Averion International
Industry: Company
DescriptionHeadquarters: Virginia Founded: 2002 Subsidiaries: Averion International (Switzerland) Ltd,
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Averion International Employees
Global Capacity January 2015 - Present
Navin Haffty & Associates May 2012 - January 2015
Independent January 2011 - May 2012
Averion International September 2008 - November 2010
Nordson Corporation 2000 - 2008
Nordson EFD 1991 - 2000
Skills
Career Management, Leadership, Cultural Transformation, Global Human Resources..., Talent Management, Employee Relations, Restructuring, Mergers, Recruiting, Organizational..., Change Management, Human Resources, Workforce Planning, Management, Process Improvement, Training, HR Policies, Integration, Budgets, Employee Benefits, Mergers & Acquisitions, Strategy, HRIS, Coaching, Onboarding, Succession Planning, Analysis, Talent Acquisition, Personnel Management, Deferred Compensation, Employee Engagement, Compensation & Benefit, Hiring, New Hire Orientations, Performance Management
Education
Capella University 2005 — 2007
B.S., Business/HR, Summa Cum Laude
Bryant University
HR Certification
Villanova University
HR Certification
Pfizer 2013 - Present
Celgene June 2008 - 2012
Roche Pharmaceuticals March 2008 - May 2008
Averion International December 2006 - March 2008
Lambda Therapeutic Research June 2003 - May 2005
Skills
Bookmarking,Hyperlinking..., Bioavailability, Phase I, Clinical Research, CTMS, Bioequivalence, GCP, ANDA, INDs, ISI Toolbox, Clinical Trials, Regulatory Affairs, Regulatory Submissions, ICH-GCP, CRO, Oncology, eCTD, Biotechnology, Pharmacokinetics, Clinical Operations, IND, BA/BE studies, FDA, Pharmaceutical Industry, Pharmacovigilance
Education
Long Island University 2006 — 2008
Master's Degree, Drug Regulatory affairs
The M. S University of Baroda 1999 — 2003
Bachelor's Degree, Pharmacy
ICON plc July 2015 - Present
ICON plc September 2014 - June 2015
Aptiv Solutions October 2013 - September 2014
Aptiv Solutions April 2012 - September 2013
MCP Clinical Research November 2011 - April 2012
Aptiv Solutions February 2010 - October 2011
Averion International May 2009 - March 2010
Veristat Inc. January 2007 - March 2008
Fresenius Biotech GmbH December 2005 - December 2006
Fresenius Biotech GmbH October 2004 - December 2005
Skills
ICH-GCP, ICF, IND, Drug Development, CRO, IDE, Medical Devices, Oncology, Clinical Research
Education
University of Arizona 1996 — 2000
BS, Nutritional Science, Chemistry
Lavin Consulting LLC July 2013 - Present
Aptiv Solutions Inc October 2010 - July 2013
Aptiv Solutions October 2010 - July 2013
Averion International October 2007 - October 2010
Averion International December 1983 - October 2007
Skills
Biostatistics, Regulatory Affairs, Medical Devices, Oncology, FDA, Cardiology, Clinical Trials, Clinical Development, Lifesciences, Clinical Research, Pharmaceutical Industry, GCP, CTMS, Infectious Diseases, CRO, Biotechnology, 21 CFR Part 11, Regulatory Submissions, Biopharmaceuticals, CDISC, Cancer, Clinical Data Management, Clinical Monitoring, Clinical Study Design, Data Management, Drug Development, EDC, Immunology, Life Sciences, Medical Writing, Medicine, Neurology, Pharmacovigilance, Protocol, Regulatory Requirements, SAS, Statistics, Survival Analysis, Therapeutic Areas, Validation
Education
Brown University 1968 — 1972
PhD, Applied Mathematics
University of Rochester 1964 — 1968
AB, Math
inVentiv Health Clinical July 2014 - Present
Aptiv Solutions August 2013 - July 2014
Aptiv Solutions (formerly Averion International) April 2004 - August 2013
Averion International March 2004 - April 2004
Averion International August 2000 - December 2003
Averion International June 1998 - August 2000
Averion International June 1996 - June 1998
Skills
Clinical Data Management, Clinical Trials, Data Management, EDC, Clinical Research, Inform, CRF design, CRO, Sop, ICH-GCP, CTMS, Oncology, GCP
Education
Northeastern University 1996 — 1998
Certificate, Health Information Administration
Boston College 1988 — 1992
BA, Psychology
Cognizant Technology Solutions July 2012 - January 2014
Pfizer Pharmaceuticals June 2009 - November 2011
Averion International April 2008 - February 2009
Infosys Technologies Ltd 2006 - 2008
Tata Consultancy Services June 2006 - September 2006
Accenture India Private Limited 2003 - 2006
Skills
Clinical Data Management, EDC, Data Management, Oracle Clinical, Clinical Trials, 21 CFR Part 11, ICH-GCP, CRO, CDISC, Validation, CTMS, Pharmaceutical Industry, GCP, SAS, Sop, Clinical Development, Computer System..., Pharmacovigilance
Education
Bangalore University
B.Sc, Biotechnology, Chemistry and Zoology
University of Mysore
Master of Science (M.Sc.), Zoology/Genetics
EMD Serono October 2012 - Present
EMD Serono, Inc. September 2007 - October 2012
EMD Serono September 2004 - September 2007
Averion International September 2003 - February 2004
Biogen Idec October 2001 - September 2003
Biogen Idec November 2000 - October 2001
Biogen Idec December 1998 - November 2000
Biogen Idec September 1996 - December 1998
Fresenius Medical Care May 1995 - September 1996
Skills
Clinical Trials, Pharmaceutical Industry, Biotechnology, Oncology, Drug Development, Immunology, Clinical Development, Biopharmaceuticals, Lifesciences, FDA, Account Management, CTMS, Clinical Research, Infectious Diseases, Medical Affairs, Medical Devices, Medicine, Strategy, Neurology
Education
University of Phoenix 2001 — 2005
Masters in Business Administration, MBA, Business Management
Westfield State College 1990 — 1994
Bachelor of Science (BS), Business Management, Administration, Finance and Accounting
Sarepta Therapeutics May 2012 - Present
Novartis Vaccines & Diagnostics February 2009 - May 2012
Aeris Therapeutics May 2008 - October 2008
Artisan Pharma March 2007 - May 2008
Clinical Assistance Programs 2003 - 2007
Averion International November 2000 - January 2004
Skills
Clinical Research, Clinical Trials, CRO, CTMS, Clinical Development, Drug Development, GCP
Education
Northeastern University
Bachelor of Arts
Bruce R Akins Jr Productions January 2009 - Present
Independence Media/MiND TV October 2014 - November 2014
Premier Research Philadelphia PA May 2008 - May 2009
Averion International November 2007 - May 2008
Immunomedics December 2005 - February 2007
Schering-Plough Research Institute (now Merck) December 2004 - September 2005
Abbott Laboratories May 2004 - November 2004
Pfizer Pharmaceuticals August 2003 - September 2003
PRA International October 2001 - July 2003
Skills
Social Media Marketing, Social Media, Sales, Microsoft Excel, Marketing Strategy, New Business Development, Advertising, Public Relations, Time Management, Project Management, Social Networking
Education
Monmouth University 1995 — 2001
Bachelor's degree, Political Science and Government
Michael B. Bless, Quality Consulting Services LLC September 2013 - Present
Aptiv Solutions, an ICON plc company September 2013 - May 2014
Aptiv Solutions April 2011 - July 2013
Averion International April 2008 - March 2011
ICON plc November 1996 - March 2008
Career break July 1995 - October 1996
Gesellschaft für wissenschaftliche Datenverarbeitung + Didaktik mbH (GWD) January 1990 - June 1995
Skills
CRO, GCP, Pharmaceutical Industry, Clinical Trials, EDC, Auditing, SOP development, CAPA, External Audit, Data Privacy, Supplier Quality..., Oncology, SOP, Quality Assurance, ICH-GCP, Clinical Development, Risk Management, Records Management, Clinical Research, Clinical Monitoring, Pharmacovigilance, Regulatory Affairs
Education
Johann Wolfgang Goethe-Universität Frankfurt am Main 1984 — 1992
University Diploma (MA equivalent)
Vertex Pharmaceuticals August 2015 - Present
Vertex Pharmaceuticals September 2011 - Present
Outcome Sciences November 2010 - September 2011
Averion International November 2007 - October 2010
Averion international Corp December 2002 - November 2007
PAREXEL January 2000 - December 2002
Parexel International Corporation July 1998 - January 2000
PAREXEL June 1996 - July 1998
Skills
Clinical Trials, Oncology, GCP, Clinical Trial..., Clinical Research, Strategic Planning, Clinical Data Management, Contract Negotiation, CRO, Life Sciences, Process Improvement, Change Management, Budget Management, Compliance, Cross-functional Team..., Mergers, Pharmaceuticals, Outsourcing, Operations Management, Clinical Development, EDC, CTMS, Lifesciences, Drug Development, Clinical Monitoring, Biotechnology, Healthcare, Pharmaceutical Industry, Validation, Budgets, Infectious Diseases, Sop, Mergers & Acquisitions, 21 CFR Part 11, Protocol, Oracle Clinical, Data Management, FDA
Education
University College London, U. of London 1992 — 1996
Biotechnology BSc (Hons)
Dulwich College
Sunovion Pharmaceuticals Inc. October 2014 - Present
