Octagon Research Solutions
Industry: Company
DescriptionFounded: 1999 Parent organization: Accenture Subsidiary: Octagon Clinical Research Solutions India Private Limited
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Octagon Research Solutions Employees
Adlib Software September 2014 - Present
Mission3 January 2014 - June 2014
AmericanPharma Technologies LLC July 2013 - January 2014
Octagon Research Solutions May 2011 - January 2012
Image Solutions, Inc. December 2002 - June 2010
Ahearn Tennis Management Group (ATMG) 1998 - 2001
Skills
Business Development, Management, Sales, Pharmaceutical Industry, Sales Operations, Biotechnology, Lifesciences, Regulatory Affairs, Marketing, Regulatory Submissions, Validation, FDA, 21 CFR Part 11, Clinical Trials, Account Management, Cross-functional Team..., Regulatory Requirements, Document Management, SaaS, Medical Devices, Sop, Clinical Development, CRO, Biopharmaceuticals
Education
Boston College - Wallace E. Carroll Graduate School of Management 1998 — 1999
Other, Business Administration
King's College 1995 — 1999
Bachelor of Science ( B.S. ) in Business Administration and Psychology, Bachelors of Science (Double Major), Business Administration / Psychology
Colors on Parade March 2011 - Present
Octagon Research Solutions June 2007 - March 2011
Insight Global January 2007 - May 2007
Skills
Customer Service, Training, Management, Automobile, Quality Assurance, Recruiting, Sales Management, Sales, Employee Benefits, Vehicles, Negotiation, Team Building, Customer Satisfaction, Process Improvement, Account Management, Strategic Planning, Sales Operations, Marketing, New Business Development, Cross-functional Team..., Operations Management, Marketing Strategy, Franchising, Sales Process, Inventory Management, Forecasting, Automotive, Business Development, Contract Negotiation, Retail, Lead Generation, CRM, Budgets, Business Strategy, Coaching, Pricing, Small Business, Strategy, Selling, B2B, Start-ups, Email Marketing, Dealers, Business Planning, Marketing Management, Product Development, Leadership, Purchasing
Education
Bloomsburg University of Pennsylvania 2002 — 2006
Bachelors, Business - Marketing
Independent Study, Sabbatical January 2015 - Present
Reed Technology & Information Services, Inc. 2011 - 2014
Onconova Therapeutics 2010 - 2010
SLS Project Management, LLC 2009 - 2010
OmniComm Systems 2008 - 2008
ICON Medical Imaging 2007 - 2008
Octagon Research Solutions 2006 - 2006
Merck 2001 - 2006
Rohm and Haas 1987 - 2000
Skills
PMP, Project Coordination, Cross-functional Team..., Business Process..., Project Management, Vendor Management, Data Import/export, Process Improvement, New Business Development, Clinical Data Management, Document Management, eCRF, Training Delivery, Remote Data Capture, Pharmaceutical Industry, Laboratory, Software Product..., Reference Manuals, Requirements Analysis, User Stories, Biotechnology, 21 CFR Part 11, Quality Assurance, Quick Start Guides, Computer System..., HL7, Product Development, CRO, Clinical Trials, Business Analysis, EDC, SharePoint, MS Project, Training, Integration, CTMS, Analysis, Data Management, GCP, PMO, Software Documentation, Management, SDLC, Enterprise Content..., Business Development, Risk Management, Documentum, Lifesciences, Trial Master File, Technical Writing
Education
Project Management Institute 2009 — 2018
PMP Certification, Project Management
Pennsylvania State University-Great Valley Graduate Center 2010 — 2010
CSM Certification, Agile SCRUM Master
La Salle University 1998 — 2001
M.S., Computer Information Science
Rutgers University-New Brunswick 1987 — 1987
B.S.
The Formosa Group dba The Formatting Formula January 2014 - Present
Accenture, LLP 2012 - 2013
Octagon Research Solutions October 2004 - November 2012
Skills
MS Word 2003, 2007,..., Document Formatting, Document Template..., Document QC
Education
Rosemont College
Bachelor's Degree, Business, Management, Marketing, and Related Support Services
Villanova University
Project Management, Project Management, Passed
Alcon, a Novartis company April 2012 - Present
Tunnell Consulting February 2011 - April 2012
Green Pharma Consulting LLC February 2011 - April 2012
Shionogi Pharma (formerly Sciele Pharma) March 2010 - December 2010
Octagon Research Solutions July 2007 - January 2010
Hertz Rent a Car January 2007 - July 2007
Temple University September 2005 - December 2006
Skills
eCTD, FDA, IND, Quality Assurance, Regulatory Affairs, GMP, Publishing, Project Coordination, Electronic Submissions, Regulatory Submissions, Document Management, Medical Devices, Adobe Acrobat, MAA, Non-disclosure..., Sop, PowerPoint, Microsoft Office, Project Management, Pharmaceutical Industry
Education
Kennesaw State University 2011 — 2013
MS, Masters in Information Systems
Temple University 2003 — 2007
BA, Sociology, Business
Accenture Life Sciences, Accelerated R&D (formally Octagon Research Solutions) October 2013 - May 2014
Octagon Research Solutions September 2012 - October 2013
Holy Redeemer Health System August 2008 - September 2012
A Woman's Place January 2012 - May 2012
Skills
Customer Service, Healthcare, Hospitals, Data Entry, Patient Safety, HIPAA, Clinical Research, Clinical Trials, Software Documentation, Pharmaceutical Industry, Proposal Writing, Proposal Generation, Proposal Leadership, Proposal Support, Pharmaceutical Sales, Medical Terminology
Education
Penn State University 2008 — 2012
Bachelor of Arts, Corporate Communication
OneBeacon Insurance October 2008 - Present
National Heritage Academies February 2008 - September 2008
Octagon Research Solutions November 2007 - January 2008
Skills
Databases, Data Warehousing, SharePoint, SQL, Business Analysis, Data Analysis, ETL, Microsoft Office, SDLC, SSIS, XML, SQL Server, T-SQL, PL/SQL, Microsoft SQL Server, Microsoft Word, Visio, Excel, Windows, Word, Database Administration, MS Project, Quality Assurance, Testing, Visual Studio, Release Management, PVCS, Data Security, SSRS, Business Intelligence, Microsoft Excel, Business Requirements, Software Documentation, Systems Analysis, Requirements Gathering, Analysis, Requirements Analysis, Visual Basic, Database Design, SQL Server Analysis..., SSAS, XSLT, Data Modeling, Data Management, Software Development, Control-M, DAX
Education
New York University 2005 — 2007
Master, Computer Science
I-Shou University 1998 — 2002
Bachelor of Science (B.S.), Computer Science
Westat May 2015 - Present
Westat August 2003 - Present
Octagon Research Solutions March 2000 - April 2003
SCIREX Corporation March 1997 - March 2000
Skills
Clinical Trials, Clinical Research, Clinical Data Management, Medical Coding, EDC, Oracle Clinical, Data Analysis, Oncology, GCP, CRO, Data Management, ICH-GCP, SAS
Education
Elizabethtown College 1991 — 1995
Bachelor of Business Administration (BBA), Business Administration and Management, General
HighPoint Solutions March 2014 - Present
Accenture February 2011 - February 2014
Octagon Research Solutions February 2011 - October 2012
Acurian September 2008 - February 2011
Synthes January 2004 - October 2008
US Navy December 1998 - December 2003
Skills
Lifesciences, Business Development, Pharmaceutical Industry, Clinical Trials, Strategy, Cross-functional Team..., Medical Devices, New Business Development, Biotechnology, Business Strategy, Program Management, Consulting, Clinical Research, Leadership, Pharmaceuticals, Strategic Planning, Strategy Development, Start-ups, Life Sciences
Education
Columbia University - Columbia Business School
Master of Business Administration (MBA)
The Ohio State University
Economics
Accenture March 2014 - Present
Octagon Research 2007 - Present
Octagon Research Solutions 2007 - September 2010
Teva Neuroscience October 2001 - January 2007
Skills
eCTD, Worldwide Regulatory..., Submission Project..., FDA, Regulatory Submissions, Regulatory Operations, Pharmaceutical Industry, Cross-functional Team..., GCP, Regulatory Requirements, IND
Education
Masters Certificate, Project Management at Villanova University 2011 — 2012
Bloomsburg University of Pennsylvania
Bachelor's degree, Marketing & Spanish
Daroff Design Inc. September 2014 - Present
Old Skool Yoga September 2014 - Present
Glass & Print November 2007 - Present
BIKRAM YOGA November 2011 - November 2014
Bikram Yoga Main Line November 2010 - September 2012
Octagon Research Solutions October 2006 - March 2008
The Arden Group March 2003 - October 2006
Skills
Financial Reporting, Microsoft Excel, Account Reconciliation, Accounts Payable, Accounts Receivable, Payroll, Financial Analysis, Invoicing, Yoga, Budgets, Bank Reconciliation, Financial Statements, Variance Analysis, Cash Flow Forecasting, Small Business, Auditing, Customer Service, Analysis
Education
David Garrigues Ashtanga Yoga 2013 — 2014
130 Hour Primary Series In-Depth Study, Yoga Teacher Training
Miami Life Center 2013 — 2013
Ashtanga Yoga Intensive
Bikram's Yoga College of India 2011 — 2011
Certified Bikram Yoga Teacher
Becker Conviser CPA Review Course 2005 — 2006
Certificate of completion, Accounting, Auditing, Finance, Regulations
Drexel University - College of Business and Administration 2001 — 2004
Bachelor of Business Administration (BBA), Accounting
Penn Medicine (University of Pennsylvania Health System) May 2013 - Present
Modern Publishing (Self Publishing Company) December 2009 - April 2013
Teva Pharmaceuticals November 2006 - October 2009
Omnicare July 2006 - September 2006
Octagon Research Solutions September 2005 - May 2006
Astra Zeneca Pharmaceutical March 2000 - June 2004
Skills
Oracle PPD, Velos, Medview, Epic, Clintrial, PDS Express, Diomedes, Microsoft Office 2011, Meditech database, SB client database, SAS viewer, Data Labs (XC) clinical, CRF/DEN, TRIM, E-Case Link
Education
Montgomery County Community College 1990 — 1991
One year, Business Administration and Management, General
Main Line Paralegal Institute 1994 — 1995
Paralegal certification., Paralegal studies.
The Daily WTF April 2010 - Present
Selikoff Solutions, LLC August 2006 - Present
JavaRanch.com October 2005 - Present
MenuLogic February 2008 - November 2008
Octagon Research Solutions July 2005 - August 2006
Siemens Medical Solutions June 2004 - July 2005
Cornell University December 2003 - May 2004
Virtual Access June 2000 - May 2002
Skills
Java, Flash, Flex Builder, JavaScript, MySQL, Oracle, Database Design, DB2, Swing, GWT, WebSphere Application..., Linux, Ant, Rational Rose, ClearCase, ClearQuest, Eclipse, Windows, Python, Photoshop, JDBC, J2EE, Message Broker, Servlets, JSP, Object Relational..., Web Services, Google Maps, Flex, HTML, CSS, PHP, XML, XSLT, AJAX, jQuery, JDO, Query Optimization, Stored Procedures, Normalization, Apache Derby, SQL Server, Tomcat, JBoss, Apache, IIS, Weblogic, Jetty, Struts, JUnit
Education
Rutgers University-New Brunswick 2006 — 2009
Computer Science
Cornell University 2002 — 2003
Masters, Computer Science
Cornell University 1999 — 2002
BA, Mathematics, Computer Science
Accenture Life Sciences September 2012 - Present
Octagon Research Solutions November 2008 - September 2012
Octagon Research Solutions, Inc. June 2006 - November 2008
Procter & Gamble Pharmaceuticals October 1998 - June 2006
Procter & Gamble March 1979 - September 1998
Skills
CDISC SDTM and SDTMIG, CDISC SEND Model, Data Modeling, Data Standards, Clinical Trials, Data Management, Pharmaceutical Industry, 21 CFR Part 11, FDA, CRO, Regulatory Submissions, Clinical Development, CDISC, Clinical Data Management, SDTM, Clinical Research, Cross-functional Team..., Regulatory Affairs, Clinical Data, CTMS, Drug Development, Pharmacovigilance
Education
Springfield College
B.S.
