Averion international Corp
Industry: Company
DescriptionHeadquarters: Virginia Founded: 2002 Subsidiaries: Averion International (Switzerland) Ltd,
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Averion international Corp Employees
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
SteepRock Inc March 2010 - Present
Averion International Corp January 2009 - March 2010
Client Associated Business January 2007 - January 2009
Suffolk University 2002 - 2006
Skills
Program Management, Specifications, Quality Assurance, Software Project..., Technical Training, Mentoring New Hires, New Hire Training, Clinical Research, Manage Client..., Customer Retention, Clinical Data Management, Clinical Trials, EDC, Account Management, Pharmaceutical Industry, Oncology, Clinical Development
Education
Suffolk University 2002 — 2006
BA, Psychology
East Lyme High School 1999 — 2002
CBSET, Inc. May 2015 - Present
Cubist Pharmaceuticals February 2013 - Present
Cubist Pharmaceuticals December 2008 - February 2013
Averion International Corp September 2008 - November 2008
Averion International Corp May 2007 - September 2008
Averion International Corp September 2006 - May 2007
Joslin Diabetes Center 2001 - 2006
Skills
Infectious Diseases, Biotechnology, Life Sciences, In Vivo, Pharmacology, Research, Diabetes, Word, Excel, PCR, Microbiology, Animal Models, Microsoft Office, PowerPoint, Science, Lifesciences, Microsoft Word, Microsoft Excel, Drug Development, SOP, Clinical Development, Clinical Trials, GCP, Pharmaceutical Industry, CRO, FDA
Education
University of California, Davis 1998 — 2001
M.S., Animal Science
Cornell University 1994 — 1998
Bachelor of Science (B.S.), Animal Science
Duke Clinical Research Institute December 2014 - Present
Harvard Clinical Research Institute June 2007 - June 2014
Averion International Corp. April 2004 - May 2007
Kendle International, Inc. December 2000 - May 2003
Pfizer March 2000 - December 2000
Skills
Clinical Trials, Clinical Data Management, CRO, CTMS, Respiratory: Diabetes..., Neurological:Repair..., Cardiovascular: MI,..., Central Nervous System:..., Dermatological:..., Genitourinary: CKD,..., Metabolic/Endocrine:..., Musculoskeletal:..., Technical Experience:..., Software: Lotus Notes,..., Software: EDC-Inform,..., Software: Clinflo,..., Software: Linno Color,..., Training: GCP, Clinical..., Software: eCOS-Merge, Affiliations/Memberships...
Education
Providence College
Master of Arts (M.A.), History
University of Connecticut 2003 — 2005
Graduate Studies in the Social Sciences
Southern Connecticut State University
Bachelor of Science (B.S.), Liberal Studies in the Social Sciences
Stanford University
Continuing Studies in the Social Sciences
Booz Allen Hamilton July 2010 - June 2013
Campbell Peachey & Associates December 2009 - July 2010
AVERION INTERNATIONAL CORP December 2007 - September 2008
TECHNICAL RESOURCES INTL August 2006 - July 2007
The Johns Hopkins University, School of Medicine January 1992 - August 2006
St. David's HealthCare May 1986 - September 1991
Skills
Information Technology, Clinical Research, Data Management, HIV, Drug Safety, Adverse Events, Adverse Event Reporting, Pharmacovigilance, Outcomes Research, Healthcare, FDA, Events, Software, Regression Testing, Testing, User Acceptance Testing, Functional Testing, Scrum, Agile Testing, Agile Methodologies, Project Coordination, ICH guidelines, 21 CFR, IND, CRO, Applications, Systems Analysis, System Integration..., Atlassian JIRA, System Testing, SQL, Database Queries, Oracle BPEL, OASIS, Section 508, Metrics, Special Event, Clinical Trials, Data Reconciliation, Abstraction, Medical Terminology, Data Coding, Case Report Forms, Manuals, Hiring Personnel, Government Agencies, Literature Reviews, Report Writing
Education
The University of Texas at Austin
Bachelor of Arts (B.A.), Microbiology, General
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
Sunovion Pharmaceuticals Inc. October 2013 - Present
Sunovion Pharmaceuticals Inc. September 2008 - October 2013
Boston Biomedical Associates July 2007 - September 2008
Averion International Corp 1998 - 2007
Averion Inc 1998 - 2006
Boston Biostatistics Inc 1998 - 2006
Skills
FDA, 21 CFR Part 11, Pharmaceutical Industry, CRO, Sop, Computer System..., Validation, Medical Devices, EDC, Clinical Research, Biotechnology, Clinical Trials, CTMS, Clinical Data Management, Change Control, Data Management, GCP, GMP, GxP, LIMS, Quality Assurance, Quality System, Regulatory Affairs, SDLC, Software Documentation, CAPA
Education
Lock Haven University of Pennsylvania 1991 — 1997
BS, Computer Information Science
ICON plc February 2013 - Present
Boston Biomedical Associates May 2012 - January 2013
Aptiv Solutions October 2004 - May 2012
Averion International Corp. October 2004 - March 2009
Education
Saint Joseph's College 1995 — 1999
B.A., Biology
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
Hoffman Consulting LLC April 2014 - Present
Publicis Touchpoint Solutions November 2013 - March 2014
Numoda Corporation November 2010 - March 2012
Averion International Corp May 2008 - September 2010
Encorium Group, Inc July 2004 - May 2008
Cytogen Corporation July 2000 - January 2003
Liposome Company, Inc March 1998 - July 2000
Sybron Chemicals, Inc April 1988 - July 1997
Skills
Mergers, SEC reporting, Biotechnology, Tax, Contract Negotiation, Life Sciences, IPO, SOX, Budgeting, Financial Analysis, Debt, Internal Controls, Audit, Due Diligence, Compliance, Healthcare, Financial Reporting, Accounting, Administration, Venture Capital, Strategic Planning, Restructuring, Start-ups, Private Equity, Medical Devices, ERP, Divestitures, Investor Relations, Risk Management, Corporate Governance, Pharmaceuticals, Business Planning, Joint Ventures, Auditing, Forecasting, Cash Flow, Contract Management, Insurance, Corporate Finance, Financial Modeling, Financial Management, Cash Management, GAAP, Consolidation, M&A due diligence, Public Companies, Business Strategy, Financial Planning, Acquisition Integration, Corporate Development
Education
Villanova University School of Law 1986 — 1989
LLM, Taxation
Temple University - James E. Beasley School of Law 1979 — 1984
JD, Law
La Salle University - School of Business Administration 1972 — 1976
BS, Accounting
UMass Medical School -- Commonwealth Medicine November 2007 - Present
Averion International Corp December 2006 - November 2007
Genzyme May 2006 - December 2006
Skills
Certified Information..., Certified in Healthcare..., Certified Compliance..., Quality Assurance, Training, Access, Policy, Clinical Research, Security, Sop, Risk Assessment, GMP, Validation, GLP, GCP, Quality Management, Auditing
Education
Park University
Bachelor's of Science, Social Psychology