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
CSC October 2014 - Present
CSC March 2014 - October 2014
PAREXEL June 2013 - March 2014
PAREXEL January 2013 - June 2013
Octagon Research Solutions March 2012 - December 2012
Octagon Research Solutions April 2011 - March 2012
MediMedia USA May 2006 - April 2011
Skills
eCTD, Regulatory Submissions, Document Management, IND, NDA, CTA, NeeS, MAA, Viewpoint, Regulatory Reporting, Adobe Acrobat, FDA, Regulatory Submission..., Regulatory Operations, Insight Publisher, eCTD Express, Documentum, Citrix Metaframe, FirstDoc, ISI Toolbox, CRO, Regulatory Requirements, Validation, GMP, Pharmaceutical Industry, GCP, ANDA, Clinical Trials, 21 CFR Part 11, Sop, Regulatory Affairs, Clinical Development, Regulations, GLP, EDC, ICH-GCP, Clinical Data Management
Education
Temple University 2009 — 2014
MS, Quality Assurance/Regulatory Affairs
Temple University 2004 — 2009
BS, Biology
Comcast Cable (Contract via Apex Systems) 2015 - Present
Comcast Business (Contract via iQuasar) 2014 - 2015
Comcast Cable 2006 - 2014
Catalyst IT Services 2005 - 2006
Verizon, Cisco and TruePosition 2001 - 2005
Octagon Research Solutions 2003 - 2004
Vectrix Business Solutions, Inc. 2000 - 2001
Accenture 1997 - 2000
Buchanan Technologies / CSSI 1995 - 1997
Ernst & Young / Kenneth Leventhal 1994 - 1995
Skills
Cross-functional Team..., Program Management, Business Intelligence, Project Management, PMO, Product Management, Software Project..., Agile Methodologies, Strategy, Leadership, E-commerce, Management, Testing, Business Process, SDLC, Software Development, Integration, Telecommunications, IPTV, Quality Assurance, VOD, Vendor Management, SOA, Team Building, Data Center, Mobile Devices, Strategic Partnerships, PMP, Process Improvement, System Deployment, Cloud Computing, Web Applications, Project Portfolio..., Agile Project Management, Aviation, Oracle, Set Top Box, System Architecture, Requirements Analysis, Six Sigma, Wireless, Scrum, Microsoft SQL Server, Private Pilot, Broadband, Streaming Media, Enterprise Software, CRM, Business Process...
Education
Texas Tech University 1987 — 1992
Bachelor's Degree, Management Information Systems and Services
south garland
Rho, Inc. January 2002 - Present
CodeCrafters, Inc. May 2000 - Present
Octagon Research Solutions December 2008 - April 2009
AIMS Co. April 1997 - September 2000
ASG, Inc. June 1994 - April 1997
University of North Carolina at Chapel Hill January 1978 - April 1981
University of North Carolina at Chapel Hill January 1978 - April 1981
University of Texas at Austin 1977 - 1978
Skills
FDA, Programming, Access, SAS programming, Data Management, CRO, CDISC, Clinical Trials, Pharmaceutical Industry, Clinical Development, Clinical Research, Validation, Database Design, Oncology, VBA, Data Mining, Statistics, Analytics, EDC, SQL, Software Documentation, Databases, Biostatistics, Lifesciences, Analysis, Statistical Programming, Data Analysis, GCP, Regulatory Submissions, 21 CFR Part 11, Biotechnology, SAS Programming, Life Sciences, Published Author
Education
University of North Carolina at Chapel Hill 1974 — 1976
MRP, City Planning
University of Pennsylvania 1970 — 1974
BA, Sociology, Regional Science
PAREXEL January 2014 - Present
Theorem Clinical Research May 2007 - January 2014
Octagon Research Solutions March 2005 - May 2007
Skills