University of Massachusetts, Amherst
M.S, Ph.D.
Quintiles August 2014 - Present
Deloitte January 2011 - August 2014
Octagon Research Solutions March 2008 - October 2010
Stelex, Inc. October 2006 - March 2008
Stelex January 2001 - September 2006
Stelex August 1992 - December 2000
IBM 1989 - 1992
Skills
FDA, SDLC, Validation, Team Building, 21 CFR Part 11, Quality Systems, GMP, Computer System..., Document Management, Quality Assurance, Compliance, Business Process..., Pharmaceuticals, Program Management, GxP, Auditing, Life Sciences, Quality System, Pharmaceutical Industry, Six Sigma, Quality Auditing, Software Documentation, Lifesciences, Sop, Change Control, CRM, Enterprise Software, ERP, SOP
Education
Stevens Institute of Technology
BE, Mechanical Engineering
New Jersey Institute of Technology
MS, Management Engineering
Bracket Global (formerly United BioSource Corporation) 2009 - Present
Octagon Research Solutions 2004 - 2009
Merck Sharp & Dohme 2000 - 2004
Omnicare 1999 - 2000
Education
Penn State University 2000 — 2002
M.S., Software Engineering
Drexel University 1993 — 1996
B.S.
TrueBridge Resources, A North Highland Company November 2014 - Present
Accenture October 2012 - Present
Octagon Research Solutions March 2012 - September 2012
Octagon Research Solutions June 2010 - March 2012
PHH Mortgage August 2006 - May 2010
Skills
Applicant Tracking..., iCIMS, Ceridian, Taleo, Recruiting, Sourcing, Hiring, New Hire Orientations, Interviews, Training, College Recruiting, Job Fairs, Talent Acquisition, Internet Recruiting, Management
Education
Rutgers University-New Brunswick 2002 — 2006
B.A., Communication and Psychology
GSK October 2014 - Present
Sunovion Pharmaceuticals Inc. January 2014 - October 2014
Regeneron Pharmaceuticals January 2010 - January 2014
GSK November 2007 - December 2009
Centocor November 2006 - November 2007
Octagon Research Solutions August 2005 - November 2006
Skills
CDISC, Statistical Programming, Validation, Oncology, Pharmaceuticals, Ophthalmology, Macros, ADAM
Education
Andhra University
M.Tech, Informational Technology
Andhra University
M.Sc, Statistics
Ohio University
MS, Mathematics with computational track
Brody Professional Development, The Knowledge Academy, Technical Institute of America, Int Institute January 2004 - Present
BRODY Professional Development, The Knowledge Acad, Tech Inst of Am January 2004 - Present
Ockham Oncology June 2012 - December 2013
AstraZeneca November 2011 - May 2012
Octagon Research Solutions January 2011 - September 2011
ePharmaSolutions October 2008 - October 2010
United BioSource Corporation (UBC) 2007 - 2008
Advanced Biologics (now INC) 2004 - 2006
Merck 1987 - 2003
Merck 1980 - 1986
Skills
Clinical Development, Pharmaceutical Industry, Certified Project..., CRO, Clinical Trials, Project Management, Program Management, Training, Oncology, Management, Project Planning, Infectious Diseases, Leadership Development, Leadership, Performance Management, Data Management, CTMS, Analysis, CRM, Strategy, Clinical Data Management, GCP
Education
University of Rochester School of Medicine and Dentistry 1973 — 1978
MS, Microbiology
Penn State University 1969 — 1973
BS, Microbiology
Merck & Co., Inc. June 2005 - Present
Octagon Research Solutions March 2002 - June 2005
Skills
PMP, Drug Development, Data Management, Clinical Trials, Clinical Data Management, Management, GCP, Sop, Pharmaceutical Industry, Clinical Development, FDA, CRO, EDC, Validation, CTMS, Vaccines, Infectious Diseases, MBA, IVRS, MS Project, Project Server, 21 CFR Part 11, Program Management, Software Documentation, Six Sigma, Regulatory Submissions, Oncology, Regulatory Affairs, Clinical Monitoring, Vendor Management, Life Sciences, Clinical Research, Process Improvement, Project Management, Cross-functional Team..., ICH-GCP, Strategy
Education
Saint Joseph's University - Erivan K. Haub School of Business 2004 — 2007
MBA, Management
Penn State University, Smeal College of Business 1997 — 2001
B.S., Business: Management Sciences & Information Systems/International Business
Germantown Academy
Lower Moreland High School
United BioSource Corporation June 2013 - Present
Jacquette Consulting February 2011 - May 2013
Pfizer July 2005 - July 2010
Octagon Research Solutions June 2004 - July 2005
First Consulting Group February 2000 - June 2004
Bristol-Myers Squibb September 1997 - February 2000
Skills
Quality Assurance, Software Quality..., Computer Systems..., 21 CFR Part 11, GCP, Quality Auditing, Public Speaking, Public Health, Epidemiology, Pharmacoepidemiology, Compliance Audits, Vendor Qualification, Vendor Management, Relational Databases, Change Control, Quality Management, Vendors, Computer System..., Pharmaceutical Industry, Sop, FDA, SOP, Validation, Clinical Trials, CTMS, Regulatory Affairs
Education
Walden University 2008 — 2020
Doctor of Philosophy (PhD)
Rutgers University-New Brunswick 1993 — 1997
BA
Acuta September 2014 - Present
Numbers Unlimited, Ltd January 1995 - Present
AstraZeneca September 2011 - August 2014
MedImmune September 2008 - September 2011
MedImmune April 2005 - September 2008
Octagon Research Solutions May 2002 - April 2005
CDC Solutions April 2000 - April 2002
Andersen Consulting (Accenture) September 1998 - April 2000
Skills
Document Management, eCTD, Regulatory Submissions, Validation, 21 CFR Part 11, Information Management, Documentum, Life Sciences, Business Analysis, Pharmaceuticals, Business Process, Requirements Analysis, IND, Biotechnology, Documentation, Records Management, Regulatory Affairs, Analysis, Problem Solving, SOP, Knowledge Management, Lifesciences, Pharmaceutical Industry, Sop, FirstDoc, Regulatory Operations, FDA, GxP, Software Documentation, CRO, Clinical Development, Clinical Trials, Change Control, Regulatory Requirements, Drug Development, Computer System..., Data Management, GCP, GMP, CAPA, Vaccines, GLP, Technology Transfer, CTMS, Clinical Data Management, V&V, Integration, Quality Assurance, Pharmaceutics
Education
Villanova University 1993 — 1997
Masters
Earlham College 1974 — 1992
Bachelor
SoftwaRx Clinical Computing, Inc October 2007 - Present
Kyowa Hakko Kirin Co., Ltd. 2007 - Present
Octagon Research Solutions 2007 - 2009
Hemispherx Biopharma, Inc February 2007 - October 2007
GE Healthcare July 2002 - February 2007
ChrisSoft Software Services, Inc. 1994 - 2002
Rohm and Haas 1995 - 2001
Premier Research Group 1987 - 2000
Nycomed 1997 - 1998
Nycomed 1997 - 1998
Skills
Clinical Trials, Pharmaceutical Industry, CRO, EDC, Data Management, Clinical Data Management, GCP, Oncology, Clinical Development, Clinical Research, SAS, Biotechnology
Education
Computer Learning Center 1983 — 1984
Certificate, Programming
Rowan University 1977 — 1981
B.A., Communications
Cherry Hill High School West 1972 — 1976
St. Peter's Elementary School
Accenture October 2012 - Present
Octagon Research Solutions August 2004 - August 2014
First Consulting Group July 1999 - June 2004
Platinum Technologies 1998 - 1999
Unisys 1985 - 1995
Unisys 1985 - 1995
Skills
Documentum, Document Management, Enterprise Content..., SDLC, 21 CFR Part 11, Computer System..., Requirements Gathering, Requirements Analysis, Software Quality..., Pharmaceutical Industry, Quality Assurance, SharePoint, Software Documentation, Regulatory Submissions, Testing, Software Implementation, Software Development, eCTD, User Acceptance Testing, Content Management
Education
Drexel University 1983 — 1985
mls
Temple University 1978 — 1980
BS
US Agency for International Development October 2010 - Present
Octagon Research Solutions December 2007 - October 2010
Merck / Telerx February 2006 - August 2007
Skills
Employee Relations, Employee Benefits, Recruiting, Benefits Administration, Human Resources, MS Project, Social Media, Management, Onboarding, Training, Analysis, Personnel Management
Education
Villanova University
SHRM HR Management Certification
Penn State University 2001 — 2005
Bachelors, Advertising / Communications
Pennsylvania State University-Great Valley Graduate Center
Project Management Certification
HomeNet Automotive February 2013 - Present
PJM Interconnection March 2009 - February 2013
Virrata Games October 2008 - February 2009
Octagon Research Solutions September 2005 - January 2008
Lionbridge Technologies, Inc. June 2003 - September 2004
Mattson Technology October 1999 - November 2002
Base10 September 1998 - September 1999
Base10 March 1997 - September 1998
Skills
Quality Assurance, Software Quality..., Quality Center, Testing, SDLC, Scrum, Agile Methodologies, Test Planning, Sales, User Acceptance Testing, Business Analysis, Software Integrations, Product Management, Process Improvement, Requirements Analysis, Cross-functional Team..., PMP, SoapUI, sonic MSQ, Websphere, service stack, Agile & Waterfall..., Subversion, Version One, Rally, Web Services, Web Analytics, Failover, Root Cause Analysis, Metrics, Load Testing, Performance Testing, Oracle, Microsoft SQL Server, SaaS, xml, Waterfall, Test Automation, System Testing, Software Documentation, SOA, Databases, Test Cases, Manual Testing, .NET, Agile Project Management, Usability Testing, C#, Java, Software Project...
Education
Rowan University
BA, English
1&1 Internet, Inc. November 2014 - Present
1&1 Internet, Inc. May 2014 - November 2014
hibu March 2014 - May 2014
hibu November 2013 - March 2014
hibu December 2012 - November 2013
Avantext, Inc. 2008 - 2012
The Compendium May 2006 - November 2008
Aquent, The Creative Group & Maxim Staffing September 2007 - June 2008
Cephalon, Frazer, Pa. – August 2006 to August 2007 August 2006 - August 2007
Octagon Research Solutions November 2005 - July 2006
Skills
Computer Proficiency, Microsoft Office, Microsoft Excel, Microsoft Word, Photoshop, Adobe, QuarkXPress, Software Quality..., Quality Assurance, Proofreading, Editing, Creative Writing, Testing, Management, Web Content, Publishing, Technical Writing, HTML, Project Management, Social Media, Graphic Design, Software Documentation, Team Leadership, Adobe Acrobat, Social Networking, Content Management, Social Media Marketing, Interviews, Editorial, Databases
Education
Rosemont College 2004 — 2007
Master's degree, English and Publishing, Cumulative GPA 3.78
Muhlenberg College 1999 — 2003
Bachelor of Arts (BA), English (Writing Concentration) and Theatre, Cumulative GPA 3.21
Rosemont School of the Holy Child
Teva Pharmaceuticals October 2014 - Present
Red Onion Saloon and Brothel Museum April 2012 - September 2014
Octagon Research Solutions October 2008 - December 2011
Octagon Research Solutions August 2007 - October 2008
Wegmans Food Markets October 2005 - August 2007
Southwind Stables January 2005 - June 2005
Skills
Word, Microsoft Office, Publishing, eCTD, Data Analysis, Document Management, Coordination, Excel, PowerPoint, Outlook, Adobe Acrobat, Customer Relations, Application Lifecycle..., Public Speaking, Research
Education
Binghamton University 2003 — 2007
BA, Anthropology
State University of NY at Binghamton 2003 — 2007
BA, Anthropology
Eli Lilly and Company November 2013 - Present
Quintiles October 2012 - November 2013
Octagon Research Solutions March 2012 - October 2012
Endo Pharmaceuticals April 2011 - December 2011
AstraZeneca R&D November 2005 - April 2011
AstraZeneca June 2001 - November 2005
Kforce, Inc. November 1999 - June 2001
ICON plc March 1998 - November 1999
Cylinics, Inc. February 1996 - March 1998
Sun Biomedical Laboratories October 1994 - February 1996
Skills
Drive development of..., Clinical Trials, Data Management, Clinical Data Management, CRO, CTMS, Clinical Development, Oncology, Sop, Pharmaceutical Industry, FDA, Protocol, Clinical Research, Therapeutic Areas, 21 CFR Part 11, Software Documentation, Drug Development, Cross-functional Team...