Aptiv Solutions September 2012 - October 2014
i3 Research / on assignment at Biogen Idec January 2012 - September 2012
Aptiv Solutions July 2011 - January 2012
Aptiv Solutions March 2010 - June 2011
Averion International October 2008 - February 2010
Averion International February 2006 - September 2008
Skills
CRO, Software Documentation, CTMS, EDC, Clinical Operations, Clinical Study Design, GCP, FDA, Clinical Research, Clinical Trials, ICH-GCP, Clinical Monitoring, Sop, 21 CFR Part 11, Pharmaceutical Industry, Therapeutic Areas, Oracle Clinical, Biotechnology, Oncology, Clinical Data Management, Drug Development, Infectious Diseases, IND, Vaccines, Regulatory Affairs, Protocol, Clinical Development, Neurology, Regulatory Submissions, Pharmacovigilance, Data Management, Cardiology, Medical Writing, Lifesciences, Diabetes, Endocrinology
Education
Suffolk University 2001 — 2005
BS, Developmental Psychology
Northeastern University
MS, Regulatory Affairs
Federal Home Loan Bank of Boston September 2014 - Present
Distributed Technology Associates, Inc. July 2010 - September 2014
Distributed Technology Associates, Inc. January 2007 - July 2010
Wolters Kluwer May 2006 - January 2007
SunGard Market Data Services April 2000 - June 2002
Averion International March 1999 - April 2000
Work/Family Directions 1987 - 1996
Skills
Microsoft SQL Server, Disaster Recovery, Software Project..., Data Warehousing, Oracle, Security, Business Analysis, Database Administration, IT Management, SSIS, T-SQL, Data Migration, Database Design, Database Admin, Databases, Crystal Reports, MySQL, Performance Tuning, Agile Project Management, IT Service Management
Education
Clark University 1997 — 1998
Bentley University 1986 — 1990
Keller Williams Realty 2013 - Present
Long & Foster Realtors 2004 - 2013
Averion International 2002 - 2002
Pfizer 1992 - 2002
pfizer 1992 - 2002
Skills
Working with First-time..., Detailed Market..., Recommendations for..., Investing in Real Estate, Helping Relocation..., Thorough Tracking of..., Database of Contractors..., Relocation, Real Estate Transactions, Mortgage Lending, Real Estate, Referrals, Data Management, Sellers, Sop, Move Up Buyers, Short Sales, Condos, Listings, REO
Education
Rensselaer Polytechnic Institute 1993 — 1996
MS, Operations Management
University of Dallas 1983 — 1987
BA, Mathematics
Drury High School 1979 — 1983
Aerotek June 2015 - Present
DOCS September 2013 - June 2015
Boston Scientific April 2002 - August 2013
Averion International June 2000 - March 2002
MedTrials, Inc. February 1998 - May 2000
Skills
CRO, GCP, FDA, Interventional..., Clinical Research, Clinical Monitoring, Medical Devices, Cardiology, Medidata, IRB, CAPA, Trial Management, Inform, CRF design, 21 CFR Part 11, Sop, Clinical Study Design, Protocol, ICH-GCP, Clinical Data Management, Vascular, Peripheral Vascular, Drug Eluting Stents, Coronary Artery Disease, Clinical Cardiology, Angioplasty, Cardiovascular Devices, Oncology, Oracle Clinical, Therapeutic Areas, Neurology, Regulatory Affairs, Infectious Diseases, Medical Writing, Pharmacovigilance, Clinical Operations, Clinical Development, Pharmaceutical Industry, Life Sciences, Healthcare, Management, Clinical Trials, CTMS, EDC, Regulatory Submissions
Education
Indiana University-Purdue University at Indianapolis 1990 — 1994
General Studies
Sunovion Pharmaceuticals Inc. May 2013 - Present
Biogen Idec January 2013 - May 2013
i3 Research/ on assignment at Biogen Idec August 2011 - January 2013
Averion International August 2009 - March 2011
CVS Pharmacy September 2008 - May 2009
Joslin Diabetes Center May 2008 - August 2008
Skills
CTMS, GCP, CRO, Clinical Development, EDC, Clinical Trials, Clinical Monitoring
Education
Stonehill College 2005 — 2009
Bachelor of Science, Neuroscience
KM Design 2002 - Present
Wellesley Education Foundation 2011 - 2014
Averion International 1991 - 2001
Skills
Interior Design, Renovation, Construction, Space-planning, Sustainable Design, Residential Design, Sustainability, Home, Construction Management, Furniture, Interior Architecture, Space planning, Design Research, Space Planning, Residential Homes, Strategic Planning
Education
Simmons Graduate School of Management 1994 — 1996
M.B.A., Business Administration
University of California, Davis 1979 — 1984
Biology
Sallie Mae December 2013 - Present
Upromise / Sallie Mae April 2007 - December 2013
Averion International 2005 - 2007
Averion International 1999 - 2005
Averion International 1998 - 1999
Averion International (Boston Biostatistics) 1994 - 1998
Battelle Ocean Sciences September 1992 - April 1994
Skills
Data Management, Oracle, SDLC, PL/SQL, Data Warehousing, Databases, Data Modeling, ETL, SQL, Database Design, Performance Tuning, Unix, Disaster Recovery, Business Intelligence, Requirements Analysis
Education
Boston University 2011 — 2013
Graduate Certificate in Data Warehouse Design and Business Intelligence
Brandeis University 2002 — 2004
Leadership; Software Development Methodologies
Boston University 1997 — 2001
MS, Computer Information Systems
Gettysburg College 1989 — 1992
BA, Computer Science and Management
IBM October 2012 - Present
IBM January 2012 - October 2012
Emptoris January 2008 - January 2012
Averion International October 2006 - February 2008
Daylor Consulting Group May 2005 - October 2006
US Environmental Protection Agency (EPA) December 2003 - May 2005
Skills
Cloud Computing, SaaS, Enterprise Software, Solution Architecture, Integration, DevOps, Solution Selling, Cloud Security, Pre-Sales Technical..., IaaS, PaaS, Pre-Sales Consulting, Cloud Applications, Agile Methodologies, Private Clouds, B2B software, Big Data, Spend Analysis, SharePoint, Enterprise Architecture, Salesforce.com, IBM SoftLayer, VMware Infrastructure, Java Enterprise Edition, Sales Enablement, Sales Engineering, Enterprise Solution..., Solution Implementation, Cloud Storage, Technical Architecture, Systems Engineering, Cloud Computing IaaS, Technology Integration, Systems Integration, SoapUI, Supply Chain Management, Contract Management, Network Security, Virtualization, Hypervisor, Analytics, Open Source Software, Linux System..., Management, Strategy, ERP, Vendor Management
Education
Northeastern University 2000 — 2005
Bachelor of Science (BS)
Alexion Pharmaceuticals, Inc. September 2014 - Present
Novartis Vaccines and Diagnostics May 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2010 - May 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - July 2010
CombinatoRx Inc. October 2008 - March 2009
CombinatoRx Inc. October 2007 - October 2008
Averion International 2001 - 2007
Averion International July 2004 - September 2006
Averion International February 2003 - July 2004
Averion International April 2001 - February 2003
Skills
Oncology, Biotechnology, Clinical Trials, Clinical Monitoring, EDC, CTMS, CRO, GCP, Pharmaceutical Industry
Education
Suffolk University
MBA, Health/Health Care Administration/Management
University of New Hampshire 1989 — 1993
Bachelor of Science (B.S.), Medical Laboratory Science
Merrimack High School 1985 — 1989
Vertex Pharmaceuticals September 2012 - Present
Quintiles January 2011 - September 2012
Averion International December 2006 - January 2011
Millennium Pharmaceuticals April 2003 - November 2005
Frontier Science March 2000 - April 2003
Quintiles July 1999 - April 2000
Boston Medical Center June 1998 - July 1999
New England Research Institutes November 1996 - June 1999
Vertex Pharmaceuticals 1996 - 1996
Abt Associates 1995 - 1996
Skills
CRO, Clinical Trials, CTMS, Clinical Research, EDC, Clinical Development, Clinical Data Management, GCP, Program Management, Oncology, ICH-GCP, Biotechnology, Process Improvement, Project Planning, Budgets, Sop, Clinical Monitoring, Pharmaceutical Industry, Staff Supervision, Outsourcing, Change Management, Medical Devices, Contract Negotiation, Therapeutic Areas, Outcomes Research, Cross-functional Team..., FDA, Strategic Planning, Vendor Management, Clinical Study Design, Regulatory Submissions, Lifesciences, Medical Affairs, Hematology, Management, IND, Quality Assurance, Protocol, Pharmacovigilance, Drug Development, 21 CFR Part 11, Medical Writing, PMO, Compliance, Regulatory Affairs, Life Sciences, SOP
Education
Boston University 2005 — 2005
PMP
Siena College 1987 — 1992
Bachelor's degree
Boehringer Ingelheim RCV GmbH & Co KG June 2012 - Present
Aptiv Solutions September 2010 - May 2012
Averion International April 2008 - September 2010
Premier Research Group June 2004 - June 2008
Skills
Clinical Monitoring, ICH-GCP, Clinical Trial..., CRO, GCP, Study Start-Up, Pharmacovigilance, Regulatory Requirements, Oracle Clinical, Oncology, CTMS, Regulatory Submissions, Infectious Diseases, EDC, Clinical Research, Neurology, Clinical Trials, Regulatory Affairs, Clinical Operations, Sop, Clinical Study Design, Drug Development, Cardiology, Rheumatology, Medical Writing, Clinical Data Management, Pharmaceutical Industry, Therapeutic Areas, Medical Affairs, Hematology, Diabetes, Clinical Development, Vaccines, Protocol, Inform, Clinical Research..., Endocrinology, Dermatology