Regulatory Submissions, Regulatory Affairs, eCTD, Pharmacovigilance, Clinical Trials, Regulatory Requirements, IND, GCP, Clinical Development, Pharmaceutical Industry, FDA, Sop, CRO, CTMS, ICH-GCP, Drug Development, 21 CFR Part 11, Therapeutic Areas, Regulations, NDA
Education
Temple University 2002 — 2005
Bachelor of Science (BS), Biology
Teva Pharmaceuticals July 2014 - Present
Teva Pharmaceuticals December 2011 - July 2014
Actelion December 2009 - December 2011
ReSearch Pharmaceutical Services 2008 - 2009
Octagon Research Solutions October 2006 - October 2008
Skills
IND, Regulatory Affairs, eCTD, FDA, Pharmaceutical Industry, Regulatory Submissions, Sop, Clinical Trials, GCP, Clinical Development, CRO, Regulatory Requirements
Education
Temple School of Pharmacy 2011 — 2015
MS, QA/RA
Temple University 2002 — 2006
BS, Biology
PRA Health Sciences March 2014 - Present
Frontage Laboratories, Inc September 2012 - March 2014
Octagon Research Solutions January 2012 - September 2012
Philadelphia University September 2011 - December 2011
Skills
Statistics, Clinical Data Management, SAS, Clinical Trials, R
Education
Temple University 2007 — 2009
Master's degree, Statistics
Accenture September 2012 - Present
Octagon Research Solutions January 2012 - September 2012
Fiberlink February 2009 - January 2012
Skills
Financial Reporting, Salesforce.com, Microsoft Office, Data Analysis, Microsoft Excel, Process Improvement, PowerPoint, Account Management, Microsoft Word, Leadership, Accounting, Salesforce.com..., Sales Operations
Education
Susquehanna University 2004 — 2008
BS, Finance and Economics
California based Biotechnology Company December 2009 - Present
Octagon Research Solutions May 2008 - November 2009
AstraZeneca April 2002 - May 2008
Merck April 1995 - April 2002
US Bioscience 1994 - 1995
National Disease Research Interchange 1993 - 1994
Skills
Clinical Trials, Clinical Research, Clinical Data Management, EDC, Pharmaceutical Industry, Clinical Development, CRO, CTMS, SAS, Data Management, Regulatory Affairs, Oncology, 21 CFR Part 11, Sop, GCP, FDA, Regulatory Submissions, ICH-GCP, Therapeutic Areas, Oracle Clinical, CDISC
Education
Temple University 1987 — 1991
BS, Health Education
Germantown Friends
Germantown Friends
Shinetech Software Inc. March 2011 - Present
Emergn Ltd July 2009 - December 2010
Exigen Services April 2007 - July 2009
SupplyScape November 2004 - March 2007
Octagon Research Solutions May 2003 - November 2004
Stractics Group November 2002 - May 2003
netNumina December 2000 - November 2002
Zero.net (Envision Development Corporation) March 2000 - August 2000
Skills
Start-ups, Strategy, CRM, Software Project..., Change Management, Agile Methodologies, Business Intelligence, Cross-functional Team..., Management Consulting, Business Development, Cloud Computing, New Business Development, Enterprise Software, Program Management, SaaS, Outsourcing, Leadership, Integration, Software Development, Management, Professional Services, IT Strategy, Salesforce.com, Telecommunications, Agile Project Management, Team Leadership, Process Improvement, Consulting, Pre-sales, Executive Management, Lead Generation, Sales Process, Sales Operations, Requirements Analysis, Strategic Visionary, Business Analysis, Product Development, Organizational..., Business Process, IT Service Management, Training, Product Management, E-commerce, Vendor Management, Quality Assurance, Analysis, Business Process...