Education
University of Phoenix 2006 — 2008
MBA, Business Administration
Rowan University 1992 — 1994
BS, Biology
Rowan College at Burlington County 1990 — 1992
AA, Health/Physical Education
inVentiv Health Clinical April 2015 - Present
Octagon Research Solutions May 2012 - Present
Accelerated R&D - Accenture Life Sciences October 2012 - April 2015
eClinical Solutions, a division of Eliassen Group January 2011 - May 2012
eClinical Solutions, a division of Eliassen Group March 2010 - February 2011
TAKE Enterprise Services, Inc. March 2007 - March 2010
TAKE Enterprise Services, Inc. October 2006 - March 2007
Karmanos Cancer Institute January 2003 - September 2006
Skills
Clinical Trials, EDC, Clinical Data Management, CRO, Data Management, Biostatistics, Oracle Clinical, SAS, Oncology, Clinical Research, Biotechnology, SAS programming, CDISC, Pharmaceutical Industry, Lifesciences, Validation, FDA, 21 CFR Part 11, Data Analysis, Medical Devices
Education
Wayne State University 2001 — 2002
Master of Science
Bangalore University 1995 — 1999
Bachelors of Engineering
Synergetic SAS Consulting Inc. Senior SAS ProgrammerCytel Inc.
Symbiance Inc. (CRO) February 2011 - December 2011
ICON plc February 2009 - December 2010
Johnson & Johnson May 2008 - February 2009
ClinPro Inc. January 2007 - May 2008
Bristol-Myers Squibb February 2006 - December 2006
Octagon Research Solutions January 2004 - February 2006
Merck August 2002 - September 2003
Purdue Pharma July 2001 - July 2002
Education
Mississippi State University 1990 — 1995
ePharmaSolutions November 2014 - Present
Collaborative Consulting October 2013 - October 2014
Accenture November 2009 - October 2013
Octagon Research Solutions November 2009 - October 2012
HealthStream, Inc. May 2003 - November 2009
Salu, Inc. 2000 - 2003
Sanofi Pharmaceuticals 1997 - 2000
Scott Specialty Gases 1995 - 1997
Skills
Account Management, Salesforce.com, New Business Development, Sales, Business Development, Sales Process, Strategic Planning, Cross-functional Team..., Marketing Strategy, Solution Selling, Sales Management, Sales Operations, Leadership, Outsourcing, Program Management, Consulting
Education
St. Joseph's University 1997 — 1999
MBA, Business, Marketing
West Virginia University 1990 — 1994
BS, Business Administration, Marketing
Paragon Solutions May 2013 - Present
LiquidHub August 2012 - May 2013
Springhouse Education and Consulting Services April 2012 - July 2012
Octagon Research Solutions September 2011 - April 2012
ePharmaSolutions September 2010 - August 2011
Accenture April 2008 - September 2010
Classified Ventures March 2007 - April 2008
GSK September 2006 - February 2007
Merck June 2000 - September 2006
Skills
Process Improvement, MS Project, Documentum, EDC, Documentation, Software Documentation, SharePoint, Project Management..., Project Management, Pharmaceutical Industry, Program Management, Cross-functional Team..., Business Intelligence, PMO, Business Process, Strategy, Enterprise Software, Management Consulting, Leadership, Resource Management, Microsoft Project
Education
Microsoft 2011 — 2011
MCTS, Managing Projects with MS Project Server 2007/2010
Microsoft 2011 — 2011
MCTS, Managing Projects with MS Project 2007/2010
Project Management Institue 2010 — 2010
PMP, Project Management
Temple University 2000 — 2002
Masters, Education
Rowan University 1995 — 1999
Bachelor of Arts, Mathematics, Minor in Physics
Teva Pharmaceuticals October 2012 - Present
Octagon Research Solutions September 2008 - October 2012
State Farm July 2007 - September 2008
Diesel June 2005 - July 2007
Skills
Pharmaceutical Industry, Sales Operations, FDA, Cross-functional Team..., Medical Devices, SOP, Clinical Trials, GMP, 21 CFR Part 11, Validation, Regulatory Requirements
Education
Chestnut Hill College
Bachelor's Degree, Business Management, Marketing
Accenture June 2014 - Present
Accenture May 2013 - May 2014
Octagon Research Solutions March 2012 - May 2013
Octagon Research Solutions May 2011 - March 2012
Nutrisystem April 2010 - February 2011
Merck April 2009 - December 2009
Hansen Properties May 2008 - April 2009
La Salle College High School 2003 - 2007
Skills
Metadata Registry, SharePoint, Business Analysis, Data Analysis, Customer Service, Visio, Sales Demonstrations, Sales, Microsoft Office, Template, eCTD, Outlook, Solution Implementation, Windows 7, ISI Writer, StartingPoint Software, StartingPoint Webinars, StartingPoint Technical..., StartingPoint..., StartingPoint Product..., Accenture Quantum -..., Microsoft Server..., Accenture Quantum Admin..., eCTD Document..., OQ Script Testing, Adobe PDF, Camtasa Studio, Axosoft OnTime, Viewpoint, FirstDoc, EndNote, Reference Manager, NI LabVIEW, Windows 8, eCTD Document Quality..., Microsoft Visio, Microsoft Project
Education
La Salle University
Bachelor of Science (B.S.), Integrated Science, Business, and Technology
Chiltern September 2015 - Present
Theorem Clinical Research June 2014 - September 2015
Accenture April 2014 - June 2014
Accenture November 2012 - April 2014
Octagon Research Solutions November 2008 - November 2012
Octagon Research Solutions September 2004 - November 2008
Skills
Business Analysis, Process Improvement, Project Management, Requirements Analysis, SDLC, Data Management, Change Management, Outsourcing, Vendor Management, Data Analysis, Program Management, Business Process..., Quality Assurance, Clinical Data Management, FDA, Lifesciences, Pharmaceutical Industry, Protocol, CDISC, eCTD, Biopharmaceuticals, 21 CFR Part 11, Cross-functional Team..., Management, Visio, CRO, Resource Management, SDTM, Clinical Trials, Regulatory Submissions, Integration, MS Project, Analysis, SharePoint, Clinical Development, ICH-GCP, Databases, Analytics, Clinical Research, Regulatory Requirements, Six Sigma, Oracle, Drug Development, Business Process, Business Intelligence, PMP, Data Quality, Life Sciences
Education
Villanova University
Master of Business Administration (M.B.A.)
The George Washington University 2010 — 2013
Master of Science (M.S.), Clinical Research Administration, 3.50
Walden University 2006 — 2009
Bachelor of Science (B.S.), Business Administration and Management, General, 3.89
Rutgers, The State University of New Jersey-Camden 2003 — 2005
Bachelor of Science (B.S.) [Incomplete-Degree Change], Computer Science
Platt College-San Diego 1999 — 2001
Associate of Science (A.S.), Web/Multimedia Management and Webmaster
AmerisourceBergen July 2014 - Present
Accenture (formally Octagon Research Solutions) April 2013 - June 2014
NextDocs September 2011 - March 2013
Octagon Research Solutions August 2006 - August 2011
Glemser Technologies August 1998 - September 2004
Skills
Computer System..., eCTD, 21 CFR Part 11, GxP, Change Control, Software Documentation, Document Management, Requirements Gathering, Validation, FDA, Project Management, Sop, Documentum, Regulatory Submissions, Regulatory Requirements, Quality Assurance, SOP, Pharmaceutical Industry
Education
Lehigh University
Lehigh University
Coupons Inc. November 2010 - February 2015
Microsoft November 2009 - November 2010
SAGE August 2009 - October 2009
Octagon Research Solutions February 2009 - May 2009
APX 2008 - 2009
Real Capital Analytics 2007 - 2008
Skills
SSRS, Microsoft SQL Server, Data Warehousing, ETL, Data Integration, SQL, SDLC, Microstrategy, Big Data, Microsoft BI SSIS, Report Development, MySQL, Linux, Netezza, Datastage, SSAS 2008, Bash, Data Feeds, Shell Scripting, JIRA, Mercurial, Hive, Cassandra, T-SQL Stored Procedures, Data Modeling, Data Migration, Databases, Database Administration, Database Design, Stored Procedures, Python, Git, Amazon S3, Google Bigquery, Google Cloud Storage
Education
Sonoma State University
BS, Computer Science
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
Sonepar USA November 2014 - Present
Accenture September 2012 - November 2014
Octagon Research Solutions March 2011 - September 2012
Octagon Research Solutions September 2009 - July 2011
Fiberlink June 2005 - September 2009
Skills
Forecasting, Financial Reporting, Financial Analysis, Data Analysis, Process Improvement, Microsoft Excel, Finance, Budgets, Microsoft Office, Due Diligence, Business Analysis, Software Documentation, Accounting, Financial Modeling, Auditing, Financial Accounting, Management, Corporate Finance
Education
Penn State University 2012 — 2014
Master of Business Administration (MBA)
Penn State University 2001 — 2005
Bachelor of Science, Accounting and Finance
Almac Group February 2013 - Present
Floating Fish Studios II January 1990 - Present
Datafarm Inc 2008 - 2010
Floating Fish Studios 1990 - 2009
Octagon Research Solutions 2002 - 2007
University of Pennsylvania Health System Division of Community Radiology January 1999 - December 2001
Donnelly Directory 1989 - 1991