Education
National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky 1996 — 2002
Ph.D, Pulmonology
Kyiv Medical Institute 1995 — 2001
MD, Pulmonology
Siemens Healthcare April 2011 - Present
Bayer HealthCare Diabetes Care 2009 - 2011
Averion International 2007 - 2009
IMS Health 2001 - 2005
GCiS China Strategic Research 2000 - 2001
Beijing Jishuitan Hospital 1996 - 2000
Skills
Oncology, Diabetes, SAS, Diagnostics, SQL, VBA, SPSS, Visual Basic, SQL Server, Data Management, Clinical Trials, CRO, EDC, GCP, Clinical Data Management, Medical Devices, Pharmaceuticals, Clinical Research, Biotechnology, CTMS
Education
Beijing Medical University
B.S, Medicine
Peking University
Bachelor of Science (BS), Medicine
Chugai Pharma USA September 2011 - Present
HOFFMANN LA ROCHE June 2007 - September 2011
Averion International September 2006 - June 2007
Millennix Inc. July 2000 - September 2006
Bracco Diagnostics October 1998 - July 2000
Dusa Pharmaceuticals December 1994 - June 1998
Daiichi Pharmaceutical Corporation January 1993 - June 1994
American Cyanamid Company July 1990 - January 1993
McMahon Publishing December 1988 - December 1991
Manhattan Eye Ear & Throat Hospital August 1985 - July 1990
Skills
Global Clinical..., Strategic..., Cross-functional Team..., Oncology, Product Development, Clinical Development, Clinical Operations, Phase 1, Clinical Trials, FDA, CTMS, Clinical Research, Clinical Monitoring, CRO, Pharmaceutical Industry, Protocol, Immunology
Education
Rutgers Center 2011 — 2011
Louisiana State University 1984 — 1988
Master of Science, Physiology
Albany State University 1978 — 1980
Bachelor of Science, Biology
Clarkstown North
UBC - An Express Scripts Company June 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson March 2011 - June 2014
Averion International July 2006 - September 2011
Wyeth Pharmaceuticals 2001 - 2005
Main Line Clinical Labs 1987 - 2001
Skills
Biomarker Discovery, CTMS, Oncology, Clinical Trials, Clinical Research, GCP, Management, Project Management, CRO, Clinical Development, Pharmaceutical Industry, Clinical Monitoring, Medical Devices, Clinical Operations, EDC, Protocol, Therapeutic Areas, Drug Development, ICH-GCP, Infectious Diseases, Regulatory Submissions, CRF design, Clinical Data Management, Pharmacovigilance, Medical Writing, Clinical Study Design, IND
Education
Bryn Mawr Hospital 1986 — 1987
Medical Technology Certification
Mansfield University of Pennsylvania 1982 — 1986
Bachelor of Arts, Biology/Medical Technology
ICON plc May 2014 - Present
Aptiv Solutions January 2011 - May 2014
Averion International November 2005 - December 2010
Millennix Oncology September 1997 - September 2005
Schering-Plough Research Institute September 1990 - September 1997
Skills
Pharmaceutical Industry, Clinical Development, CRO, Oncology, Medicine, Biopharmaceuticals, Clinical Trials, Drug Development, Lifesciences, Biotechnology, EDC, CTMS
Education
Cornell University
BS, MD
MediVector June 2013 - Present
EnVivo Pharmaceuticals December 2011 - June 2013
Clinical Operations Specialist July 2007 - December 2011
Peptimmune March 2002 - July 2007
Averion International January 2001 - March 2002
Genzyme Biosurgery August 1997 - January 2001
New England Baptist Hospital August 1985 - August 1997
Skills
Clinical Development, Clinical Trials, Clinical Research, CRO, Lifesciences, Oncology, Medical Writing, CTMS, Drug Development, Clinical Monitoring, Protocol, Pharmacovigilance, EDC, Clinical Operations, Regulatory Affairs, ICH-GCP, Biopharmaceuticals, Sop, Vaccines, IND, Medical Devices, Neurology, GCP, Pharmaceutical Industry, Therapeutic Areas, Cross-functional Team..., Regulatory Submissions, Drug Discovery, Biotechnology, FDA, Immunology, Infectious Diseases
Education
University of Massachusetts Boston
BS, Biology
New Hampshire Technical Institute
AD, Nursing - RN
Aeras December 2012 - Present
Aeras January 2011 - December 2012
Averion International September 2008 - December 2010
Skills
GCP, EDC, Clinical Research, Sop, Process Improvement, Data Management, Budgets, Clinical Operations, MS Project, Clinical Trials, CTMS, CRO, Clinical Development, Clinical Study Design, Infectious Diseases, Medical Devices, ICH-GCP, Vaccines
Education
Frederick Community College 2012 — 2015
Associate's degree, Registered Nursing/Registered Nurse
University of Maryland Baltimore County 2004 — 2008
Bachelor's degree, Psychology
Deciphera Pharmaceuticals September 2014 - Present
AlloCure May 2012 - September 2014
Molecular Insight Pharmaceuticals March 2011 - May 2012
Averion International September 2009 - March 2011
Bard Electrophysiology July 2008 - May 2009
Biogen Idec July 2006 - July 2008
Biogen Idec July 2005 - July 2006
Biogen Idec July 2002 - July 2005
Phase Forward March 2000 - July 2002
Quintiles July 1996 - February 2000
Skills
Clinical Monitoring, Clinical Data Management, Clinical Trial..., ICH-GCP, EDC, Clinical Research, GCP, Clinical Trials, CTMS, CRO, CRF design, Inform, Protocol Development, Patient Recruitment, Medical Writing
Education
Boston University
Bachelor of Science, Biomedical Laboratory and Clinical Sciences (summa cum laude)
The University of Connecticut
Ecology & Evolutionary Biology
University of Wisconsin-Madison
Engineering
Wilton High School
YPrime May 2014 - Present
F.M. Consulting February 2009 - Present
Frontage Laboratories, Inc May 2013 - January 2014
Jubilant Life Sciences Ltd April 2011 - January 2013
Medtox Laboratories May 2007 - June 2009
Averion International September 2001 - May 2007
Quintiles May 1998 - September 2001
Skills
CRO, Technology Transfer, Biotechnology, Clinical Trials, Clinical Development, Data Management, Drug Discovery, Drug Development, Pharmaceutical Industry, Clinical Research, Biopharmaceuticals, Medical Devices, GCP, Oncology, Lifesciences, Strategic Alliances, CTMS, Life Sciences, Regulatory Affairs, Infectious Diseases, Sop, Regulatory Submissions, Business Development, New Business Development, FDA, Pharmacovigilance, Regulatory Requirements, EDC, REMS, Integration, Business Intelligence, Testing
Education
Framingham State College
ICON plc June 2015 - Present
Boston Biomedical Associates October 2014 - June 2015
Aptiv Solutions August 2011 - October 2014
Averion International September 2010 - August 2011
Averion International June 2007 - August 2010
smith&jones January 2009 - April 2009
Skills
Clinical Data Management, EDC, CRO, Clinical Trials, SQL, Public Speaking, Computer System..., CRF design, Oncology, CTMS, CDISC, GCP, Validation, Data Management, Clinical Development, Clinical Research, Pharmaceutical Industry
Education
Northeastern University 2007 — 2010
Bachelor of Arts, Communication Studies/Media Studies
DePuy Synthes Spine June 2009 - Present
DePuy Spine May 2004 - June 2009
DePuy Spine June 2001 - May 2004
Averion International June 1996 - June 2001
MDCI June 1993 - June 1996
EMD Serono, Inc. January 1993 - June 1993
Private Healthcare Systems June 1992 - January 1993
Skills
Clinical Development, Biotechnology, Clinical Research, Clinical Study Design, Regulatory Submissions, Regulatory Affairs, Oncology, Pharmaceutical Industry, PMA, 21 CFR Part 11, Validation, Biostatistics, Clinical Trials, Data Management, Orthopedic, FDA, SAS, Biomedical Engineering, Medical Devices, Clinical Data Management, EDC
Education
University of Massachusetts Lowell 1991 — 1993
M.S., Statistics
University of Massachusetts Dartmouth 1987 — 1991
B.S., Mathematics w/ Computer Science Minor
Bridgewater-Raynham Regional High School 1984 — 1987
HS, college bound, 9-12
Self December 2012 - Present
Novella April 2009 - November 2012
Averion International July 2006 - December 2008
CRA Self employed January 2005 - June 2006
Clinical Cardiovascular Research April 2002 - November 2004
Skills
CTMS, Clinical Trials, GCP, CRO, Infectious Diseases, Pharmaceutical Industry, Therapeutic Areas, ICH-GCP, Clinical Operations, Regulatory Submissions, Clinical Data Management, Regulatory Affairs, Medical Devices, IRB, Pharmacovigilance, Clinical Research, Protocol, Clinical Monitoring, Biotechnology, Oracle Clinical, Drug Development, Vaccines, Medidata, CRF design, Inform, IND, Hematology, Medical Writing, Patient Recruitment
Education
University of Alabama at Birmingham 1994 — 1996
MPH, Epidemiology
Michigan State University
JD
Data ForeThought May 2014 - June 2015
Policy Analysis Inc. June 2011 - May 2014
Ariad Pharmaceuticals April 2006 - September 2010
Averion International April 2000 - April 2006
Skills
SAS programming, Credit for 3 Actuary..., Teaching experience...