Education
Stonehill College
BA, English
Teva Pharmaceuticals December 2014 - Present
Otsuka Pharmaceutical Companies (U.S.) 2012 - 2014
Octagon Research Solutions November 2010 - December 2012
Skills
Pharmaceutical Industry, FDA, Microsoft Office, Customer Service, Microsoft Excel, Adobe Acrobat, Regulatory Affairs, Clinical Trials, eCTD, Social Media, Sales, Leadership, Marketing, Publishing, Regulartory Submissions
Education
Temple University 2007 — 2010
Bachelor of Arts (B.A.), Advertising
HTH Worldwide February 2013 - Present
Octagon Research Solutions May 2010 - February 2013
The Judge Group June 2009 - May 2010
Kforce February 2008 - April 2009
InterCall April 2006 - February 2008
D.O.C.S Dental Organization for Conscious Sedation January 2005 - April 2006
Skills
Salesforce.com, Recruiting, Account Management, Sales, Cold Calling, Project Management, Sales Process, SaaS, Technology Integration, Lead Generation
Education
University of South Carolina-Columbia 1999 — 2004
BA, Psychology
Upper Dublin High School 1995 — 1999
Octagon Research Solutions Developer Level IIIObjectBuilders2003 - 2004
Convergent Solutions June 1998 - October 2002
Skills
SDLC, Java, Documentum, SQL
Education
Swarthmore College 1994 — 1998
Applied Clinical Intelligence March 2009 - Present
Octagon Research Solutions January 2008 - February 2009
Bristol Myers Squibb June 2006 - January 2008
Premier Research Group January 2005 - May 2006
Premier Research Group March 2004 - January 2005
Premier Research Group September 2003 - March 2004
Premier Research Group December 2001 - September 2003
Premier Research Group October 2001 - December 2001
DuPont Pharmaceuticals June 1998 - July 2001
Skills
Oracle Clinical..., DataFax (fax-based), Oracle Clinical (RDC), eCaseLink (EDC), DATATRAK (EDC), ICTM (EDC), Viedoc and VPC (EDC), iMedNet (EDC), SAS programming, Proficient in Microsoft..., MedDRA (medical..., WHO Drug (medical..., CDISC
Education
University of Delaware 1994 — 1998
BA, Biological Sciences
CSC May 2013 - Present
Accenture September 2012 - May 2013
Octagon Research Solutions June 2007 - August 2012
Insight Global August 2006 - May 2007
Skills
Business Analysis, Project Management, Software Development, Pharmaceutical Industry, SDLC, Customer Support, Software Implementation, Regulatory Submissions, Regulatory Affairs, Analysis, SaaS, Document Management, User Acceptance Testing, Validation, Software Documentation, Training Delivery, Requirements Analysis, System Testing, Requirements Gathering, Software Development..., Drug Development, Clinical Data Management, Client Liaison, Communication Skills, Management, SharePoint
Education
Villanova University 2009 — 2010
Masters Certificate, Business Analysis
University of Delaware 2002 — 2006
BA, Communication, Geography
Veeva Systems February 2013 - Present
Oracle July 2012 - February 2013
ClearTrial -- Acquired by Oracle 3/2012 March 2009 - July 2012
Octagon Research Solutions November 2006 - March 2009
Ion Networks, Inc January 2004 - November 2006
Liquent, Inc. December 1997 - January 2004
Skills
Pharmaceuticals, Life Sciences, Pharmaceutical Industry, Business Development, Lifesciences, Clinical Trials, Biotechnology, Account Management, CRO, Clinical Development, Cross-functional Team..., EDC, Enterprise Software, Medical Devices, Oncology, Product Launch, Product Management, Regulatory Affairs, SaaS, Sales, Start-ups
Education
University of Delaware 1996 — 1999
BS, Business Administration: Marketing
SynapTech Solutions, Inc. March 2004 - Present
ResCap Liquidating Trust July 2013 - September 2014
Turnberry Solutions, Inc., Blue Bell, PA March 2010 - June 2013
GSK April 2011 - May 2011
AstraZeneca Pharmaceuticals June 2008 - April 2011
PRIME Technology Group July 2006 - March 2010
Octagon Research Solutions September 2007 - December 2007
APS Healthcare, Inc. July 2006 - September 2007
Morgan Lewis & Bockius, LLP September 2005 - June 2006
Power Medical Interventions May 2005 - July 2005
Skills
SDLC, Program Management, Integration, PMP, SharePoint, Business Intelligence, Requirements Analysis, SaaS, Enterprise Architecture, MS Project, Process Improvement, IT Management, Team Building, Product Management, Management, Leadership, Project Management, Consulting, Vendor Management, Databases, Strategic Planning, Change Management, Organization, Business Analysis, Analytical Skills, CRM, Strategy, Training, Enterprise Software, Quality Assurance, Software Development, PMO, Project Delivery, Data Warehousing, Project Planning, Microsoft Project, Business Process, IT Strategy, Cross-functional Team..., Information Technology, Cloud Computing, Software Project...
