, Vaccines, Medical Writing, Biopharmaceuticals, Neurology, Data Management, ICH-GCP, Validation, Endocrinology, Regulatory Requirements, Medical Affairs, SOP
Education
Harvard University School of Public Health 1997 — 1998
Texas Christian University - M.J. Neeley School of Business 1993 — 1995
MBA
Texas State University 1987 — 1989
BBA
The University of Texas at Dallas 1985 — 1987
The University of Texas at Austin 1983 — 1987
Lake Highlands High School
Yes
Aptiv Solutions, an ICON plc company May 2014 - May 2015
Sarah Cannon Research Institute June 2010 - May 2014
Aegis Sciences Corporation March 2009 - June 2010
Skills
Clinical Trials, Clinical Research, Oncology, EDC, Life Sciences, GCP, Research, SOP, ICH-GCP, Clinical Trial..., Data Management, Clinical Data Management, Sop, 21 CFR Part 11, CRO, CTMS, Clinical Development, Clinical Monitoring, Data Analysis, FDA, GMP, Lifesciences, Pharmaceutical Industry, Quality Assurance, Validation
Education
Alabama Agricultural and Mechanical University
BS, Biology
Premier Research May 2015 - Present
Radius Product Development September 2013 - April 2015
Aptiv Solutions, an ICON plc company November 2007 - July 2013
Aptiv Solutions November 2004 - November 2007
PAREXEL October 2000 - October 2004
PAREXEL September 1996 - October 2000
Skills
Financial Analysis, Proposal Writing, Budgeting, Financial Reporting, Revenue Recognition, Revenue Forecasting, Billing, Accounts Receivable, Budgets, Invoicing, Forecasting, Auditing, Clinical Trials, CRO, Management, CTMS, Clinical Research, Sarbanes-Oxley Act, Clinical Development, Project Management, Change Management, GCP, Accounting, Variance Analysis, Accruals, Internal Audit, Account Reconciliation, Training, Mergers & Acquisitions, Process Improvement, Data Analysis, Acquisition Integration, Costpoint, Software Documentation, Cross-functional Team..., Data Management, Project Planning, Pharmaceutical Industry, Contract Negotiation, Contract Management, Integration, Analysis, EDC
Education
University of Massachusetts Lowell 2014 — 2018
Pursuing Bachelor of Business Administration, Business Administration and Management, General
Johnson & Wales University
Associate of Science
Leidos 2015 - Present
Aptiv Solutions, an ICON plc company 2012 - 2015
General Dynamics Advanced Information Systems 2006 - 2012
Deltek 2003 - 2006
General Dynamics Advanced Information Systems 2002 - 2003
GENERAL DYNAMICS - INFORMATION TECHNOLOGY 1997 - 2002
Skills
Deltek, Cognos, Costpoint, Impromptu, Cognos ReportNet, Analysis, Business Analysis, SQL, Oracle E-Business Suite, Business Intelligence, Accounting, Project Management, Program Management, Databases, TS SCI Clearance, Microstrategy, Oracle Financials, Oracle Discoverer, Security Clearance, GCS
Education
George Mason University
MS
Sewanee-The University of the South
BA
Social & Scientific Systems July 2014 - Present
Aptiv Solutions, an ICON plc Company May 2013 - July 2014
Red Hat 2012 - 2013
Teleflex Medical 2010 - 2012
Campbell Alliance June 2008 - November 2009
Clinical Data (formerly Genaissance Pharma and DNA Sciences) January 2002 - January 2008
Aerotek/Option One Staffing February 1999 - January 2002
Skills
Employee Relations, Performance Management, Benefits, Recruitment and..., Training & Development, Change Management, Employee Benefits
Education
University of North Carolina at Chapel Hill 1994 — 1998
BS, Business Administration; Organizational Behavior
Duke University
Continuing Education Program, HR Management
Aptiv Solutions, an ICON plc company May 2014 - December 2014
Aptiv Solutions April 2013 - April 2014
Quintiles February 2011 - April 2013
Quintiles October 2008 - February 2011
Scene Change Inc. November 2006 - October 2008
Jones Apparel Group February 1996 - October 2006
Schering-Plough 1995 - 1996
EMI Records 1993 - 1995
Bristol-Myers Squibb 1992 - 1993
Standard Management Company 1990 - 1992
Skills
Cross-functional Team..., Retail, Process Improvement, Apparel, Trend Analysis, Management, Fashion, Forecasting, Sportswear, Technical Design, Budgets, Real Estate, Product Development, Start-ups, Social Media, Microsoft Office, Negotiation, Marketing Strategy, Clinical Development, Clinical Trials, Clinical Research, Project Management, Project Coordination, Project Finance, MS Project, Salesforce.com, Microsoft Excel, Adobe Acrobat, Adobe Creative Suite, PLM Tools, Proposal Writing, Pharmaceutical Industry, CRO, Business Development, Strategy, Strategic Planning, Marketing, Analysis