Education
McGill University
Bachelor of Arts (B.A.), Mathematics and Statistics
Worldwide Clinical Trials August 2014 - Present
Forest Research Institute July 2009 - April 2014
Research Dynamics Consulting Group October 2007 - May 2009
Averion International June 2006 - September 2007
Hoffmann-La Roche 1988 - 2006
Skills
Oncology, CTMS, Clinical Trials, Hematology, Clinical Monitoring, Infectious Diseases, Clinical Development, EDC, GCP, ICH-GCP, Clinical Operations, CRO, Biotechnology, FDA, Therapeutic Areas, Pharmacovigilance, Clinical Research, Clinical Data Management, Pharmaceutical Industry, Drug Development, Sop, Oracle Clinical, Endocrinology, Medical Writing, Regulatory Submissions, SOP
Education
Nazareth College 2005 — 2009
MS
Wagner College 1979 — 1983
BS
Sancilio & Company, Inc. (SCI) January 2005 - Present
Averion International 2004 - 2008
AAIPharma 1979 - 2002
Applied Analytical Industries (AAI) 1979 - 2002
Burroughs Wellcome Company 1976 - 1979
Skills
Product Development, Pharmaceutical Industry, Validation, R&D, CRO, FDA, Contract Negotiation, Lifesciences, Drug Development, Quality System, Quality Assurance, Biotechnology, Technology Transfer, Analytical Chemistry, Competitive Analysis, New Business Development, Cross-functional Team..., Sop, Chemistry, Pharmaceutical Sales, GMP, Medical Devices, CMC, Strategy, Leadership, GLP, CAPA, Marketing Strategy, NDA, Clinical Development, Strategic Planning, Regulatory Affairs, Team Building, Business Development, Chromatography, HPLC, Pharmaceutics, Licensing, Laboratory, Clinical Trials, Account Management, Product Launch, Sales Management, Biopharmaceuticals, 21 CFR Part 11, Change Control, Commercialization, ANDA, Regulatory Submissions, Organic Chemistry
Education
Rutgers, The State University of New Jersey-Newark 1969 — 1974
Ph.D., Analytical Chemistry & Physical Chemistry
Shire Pharmaceuticals April 2014 - Present
Shire Pharmaceuticals March 2012 - April 2014
Shire Pharmaceuticals May 2010 - March 2012
BioBridges, LLC October 2009 - August 2010
Infinity Pharmaceuticals November 2009 - April 2010
Altus Pharmaceuticals October 2008 - September 2009
Altus Pharmaceuticals March 2008 - October 2008
AMAG Pharmaceuticals August 2006 - March 2008
Averion International October 2005 - August 2006
Skills
Biostatistics, Clinical Trials, Clinical Research, SAS, FDA, CRO, Data Analysis, Regulatory Submissions, Study Design, CDISC, Protocol Development, Statistical Programming, EDC, Clinical Study Design, 21 CFR Part 11, Clinical Data Management, Clinical Development, Protocol
Education
Harvard T.H. Chan School of Public Health 2000 — 2002
MS, Biostatistics
Worcester Polytechnic Institute 1996 — 2000
BS, Actuarial Mathematics
Pratt & Whitney July 2011 - Present
Trade Wings August 2009 - July 2010
Averion International September 2008 - September 2009
Acronis Inc April 2006 - September 2008
Resources Global Professionals May 2005 - September 2006
Skills
Strategic Planning, Executive Management, Board of Directors, Corporate Finance, Mergers, Acquisition Integration, Operations Management, Financial Modeling, Start-ups, Business Strategy, Investments, Restructuring, Budgets, Business Development, Mergers & Acquisitions, Entrepreneurship, Business Process..., Leadership, Strategic Financial..., Management, Strategy, Financial Analysis, Finance, Cross-functional Team..., Venture Capital, Corporate Development, Competitive Analysis, M&A experience, Due Diligence, Private Equity, Business Planning, Valuation, Management Consulting, Internal Controls, Consulting, Risk Management, Sarbanes-Oxley Act, Emerging Markets, Auditing, Program Management, Analysis, Project Management, Product Management, Strategic Partnerships, Process Improvement, New Business Development, Marketing Strategy, Portfolio Management, Negotiation, Business Analysis
Education
Massachusetts Institute of Technology - Sloan School of Management 2010 — 2011
MBA, Finance
Massachusetts Institute of Technology - Sloan School of Management 2010 — 2011
Master of Business Administration (M.B.A.), Finance and Financial Management Services
Merck August 2012 - Present
Merck Sharp & Dohme June 2010 - Present
Merck Sharp & Dohme June 2009 - June 2010
Averion International April 2008 - June 2009
sanofi-aventis 2006 - 2008
Skills
Clinical Trials, Clinical Trial..., Clinical Research, Pharmaceutical Industry, CTMS, Clinical Development, Regulatory Submissions, EDC, ICH-GCP, Sop, GCP, CRO, Oncology, Cardiology, Clinical Monitoring, Medical Affairs, SOP
Education
Pécsi Tudományegyetem 2000 — 2006
Medical Doctor
WCCT Global February 2015 - Present
ePharmaSolutions September 2011 - June 2014
SiteAvail, Inc. November 2002 - June 2013
ClinTec International 2007 - 2008
Afferenz 2006 - 2007
SCIREX Corporation 2005 - 2005
LifeTree Technologies 2001 - 2002
Averion International 1998 - 2001
IBRD 1997 - 1998
Pharmaceutical Research Plus 1996 - 1997
Skills
Sales, Listening, Clinical Development, Strategic Partnerships, CRO, Clinical Research, Clinical Trials, CRM, Pharmacology, Pharmaceutical Industry, Proposal Writing, New Business Development, EDC, Patient Recruitment, CTMS, Biotechnology, Lifesciences, Business Development, Healthcare, Cross-functional Team..., Account Management
Education
University of Hartford 1983 — 1987
BA, Double Major in Biology and Economics
Kelly Services January 2010 - Present
Kelly Services January 2010 - June 2012
Manpower August 2009 - January 2010
The Judge Group January 2006 - July 2009
RCA Research 2009 - 2009
RCA Research April 2005 - January 2006
Averion International March 1997 - April 2005
Kforce - Hall Kinion 1996 - 1997
United States Department of Defense 1993 - 1996
United States Marine Corps 1989 - 1994
Skills
Talent Acquisition, Pharmaceutical Industry, Technical Recruiting, Recruiting, Start-ups, Strategic Planning, Project Management, Strategy, Sourcing, Vendor Management, Management, Risk Management, Outsourcing, New Business Development, Leadership, Coaching, Analysis, Business Development, Process Improvement, Change Management, Consulting, Mergers & Acquisitions, Security, Entrepreneurship, Sales, Negotiation, Sales Operations, Enterprise Software, Marketing, CRM, Professional Services, Training, Temporary Placement, Executive Search, Talent Management, Contract Recruitment, Applicant Tracking..., Internet Recruiting, Staffing Services, Information Technology, Temporary Staffing, Finance, Executive Management, Benefits Negotiation, Human Resources, Performance Management, Permanent Placement, Interviews, College Recruiting, Onboarding
Education
University of Alabama
Major: Political Science
Hippocratic Solutions LLC March 2008 - Present
Averion International 2007 - 2008
Huntingdon Life Sciences 2006 - 2007
PAREXEL 2005 - 2006
Image Solutions, Inc. 2000 - 2005
Skills
Medical Billing, Podiatry, Insurance Billing, Credentialing, Practice Management, Physician Practice..., Insurance Claims, EHR, EMR, Physician Billing, Medical Coding, Insurance, Billing, Healthcare, Revenue Cycle, HIPAA, Strategic Planning, Surgery, Business Strategy, Medicare, Business Planning, Hospitals, Healthcare Management, Healthcare IT, Account Management, Customer Relations, Team Building, Cardiology, Oncology, Consultative Selling, Cold Calling, Sales Management, Radiology, Life Sciences, Biotechnology, Pharmaceuticals, Claims, Healthcare Industry, Healthcare Consulting, Managed Care, Internal Medicine, Orthopedics, Urology, Dermatology, Pharmaceutical Industry, Physicians, Surgeons, Revenue Cycle Management, Physician Relations, Wound Care
Education
Rutgers University-New Brunswick 1995 — 2000
BA, Communications
L-3 Communications July 2012 - Present
Broadleaf Services January 2012 - July 2012
Salient Surgical Technologies, Inc. April 2010 - January 2012
INFRAREDX November 2007 - May 2010
Averion International 2002 - 2007
BioTransplant Inc 1996 - 2002
US EPA January 1991 - 1996
Skills
Process Improvement, Disaster Recovery, Integration, Strategy, ERP, Project Management, SAP, Business Continuity, Program Management, Change Management, Product Development, ISO, Medical Devices, Sarbanes-Oxley Act, Manufacturing, Global Experience, Networking, Management, Vendor Management, Information Technology, Leadership, Cross-functional Team..., Security, Strategic Planning, Consulting, Training, Team Building, Software Documentation, System Deployment, IT Operations, IT Service Management, Cloud Computing, Hardware, Budgets, Sales, Troubleshooting, Infrastructure, Enterprise Software, Business Intelligence, IT Strategy, Analysis, Business Analysis, FDA, SharePoint, Windows Server, System Administration, VMware, Quality Assurance, Leadership Mentoring, Strategic Visionary
Education
Walden University 2013 — 2014
Doctor of Business Administration, Information Technology
University of Massachusetts Boston 2002 — 2004
MBA, Business, Information Technology
University of Massachusetts Lowell 2002 — 2004
MBA, Business
Northeastern University 1991 — 1996
BS/BA, Information Technology
L-3 Communications May 2015 - Present
Medtronic Advanced Energy LLC (Salient Surgical Technologies, Inc.) January 2011 - May 2015
Averion International Corp. May 2005 - January 2011
Massachusetts State Police Crime Lab - DNA Unit June 2004 - 2007
Averion International July 2005 - June 2006
Biogen Idec 2003 - 2004
Workgroup Technology 1999 - 2004
Workgroup Technology 1999 - 2004
Skills