Education
University of Delaware
BSEE
Trion Group, a Marsh & McLennan Agency, LLC Company June 2014 - Present
PointRoll September 2010 - August 2013
Octagon Research Solutions February 2009 - June 2009
Highpoint Solutions November 2007 - February 2009
Interphase Systems 2009 - 2009
Database Solutions 2007 - 2007
Omicron Consulting 2006 - 2007
Antares Technology Solutions 2005 - 2006
Aramark Sports & Entertainment 2003 - 2006
Database Solutions November 2004 - November 2005
Skills
Project Management, Time Management, Leadership, Agile Methodologies, Software Development, Management, SQL, Microsoft SQL Server, Databases, JavaScript, Business Intelligence, XML, Business Analysis, SDLC, .NET, T-SQL, ASP.NET
Education
University of Louisiana at Monroe 1988 — 1992
Bachelor of Science (B.S.)
RELOVATE January 2014 - Present
TrialScope June 2014 - Present
VoteTocracy June 2013 - Present
Rapid Pathogen Screening, Inc. May 2013 - Present
The Charles T. Saldarini Group,LLC January 2006 - Present
Informed Medical Communications January 2007 - December 2012
Octagon Research Solutions January 2006 - December 2012
Cadient Group January 2008 - June 2012
Sentrx (acquired by TeleRx) April 2009 - October 2011
PDI July 1987 - October 2005
Skills
Strategy Development, Business Turnaround, Leadership Development, Start-ups, Leadership, Entrepreneurship, Program Management, Analytics, Marketing, Integrated Marketing, Market Research, Product Development, Online Marketing, Executive Management, Sales, Biotechnology, Integration, Outsourcing, Lifesciences, Brand Management, Biopharmaceuticals, Commercialization, Mergers & Acquisitions, Life Sciences, New Business Development, Pharmaceutical Industry, Process Improvement, Strategy
Education
Syracuse University 1981 — 1985
AB, Political Science, Comunications Management
WIRB-Copernicus Group July 2015 - Present
Accenture October 2012 - January 2014
Octagon Research Solutions July 2011 - October 2012
Octagon Research Solutions October 2010 - July 2011
Octagon Research Solutions, Inc. August 2007 - October 2010
Octagon Research Solutions January 2006 - August 2007
Octagon Research Solutions September 2004 - January 2006
Octagon Research Solutions March 2004 - September 2004
Octagon Research Solutions July 2003 - March 2004
Octagon Research Solutions June 2002 - July 2003
Skills
Validation, Regulatory Submissions, Document Management, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., Project Management, FDA, Business Process, SharePoint, Quality Assurance, Sop, Business Analysis, Change Control, Software Documentation, eCTD, Documentum, Software Implementation..., Software Implementation, People Management, Technology Integration, Consulting, Change Management, Team Building, Team Leadership, Management, Cross-functional Team..., Program Management, Process Improvement, Requirements Analysis, IT Strategy, Business Intelligence, Strategy, Life Sciences, Vendor Management, CRO, Training, Data Management, Integration, Business Development, Instructional Design, Technical Writing, Organizational..., Business Partner Support, User Interface Design, User Experience Design, User Acceptance Testing, Microsoft Project, Project Planning, Project Portfolio...