Skills
Leadership, Management, Networking, SharePoint, Advertising, Editing, Databases, Regulatory Submissions, SQL, Quality Assurance, FDA, Regulatory Affairs, Troubleshooting, Testing, Pharmaceutical Industry, Training
Education
Shippensburg University of Pennsylvania 1984 — 1988
B.A., Communications, Radio/TV/Film, Speech Minor
RJT Compuquest May 2011 - November 2012
Octagon Research Solutions July 2010 - April 2011
Octagon Research Solutions 2010 - April 2011
Sparta Systems, Inc. 2009 - August 2010
Open Text November 2006 - January 2009
OpenText 2008 - 2009
BearingPoint December 2003 - December 2006
Oracle/Siebel 1998 - 2003
Dynamic Interactive Business Systems Inc. 1982 - 1989
Dynamic Interactive Business Systems Inc. 1982 - 1989
Skills
ERP, Archives, Enterprise Software, Document Management, Professional Services, Enterprise Content..., Cloud Computing, Business Development, Business Intelligence, CRM, Business Analysis, New Business Development, Cross-functional Team..., Management, Program Management, Start-ups, Process Improvement, IT Strategy, Product Management, Project Management, Sales Operations, Vendor Management, Business Strategy, Strategic Partnerships, Change Management, Sales, Business Process, Pharmaceutical Industry, Consulting, Integration, Selling, Enterprise Architecture
Education
Northern Arizona University-The W. A. Franke College of Business 1980 — 1984
BS
SAS Institute Inc. February 2011 - Present
CDISC June 2008 - Present
lexjansen.com July 2003 - Present
Octagon Research Solutions June 2008 - February 2011
Take Solutions Inc. July 2007 - June 2008
Organon USA Inc. April 2004 - July 2007
NV Organon January 1992 - March 2004
Statistics Netherlands (CBS) September 1990 - December 1991
Skills
SAS, CDISC, CDISC Define-XML, CDISC-ODM, XML, Data Standards, Web Development, Software Development, Pharmaceuticals, SAS/SQL, XML Tools, Pharmaceutical Industry, SAS programming, Programming, SDTM, Biostatistics, Clinical Trials, SAS Programming, Clinical Research
Education
Eindhoven University of Technology 1980 — 1988
MS, Mathematics
Van der Puttlyceum, Eindhoven 1974 — 1980
VWO (Atheneum)
Navigate Corporation March 2014 - Present
Arcane Supply Company February 2014 - Present
IBEC Ventures May 2013 - May 2014
Accenture December 2011 - February 2014
Octagon Research Solutions November 2010 - December 2011
Bankhaus Gutmann May 2008 - August 2008
Skills
Microsoft Excel, Leadership, Strategy, SAP, Public Speaking, Financial Analysis, PowerPoint, Microsoft Office, Management, Team Leadership, Project Management, CRM, Regulatory Affairs, Finance, German, SPL, Citrix, Marketing Strategy, Photoshop, Changepoint, Cognos ReportNet, Analysis, Microsoft Dynamics SL, Viewpoint, Oxygen XML Editor, Lightroom, Streamlining Complex..., Business Process..., Process Implementation, SAP Financial, Brand Management, ISI Toolbox, Microsoft Dynamics, HTML, Data Analysis, Change Management, Project Finance, Visio, Microsoft Word, Social Media
Education
Grove City College 2005 — 2009
BS, International Business, International Marketing, German
Calvary Christian Academy 1998 — 2005
UGI Corporation September 2015 - Present
CSL Behring March 2013 - May 2015
CSL Behring January 2013 - March 2013
Octagon Research Solutions June 2012 - September 2012
Venio, LLC D/B/A Keane March 2010 - February 2012
Tunnell Consulting, Inc. March 2003 - June 2009
Skills
HRIS, Applicant Tracking..., Training, Leadership, Management, Microsoft Excel, Benefits Administration, Onboarding, Recruiting, Human Resources, PowerPoint, Employee Benefits, Business Process Mapping, Employee Training, Employee Recognition, Talent Acquisition, Deferred Compensation, Sourcing, HR Policies, Microsoft Word, SAP, Benchmarking, Compensation, HR Project Management, Notary Public, Performance Management, Employee Surveys, Event Planning, Microsoft Outlook 2010, Salesforce Administrator, Microsoft Office 2007, Microsoft Excel 2010, Microsoft PowerPoint..., Smart Draw, Payroll Processing, Marketing Communications, Email Marketing, Office Relocation, Relocations, Proposal Writing, FMLA, ADP Payroll, Ad-Hoc Reporting, Paychex, Employee Handbooks, Employee Wellness, Purchase Orders, Project Management, Software Documentation, Employee Relations
Education
Albright College 2013 — 2015
Bachelor of Science (BS), Business Administration and Management, 3.5
Montgomery County Community College 2009 — 2012
Associate of Science (AS), Business Administration, 3.5
Immaculata University 2008 — 2009
B.A., Human Performance Management/Organizational Dynamics, Human Resources, 3.8
Accenture March 2013 - Present
Accenture October 2012 - March 2013
Octagon Research Solutions August 2011 - October 2012
Moriarty Environmental Solutions, Inc July 2011 - August 2011
DMH Diving February 2011 - June 2011
USM, Inc. September 2009 - August 2010
USM, Inc September 2009 - September 2009
Marine Mammal Stranding Center October 2008 - March 2009
Fox News Channel 8 January 2008 - April 2008
High Point University August 2007 - April 2008
Skills
PowerPoint, Customer Service, Microsoft Office, Microsoft Excel, Fundraising, Nonprofits, Research, Sales, Editing, Photoshop, Data Entry, Visio, Newsletters, Microsoft Word, Outlook, Leadership, Time Management, Interviews, Project Management, Strategic Planning, Teamwork, Social Media, Budgets, Event Planning
Education
High Point University 2004 — 2008
BA, Communications (Broadcasting & Media Studies)
Philadelphia Montgomery Christian Academy 2000 — 2004
Therakos, Inc. July 2014 - Present
Performance Development Group March 2014 - April 2014
Proconex May 2013 - March 2014
GlaxoSmithKline January 2011 - April 2013
Almac Group November 2010 - December 2010
Octagon Research Solutions July 2007 - October 2008
ACE Group June 2004 - July 2007
Aventis Behring January 2002 - June 2004
Skills
Microsoft Excel, Outlook, Customer Service, Software Documentation, Microsoft Word, Microsoft Office 2010, Microsoft Power Point, Administrator of the..., Administrator of the..., Certified Training..., Access for PeopleSoft, Lotus Notes customized..., SharePoint Internet..., Siebel, Adobe Acrobat 8..., Management, Time Management, Training, Project Planning, Adobe Acrobat, Project Management, Team Building, PowerPoint, FLEx, NOMIS, Metastorm BPM (Phoenix), Alliance, Microsoft Office, Office 2010, Flex, Analysis, GMP, Budgets, Validation, Leadership
Education
Villanova University 2014 — 2015
Certified Associate Project Manager, Project Management
Immaculata University 2003 — 2005
BA, Magna Cum Laude, Human Performance Management
The Chubb Institute 1998 — 1999
Data & Networking Certification
Main Line Paralegal 1996 — 1996
Paralegal Certificaiton, Legal Education
ArisGlobal August 2015 - Present
Oracle January 2013 - July 2015
CSC February 2012 - January 2013
Octagon Research Solutions August 2008 - August 2011
Elsevier January 2005 - August 2008
Wolters Kluwer August 1999 - December 2004
Allscrips Pharmaceuticals April 1994 - August 1999
Dictaphone February 1992 - March 1994
Skills
Consultative Selling, Sales Driven, Multitasker, Large and Complex Sales..., Professional Services, Complex Sales, Selling, Pharmaceutical Industry, Sales, Lifesciences, Account Management, Biotechnology, Business Development, Clinical Trials, Cross-functional Team..., Life Sciences, Enterprise Software, Management, Marketing, New Business Development, Product Development, Sales Operations, Strategic Planning, Strategy
Education
Fairmont State University 1986 — 1991
BS, I/O Psych
Eliassen Group December 2012 - Present
eClinical Solutions, a division of Eliassen Group/Terra Infotech 2006 - January 2013
Octagon Research Solutions August 2006 - October 2006
Education
HPS
HPS
New Jersey Institute of Technology
MS, Computer Science
Public Defender Service for the District of Columbia September 2015 - Present
Community Legal Services June 2015 - August 2015
Penn State University November 2013 - December 2013
Pennsylvania Democratic Party July 2013 - August 2013
Penn State University January 2013 - May 2013
Obama for America August 2012 - November 2012
Octagon Research Solutions May 2011 - August 2011
Skills
Direct Examination, Client Interviewing, Legal Research, Legal Writing, Westlaw, Legal Server, SSI Law, Federal Regulations, Client Contact, Politics, Research, Public Benefits, Community Outreach, Political Campaigns, Political Science, Nonprofits, Volunteer Management, Databases, Public Speaking, Editing, History, Letter Writing, Microsoft Office, Data Entry, Clinical Trials, Voter Activation..., Voter Contact, Voter Registration, GOTV, Opposition Research, Writing, Event Planning, Microsoft Word, Leadership, Community Organizing
Education
Georgetown University Law Center 2014 — 2017
Doctor of Law (J.D.)