Validation, Training, Management, FDA, Clinical Trials, Clinical Data Management, Medical Devices, Disaster Recovery, Manufacturing, Data Management, Help Desk Support, SharePoint, Change Control, GMP, Quality Assurance, Process Improvement, Visio, Biotechnology, Integration, Vendor Management, EDC, CRO, Clinical Research, Cross-functional Team..., Lifesciences, 21 CFR Part 11
Education
Northeastern University 2003 — 2005
MS, Bioinformatics
Saint Anselm College 1989 — 1992
BA, Biology, Chemistry
Organogenesis April 2006 - September 2014
Vertex Pharmaceuticals 2005 - 2006
Averion International 2003 - 2004
Organogenesis Inc. 1994 - 2002
Organogenesis Inc. 1992 - 1994
Skills
Biotechnology, Clinical Trials, Lifesciences, Oncology, Infectious Diseases, Pharmaceutical Industry, Immunology, Medical Devices, Clinical Development, GCP, CTMS, Clinical Research, Drug Development, FDA, Life Sciences, Medical Affairs
Education
Boston University 1987 — 1991
Bachelor's Degree, Biology
* 2011 - Present
Spyglass Hill Condominium Association 2011 - Present
IntrinsiQ, LLC 2010 - 2011
Averion International 2008 - 2010
Symbiance 2005 - 2008
Skills
Pharmaceutical Industry, Clinical Research, SAS, Data Analysis, Clinical Trials, Statistics, Biostatistics, Data Management, SPSS, Oncology, Research, Lifesciences, Biotechnology, Healthcare, Quality Assurance, Management, CRO, Project Management, Medical Devices
Education
Carnegie Mellon University
B.S., Statistics
Quintiles Outcome: Real World and Late Phase Research February 2011 - Present
Outcome Sciences, Inc. January 2010 - February 2011
Averion International November 2008 - December 2009
Altus Pharmaceuticals December 2007 - October 2008
Altus Pharmaceuticals July 2007 - November 2007
Averion International September 2006 - June 2007
Averion Inc. July 2005 - August 2006
Averion Inc. March 2004 - July 2005
Averion Inc. April 2002 - March 2004
Averion Inc. August 2000 - March 2002
Skills
Clinical Trials, CRO, CDISC, Biostatistics, Clinical Data Management, Oncology, EDC, Clinical Research, Clinical Development, Pharmaceutical Industry, Biotechnology, Infectious Diseases, Data Management, Lifesciences, SAS, GCP, SAS programming, Statistical Programming
Education
Boston University 1995 — 1997
MPH, Biostatistics and Epidemiology
Brandeis University 1987 — 1991
BA, Psychology
CHAT 1983 — 1986
Novartis Influenza Vaccines January 2015 - Present
Novartis Vaccines September 2013 - December 2014
Novartis Vaccines and Diagnostics July 2012 - September 2013
Novartis Vaccines and Diagnostics May 2011 - July 2012
Novartis Vaccines and Diagnostics March 2010 - May 2011
Novartis Vaccines and Diagnostics November 2007 - March 2010
Artisan Pharma, Inc. June 2007 - November 2007
Genzyme 2005 - 2007
Averion International 2003 - 2004
Averion International 2000 - 2003
Skills
Vaccines, International Project..., Line Management, Clinical Monitoring, Infectious Diseases, Clinical Trial..., Pharmaceutical Industry, Biopharmaceuticals, Neurology, Health Economics, Clinical Operations, Clinical Trials, Clinical Research, Pharmacovigilance, Management, Clinical Development, Biotechnology, Regulatory Submissions, EDC, CTMS, CRO, Process Improvement, Therapeutic Areas, Outsourcing, Drug Development, GCP, ICH-GCP
Education
Boston University 2000 — 2002
MPH
Clark University 1993 — 1997
Bachelor's degree
Veristat February 2014 - Present
Veristat Inc. July 2011 - Present
Veristat May 2009 - July 2011
Veristat January 2007 - May 2009
Averion International 2004 - 2007
Skills
Biotechnology, Biostatistics, CDISC, CRF design, CRO, Clinical Data Management, Clinical Development, Clinical Research, Clinical Study Design, Clinical Trials, EDC, FDA, GCP, Infectious Diseases, Oncology, Pharmaceutical Industry
Education
Bryant University 2009 — 2011
Master of Business Administration (M.B.A.)
Boston University 2000 — 2004
Bachelor of Arts (BA), Mathematics and Statistics
Boston University
Master of Arts (MA), Mathematics and Statistics
ARIAD Pharmaceuticals, Inc. January 2015 - Present
ARIAD Pharmaceuticals, Inc. January 2013 - January 2015
ARIAD Pharmaceuticals, Inc. February 2011 - January 2013
Prometrika June 2008 - January 2011
Stryker Biotech January 2008 - June 2008
Stryker biotech April 2007 - December 2007
Averion International August 2004 - April 2007
Skills
Clinical Development, Clinical Research..., CRO, Pharmaceutical Industry, CTMS, Clinical Operations, Clinical Research, Clinical Trials, GCP, Medical Writing, FDA, EDC, Clinical Monitoring, Biotechnology
Education
MGH Institute of Health Professions 2008 — 2010
Masters, Clinical Investigation
Holliston High School
Saint Anselm College
ICON plc May 2014 - Present
Aptiv Solutions January 2012 - May 2014
Aptiv Solutions March 2009 - January 2012
Averion International 2009 - 2011
Genesis Counseling Services, Inc. May 2006 - March 2009
Averion International December 2007 - February 2009
Averion International May 2006 - December 2007
Averion Inc. April 2004 - May 2006
Skills
CTMS, EDC, Clinical Trials, Clinical Monitoring, Clinical Research, Clinical Operations, CRO, GCP, ICH-GCP, Therapeutic Areas, Protocol, Sop
Education
Framingham State University 2003 — 2006
MA, Counseling
Framingham State University 1999 — 2003
BA, Psychology
Framingham High School 1995 — 1999
Diploma
Board of Health Commission January 2014 - Present
Alexion Pharmaceuticals May 2009 - Present
PharmaSUG November 2013 - June 2014
Lincoln College of New England January 2011 - December 2013
PAREXEL May 2008 - July 2009
Quanticate October 2007 - May 2008
Averion International October 2006 - October 2007
DM-STAT, Inc. May 2003 - October 2006
Skills
Clinical Trials, SAS, SAS programming, Biostatistics, Oncology, CDISC, Clinical Data Management, Clinical Research, Epidemiology, CRO, Statistical Programming, Data Management, Statistics, Clinical Development, EDC, Programming, Oracle Clinical, Infectious Diseases, SAS Certified Base..., CTMS, Diabetes, Drug Development, GCP, Protocol, SDTM, Sop, SAS Certified Platform..., Java, R, Python, VBA, SAS Programming
Education
Boston University 2014 — 2016
Master's Degree, Health Informatics
Boston University 2003 — 2006
Master's Degree, Biostatistics
St. John's University, The Peter J. Tobin College of Business 1995 — 1999
Bachelor's Degree, Business Management
Averion International Senior Research Assistant IIJoslin Diabetes CenterMarch 2001 - September 2006
Education
Cornell University 1994 — 1998
PRA Health Sciences August 2013 - Present
PRA Health Sciences November 2012 - Present
PRA Health Sciences September 2009 - November 2012
PRA Health Sciences September 2007 - September 2009
Averion International January 2007 - September 2007
Averion International August 2006 - January 2007
Millennix December 2005 - August 2006
PPD October 2003 - October 2005
Omnicare Clinical Research (Contractor) January 2003 - August 2003
Skills
Clinical Data Management, EDC, CDISC, CRO, Medidata, Oracle Clinical, Oncology, SDTM, Project Management, Vendor Management, Databases, Data Management, CRF design, Sop, ICH-GCP, GCP
Education
The College of Saint Rose
BA, Biology
PRA Health Sciences May 2010 - Present
Averion International 2009 - 2010
Metropolitan Research Associates August 2007 - September 2009
MDS Pharma Services October 2004 - April 2007
Endpoint Research 2007 - 2007
Kendle International 2001 - 2004
Premier Research 2000 - 2001
i3 Research August 1999 - August 2000
i3 Research August 1997 - August 1999
Skills
CTMS, Clinical Monitoring, CRO, Clinical Research, Clinical Data Management, GCP, Clinical Trials, Vaccines, Pharmaceutical Industry, Clinical Research..., Therapeutic Areas, ICH-GCP, Oncology, EDC, Clinical Development
Education
County College of Morris 1985 — 1988
A.A.S./RN, Nursing
Semmelweis Egyetem 1978 — 1981
medicine
Bethany College 1977 — 1978
Boston Biomedical Associates August 2014 - Present
Boston Biomedical Associates July 2010 - Present
Boston Scientific September 2008 - July 2010
Averion International July 2001 - September 2008
BioChem Pharma November 2000 - June 2001
AAI Development Services 1999 - 2000
Children's Hospital of Michigan 1991 - 1999
Children's Hospital of Michigan 1991 - 1999
Laventhol & Horwath 1985 - 1990
Skills
Medical Devices, CAPA, Clinical Trials, GCP, CTMS, Clinical Development, CRO, Pharmaceutical Industry, FDA, Clinical Research, EDC, Biotechnology, Clinical Operations, Project Management, Clinical Research..., Employee Training
Education
Michigan State University 1983 — 1985
BA - Communications & Human Resources, Communications and Human resources
Macomb Community College 1979 — 1983
Assoc ofApllied Science - Business, Business/Communicagion
Novartis November 2013 - Present
Novartis August 2012 - November 2013
Aptiv Solutions 2008 - August 2012
Averion International 2006 - 2008
Averion International 2003 - 2006
Education
Howard University
BS
University of Hartford
MA
PAREXEL February 2013 - Present
PAREXEL March 2005 - Present
Averion International May 2009 - February 2010
Hewlett-Packard Financial Services October 1999 - February 2005
Glaser Advertising April 1988 - December 1996
Skills
Contract Negotiation, Management, Business Development, Negotiation, Proposal Writing, Vendor Management, Cross-functional Team..., Project Management, Purchasing
Education
Bryant University
Central Connecticut State University
Marketing
eClinical Solutions March 2011 - Present
eClinical Solutions October 2010 - March 2011