Education
Villanova University 2007 — 2007
Master Certificate, Project Management
University of Delaware 1998 — 2002
Bachelor's degree, Communication and Media Studies, GPA 3.5
University of Delaware 1998 — 2002
Bachelor of Arts (B.A.), English Language and Literature, General, GPA 3.75
PPD July 2013 - Present
PRA International April 2012 - June 2013
Theorem Clinical Research August 2011 - March 2012
eClinical Solutions, a division of Eliassen Group March 2011 - July 2011
Octagon Research Solutions October 2005 - February 2011
Octagon Research Solutions July 2005 - October 2005
Syntel India Ltd. 2000 - 2001
Skills
SAS, CDISC, Clinical Trials, Data Analysis, SDTM, Clinical Data Management, FDA, EDC, CRO, Data Management, 21 CFR Part 11, Oncology, Clinical Research, CRF design, ICH-GCP, Regulatory Affairs, CTMS, Quality Assurance, GCP, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, SAS programming, Regulatory Submissions, Protocol, Validation, SAS Programming
Education
International Institute of Advanced Marketing 1999 — 2000
Advanced Diploma, Marketing & Advertising
S.N.D.T. University 1995 — 1996
Post Graduate Diploma, Communication & Media
University of Mumbai 1992 — 1995
BA, English Literature
Bhavan's Sri Ramakrishna Vidyalaya 1985 — 1990
Adrienne Boyance April 2010 - Present
Octagon Research Solutions January 2006 - April 2010
Merck 1999 - 2006
Skills
CDISC, Data Management, SDTM, Data Standards, Clinical Data, Pharmaceutical Industry, Clinical Trials, 21 CFR Part 11, Clinical Development, CRO, Clinical Data Management, EDC, FDA, Regulatory Submissions, SAS, Oncology, GCP, Biotechnology, Computer System..., CTMS
Education
Temple University
INC Research April 2010 - Present
INC Research (acquired MDS Pharma Services GCD) June 2009 - November 2010
MDS Pharma Services February 2009 - May 2009
Encorium Group July 2006 - September 2008
GlaxoSmithKline June 2005 - July 2006
Octagon Research Solutions October 2004 - May 2005
Pharmanet (formerly Medex Clinical Trial Services) 2000 - 2003
Medex Clinical Trial Services 1998 - 2001
Medex Clinical Trial Services July 1997 - July 1998
Medex Clinical Trial Services February 1995 - July 1997
Skills
Clinical Data Management, CTMS, EDC, Oracle Clinical, Therapeutic Areas, Oncology, CRO, Clinical Research, ICH-GCP, SAS programming, GCP, Clinical Trials, Clinical Development, CDISC, Data Management
Education
Temple University 1978 — 1982
Business Administration/Computer Science
Kroft-Klene May 2014 - Present
Croftgate USA February 2010 - Present
iMomentous August 2012 - June 2013
PHT Corporation June 2008 - October 2009
Octagon Research Solutions 2006 - 2008
Skills
Pharmaceutical Industry, Clinical Trials, Biotechnology, FDA, Cross-functional Team..., Salesforce.com, Strategic Planning, Business Development, Lifesciences, Account Management, Product Development, Healthcare, Marketing, Mobile Devices, Process Improvement, Recruiting, Sales Operations, SaaS, Enterprise Software, Strategic Partnerships, Training, Sales, Management, Start-ups
Education
Susquehanna University 1977 — 1981
Bachelor of Science (BS), Finance
Radnor HS
MD Anderson Cancer Center September 2014 - Present
Ludwig Institute for Cancer Research November 2010 - August 2014
sanofi-aventis January 2010 - November 2010
Sanofi-aventis July 2005 - December 2009
Octagon Research Solutions August 2003 - July 2005
sanofi-aventis November 2002 - July 2003
Servier February 2002 - August 2002
LAAS-CNRS September 2000 - September 2001
Skills