Pennsylvania State University, University Park 2010 — 2013
B.A. with high distinction, 3.95 GPA, Political Science, History
Radnor High School 2006 — 2010
The World Bank February 2014 - Present
Saha Global March 2013 - July 2013
Inter-American Defense Foundation May 2012 - May 2013
Georgetown University June 2012 - September 2012
Octagon Research Solutions June 2011 - September 2012
NBC News January 2012 - May 2012
Skills
International Relations, Research, PowerPoint, Microsoft Office, International..., Social Media, Political Science, Public Speaking, Spanish, Microsoft Excel, International..., Foreign Policy, Teamwork, Microsoft Word, Policy Analysis, Project Management, Social Networking, Nonprofits, Community Outreach, Qualitative Research, Spanish fluency:..., Strategic Planning, International Security, Journalism, Latin American Studies, Fundraising, Public Policy, Politics, Business Analysis, Stata, Brazilian Portuguese, Mobile Applications, Customer Relationship..., Industry Research, Market Research, Web Applications
Education
The George Washington University - School of Business 2015 — 2015
Associate's Certificate in Business Analysis
Georgetown University 2009 — 2013
Edmund A. Walsh School of Foreign Service, Bachelor of Science in Foreign Service (BSFS), International Politics
University of Buenos Aires 2011 — 2011
Facultad de Ciencias Sociales, International Politics
PAREXEL December 2013 - Present
ReSearch Pharmaceutical Services May 2008 - November 2013
Octagon Research Solutions June 2004 - May 2008
Skills
Fundraising, Non-profits, Social Media, Public Speaking, Regulatory Submissions, eCTD, Regulatory Affairs, GCP, FDA, Weddings, Ceremonies, Event Planning, Grand Openings, Emcee, Special Event, Public Relations, Receptions, Dinners, Baby Showers, Holidays, Award Ceremonies, Celebrations, Meeting Planning, Social Media Marketing, Event Management, Birthdays, Customer Service, Event Producing, Nonprofits, Coordinating Special..., Clinical Trials, Corporate Events, Venue Relations, Wedding Management, Wedding Planning, Private Events, Bar/Bat Mitzvahs, Floral Design, Catering, Clinical Research
Education
Bryn Mawr College 2000 — 2004
Bachelor of Arts (B.A.), Religion
Bryn Mawr College 2000 — 2004
Bachelor of Arts (B.A.), Religion/Religious Studies
inVentiv Health August 2014 - Present
PAREXEL June 2012 - August 2014
Octagon Research Solutions April 2007 - June 2012
Skills
CDISC, Clinical Data Management, Oracle Clinical, SAS programming, SAS, ADAM, Statistical Programming, SDTM, 12 Oncology, Biostatistics, Clinical Trials, CRO, EDC, SAS Programming
Education
Osmania University
Doctor of Philosophy (PhD), Biology
PA Democratic State Committee May 2014 - Present
MontCo Democratic Women's Leadership Initiative January 2012 - Present
Habitat for Humanity of Montgomery County, PA 2008 - Present
Upper Dublin Democratic Committee 2007 - Present
PharmaSUG 1998 - Present
Philadelphia University 1997 - Present
National Voluntary Organizations Active in Disaster November 2011 - June 2012
Octagon Research Solutions November 2008 - June 2010
PharmaSUG 2009 - 2009
Wyeth Pharmaceuticals 2005 - 2007
Skills
Leadership Development, Pharmaceutical Industry, Clinical Research, Oncology, Clinical Trials, SAS, Statistics, Data Management, Biotechnology, Data Analysis, Clinical Development, FDA
Education
Bryn Mawr College 1969 — 1973
BA, Sociology
Haverford College 1967 — 1975
Accenture October 2012 - Present
Octagon Research Solutions May 2012 - October 2012
MFS Investment Management July 2011 - December 2011
Simon Property Group - South Shore Plaza July 2010 - December 2010
Shoebuy.com July 2009 - December 2009
Skills
Microsoft Office, Microsoft Excel, Customer Service, Marketing, Taleo, iCIMS, PowerPoint, Teamwork, Microsoft Word, Outlook, Interpersonal..., Organization &..., Oral & Written..., Analytical Skills, Social Media, SharePoint, Talent Acquisition, Interpersonal..., Leadership, Management, Recruiting, Temporary Placement, Onboarding, Communication, Interviews
Education
Northeastern University 2007 — 2012
Bachelor of Science Degree
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
GlobalSubmit August 2013 - December 2013
Cadence Pharmaceuticals January 2012 - May 2012
Ambit Biosciences August 2010 - January 2011
Consultant: Arena Pharmaceuticals August 2009 - December 2009
Cadence Pharmaceuticals November 2008 - May 2009
Sirion Therapeutics September 2007 - November 2008
Wyeth March 2005 - March 2007
Octagon Research Solutions October 2003 - March 2005
Skills
FDA, Pharmaceutical Industry, Regulations, Regulatory Affairs, NDA, IND, Regulatory Submissions, Regulatory Operations
Education
State University of New York College at Buffalo
Octagon Research Solutions July 2007 - Present
Accenture March 2007 - Present
Octagon Research Solutions March 2007 - Present
Octagon Research Solutions March 2007 - April 2014
Tyler Persona Associates July 2001 - January 2007
Tyler Personal Associates July 2001 - January 2007
Tyler Company 2001 - 2007
Conestoga Masonry January 1988 - January 2001
Conestoga Masonry January 1988 - January 2001
Skills
Pharmaceutical Industry, eCTD, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Clinical Development, Human Resources, Management, Business Development, Salesforce.com, Training, Sales, Healthcare, Interviews
Education
Immaculata College
PRA Health Sciences July 2014 - Present
Oracle HealthSciences (Acquired ClearTrial) July 2012 - June 2014
ClearTrial LLC July 2010 - July 2012
Octagon Research Solutions 2007 - July 2010
ICON Clinical Research September 2005 - February 2007
Curtis Winery January 2005 - August 2005
US Air Force May 2000 - July 2004
Skills
Clinical Trials, Pharmaceutical Industry, Knowledge Management, Biotechnology, Clinical Research, Sales, Contract Management, Proposal Writing, Personality, EDC, Cross-functional Team..., Regulatory Affairs, SaaS, CTMS, Clinical Data Management, Data Management, Account Management, Clinical Development, Lifesciences, CRO, Life Sciences
Education
Penn State University 1995 — 2000
Bachelors of Science, Bio-Behavioral Health
Octagon Research Solutions 2011 - Present
Greater Media May 2008 - 2011
Greater Media September 2007 - May 2008
WXAC 91.3 FM Albright College Radio September 2004 - May 2008
Greater Media May 2007 - September 2007
Skills
Photoshop, Radio, Broadcast
Education
Albright College 2004 — 2008
Bachelor of Science, Music Business, Business Administration and Communications
Denovonow June 2012 - Present
Oink March 2012 - Present
Maxwell Systems September 2006 - February 2014
Octagon Research Solutions September 2004 - September 2012
Energy Solutions International September 2006 - December 2011
InnaPhase Corporation January 2001 - May 2005
Skills
E-commerce, Business Strategy, Software Development, Entrepreneurship, Mergers & Acquisitions, Management Consulting, Mergers, Sales, Product Management, Management, Project Management, Business Process..., Strategy, Product Development, Start-ups, Investor Relations, SaaS, Venture Capital, Executive Management, Marketing, Strategic Partnerships, Social Media, Strategic Planning, Online Marketing, Team Building, Private Equity, Digital Marketing
Education
The Nottingham Trent University 1982 — 1988
Doctor of Philosophy (PhD), Quantum Physics
Nottingham Trent University 1982 — 1986
Bachelor of Science (BSc) First class with Honours, Applied Chemistry
Octagon Research Solutions March 2003 - Present
Taylor Gifts January 2002 - March 2003
Independent Consulting May 2001 - December 2001
MedImmune October 1999 - February 2001
US Bioscience June 1996 - October 1999
GI Communications October 1993 - May 1996
Education
Drexel University 1988 — 1993
Bachelors, Information Systems
•Delaware Valley CDISC Users Network (DV_CDISC_UN) 2005 - Present
PhilaSUG 1990 - Present
PharmaNet/i3 2011 - February 2014
NESUG 1992 - November 2013
Self employed April 2009 - September 2011
Octagon Research Solutions August 2007 - April 2009
AstraZeneca August 1997 - August 2007
AstraZeneca 1997 - 2007
Merck Research Labs 1995 - 1997
Scott Paper 1970 - 1983
Skills
IT Strategy, SAS, Validation, Unix, Testing, Data Quality, HTML, Data Cleaning, COBOL, Fortran, Data Integrity, SAS programming, Data Management, Clinical Trials, Data Analysis, Pharmaceutical Industry, Clinical Data Management, 21 CFR Part 11, Data Mining, EDC, Statistics, Business Intelligence, Data Warehousing, Clinical Research, CDISC, Oncology, Statistical Programming, SDLC, Analysis, Clinical Development, Databases, Data Validation, Analytics, SDTM, Statistical Modeling, Oracle Clinical, Regulatory Submissions, CTMS, FDA, GCP, Therapeutic Areas, ICH-GCP, Computer System..., SAS Programming, SAS Base
Education
Penn State University 1961 — 1965
Bachelor's degree, Business Administration and Management, General
Accenture October 2012 - Present
Octagon Research Solutions July 2011 - October 2012
Pfizer Pharmaceuticals March 2001 - March 2011
Skills
21 CFR Part 11, Pharmaceutical Industry, Validation, SDLC, FDA, Clinical Trials, Cross-functional Team..., Vendor Management, Software Documentation, Business Analysis, Biotechnology, Quality Assurance
Education
New Hampshire 1984 — 1986
MBA, Business Administration
Hartwick College 1969 — 1973
BA, Physics
MEDecision March 2009 - Present
Virrata Games August 2008 - March 2009
Dean Parker Solutions LLC August 2008 - March 2009
Ciber Inc. 2006 - 2008
Octagon Research Solutions 2003 - 2006
RewardsPlus of America October 2000 - November 2001
Cendant Mortgage October 1998 - October 2000
Alliance Consulting December 1997 - September 1998
ITS 1994 - 1997
Innovative Tech Systems 1994 - 1997
Education
Rensselaer Polytechnic Institute 1987 — 1989
Elsevier September 2008 - Present
Simax May 2000 - Present
Octagon Research Solutions December 2004 - September 2008
The Satori Group November 2003 - December 2004
First Consulting Group 1995 - 2003
ISCG 1995 - 2003
Integrated Systems Consulting Group (ISCG) 1995 - 2000
unisys 1993 - 1995
Positek September 1987 - May 1993
Skills
User Interface Design, User-centered Design, Usability, User Interface, Agile Methodologies, Usability Testing, Requirements Gathering, Business Analysis, Requirements Analysis, SDLC, Interaction Design, User Experience, Software Documentation, Information Architecture
Education
Penn State University 1973 — 1977
BS, Science
Penn Medicine (University of Pennsylvania Health System) October 2014 - Present
University of Pennsylvania October 2009 - August 2012
Octagon Research Solutions September 2008 - September 2009
Einstein Healthcare Network February 2007 - September 2009
University of Pennsylvania May 2005 - July 2008
Skills
Behavioral Health, Psychology, Public Health, Mental Health, Program Evaluation, Clinical Research, Innovation Consulting, Healthcare, Research, SPSS, Grant Writing, Data Analysis, Program Development, Community Outreach, Qualitative Research, Management, Clinical Trials, Social Media
Education
New York University 2012 — 2014
Master's Degree, Public Health
University of Pennsylvania 2006 — 2012
Post Baccalaureate Program
La Salle University 2006 — 2008
Post Baccalaureate Certificate, Pre-medical Program
Penn State University 2000 — 2004
Bachelor of Science (BS), Psychology
IBM August 2015 - Present
Zinc Ahead Ltd 2014 - 2015
NASDAQ OMX March 2012 - May 2014
Octagon Research Solutions January 2010 - March 2012
Anchor-Staffing 2009 - 2010