Education
Rutgers, The State University of New Jersey-Newark 2003 — 2013
MBA
Franklin University
Bachelor of Applied Science (BASc), Business Administration and Management, General
DOCS January 2014 - Present
Aptiv Solutions December 2012 - January 2014
Aptiv Solutions July 2011 - December 2012
Aptiv Solutions, an ICON plc company October 2008 - July 2011
Fulcrum Pharma Developments, Inc. January 2006 - October 2008
Health Center "Novi Beograd" June 2000 - 2004
Skills
Clinical Research, Clinical Development, Cross-functional Team..., Drug Development, Contract Negotiation, Program Management, Pharmaceutical Industry, Biotechnology, Clinical Trials, Oncology, Lifesciences, FDA, CRO, Regulatory Submissions, R&D, IND, Infectious Diseases, Medical Devices, Management, Drug Discovery, CTMS, Validation, Therapeutic Areas
Education
North Carolina State University - College of Management 2005 — 2008
MBA, BioPharma Management
Univerzitet u Beogradu 1993 — 2000
Doctor of Dental Medicine
ICON plc May 2014 - Present
Aptiv Solutions, an ICON plc company January 2012 - April 2014
Medical Device Consultants, Inc. 2008 - 2011
Education
Providence College 1992 — 1996
Lifespan September 2014 - Present
Lifespan January 2014 - August 2014
Rhode Island Public Expenditure Council May 2009 - April 2014
University of Rhode Island August 2012 - May 2013
Aptiv Solutions, an ICON plc company August 2011 - August 2012
Aptiv Solutions, an ICON plc company April 2010 - August 2011
Brown University November 2009 - April 2010
Liberty Mutual Insurance May 2008 - June 2009
Vantage Deluxe World Travel May 2007 - May 2008
Nixon Peabody LLP May 2006 - May 2007
Skills
Research, Legal Writing, Legal Research, Nonprofits, Policy, Data Analysis, Program Evaluation, Qualitative Research, Analysis, Training, Program Management, Public Policy, Proposal Writing, Leadership, Strategy, SPSS, Policy Analysis, Statistical Data..., Data Collection, Quantitative Research, Multivariate Statistics, Survey Research, Public Finance, Survey Design, Educational Research, Economic Research, Report Writing, Operations Management, Business Analytics, Legislative Research, Public Administration, Project Management, Corporate Governance, Taxations, Data Governance, Contract Negotiation, Contract Management, Change Management, Process Improvement, Consulting
Education
University of Rhode Island 2012 — 2019
PhD
Roger Williams University
MPA
Georgetown University
Post-Baccalaureate Certificate
Roger Williams University
BA
Washington Internship Institute 2002 — 2003
Embassy & Diplomatic Scholars Program
Ludwig-Maximilians Universität München 2002 — 2002
Aptiv Solutions, an ICON plc company July 2014 - Present
Alere San Diego January 2012 - August 2014
Self December 2009 - January 2012
Skills
Clinical Trials, Cardiology, Medical Devices, Medical Terminology, Pulmonology, Clinical Research, Business Travel, Electronic Data Capture, Pharmaceutical Industry, Clinical Development, Biotechnology, EDC, Lifesciences, GCP, CRO, Asthma, FDA, 21 CFR Part 11, Infectious Diseases, Diabetes, Clinical Monitoring, Life Sciences
Education
New Mexico State University 1987 — 1991
BBA, Business - Marketing
Aptiv Solutions, an ICON plc company January 2012 - Present
BNY Mellon July 2010 - April 2011
PNC Global Investment Servicing 2007 - 2010
PFPC 2001 - 2007
Skills
Project Management, Financial Analysis, Financial Reporting, Revenue Analysis, Sales Management, Sales Operations, Account Management, Revenue Forecasting, Financial Services, Financial Planning, Financial Modeling, Analysis, Finance, Business Analysis, New Business Development, Marketing, Forecasting, Management, Budgets, Process Improvement
Education
University of Ghana
BA
Aptiv Solutions, an ICON plc company October 2011 - Present
SRA International September 2008 - September 2011
PAREXEL May 2006 - August 2008
Skills
Data Management, Clinical Data Management, CRO, EDC, Oracle Clinical, CTMS, ICH-GCP, Pharmaceutical Industry
Education
Appalachian State University
University of North Carolina at Greensboro
Bachelor of Science (BS), Marketing/Marketing Management, General