Immunology, Oncology, Clinical Trials, Clinical Development, Regulatory Submissions, Protocol, FDA, Clinical Research, IND, Drug Development, Pharmaceutical Industry, Vaccines, Diabetes, Clinical Study Design, Cancer, EDC, Clinical Monitoring, Phase I, Management, Biotechnology, Cross-functional Team..., Pharmaceuticals, Clinical Trial..., Neuroscience, Protocol Development, Biomarkers, Monoclonal Antibodies, Clinical Data Management, GCP, CRO, CTMS
Education
Université Paul Sabatier (Toulouse III) 1993 — 2002
Doctor of Pharmacy (Pharm.D.), Pharmaceutical Sciences
Université Victor Segalen (Bordeaux II) 2001 — 2002
Post graduate degree, Neurosciences
Université Paul Sabatier (Toulouse III) 1997 — 2000
Master's degree, Biological and Biomedical Sciences
KSM Technology Partners September 2006 - Present
Octagon Research Solutions 2003 - 2004
First Consulting Group 1994 - 2004
ISCG 1994 - 2004
Education
Temple University 1989 — 1993
B.S., Physics, Mathematics
Octagon Research Solutions November 2010 - Present
PPD July 2008 - May 2010
PPD December 2006 - July 2008
PPD June 2002 - December 2006
BMC Software Inc. October 1995 - June 2001
Northern Telecom, Consulting Projects October 1994 - September 1995
Centers for Disease Control, Consulting Projects March 1993 - September 1994
Skills
Clinical Trials, Biostatistics, CDISC, Oracle Clinical, SAS, Data Management, SDTM
Education
University of California, Davis
M.S., Biochemistry and Nutrition
ICON plc 2012 - Present
Amgen March 2010 - March 2012
Octagon Research Solutions July 2008 - February 2010
sanofi-aventis July 2007 - June 2008
Wyeth Pharmaceuticals January 2005 - June 2007
MPI Research 2004 - 2005
Skills
SAS, Health Outcomes, Unix Shell Scripting, ISS, Clinical Trials, CDISC, FDA, 21 CFR Part 11, SAS/SQL, Statistical Programming, Biostatistics, Data Analysis, Clinical Research, SQL, SAS programming, Pharmaceutical Industry, SDTM, Statistics, Data Management, SAS Programming
Education
The University of Texas at San Antonio 2001 — 2003
Master of Science (M.S.), Mechanical Engineering
IMS Health May 2015 - Present
IMS Health January 2013 - May 2015
Reval December 2011 - December 2012
Octagon Research Solutions May 2011 - November 2011
MTI Information Technologies July 2007 - April 2011
ICON plc December 2006 - July 2007
FXpress Corporation August 2001 - December 2006
FNX Limited October 2000 - August 2001
Verizon June 2000 - October 2000
Skills
.NET, C#, Visual Studio, Microsoft SQL Server, ASP.NET, Visual Basic, T-SQL, Testing, WCF, Web Applications
Education
Temple University 1993 — 2000
Bachelor of Science (BS), Computer and Information Sciences, General
Accenture October 2012 - Present
Octagon Research Solutions January 2006 - October 2012
Open Text Corporation October 1999 - January 2006
Microstar Software June 1996 - October 1999
Computer Sciences Corporation May 1995 - June 1996
BeaconPMG 1989 - 1995
Skills
Enterprise Content..., Document Management, Knowledge Management, Documentum, Business Analysis, Computer System..., Enterprise Architecture, Software Project..., SharePoint, Business Process..., Enterprise Software, IT Strategy, SDLC, 21 CFR Part 11, Regulatory Submissions, Requirements Analysis, Pharmaceutical Industry, FDA, Solution Architecture, Validation, Data Management, Project Management, Requirements Gathering, Regulatory Affairs, Software Documentation, Clinical Data Management, Change Control, Regulatory Requirements, CRO, EDC, Sop, GCP, SOP
Education
The University of Akron 1985 — 1989
The University of Akron 1985 — 1989
Education
University of Akron 1985 — 1989