eClinical Solutions September 2006 - October 2010
ARS June 2005 - September 2006
Medway Animal Hospital March 2004 - August 2005
J&J Depuy January 2004 - February 2004
EMD Serono April 2002 - February 2003
Averion International August 1999 - March 2002
PAREXEL April 1997 - July 1999
Skills
EDC, CRO, 21 CFR Part 11, Clinical Trials, Data Management, Pharmaceutical Industry, Sop, SDLC, FDA, Medidata, Oncology, Clinical Data Management, Project Management, Computer System..., Phase I, Biotechnology, CDISC, Clinical Research, Lifesciences, GCP, CTMS, Oracle Clinical, Clinical Development, ICH-GCP, Validation
Education
Framingham State University 1990 — 1994
Northeastern University
Consultant June 2015 - Present
PRA Health Sciences December 2014 - June 2015
Genentech December 2008 - November 2014
i3 Research April 2008 - December 2008
Quintiles May 2006 - April 2008
PRA International April 2004 - May 2006
PRA International July 2002 - April 2004
Sepracor February 2002 - June 2002
Averion International May 2001 - April 2002
Skills
Oncology, Clinical Research, EDC, CTMS, ICH-GCP, Ophthalmology, Clinical Operations, Clinical Research..., Clinical Trials, GCP, CRO, Clinical Monitoring, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, SOP, Protocol, FDA, Clinical Data Management
Education
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (BS), Biology, General
Eastern Connecticut State University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
rEVO Biologics June 2013 - Present
Biogen Idec Hemophilia January 2012 - June 2013
Covidien May 2011 - January 2012
Covidien September 2008 - May 2011
Averion International Corp. March 2008 - September 2008
Averion International January 2004 - March 2008
PPD June 2001 - November 2003
Dana-Farber Cancer Institute 1999 - 2001
Skills
Clinical Trials, Clinical Research, Oncology, Pharmaceutical Industry, Clinical Development, EDC, Clinical Operations, CRO, Clinical Research..., GCP, CTMS, Biotechnology
Education
Mount Holyoke College 1995 — 1999
Sepracor October 2005 - Present
Biogen 2004 - 2005
Averion International March 2004 - August 2004
Biogen October 2003 - February 2004
Abt Associates January 2003 - October 2003
Millenium Pharmaceuticals June 2002 - October 2002
AAI Development Services June 2000 - June 2002
VA Medical Center October 1998 - June 2000
New England Research Institutes July 1997 - July 1998
Children's Hospital Boston June 1995 - July 1997
Education
Boston University 1993 — 1995
MPH, Health Education
Syracuse University 1989 — 1993
BA, Psychology, Public Policy (health)
Aptiv Solutions November 2010 - Present
Averion International 2001 - 2010
Skills
CRO, Clinical Development, Clinical Trials, Therapeutic Areas, Oncology, IND, Drug Development, Pharmaceutical Industry, Vaccines, Clinical Research, Phase I, Biotechnology, Sop, FDA, Protocol, Lifesciences, Patient Recruitment, Science, Biologics, R&D, EDC, Clinical Study Design, Validation, GCP, Clinical Monitoring, CTMS, Clinical Data Management
Education
University of Medicine and Dentistry of New Jersey
Doctor of Philosophy (PhD)
Averion International February 1998 - May 2005
Education
University of Rhode Island 1987 — 1991
bs, nutrition
CorInsights January 2013 - Present
Aptiv Solutions August 2008 - January 2013
ADVANCED IMMUNE THERAPEUTICS 2008 - 2012
Averion International August 2009 - September 2010
United Therapeutics 2002 - 2008
AltaRex 1999 - 2002
Abbott Diagnostics 1996 - 2000
Abbott Laboratories 1996 - 1999
Rhone Poulenc Rorer 1986 - 1991
GlaxoSmithKline 1972 - 1986
Skills
Pharmaceutical Industry, Biotechnology, CRO, Clinical Development, Medical Devices, Marketing Strategy, Marketing Communications, New Business Development, Business Strategy, Marketing Management, Product Marketing, Sales & Marketing..., International Sales, Strategic Consulting, Clinical Trials, Business Development, Clinical Research, Strategy, Oncology, Immunology, Lifesciences, Drug Development, FDA, EDC, Commercialization, Clinical Operations, Biopharmaceuticals, Leadership, Marketing, Pharmaceutics, Dermatology, Cardiology, GCP, CTMS, Infectious Diseases, Vaccines, Therapeutic Areas, Regulatory Submissions, Technology Transfer, Drug Discovery, Clinical Monitoring, Regulatory Affairs, IND, ICH-GCP
Education
Drexel University - College of Business and Administration 1967 — 1972
Marketing, Management, Labor Relations
Harvard Business School
Strategic Marketing Management Program for Executives
Dartmouth College - The Tuck School of Business at Dartmouth
Pharmaceutical Marketing
Ascentiant International Corp 2007 - Present
FraXon Technologies Inc 2010 - 2011
Averion International July 1996 - May 2007
IT&E International 1996 - 2007
Tech Aid 1979 - 1992
Skills
Start-ups, Strategic Planning, FDA, Medical Devices, 21 CFR Part 11, Business Management, Management, Cross-functional Team..., Regulatory Affairs, Process Improvement, New Business Development, Product Management, Pharmaceutical Industry, Mergers & Acquisitions, Quality System, Strategy, Quality Assurance, Business Development, Business Planning, Forecasting, Project Management, Validation, Software Documentation, Executive Management, Program Management, Leadership, Sourcing, Business Process..., Vendor Management, Outsourcing, Consulting, Change Management, Technical Recruiting, Training, Talent Acquisition, CRM
Education
University of Maryland College Park 1961 — 1971
Bachelor of Arts (B.A.), Political Science and Government
Long Island University, Southampton Campus
Mystic Valley Elder Services February 2007 - Present
Insperity February 2005 - February 2007
Averion International 2001 - 2004
Globeset, Inc. 1996 - 2000
UniSQL 1991 - 1994
Execucom 1988 - 1991
Linpro of TX 1981 - 1986
Skills
Case Managment, Human Resources, Program Development, Nonprofits, Medicaid, Social Services, Crisis Intervention, Community Outreach, Home Care, Healthcare Management, Fundraising, Hospitals, Research, Recruiting, Psychotherapy, Healthcare, Training, Mental Health, Treatment, Nursing, Coaching, Customer Service, Elder Care
Education
Eastern Michigan University 1975 — 1976
MA, Ed, Guidance, Counseling and Personel
Syracuse University 1970 — 1973
A.B, Social Services
Binghamton Central High
Questex LLC August 2007 - Present
Sycamore Networks February 2007 - August 2007
Averion International May 1996 - January 2007
Brewster Wallcovering June 1991 - May 1996
Ernst & Young July 1987 - May 1990
KPMG Peat Marwick July 1985 - June 1987
Skills
Financial Analysis, Budgets, Mergers, Acquisition Integration, Sarbanes-Oxley Act, Financial Reporting, Accounting, SEC filings, Strategic Planning, Revenue Recognition, Forecasting, Process Improvement, Strategic Financial..., GAAP, QuickBooks, Treasury Management, Budget Models, Auditing, Invoicing, Financial Statements, Financial Accounting, Internal Controls, Financial Modeling, Finance, CPA, Accounts Payable, Cash Management
Education
Bentley University 1981 — 1985
Bachelor of Science (B.S.), Accountancy
Oxford Performance Materials, Inc. July 2014 - Present
Cedarledge Enterprise, LLC September 2010 - Present
Premier Research December 2010 - July 2014
Cornerstone Therapeutics October 2008 - January 2014
Warburg Pincus May 2010 - December 2010
Oncopartners April 2008 - August 2010
Averion International December 2006 - April 2008
SCIREX Corporation 2002 - 2006
Skills
Biotechnology, Business Development, Clinical Development, CRO, Due Diligence, Finance, Leadership, Medical Devices, Mergers, Mergers, Oncology, Pharmaceutical Industry, Pharmaceutics, Private Equity, Clinical Trials
Education
The University of Connecticut School of Business 1997 — 1999
MBA, Finance
Fairfield University 1986 — 1990
BS, Accounting
Synta Pharmaceuticals June 2015 - Present
Biogen Idec August 2012 - June 2015
Green Key Resources May 2012 - August 2012
Dyax October 2011 - May 2012
Outcome Life Sciences August 2011 - October 2011
Prometrika LLC May 2008 - August 2011
Averion International September 2006 - May 2008
Radionics 2005 - 2006
Skills
Clinical Trials, EDC, CDISC, Oracle Clinical, SAS, CRF design, Clinical Data Management, Data Management, 21 CFR Part 11
Education
University of Massachusetts at Lowell 1994 — 2002
BS, Industrial Management
Biogen Idec April 2014 - Present
PAREXEL September 2011 - April 2014
Averion International July 2007 - September 2011
AAI Pharma August 2005 - July 2007
AAI Pharma August 2001 - August 2005
Skills
Clinical Data Management, EDC, CRO, Inform, Oracle Clinical, Clinical Trials, GCP, CTMS, Data Management, CRF design, ICH-GCP, Oncology
Education
Framingham State University 1998 — 2002
Cogstate July 2015 - Present
CRI Lifetree November 2012 - Present
Wake Research Associates March 2015 - July 2015
PRA Health Sciences January 2013 - February 2015
Lifetree Clinical Research November 2008 - November 2012
Averion International June 2008 - November 2008
Paragon Biomedical 2006 - 2008
Skills
Central Nervous System, Biotechnology, CRO, Medical Devices, Clinical Development, CTMS, EDC, Oncology, GCP, Drug Development, Clinical Monitoring, ICH-GCP, Infectious Diseases, Neurology, Therapeutic Areas, Cardiology, Clinical Trials, Clinical Data Management, Pharmaceutical Industry, Protocol, Phase 1, New Business Development, Networking
Education
Elon University 1994 — 1999
Bachelor Science, Business Administration
Elon University - Martha and Spencer Love School of Business 1994 — 1999
Bachelor, Business Administration