Kroenke Sports Enterprises September 2008 - December 2008
Tekmark Global Solutions June 2007 - August 2007
Skills
Marketing, Sales, New Business Development, Salesforce.com, Management, Account Management, Marketing Strategy, CRM, Social Media Marketing, Pharmaceutical Industry, Strategic Planning, Marketing Communications, Social Media
Education
University of Denver - Daniels College of Business
Marketing, Business
Dickinson College
The Pennington School
Nuix February 2015 - Present
Almac Group October 2013 - January 2015
Penn Mutual March 2011 - September 2013
Touchstone Wireless February 2010 - February 2011
Isolagen April 2008 - April 2009
ING Clarion Real Estate Securities 2007 - 2008
SunGard Availability Services 2005 - 2007
Octagon Research Solutions April 2004 - May 2005
Whitestone Associates, Inc. May 2003 - May 2004
Skills
Microsoft Excel, Outlook, Administrative..., PowerPoint, Process Scheduler, Microsoft Office
Education
Carnegie Mellon University 1998 — 2000
King's College 1993 — 1997
Pilgrim Quality Solutions January 2015 - Present
Accenture September 2012 - December 2014
Octagon Research Solutions January 2011 - August 2012
Octagon Research Solutions March 2009 - December 2010
PERFMAN April 2008 - March 2009
Fiberlink Communications Corporation December 1999 - March 2008
AT&T April 1996 - December 1999
Education
Gettysburg College 1986 — 1989
BA, Business/Management
Infotree Service March 2015 - Present
Bayshore Moving & Storage - Agent for Allied Van Lines July 2014 - December 2014
Sheraton Suites Wilmington January 2014 - June 2014
Reliant Renal Care, Inc. October 2012 - December 2013
QVC March 2011 - October 2012
Intracorp January 2010 - May 2010
Octagon Research Solutions November 2008 - April 2009
PointRoll, Inc. October 2006 - March 2008
Alliance Consulting October 2005 - August 2006
WE-enroll, Inc. January 2003 - October 2005
Skills
Human Resources, Employee Benefits, Employee Relations, Onboarding, Recruiting, HRIS, Training, Performance Management, Management, Benefits Administration, Applicant Tracking..., PeopleSoft, Personnel Management, Healthcare, HR Policies, Payroll, Talent Acquisition, Deferred Compensation, Process Improvement, FMLA, Strategic Planning, Leadership, Policy, Succession Planning, Employee Training, Talent Management, Change Management, Team Building, Customer Service, Leadership Development, Labor Relations, Software Documentation, Organizational..., Employee Engagement, Workforce Planning, Hiring, Vendor Management, Project Management, Team Leadership, Coaching, Microsoft Excel, Account Management, Budgets, Internet Recruiting, Sourcing, Interviews, Microsoft Office, Staff Development, Staffing Services, Radford Surveys
Education
Neumann University 2009 — 2009
BS, Liberal Arts
Del. County Community College 1987 — 1990
Associates, Behavioral Science
University of Dayton 1985 — 1987
Psychology
Portola Pharmaceuticals February 2015 - Present
Roche Molecular Systems January 2011 - February 2015
Clinovo August 2009 - January 2011
Octagon Research Solutions July 2008 - August 2009
Medtronic August 2006 - July 2008
Kaiser Permanente July 2005 - August 2006
Boston Scientific March 2002 - February 2004
Northern California Cancer Center March 2000 - March 2002
Skills
Medical Devices, SPSS, Clinical Research, GCP, FDA, Clinical Data Management, Protocol, Clinical Trials, Validation, CRO, EDC, Clinical Development, SAS, CTMS, Data Management, CDISC, CRF design, Sop, Clinical Study Design, Oncology
Education
Saint Mary's College of California
Master of Business Administration (MBA)
California State University-Hayward
Bachelor of Science (BS)
IMS Health June 2007 - Present
Octagon Research Solutions 2006 - 2007
GlaxoSmithKline June 2001 - March 2005
glaxosmithkline 2001 - 2005
SmithKline Beecham October 1999 - May 2001
First Consulting Group (FCG) 1994 - 1998
Prudential Insurance 1988 - 1994
Education
Philadelphia University 1984 — 1988
Bachelor of Science (B.Sc.), Computer Science
Biogen Idec December 2013 - Present
Vertex Pharmaceuticals June 2011 - November 2013
Octagon Research Solutions 2007 - 2011
Education
University of Kentucky 2004 — 2006
MS, Biomedical Engineering
Madurai Kamaraj University 1998 — 2002
BS, Electronics and Communication Engineering
Author September 2013 - Present
Octagon Research Solutions December 2007 - September 2013
Octagon Research Solutions March 2004 - 2007
Catholic Health Initiatives June 2001 - February 2004
Smiths Industries Aerospace May 1997 - June 2001
Smiths Industries Aerospace October 1991 - April 1997
Skills
Program Management, Quality Assurance, Management, Regulatory Submissions, Project Management, HRIS, ADP HRB, HR Project Management, Human Resources, Benefits Administration, Strategy, Recruiting, Training, Team Building, Employee Benefits, Change Management, Adobe Acrobat, PMP, Pharmaceutical Industry, Process Improvement, Medical Devices, Cross-functional Team..., Publishing, Applicant Tracking..., Vendor Management, Leadership Development, Strategic Planning, Testing, Books, Performance Management, Employee Relations, Clinical Research, Business Process..., FDA, Talent Acquisition, Leadership
Education
Pennsylvania State University-Great Valley Graduate Center 1994 — 1999
MS, Software Engineering
Brown University
Bachelor of Arts (B.A.), Economics
Drexel University
MBA, Business
Christian Brothers University July 2015 - Present
Christian Brothers University August 2011 - Present
Smith Hanley Consulting Group February 2011 - June 2011
JRF America September 2010 - January 2011
LaSalle College High School September 2009 - August 2010
Octagon Research Solutions November 2008 - November 2009
University of South Carolina November 2004 - July 2008
Skills
Spectroscopy, UV/Vis, Mass Spectrometry, Chemistry, Chemometrics, Classroom Instruction, Analytical Chemistry, IR spectroscopy, Chromatography
Education
University of South Carolina-Columbia 2004 — 2008
Ph.D, Analytical Chemistry
Muhlenberg College 2000 — 2004
B.S, Chemistry
PAREXEL September 2012 - Present
United BioSource Corporation July 2011 - September 2012
United BioSource Corporation July 2009 - July 2011
Draeger Medical September 2008 - May 2009
Octagon Research Solutions April 2007 - September 2008
DynPort Vaccine Company LLC (DVC) 2001 - 2007
MedImmune September 1997 - January 2001
North American Vaccine 1997 - 1997
University of Virginia 1993 - 1997
Skills
FDA, Validation, Biotechnology, Cross-functional Team..., Program Management, Pharmaceutical Industry, Change Control, Medical Devices, SDLC, PMP, Project Management, Quality Assurance, Clinical Trials, Sop, Process Improvement, Product Development, Leadership, Product Management, Regulatory Affairs, CRO
Education
Frostburg State University 1999 — 2001
MBA, Management
Mansfield University of Pennsylvania 1992 — 1996
BS, Biology
Gateway Ticketing Systems August 2008 - Present
Steel River Playhouse 2008 - 2014
Steel River Playhouse 2008 - 2014
Adagio Technology Associates July 2005 - August 2008
Octagon Research Solutions July 2004 - July 2005
Catholic Health Initiatives 1995 - 2004
Skills
Project Management, Resource Management, CRM, Business Process..., Strategic Planning, Management, Leadership, Software Development, Team Leadership, SaaS, Product Development, Operations Management, IT Strategy, Customer Service, Business Analysis
Education
Shenandoah University 1985 — 1988
Accenture, formally Octagon Research Solutions November 2010 - Present
Octagon Research Solutions May 2010 - November 2010
Octagon Research Solutions January 2009 - May 2010
Octagon Research Solutions March 2007 - January 2009
Octagon Research Solutions August 2005 - March 2007
Musco Family Olive Co June 2004 - August 2004
Skills
Windows, Microsoft Office, eCTD, Business Process Design, Quantum, Submission Management, Document Management, Microsoft Project, Adobe Acrobat, Axosoft OnTime, Food Preparation, Kitchen Management, Menu Design, Business Analysis, Project Planning, Requirements Gathering, Problem Solving, Software Documentation, MS Project, Cross-functional Team..., FDA, OnTime, Process Improvement, Quality Assurance, Regulatory Submissions, Requirements Analysis, Visio
Education
La Salle University 2001 — 2005
BS, Biotechnology, Energy and Natural Resource Management, Information Knowledge Management
Villanova University 2012 — 2013
Master Certificate in Business Analysis, Business Analysis, Business Intelligence
PRA International October 2010 - Present
Omnicare Clinical Research June 2009 - September 2010
Triple screen June 2009 - November 2009
Octagon Research Solutions October 2005 - June 2009
Comsys worked for client Pfizer(Mapping Project) May 2005 - October 2005
SBC Communications October 2004 - April 2005
Skills
SAS, CDISC, Clinical Data Management, Clinical Trials, Statistical Programming, 21 CFR Part 11
Education
Osmania University 1997 — 2002
Osmania University
MS, Computer Science
Osmania University
BS, Computer Science & Statistics
Accenture October 2012 - Present
Octagon Research Solutions July 2008 - September 2012
Octagon Research Solutions March 2008 - June 2008
Independent Consulting January 2008 - March 2008
Shire Pharmaceuticals July 2005 - November 2007
GlaxoSmithKline March 1998 - June 2005
First USA October 1994 - April 1998
DuPont June 1991 - October 1994
Skills
CDISC, Statistical Programming, Clinical Data Management, Data Management, SAS, Programming, Validation, Medidata, Regulatory Submissions, Pharmaceutical Industry
Education
West Chester University of Pennsylvania 1990 — 1991
M.S., Computer Science
Bucknell University 1985 — 1989
B.S., Computer Science
Choate Rosemary Hall 1981 — 1985
Karra Consulting, LLC December 2014 - Present
Novartis Pharmaceuticals January 2013 - December 2014
Amgen Pharmaceuticals March 2012 - November 2013
Novartis Pharmaceuticals January 2010 - February 2012
Take Solutions October 2008 - January 2010
Octagon Research Solutions January 2006 - October 2008
Kalsh Consulting July 2004 - December 2005
Skills
SAS, CDISC, Pharmaceutical Industry, Clinical Trials, SAS Programming, CRO, SQL, GCP, Oncology, Data Management
Education
University of Idaho 2002 — 2004
MS, Bioinformatics and Computational Biology
Jawaharlal Nehru Technological University 1998 — 2002
BE, Computer Science
Threshold Pharmaceuticals October 2014 - Present
PAREXEL May 2012 - October 2014
AstraZeneca Pharmaceuticals November 2009 - May 2012
AstraZeneca June 2008 - November 2009
Omnicare January 2008 - June 2008
Octagon Research Solutions March 2007 - January 2008
AstraZeneca November 2005 - March 2007
AstraZeneca November 2000 - May 2005
Skills
GCP, Oncology, CTMS, FDA, SOP, Electronic Data..., Clinical Data Management, Clinical Monitoring, Oncology Clinical..., Cross-functional Team..., Pharmaceutical Industry, Clinical Research, Clinical Trials, Sop, Therapeutic Areas, CRO, Lifesciences, Inform, Drug Development, Regulatory Submissions, Regulatory Requirements, IND, Phase I, ICH-GCP, Protocol, Biotechnology, IRB, EDC, Clinical Operations, Data Management, Clinical Development, 21 CFR Part 11, Clinical Study Design, Validation, CRF design, Infectious Diseases, Life Sciences
Education
Cedarville University 1989 — 1993
BA Liberal Arts, Majoring in Social Work
Bryan College
Accenture August 2012 - Present
PhUSE 2012 - 2015
Octagon Research Solutions March 2006 - August 2012
Premier Research Group February 2004 - March 2006
Scp communications July 2000 - January 2004
American Tower April 2000 - July 2000