BA, Secondary Education, Math
Wadsworth High School 1981 — 1985
TraceLink September 2015 - Present
ClearPoint December 2014 - August 2015
Accenture September 2008 - December 2014
Octagon Research Solutions September 2008 - October 2012
Merck September 2005 - September 2008
Abbott Laboratories January 2004 - September 2005
Skills
Sales, Life Sciences, Business Development, Leadership, Outsourcing, Cross-functional Team..., Pharmaceutical Industry, Clinical Trials, Consulting, Integrated Marketing, Lifesciences, Biotechnology, Clinical Research, Strategic Planning, Oncology, CRO, Clinical Development, Supply Chain, Strategy, Healthcare, New Business Development
Education
University of North Carolina at Chapel Hill 1995 — 2000
BA, Communicatation Studies
Teva Pharmaceuticals March 2013 - Present
Teva Pharmaceuticals May 2010 - March 2013
Octagon Research Solutions August 2006 - May 2010
Skills
eCTD, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, IND, Regulatory Requirements, Documentum, FDA, Sop, Clinical Trials, Therapeutic Areas, GMP, Validation
Education
Temple University
Strategic Capital Consulting Co LLC August 2011 - Present
PJ Fitzpatrick May 2009 - August 2011
Wells Fargo Home Mortgage June 2007 - December 2008
R. H. Cooper, Ltd. August 2004 - June 2007
Coast to Coast Mortgage April 2004 - August 2004
Octagon Research Solutions June 2001 - April 2004
Education
University of Delaware 1996 — 2000
Bachelors, Biology
Accenture (formerly Octagon Research Solutions) October 2012 - Present
Octagon Research Solutions September 2004 - Present
Skills
FDA, IND, Pharmaceutical Industry, Regulatory Submissions, Clinical Trials, Sop, Regulatory Affairs, 21 CFR Part 11, EDC, Validation, GCP, Regulatory Requirements
Education
University of Pittsburgh 2000 — 2004
Bachelor of Science (B.S.), Psychology
Merrill DataSite September 2011 - November 2013
Celerion September 2010 - June 2011
ICON Development Solutions July 2009 - September 2010
Octagon Research Solutions November 2006 - January 2009
Gene Logic Labs- CRO services December 2004 - November 2006
Covance July 1997 - August 2002
Skills
Drug Development, Business Development, Phase I, Clinical Research, Regulatory Affairs, Clinical Pharmacology, Bioanalysis, Biotechnology, Salesforce.com, Clinical Data Management, Clinical Development, Clinical Trials, CRO, Pharmaceutical Industry, Lifesciences, Oncology, FDA, Commercialization, Medical Devices, Technology Transfer, Life Sciences
Education
University of Wisconsin-Madison 1981 — 1986
Bachelor
University of California, San Diego 2002 — 2008
Wauwatosa
Endo Pharmaceuticals February 2010 - Present
Octagon Research Solutions October 2004 - February 2010
Sanofi Pasteur April 2002 - October 2004
ICON Clinical Research July 1998 - April 2002
Skills
eCTD, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, CRO, Clinical Development, Pharmaceutical Industry, Lifesciences, Drug Development, NDA, FDA, IND, Clinical Trials, GCP, Pharmacovigilance, Sop, GxP, 21 CFR Part 11, ANDA, Biopharmaceuticals, CMC
Education
Temple University 1994 — 1998
Bachelor of Science (B.S.), Health Information Management
University of Pittsburgh 1992 — 1994
Octagon Research Solutions May 2009 - Present
RR Donnelley November 1995 - December 2008
CSC Networks November 1993 - November 1995
Albums by Cilmi January 1991 - December 1993
Education
The University of the Arts 1980 — 1981
BFA
University of Maryland College Park 1978 — 1979
Theradex October 2012 - Present
ICON Medical Imaging November 2009 - October 2012