Medtronic October 2014 - Present
Covidien July 2013 - October 2014
Covidien September 2011 - July 2013
Covidien June 2008 - September 2011
Averion International September 2006 - May 2008
Averion International January 2004 - September 2006
Chiron Corporation June 1998 - August 2002
Skills
Clinical Trials, EDC, Clinical Development, GCP, CTMS, CRO, FDA, Biotechnology, Pharmaceutical Industry, Medical Devices, Clinical Monitoring, Lifesciences, Clinical Research, ICH-GCP, Clinical Data Management, Regulatory Affairs, Sop, 21 CFR Part 11, Drug Development
Education
The College of Wooster
Bachelor's Degree, Biochemistry
Collegium Pharmaceutical February 2014 - Present
Repligen Corporation April 2011 - July 2013
Repligen Corporation August 2007 - April 2011
Repligen Corporation July 2005 - August 2007
Averion International March 2004 - July 2005
Atlanta Center for Medical Research 2000 - February 2004
Skills
Clinical Trials
Education
Fairfield University 1991 — 1995
Bachelor of Arts (B.A.), Psychology Major, Math Minor, Graduated cum laude
Vertex Pharmaceuticals March 2013 - Present
Sallie Mae July 2011 - December 2012
Averion International February 2009 - July 2011
Averion International October 2006 - February 2009
Averion International January 2004 - September 2006
Averion International November 2000 - December 2003
Skills
Data Management, 21 CFR Part 11, C#, ASP.NET, Crystal Reports, PL/SQL, Oracle RDBMS, VMware, SharePoint, Clinical Trials, Citrix, Firewalls, SQL, JavaScript, HTML, UNIX, NAnt, Oracle Forms, Toad
Education
Bentley College
MBA, Finance Concentration
Northeastern University
BS, Civil Engineering
Aptiv Solutions June 2011 - Present
Averion International August 2005 - May 2011
Averion Inc. August 2002 - July 2005
Boston Biostatistics August 1998 - July 2002
Epidemiology Resources Inc. September 1996 - August 1998
Skills
CDISC, Biostatistics, GCP, Statistics, Clinical Data Management, SAS programming, Clinical Trials, SAS, CRO, Clinical Development, EDC
Education
Boston University
MA, Biostatistics
The University of Hong Kong
Bachelor of Arts (B.A.), English and Economics
Ascensus December 2013 - Present
Upromise, a subsidiary of Sallie Mae May 2011 - December 2013
Averion International June 2000 - April 2011
Work Technology Corporation 1999 - 2000
Brookline Schools Staff Children's Center 1990 - 1999
Education
Boston University 1998 — 1999
Certificate, Client Server
Wheelock College
MS, Education, Administration
University of Massachusetts, Amherst 1977 — 1978
BA, Education, Human Services
Boston College 1973 — 1976
Education
Guilford High School 1969 — 1974
Acerta Pharma B.V. July 2015 - Present
Roche Molecular Systems June 2014 - June 2015
Independent SAS Consultant March 2014 - May 2014
Novartis August 2011 - March 2014
Thomson Reuters May 2010 - August 2011
Accenture Services May 2009 - April 2010
Averion International October 2008 - April 2009
SDC Clinical February 2008 - September 2008
SDC Clinical February 2007 - October 2007
Skills
SAS, Python, SQL, Unix, Pharmaceutical Industry, Data Analysis, CRO, Oracle, Clinical Trials, PL/SQL, Data Warehousing, Clinical Data Management, SAS Programming, Analysis, SAS Certified Base..., Data Management, Programming, GCP, Databases, CDISC
Education
Bradley University 2005 — 2007
M.S, Engineering
Kakatiya University 2001 — 2005
B. Tech, Engineering
Gowtham
Alexion Pharmaceuticals, Inc. January 2015 - Present
ICON plc August 2014 - October 2014
Aptiv Solutions August 2011 - October 2014
Averion International September 2007 - August 2011
Skills
Clinical Trials, CTMS, CRO, GCP, EDC, FDA, Clinical Research, ICH-GCP, Pharmaceutical Industry, Oncology, Clinical Data Management, Clinical Development, Training, Protocol, Biotechnology, 21 CFR Part 11, Microsoft Office, SOP, Medical Devices, Clinical Monitoring, Regulatory Affairs, Data Management, Life Sciences
Education
Providence College 1994 — 1998
B.A., History, Anthropology
Kimball Union Academy 1993 — 1994
Weston High School 1989 — 1993
Quintiles May 2015 - Present
PPD April 2013 - November 2014
Veristat, Inc November 2008 - April 2013
Averion International September 2008 - October 2008
Abt Associates April 2008 - August 2008
Johnson & Johnson April 2007 - April 2008
CIGNA Healthcare October 2006 - April 2007
Skills
Clinical Trials, Biostatistics, Oncology, SAS, SAS programming, Cancer, Data Analysis, Survival Analysis, CDISC, CRO, Validation, EDC, Infectious Diseases, Vaccines, Immunology, Clinical Study Design, Clinical Development
Education
University of North Texas Health Science Center at Fort Worth 2004 — 2006
MPH, Biostatistics
Maharashtra University of Health Sciences 2001 — 2004
M.D, Internal Medicine
Maharashtra University of Health Sciences 1995 — 2001
B.A.M.S., Ayurveda Medicine and Surgery
Sapient Global Markets June 2015 - Present
Commonwealth Care Alliance March 2014 - June 2015
Commonwealth Care Alliance June 2012 - March 2014
Partners HealthCare June 2010 - June 2012
State Street November 2009 - June 2010
State Street November 2007 - November 2009
Averion International 2006 - 2006
Skills
Microsoft Excel, Access, Financial Modeling, Financial Analysis, SQL, P&L Analysis, Finance, Financial Accounting, Analysis, Data Warehousing, Budgets, Business Analysis, Medicare, Medicaid, Data Analysis, Financial Reporting, Insurance, Process Improvement
Education
University of California, Davis 2003 — 2006
BS, Managerial Econonmics
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
Candidate for Master of Business Administration (MBA)
Clinical Research Consulting, Inc. April 2012 - Present
Syndax February 2009 - February 2012
Averion International 2006 - December 2008
Genzyme 1996 - 2006
PAREXEL 1993 - 1995
Massachusetts Eye and Ear 1988 - 1993
Skills
EDC, Pharmaceuticals, Clinical Monitoring, Clinical Trial..., GCP, CRO, Infectious Diseases, CTMS, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, ICH-GCP, Oncology, Clinical Data Management, Clinical Trials, Clinical Research, Drug Development
Education
University of Massachusetts, Amherst 1984 — 1988
BA, zoology
Veristat, Inc. 2007 - Present
Red Sky Sound December 2005 - Present
Averion International 1998 - 2007
Ernst & Young February 1988 - July 1998
Education
Southern Illinois University, Carbondale 1980 — 1985
BS, Radio-Television
FORUM Pharmaceuticals July 2015 - Present
FORUM Pharmaceuticals (formerly EnVivo Pharmaceuticals) December 2013 - June 2015
AVEO Oncology January 2013 - December 2013
AVEO Pharmaceuticals January 2011 - December 2012
AVEO Pharmaceuticals March 2009 - December 2010
Acusphere, Inc. July 2004 - February 2009
Averion International June 2000 - July 2004
Skills
Oncology, Clinical Development, Clinical Trials, Medical Writing, Drug Development, Medicine, Biotechnology, Pharmaceutical Industry, FDA, IND, CTMS
Education
University of California, Los Angeles
MS, MPH, microbiology & immunology, public health
University of Virginia
BA, Biology
Contract July 2015 - Present
Lantheus Medical Imaging September 2014 - July 2015
Telerx (formerly Sentrx) December 2012 - September 2014
AMAG Pharmaceuticals July 2012 - October 2012
Cell Therapeutics, Inc. November 2011 - June 2012
EMD Serono August 2010 - November 2011
Averion International October 2009 - August 2010
PAREXEL International March 2007 - October 2009
SkinCare Physicians October 2005 - March 2007
Boston EMS 1995 - October 2005
Skills
Clinical Trials, GCP, Regulatory Affairs, Pharmaceutical Industry, Pharmacovigilance, Clinical Research, Oncology, Clinical Development, CTMS, FDA, Drug Safety, CRO, Biotechnology, Sop, Medical Devices, Cardiology, 21 CFR Part 11, Biopharmaceuticals, Clinical Data Management, Clinical Operations, Drug Development, GLP, GxP, ICH-GCP, IND, Infectious Diseases, MedDRA, Medical Affairs, Medical Writing, Medicine, Neurology, Pharmaceutics, Regulatory Submissions, Therapeutic Areas, SOP
Education
Northeastern University 2008 — 2010
MS, Regulatory Affairs for Drugs, Devices, and Biologics
Altra Industrial Motion 2008 - Present
Averion International March 2007 - August 2008
MacroChem Corp. June 2001 - March 2007
Summit Technology, Inc. September 1999 - May 2001
Holland & Knight LLP 1997 - 1999
Nutter McClennen & Fish LLP 1993 - 1997
Skills
Mergers, Compliance, Contract Negotiation, Corporate Law, Litigation
Education
Boston College Law School 1989 — 1992
J.D., Law
Providence College 1984 — 1988
B.S., Physics
Rutgers University January 2011 - Present
Regis College 2010 - Present
GlaxoSmithKline 2007 - Present
Boston University School of Medicine 2007 - Present
Drexel University College of Medicine 2006 - Present
Northeastern University 2005 - 2012
PAREXEL 2004 - 2007
Phase Forward 1999 - 2004
Averion International 1998 - 1999
Becton Dickinson Transdermal Systems 1996 - 1997
Skills
Clinical Research, GCP, Clinical Trials, Clinical Development, Training, Pharmaceutical Industry, Biotechnology, Oncology
Education
Fairleigh Dickinson University
M.B.A., Management
Saint Joseph's University
B.S., Biology
Wagner College
M.S., Microbiology
Boston Biomedical Associates July 2012 - Present
Boston Biomedical Associates August 2010 - July 2012
Boston Biomedical Associates September 2006 - August 2010
Averion International January 1999 - September 2006
Seragen December 1997 - July 1999
MTRA 1995 - 1997
PAREXEL 1992 - 1995
Skills