eResearch Technology June 1998 - April 2000
County of Chester December 1995 - June 1998
First Data Corporation October 1994 - December 1995
Skills
Database Administration, Unix Administration, Perl, SAS, PL/SQL, CDISC, XML, Linux, HTML, JavaScript, AIX, CSS, XSL, Ksh, eCTD, Unix, MDR, Life Science Industry, SDLC, SDTM, Microsoft SQL Server, Data Warehousing, Clinical Trials, Data Modeling, Solaris, Integration, Data Management, Testing, IBM AIX
Education
The Ohio State University 1991 — 1994
MCRP
Central China Normal University 1984 — 1986
Master's Degree
Hubei University 1978 — 1982
Bachelor's Degree
Accenture October 2012 - Present
Octagon Research Solutions October 2010 - September 2012
PharmaNet Development Group, Inc. November 2002 - August 2010
Sanofi-Synthelabo April 2000 - June 2002
SmithKline Beecham March 1999 - April 2000
Rhone-Poulenc Rorer September 1996 - February 1999
Merck July 1995 - September 1996
Boehringer Ingelheim Pharmaceuticals November 1993 - July 1995
Skills
SAS, SAS programming, CDISC, Statistical Programming, Clinical Research, Programming, Clinical Trials, CRO, Data Management, Clinical Data Management, Validation, Data Analysis, Biostatistics, Clinical Development, Statistics, Pharmaceutical Industry, 21 CFR Part 11, Operational Excellence
Education
Southern Connecticut State University 1990 — 1993
BS, Computer Science
Octagon Research Solutions March 2011 - Present
Johnson & Johnson April 2009 - July 2010
Teva Neuroscience 2001 - 2007
Teva Pharmaceuticals March 1998 - March 2001
Skills
Integration, Software Documentation, Visio, Business Analysis, Process Improvement, SQL, SDLC, Requirements Analysis, Data Warehousing, Quality Assurance, Requirements Gathering, Business Intelligence, SharePoint, Databases, Software Project..., Vendor Management, Oracle, Visual Basic, MS Project, IT Management, Testing, Disaster Recovery, Microsoft SQL Server, 21 CFR Part 11, Access
Education
DeSales University
ATS October 2012 - Present
Department of Navy Contractor April 2009 - September 2012
Octagon Research Solutions June 2008 - February 2009
United BioSource Corporation April 2007 - January 2008
Skills
Program Management, Management, Proposal Writing, Analysis, Government, Strategic Planning, Software Documentation, Leadership, Process Improvement, Requirements Analysis
Education
Pennsylvania State University-Great Valley Graduate Center 2006 — 2008
Master of Business Administration (MBA), Health Care Management
Beyond.com August 2011 - Present
Beyond.com December 2005 - August 2011
Octagon Research Solutions March 2005 - December 2005
Skills
Salesforce.com, Lead Generation, Email Marketing, SEM, Online Advertising, Digital Marketing, Social Media Marketing, Digital Media, Event Planning, Account Management, Pricing Analysis, Implementation Plans, Product Management, Product Marketing, Sales Operations, Marketing, Analytics, Direct Marketing, Mobile Marketing, Online Marketing, Marketing Strategy, Business Development, Cold Calling, Sales, Recruiting, Sales Process, B2B, Marketing Communications, New Business Development, Digital Strategy, CRM, SEO, Google Adwords, Social Networking, Media Planning, Affiliate Marketing, Advertising
Education
La Salle University 2000 — 2004
Medidata Solutions 2014 - Present
Merck August 2013 - December 2014
Vanguard January 2013 - July 2013
McKesson Health IT August 2012 - December 2012
Defense Logistics Agency August 2011 - August 2012
Octagon Research Solutions August 2008 - August 2011
Johnson & Johnson November 2007 - July 2008
Skills
SDLC, Databases, PL/SQL, Business Intelligence, Oracle SQL Developer, SQL, Oracle, ETL, Data Warehousing, XML, JavaScript
Education
Pennsylvania State University-Great Valley Graduate Center 1998 — 1999
Master's degree, Information Science
University of Arizona 1982 — 1986
Bachelor of Science (B.S.), Chemistry (Minor in Mathematics)
LIQUENT, a PAREXEL® Company March 2012 - Present
Merck October 2004 - March 2012
Octagon Research Solutions 2001 - 2004
Skills
FDA, Pharmaceutical Industry, Regulatory Affairs, Regulatory Requirements, Clinical Trials
Education
University of the Sciences in Philadelphia 1997 — 2000
BS
Quinnipiac University 1996 — 1997
Caroline Fediw, Inc SAS ProgrammerICON Clinical Research2009 - Present
Octagon Research Solutions 2006 - Present
Education
West Chester University of Pennsylvania 2005 — 2007
M.S., Applied Statistics
West Chester University of Pennsylvania 1995 — 1997
M.S., Educational Research
La Salle University 1979 — 1983
B.A., Computer Science
ICON Clinical Research April 2014 - Present
ICON Clinical Research June 2007 - March 2014
Octagon Research Solutions 2006 - 2007
ERT 2002 - 2004
ECRI 2001 - 2002
Kennedy Health System 2000 - 2002
Skills
CRO, Infectious Diseases, Clinical Trials, Therapeutic Areas, CTMS, EDC, GCP, Biotechnology, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Operations, Clinical Research, ICH-GCP, Pharmaceutical Industry
Education
Kennedy Memorial Health System 2000 — 2002
Surgical Foot and Ankle Residency, Podiatric Medicine Residency Programs
New York College of Podiatric Medicine 1996 — 2000
DPM, Podiatrist
Cabrini College 1992 — 1996
BS, Biology
Bishop Hoban High School 1988 — 1992
Accenture December 2014 - Present
Accenture October 2012 - November 2014
Octagon Research Solutions December 2011 - September 2012
Merck February 2002 - November 2011
KForce March 2000 - January 2002
SCIREX Corporation May 1998 - March 2000
Skills
Clinical Data Management, EDC, CRF design, Clinical Trials, Database Design, Oncology Clinical..., Electronic Data..., Continuous Improvement, Quality Assurance, Clinical Trial Design, Oracle SQL Developer
Education
Bloomsburg University of Pennsylvania
BS, Biology
Temple University
MS, Quality Assurance and Regulatory Affairs
MedImmune August 2015 - Present
Novartis May 2015 - July 2015
GSK June 2007 - April 2015
Encorium 2006 - 2007
Octagon Research Solutions 2005 - 2006
ICON plc 2003 - 2005
Covance September 2000 - April 2003
Skills
Inform, EDC, Clinical Data Management, CRO, Clinical Trials, MedDRA, Training & Development, WHO Drug, Special Projects, Group Presentations, Pharmaceutical Industry, Oncology, Data Management
Education
Penn State University
Bachelor of Science (BS), Business Administration and Management, General
PPD October 2013 - Present
PPD April 2012 - September 2013
PPD July 2011 - April 2012
Liquent, Inc. June 2009 - April 2011
Octagon Research Solutions June 2007 - February 2009
Endo Pharmaceuticals May 2000 - May 2007
DuPont Pharmaceuticals October 1999 - April 2000
Cephalon September 1995 - October 1999
Skills
Regulatory Affairs, Pharmaceutical Industry, FDA, 21 CFR Part 11, Regulatory Requirements, Clinical Trials, Regulatory Submissions, Validation, Lifesciences, Computer System..., Sop, Biotechnology, Clinical Data Management, Technology Integration, GMP, Technology Transfer, Regulations, eCTD, Clinical Development, CRO, Strategy, Oncology, IND, GCP, Change Control, CTMS, Document Management, EDC, Clinical Research, Data Management, Pharmacovigilance, Pharmaceutics, Strategic Technology..., SOP
Education
University of Phoenix 2002 — 2005
BS, Information Technology
Penn State University 1987 — 1989
AS / Paralegal Certificate, Business Law
Shire Pharmaceuticals June 2011 - Present
Octagon Research Solutions 2005 - 2011
PharmaNet Development Group, Inc. 2002 - 2003
IBAH 1988 - 2000
Skills
Clinical Trials, Clinical Data Management, Pharmaceutical Industry
Education
La Salle University
Bachelor's degree, Computer and Information Science
DePuy Synthes April 2014 - Present
Teva Pharmaceuticals June 2013 - April 2014
Octagon Research Solutions February 2012 - May 2013
Octagon Research Solutions April 2010 - February 2012
Octagon Research Solutions January 2009 - April 2010
Skills
Regulatory Operations, Regulatory Submissions, FDA, Validation, Pharmaceutical Industry, Clinical Trials, eCTD, Regulatory Affairs, 21 CFR Part 11, IND, Clinical Development, Sop, GCP, Document Management, Documentum, ANDA, Biotechnology, EDC, Lifesciences, CRO, Medical Devices
Education
Drexel University 2012 — 2015
Master of Science (M.S.), Biomedical Engineering
Drexel University 2003 — 2008
Bachelor of Science (BS), Biomedical/Medical Engineering
Bayer July 2015 - Present
Merck December 2013 - July 2015
Merck June 2012 - December 2013
Merck September 2011 - June 2012
Octagon Research Solutions April 2011 - September 2011
Octagon Research Solutions April 2009 - April 2011
Octagon Research Solutions April 2008 - April 2009
Octagon Research Solutions April 2007 - April 2008
Skills
Regulatory Submissions, eCTD, Regulatory Affairs, FDA, IND, Regulatory Requirements, Pharmaceutical Industry, NDA, Clinical Trials, Sop, Validation, Clinical Development, 21 CFR Part 11, Drug Development, GCP
Education
Mercer County Community College 2006 — 2007
Certificate in Pharmaceutical Drug Development
Bucks County Community College 2004 — 2006
Concentration of Courses in the Life Sciences
Gettysburg College
Bachelor of Arts (B.A.), Philosophy
BioClinica December 2010 - Present
Octagon Research Solutions August 2005 - December 2010
Dataceutics 1999 - 2005
Decision Associates, Inc February 1997 - June 1999
Skills
Validation, Quality Assurance, 21 CFR Part 11, Computer System..., FDA, Pharmaceutical Industry, GxP, Sop, Project Management, Clinical Trials, GMP, Clinical Data Management, Change Control, Regulatory Submissions, CAPA, GCP, Software Documentation, Regulatory Affairs, LIMS
Education
Penn State University 1991 — 1996
Bachelors, Computer Science & Engineering
Penn State University
Bachelor's degree, Computer Science and Engineering
CSC - Computer Sciences Corporation April 2014 - Present
La'Sarah-evette Motley, LLC November 2009 - Present
Baxter International Inc. April 2013 - April 2014
CSC December 2012 - April 2013
Tunnell Consulting June 2009 - April 2012
ReSearch Pharmaceutical Services December 2008 - March 2009
Octagon Research Solutions November 2007 - September 2008
Octagon Research Solutions November 2006 - November 2007
Skills
Publishing, Creative Writing, Pharmaceutical Industry, Adobe Acrobat, Regulatory Submissions, Quality Assurance, Document Management, eCTD, FDA, Microsoft Office, Sop, Clinical Trials, Project Management, Training, Regulatory Affairs, Software Documentation, Medical Devices, Management, Editing, PowerPoint, Team Leadership, Clinical Research, SOP
Education
American InterContinental University 2004 — 2006
Associate of Arts (A.A.), Business Administration, 3.93
Johnson & Johnson Senior Regulatory AssociateJohnson & JohnsonApril 2009 - Present
Octagon Research Solutions September 2004 - June 2007
Skills
eCTD, Regulatory Affairs, FDA, Regulatory Submissions
Education
Cabrini College 2007 — 2010
Masters of Science, Organizational Leadership
Ursinus College 2000 — 2004
Bachelors of Art, Management and Marketing, English
Accenture November 2014 - Present
Accenture October 2012 - November 2014
Octagon Research Solutions January 2009 - October 2012
AECOM March 2008 - January 2009
Iberdrola Renewable Energy Services October 2006 - March 2008
Community Energy June 2005 - October 2006
Skills
Financial Analysis, Due Diligence, Accounting, Budgets, Financial Reporting, Strategic Planning, Management, Leadership, Project Management, Process Improvement, Analysis, Program Management
Education
Villanova University 2012 — 2014
Master of Business Administration (M.B.A.)