Octagon Research Solutions September 2007 - March 2009
Skills
GCP, SOP, 21 CFR Part 11, FDA, Validation, CRO, GLP, Pharmaceuticals, Clinical, Computer System..., GxP, Regulatory Submissions, Regulatory Requirements, GMP, cGMP, Regulatory Documentation, eCTD, Change Control, EDC, Clinical Research, Pharmaceutical Industry
Education
University at Albany, SUNY 1998 — 2001
B.S., Business Administration
University of New Hampshire - Whittemore School of Business and Economics 1997 — 1998
Mapi Group May 2014 - Present
ReSearch Pharmaceutical Services March 2013 - Present
ReSearch Pharmaceutical Services August 2011 - March 2013
ReSearch Pharmaceutical Services June 2009 - August 2011
PRA International December 2007 - June 2009
Octagon Research Solutions September 2007 - December 2007
Covance June 2006 - August 2007
AAIPharma Services Corp. January 2006 - June 2006
Charles River Laboratories July 2004 - January 2006
AAIPharma Services Corp. November 2001 - July 2004
Skills
Operational Oversight, Financial Planning, Corporate Communications, Clinical Trials, Microbiology, Therapeutic Areas, Strategic Financial..., Quality Assurance, CRO, CTMS, 21 CFR Part 11, Clinical Development, Data Management, GMP, Pharmaceutical Industry
Education
University of North Carolina at Wilmington 1991 — 1995
BS, Biology
Lockheed Martin August 2015 - Present
Ellucian August 2011 - August 2015
Octagon Research Solutions September 2010 - August 2011
SunGard Higher Education October 2008 - September 2010
Duane Morris LLP June 2007 - October 2008
LTK Engineering Services January 1999 - June 2007
CRC Industries October 1992 - December 1994
Griener Engineering Sciences May 1985 - January 1992
TechLaw, Inc. January 1985 - May 1985
Skills
Business Development, Proposal Writing, Project Management, RFP, Leadership, Marketing, Strategy, Program Management, Team Management, Cross-functional Team..., Enterprise Software, Procurement, Sales, Professional Services, CRM, Contract Management, Proposal Leadership, Consulting, SaaS offerings, SaaS
Education
Temple University 1987 — 1992
MBA, Marketing
West Virginia University Institute of Technology 1980 — 1984
Bachelor of Science, Civil Engineering
Recording Industry Association of America November 2014 - Present
Recording Industry November 2010 - October 2014
Recording Industry November 2006 - October 2010
Octagon Research Solutions July 2006 - November 2006
Skills
Microsoft Excel, Budgets, Auditing, Financial Reporting, Financial Analysis, Financial Accounting, Financial Statements
Education
The George Washington University - School of Business 2002 — 2006
Bachelor of Accountancy, Accounting
Accenture Senior Technical AnalystAccenture2013 - Present
Octagon Research Solutions 2011 - 2013
Bucks County Community College September 2009 - June 2011
Quad Systems Inc. 1985 - 1989
Skills
Technical Support, Hardware Deployments, IT Asset Management, VMware Infrastructure, Oracle Fusion Middleware, Remote Troubleshooting, VMware View, IT Hardware Support, Customer Support, Windows 7, Help Desk Support, Virtual Desktop, Mobile Devices, Microsoft Office, Graphic Design, Photoshop, Adobe Acrobat, Storage Management, Process Improvement, Software Documentation, Project Management
Education
Temple University
Bachelor of Science (BS), Electrical Engineering
Villanova University
Master of Science (MS), Computer Science
Pfizer November 2010 - Present
Octagon Research Solutions April 2006 - November 2010
Octagon Research Solutions September 2004 - April 2006
Education
University of Delaware 2000 — 2004
Bachelors