Quality Auditing, EDC, Quality Assurance, Clinical Research, 21 CFR Part 11, Validation, GCP, Clinical Trials, Clinical Data Management, SAS Programming, Quality System, SAS programming, Vaccines, Cardiology, Oncology, CRO, GMP, Data Management, Sop, Pharmaceutical Industry
Education
Northeastern University
MS, Engineering Mgmt, CIS
University of Rhode Island
BS, Industrial/Manufacturing Engineering
Aptiv Solutions, an ICON pic company July 2011 - Present
Averion International November 2008 - July 2011
Education
Gubkin Russian State University of Oil and Gas (former Moscow State Academy of Oil and Gas) 1983 — 1988
Akebia Therapeutics March 2015 - Present
Alkermes August 2013 - March 2015
AVEO Pharmaceuticals February 2012 - June 2013
Vertex Pharmaceuticals May 2010 - February 2012
Charles River Laboratories October 2006 - May 2010
Averion International 2004 - 2006
ImmunoGen, Inc. 1997 - 2004
Skills
GLP, 21 CFR Part 11, Quality Assurance, Sop, FDA, Validation, CAPA, GxP, Drug Discovery, CRO, Change Control, Clinical Trials
Education
Harvard University
MLA, Biology
University of Massachusetts, Amherst
BS, Animal Science
PAREXEL International May 2014 - Present
PAREXEL International December 2013 - Present
PROMETRIKA January 2008 - December 2013
Averion International June 2006 - December 2007
Skills
Project Management, EDC, Pharmaceutical Industry, Clinical Data Management, Data Management, GCP, Therapeutic Areas, Oncology, Clinical Development, 21 CFR Part 11, Oracle Clinical, CRO, Clinical Trials, Biotechnology, Clinical Monitoring, Regulatory Submissions, Quality Assurance, SAS, Sop, Medical Devices, ICH-GCP, Validation, CDISC, Budgets, Biostatistics, Clinical Research, CTMS, Drug Development, Vaccines, FDA
Education
Clark University 1984 — 1988
Bachelor of Arts (BA), Mathematics and Education
Clinical Assistance Programs June 2015 - Present
Veristat October 2013 - June 2015
PAREXEL November 2011 - September 2013
PAREXEL May 2011 - October 2011
PAREXEL March 2010 - April 2011
Clinquest, Inc. July 2008 - November 2008
Averion International December 2007 - February 2008
Charles River Laboratories 2002 - 2007
Skills
CRO, EDC, Clinical Trials, GCP, Clinical Research, CTMS, Biotechnology, ICH-GCP, GLP, Sop, Lifesciences, FDA, ELISA, SOP
Education
Albright College 1997 — 2001
BS, Biochemistry
Averion International 2008 - 2010
Averion International 2006 - 2008
Premier Research Group July 2006 - September 2006
Averion International 2002 - 2006
Heart & Vascular Institute of Florida 1998 - 2002
Education
Florida State University 1972 — 1975
BSN
Averion International October 2007 - August 2010
CardioCare LLC January 2003 - October 2007
The Washington Clinic, Chtd. October 1994 - January 2003
Solano Dermatology Associates November 1991 - June 1993
Harvard University School of Public Health February 1986 - February 1987
The Alcoholism Council of Contra Costa, Inc. June 1984 - June 1985
Herrick Hospital June 1982 - June 1983
Beth Israel Hospital June 1980 - June 1982
Skills
Clinical Trials, GCP, Cardiology, Clinical Research, EDC, Primary Care, Physicians, Medicine, Nursing, Clinical Monitoring, Patient Education, CTMS, Budgets, Oncology, ICH-GCP, Hospitals, Clinical Development, CRO, Surgery
Education
University of California, Berkeley 1983 — 1985
MPH, Behavioral Sciences
Northeastern University 1974 — 1980
BSN, Nursing
Aptiv Solutions June 2011 - Present
Averion International August 2010 - June 2011
Averion International February 2002 - August 2010
Averion International May 2007 - July 2008
Averion International May 2006 - July 2008
Corporate Health Resources (CHR), Inc. April 2001 - November 2001
Chestnut Lodge Hospital February 1996 - April 2001
Comprehensive Health Services November 1987 - May 1991
Skills
Clinical Trials, GCP, Clinical Research, Software Documentation, Data Analysis, MedDRA, Sop, FDA, Data Entry, Protocol, Management, Clinical Data Management, EDC, CTMS, CRO, Quality Assurance, ICH-GCP, Oracle Clinical, SOP
Education
North Carolina Central University 1976 — 1980
Registered Nursing/Registered Nurse
Biogen Idec June 2014 - Present
Biogen Idec February 2013 - May 2014
Averion International September 2010 - February 2013
Veristat, Inc. March 2008 - September 2010
Averion International January 2006 - February 2008
Averion International January 2001 - January 2006
PAREXEL January 1996 - January 2001
Education
Clark University 2005 — 2006
CCA, Medical Coding
Massachusetts College of Pharmacy and Health Sciences 1983 — 1988
BS, Pharmacy
Biogen 2014 - Present
Biogen 2012 - 2014
Biogen Idec 2002 - 2012
Averion International 1999 - 2002
New England Research Institutes, Inc. (NERI) 1994 - 1999
Education
Colgate University 1986 — 2000
BA, Psycology
Yale University 1992 — 1994
MPH, Biostatistics
PAREXEL INFORMATICS April 2009 - Present
PAREXEL INFORMATICS October 2006 - April 2009
Metatomix June 2006 - October 2006
Empirix September 2005 - June 2006
Empirix September 2004 - September 2005
PAREXEL INFORMATICS February 2003 - August 2004
Paperspace (Formerly Paperexchange) October 2000 - February 2003
Averion International June 2000 - October 2000
Newton-Wellesley Hospital September 1999 - June 2000
MEDITECH July 1998 - September 1999
Skills
21 CFR Part 11, Process Improvement, Project Management, Computer System..., Cross-functional Team..., Validation, Data Management, SDLC, Strategic Planning, Six Sigma, Strategy, Software Project..., Business Intelligence, Project Portfolio..., Release engin, Release Management, SQL, Windows, Oracle Applications, Oracle, SSH, XML, Linux, Remote Desktop, SVN, IT Management, Application Architecture, Application Lifecycle..., Management, Databases
Education
Babson College - Franklin W. Olin Graduate School of Business
Master of Business Administration (M.B.A.)
University of Massachusetts, Amherst 1992 — 1996
Bachelors of Science, Biology
Vertex Pharmaceuticals August 2011 - Present
Parexel International January 2011 - July 2011
Genzyme April 2002 - December 2010
Averion International 2001 - 2002
PAREXEL 1998 - 2001
Skills
Clinical Data, EDC, Clinical Data Management, Clinical Trials, GCP, 21 CFR Part 11, CRO, CDISC, Clinical Development, Oracle Clinical, ICH-GCP, CRF design
Education
Boston University 1996 — 1998
B.S, Biology
Elmira College 1994 — 1996
Biology
EMD Serono, Inc. May 2008 - Present
Molecular Insight Pharmaceuticals July 2007 - April 2008
EMD Serono, Inc. March 2000 - June 2007
Averion International July 1998 - February 2000
Education
Boston University
Master of Public Health (M.P.H.), Biostatistics and Epidemiology
Providence College
Bachelor of Science (B.S.), Biology, General
Sideris Pharmaceuticals May 2014 - Present
Idenix Pharmaceuticals October 2003 - April 2014
Averion International March 2000 - October 2003
Skills
Clinical Development, Drug Development, CRO, Clinical Research, Clinical Trials, Infectious Diseases, CTMS, Lifesciences, Drug Discovery, GCP, Clinical Monitoring, Pharmaceutical Industry, Oncology, FDA, Regulatory Submissions, Biotechnology, Therapeutic Areas, Life Sciences
Education
Boston College 1991 — 1995
B.S., Biology
Northborough Public School Disrict 2014 - Present
Leominster Public School District 2012 - 2014
Quintiles Transnational 2010 - 2012
Boston Scientific 2008 - 2010
Averion International 1998 - 2008
Skills
EDC, Clinical Data Management, Clinical Data, CRO, GCP, Clinical Trials, Oracle Clinical
Education
Bridgewater State College 1988 — 1992
Bachelor of Arts and Science, Communication Disorders
Abbott Vascular January 2010 - Present
ClinOps 2009 - 2009
Averion International 2008 - 2009
Kinemed Inc 2007 - 2007
Louisiana Tech University 2006 - 2007
Skills
Oracle Clinical, SAS programming, CDISC, Clinical Trials, SAS, Biostatistics, Statistical Programming, Clinical Data Management, GCP, 21 CFR Part 11, SAS Programming, Validation, Data Analysis
Education
Louisiana Tech University 2005 — 2007
MS, Biomedical Engineering
Osmania University 2001 — 2005
Bachelors, Biomedical Engineering
Shirisha Vidya Niketan
Triangle Clinical Trial Mgmt September 2006 - Present
Rho 2009 - 2012
Omeros Corporation 2008 - 2011
Averion International 2007 - 2009
Medifacts International 2004 - 2006
Inveresk Research 2000 - 2004
Duke University Medical Center July 1996 - May 2000
Education
University of North Carolina at Chapel Hill 1994 — 1996
Bachelor's degree, Registered Nursing/Registered Nurse
University of North Carolina at Chapel Hill 1988 — 1992
Bachelor's degree, Biology, General
Cyber-Ark Software May 2013 - Present
Sophos Plc July 2009 - April 2013
Sophos Plc June 2008 - July 2009
Sophos Plc March 2007 - June 2008
Averion International October 2006 - March 2007
IT Consultant June 2004 - September 2006
Skills
CompTIA A+ Certification, Information Security, Advanced Troubleshooting, Enterprise Anti-Virus, Server Management, Microsoft WIndows, Technical Support, Software Installation, Servers, Troubleshooting, Windows, Security, Antivirus, Computer Security, Sophos, Help Desk Support, Software Documentation, SaaS, VMware, Computer Hardware, Operating Systems, TCP/IP, DNS, Enterprise Software, Cloud Computing, Network Security, System Deployment, Data Center, Encryption, Virtualization, Testing, Active Directory, Networking, Windows Server, Firewalls, Linux, Microsoft Exchange
Education
Clark University 2001 — 2001
PC Service and Support, Information Technology, Passed
UMass Dartmouth 1999 — 2000
Mechanical Engineering
Atlantic Union College 1997 — 1999
Accounting and Business/Management, 3.9 GPA