Eastern University 1998 — 2002
BA, Business
Oracle March 2012 - Present
Octagon Research Solutions September 2008 - July 2011
Octagon Research Solutions October 2006 - September 2008
Shire Pharmaceuticals July 2006 - October 2006
Skills
SQL, Java, Lifesciences, XML, Microsoft SQL Server, FTP software, VMware, Windows 7, Weblogic, Oracle Applications
Education
Southern Methodist University 1995 — 1999
B.S., Operations Research, Minors in Math and Business
EXTEDO 2015 - Present
Delaware Valley Fencers Club September 2012 - February 2015
Octagon Research Solutions April 2011 - November 2012
Octagon Research Solutions March 2008 - June 2010
Octagon Research Solutions July 2006 - March 2008
Octagon Research Solutions August 2005 - July 2006
Education
Haverford College 2001 — 2005
BA, Psychology
Teva Pharmaceuticals March 2015 - Present
GlaxoSmithKline February 2013 - March 2015
CSL Behring June 2006 - February 2013
Wyeth 2005 - 2006
Octagon Research Solutions June 2004 - May 2005
Skills
Documentum, eCTD, Regulatory Affairs, FDA, Pharmaceuticals, Labeling, Clinical Trials, Clinical Research, Regulatory Submissions, Drug Development, IND, GCP, Regulatory Requirements, 21 CFR Part 11, Biopharmaceuticals, Therapeutic Areas, Pharmaceutical Industry, Sop, Oncology, GxP, Clinical Development, Vaccines, SOP, Pharmacovigilance, Medical Affairs, Change Control
Education
Bloomsburg University of Pennsylvania
BS, Biology
Intelleges April 2015 - Present
Consultant May 2012 - Present
onlinemechanix.com January 2012 - June 2014
onlinemechanix.com January 2012 - September 2013
Accelrys-Formerly VelQuest Corp January 2009 - March 2012
Extedo, Inc September 2007 - December 2008
Octagon Research Solutions August 2006 - September 2007
Sycamore Group April 2004 - August 2006
Exigent Group November 2001 - April 2004
Associates In Medical Marketing May 2001 - November 2001
Skills
Business Development, Strategy, Management Consulting, Start-ups, Sales Effectiveness, Marketing Strategy, New Business Development, Product Development, CRM, Management, Sales Process, Enterprise Software, Pharmaceutical Industry, Market Analysis, Selling, Integration, Consulting, Product Management, Sales Improvement, Project Management, Leadership, Marketing, Sales, Strategic Partnerships, Social Media Marketing, Complex Enterprise Sales, Medical Devices, Lifesciences, Public Relations, Lead Generation, Business Intelligence, Cross-functional Team..., SaaS, Change Management, Product Marketing, Manufacturing, Business Strategy, Cloud Computing, Salesforce.com, Account Management, Solution Selling, Contract Negotiation, Go-to-market Strategy, Executive Management, Entrepreneurship, Competitive Analysis, Product Launch, Business Planning, .com startup, I make it happen
Education
Rutgers University 1979 — 1983
B.S, Biology
Rutgers University-New Brunswick 1978 — 1982
BS, Biology and Philosophy
Merck September 2013 - Present
BioClinica June 2011 - June 2013
Document Solutions March 2009 - June 2011
Octagon Research Solutions September 2008 - February 2009
Skills
SharePoint, Leadership, EDC, Data Analysis, Software Documentation, CTMS, Pharmaceutical Industry, Microsoft Office, Quality Assurance, CRO
Education
Temple University School of Medicine 2009 — 2011
Master of Science (MS), Pharmaceutical Quality Assurance/Regulatory Affairs
Saint Joseph's University 2002 — 2006
Bachelor of Science (BS), Biology, General
Chestnut Hill Academy
Accenture Life Sciences October 2012 - Present
Octagon Research Solutions January 2009 - October 2012
Procter and Gamble 1991 - 2008
Education
Miami University 1969 — 1973
Bachelor of Arts (B.A.), Zoology/Pre-Med
Accenture August 2012 - Present
Octagon Research Solutions October 2011 - August 2012
CSC January 2011 - November 2011
Image Solutions, Inc. September 2009 - December 2010
Apyx, Inc June 2003 - December 2009
Centocor April 2000 - June 2003
Sanofi Pasteur September 1996 - April 2000
Skills
IND, Regulatory Operations, Regulatory Submissions, Pharmaceutical Industry, Product Lifecycle..., FDA, 21 CFR Part 11, Document Management, Computer System..., eCTD, Regulatory Affairs, Regulatory Requirements, Regulations, Documentum, Validation
Education
Penn State University 1992 — 1996
BS, Environmental Resourse Management
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
Comcast April 2013 - Present
PNC Wealth Management August 2012 - April 2013
Rovi February 2012 - July 2012
Octagon Research Solutions October 2010 - January 2012
NextGen Healthcare Information Systems April 2010 - October 2010
PNC June 2005 - March 2010
Verizon August 2003 - May 2005
Skills
ADO.NET, VB.NET, ASP.NET, C#, T-SQL, SQL Server, LINQ, WCF, IIS, .NET, AJAX, Web Services, Agile, XML, Visual Studio, SSRS, SOA, SSIS, ASP.NET MVC, SQL, jQuery, ASP, JavaScript, Visual Basic, HTML, VSS, Entity Framework, ASP.NET AJAX, Stored Procedures, Web Applications, OOP, CSS, Scrum, SOAP, Databases, VBScript, JSON, MVC, Software Development, SQL Server 2000-2008, Telerik, NUnit, Database Design, Microsoft SQL Server, SDLC, UML, Oracle, Agile Project Management, Subversion, Visio
Education
Osmania University
Master in computer Science, Computer Science
Teva Pharmaceuticals January 2008 - Present
Johnson & Johnson August 2005 - December 2007
Octagon Research Solutions June 2004 - July 2005
GSK August 2003 - June 2004
On Assignment Lab Support August 2002 - August 2003
Skills
Regulatory Affairs, Sop, eCTD, IND, FDA, Pharmaceutical Industry, Clinical Trials, Validation, 21 CFR Part 11, Biotechnology, GMP, Regulatory Submissions, Quality Assurance, Cross-functional Team..., Regulatory Requirements, Change Control, SOP
Education
Temple University 2005 — 2007
MS, Quality Assurance and Regulatory Affairs
Bowling Green State University 2000 — 2003
MS, Micro/Molecular Biology
The College of Wooster 1994 — 1998
BA, Biology
Janssen Pharmaceutical Companies of Johnson and Johnson 2010 - Present
Accenture 2007 - 2010
Octagon Research Solutions 2004 - 2007
Unisys 1999 - 2004
Skills
Pharmaceutical Industry, Standards Development, Data Management, Master Data Management, CDISC, Data Governance, Validation, Business Process..., Business Analysis, Clinical Data Management, Project Management, MedDRA, Oracle Clinical, CDISC SDTM, Medidata Rave, 21 CFR Part 11
Education
Franklin & Marshall College
Bachelor's degree
Gwynedd Mercy University
Management Information Systems, General
PRA International August 2013 - Present
Octagon Research Solutions December 2010 - July 2013
Georgetown University Medical Center January 2005 - June 2009
Skills
Data Analysis, SAS, Databases, Perl, SAS programming, Algorithms, Clinical Trials, Clinical Data Management, CRO, Data Management, EDC, Biostatistics, Pharmaceutical Industry, GCP, 21 CFR Part 11, Biotechnology, FDA, Statistical Programming, SAS Programming
Education
Georgetown University 2006 — 2009
Master, Biostatistics
University of Northern Virginia
Master, Computer Science
Institute of Photographic Chemistry, Chinese Academy of Sciences 1995 — 1998
M.S, Physical Chemistry
Wuhan University 1990 — 1994
B.S, Chemistry
Philadelphia University
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson August 2009 - September 2014
Octagon Research Solutions 2005 - 2009
Skills
Regulatory Submissions, Regulatory Affairs, eCTD, Pharmaceutical Industry, Regulatory Requirements, Clinical Trials, FDA, 21 CFR Part 11, Clinical Development, SOP, Biotechnology, GCP
Education
Messiah College 1999 — 2003
Octagon Research Solutions February 2007 - Present
Insurance Data Processing, Inc September 2002 - January 2007
Education
Cisco Networking Academy 2008 — 2009
Cisco Networking
Lansdale School of Business 2000 — 2002
Associates, Network Administration
Montgomery County Community College 1997 — 1999
Computer Science
Legal Aid Foundation of Los Angeles September 2014 - Present
Legal Aid Foundation of Los Angeles November 2013 - September 2014
Independent September 2012 - November 2013
Dover AFB, Area Defense Counsel May 2011 - September 2011
United States Magistrate Court May 2010 - September 2011
Octagon Research Solutions June 2008 - July 2009
Skills
Legal Research, Westlaw, Legal Writing, Litigation, Civil Litigation, Criminal Law, Courts, Commercial Litigation, Lexis, Appeals, Legal Assistance, Personal Injury, Criminal Defense, Legal Issues, Editing, Trials, Copyright Law, Research, Motions, Health Law, Licensing, Legislation, Legislative Relations, Administrative Law, Trademarks, Document Drafting, Corporate Law, Public Policy, Arbitration, Legal Advice, Employment Law, Oral Arguments, Legislative Research, Constitutional Law, International Business..., Election Law
Education
Drexel University 2009 — 2012
J.D., Law
University College Dublin 2006 — 2007
Master of Science (MSc), International Relations and National Security Studies
Temple University 2003 — 2006
B.A., Political Science and History
Muhlenberg College
Accenture October 2012 - Present
Octagon Research Solutions September 2000 - September 2012
Skills
FDA, Pharmaceutical Industry, Clinical Development, Regulatory Submissions
Education
Penn State University
Bachelors of Science in Management Science and Information Systems
Octagon Research Solutions
Skills
Software Documentation, 21 CFR Part 11, SDLC, CDISC, Change Control, Cross-functional Team..., Computer System..., Business Analysis, EDC, Oracle Clinical, FDA, GxP, CRO, Data Management, Clinical Data Management
Education
Drexel University - College of Business and Administration 1978 — 1983
BS, Management Information Systems
inVentiv Health Clinical December 2004 - Present
PharmaNet Development Group, Inc. December 2004 - December 2005
Cephalon August 2004 - December 2005
AstraZeneca September 2003 - July 2004
Octagon Research Solutions May 2001 - June 2003
AstraZeneca February 2001 - May 2001
SCIREX Corporation May 1998 - February 2001
Skills
Clinical Data Management, EDC, CRF design, GCP, CRO, Data Management, Clinical Trials, Sop, Validation, Oncology, Clinical Research, SAS, Inform, 21 CFR Part 11, OC RDC
Education
Cabrini College 1994 — 1996
Bachelor of Science, Biology
Delaware County Community College 1992 — 1993
Associates in Science, Biology
Chiltern January 2014 - Present
Theorem Clinical Research July 2012 - January 2014
Theorem Clinical Research July 2009 - July 2012
Octagon Research Solutions October 2007 - June 2009
AstraZeneca April 2002 - September 2006
ERT May 2000 - April 2002
Skills
CDISC, Clinical Data Management, Statistics, SAS, Clinical Trials, SDTM, EDC, Biostatistics, SAS programming, SAS Programming, Statistical Programming
Education
Villanova University 2004 — 2006
M.S., Applied Statistics
Penn State University
B.S., Mathematics
CBSS Exec & Operations April 2005 - October 2012
Amgen April 2005 - October 2012
Amgen Inc January 2007 - January 2012
Amgen Inc January 2005 - January 2007
Octagon Research Solutions January 2002 - January 2005
DEL TOYOTA January 2001 - January 2002
HEALTHCARE MANAGEMENT CONTROL January 2000 - January 2001
COMCAST METROPHONE January 1995 - January 2000
COMCAST METROPHONE January 1995 - January 2000
Skills
Communication Skills, Process Improvement, Critical Thinking, Coaching Staff, Cross-functional Team..., Organization, Microsoft Office, Listener, Customer Service
Education
California Lutheran University 2005 — 2011
B.S Degree, Organizational Leadership; Business Administration
CHI Institute 2000 — 2002
Associate, Networking Engineering
CSL Behring February 2013 - Present
Octagon Research Solutions October 2008 - February 2013
AstraZeneca July 1997 - December 2007
Skills
Microsoft Word, Regulatory Affairs, eCTD, Global Regulatory..., Regulatory Requirements, 21 CFR Part 11, CRO, Sop, Computer System..., Pharmaceutical Industry, FDA, Change Control, Validation, IND, Biotechnology, Biopharmaceuticals, Pharmacology, Lifesciences
Education
Penn State University 1991 — 1993
Non-degree, Psychology
Immaculata University
Bachelor of Arts (B.A.), Bus. Mgt./HR
Accenture Inc. October 2012 - Present
Octagon Research Solutions January 2011 - October 2012
Skills
CDISC, Pharmaceutical Industry, SAS
Education
Philadelphia University 2010 — 2010
SAS Programming Certificate, SAS Programming for Pharmaceutical Industry
The University of Queensland 2004 — 2005
Master of Science (MS), Agriculture Studies
Crothall Healthcare November 2012 - Present
Octagon Research Solutions January 2010 - October 2012
Skills
-Computer..., -Drafting experience:..., -Organic Lab experience, -Cadaver Lab experience, Brainstorming/Teamwork..., Medical Devices, Training, Data Analysis, Biomedical Engineering, Management, Software Documentation, Team Building, Clinical Trials, Process Improvement, FDA, Microsoft Excel, Strategic Planning, Business Analysis, Quality Assurance, Healthcare, Project Management
Education
Drexel University 2004 — 2009
Bachelor of Science (BS), Biomedical/Medical Engineering
Brazen Garage Squad August 2013 - Present
In-Home Advanced Technologies September 2009 - January 2011
Octagon Research Solutions October 2007 - April 2009
Education
Bryn Mawr College 2003 — 2006
Computer Science
Abington Friends School 2000 — 2003