Aptiv Solutions
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Aptiv Solutions Employees
Employee
Years
Job
Industry
Keith Mortara Keith Mortara's Aptiv Solutions Experience November 2007 - February 2012
Job Clinical Database Programmer at Ocular Therapeutix, Inc.
Industry Information Technology and Services
Experience
Ocular Therapeutix, Inc. June 2014 - Present
Veristat Inc. February 2012 - June 2014
Aptiv Solutions November 2007 - February 2012
Mortara Systems Solutions 1997 - 2006
Bayer Pharmaceuticals 1997 - 2002
Avalon Software 1995 - 1997
Voss Family Farm 1977 - 1981
Skills
Database Administration, Data Management, GCP, Clinical Trials, Computer System..., Clinical Data Management, Databases, ERP, Software Development, CDISC, CRO, 21 CFR Part 11, Oracle Clinical, ICH-GCP, Inform, Clinical Development, Protocol, FDA
Education
University of Arizona 1981 — 1983
N/A, Math, Science
Ocular Therapeutix, Inc. June 2014 - Present
Veristat Inc. February 2012 - June 2014
Aptiv Solutions November 2007 - February 2012
Mortara Systems Solutions 1997 - 2006
Bayer Pharmaceuticals 1997 - 2002
Avalon Software 1995 - 1997
Voss Family Farm 1977 - 1981
Skills
Database Administration, Data Management, GCP, Clinical Trials, Computer System..., Clinical Data Management, Databases, ERP, Software Development, CDISC, CRO, 21 CFR Part 11, Oracle Clinical, ICH-GCP, Inform, Clinical Development, Protocol, FDA
Education
University of Arizona 1981 — 1983
N/A, Math, Science
Elizabeth Booth Elizabeth Booth's Aptiv Solutions Experience 2013 - 2013
Job Executive Administrative Assistant at CPI Radant Technologies
Industry Mechanical or Industrial Engineering
Experience
CPI Radant Technologies July 2015 - Present
Ball Financial Services April 2014 - Present
Aptiv Solutions 2013 - 2013
Skills
Administrative..., Microsoft Office, Writing, Proofreading, Editing, Communication Skills, Client Liaison, Customer Service, Travel Arrangements, Calendars, Trade Promotions, Data Entry
Education
School of Visual Arts 1994 — 1996
Master of Fine Arts (MFA), Illustration
University of Pennsylvania 1985 — 1988
Bachelor of Arts (BA), History of Art
Mount Holyoke College 1984 — 1985
Middlesex School 1981 — 1984
CPI Radant Technologies July 2015 - Present
Ball Financial Services April 2014 - Present
Aptiv Solutions 2013 - 2013
Skills
Administrative..., Microsoft Office, Writing, Proofreading, Editing, Communication Skills, Client Liaison, Customer Service, Travel Arrangements, Calendars, Trade Promotions, Data Entry
Education
School of Visual Arts 1994 — 1996
Master of Fine Arts (MFA), Illustration
University of Pennsylvania 1985 — 1988
Bachelor of Arts (BA), History of Art
Mount Holyoke College 1984 — 1985
Middlesex School 1981 — 1984
Martin Valania, CQA, CQM, PMP Martin Valania, CQA, CQM, PMP's Aptiv Solutions Experience January 2012 - December 2014
Job Sr. Vice President, Quality Assurance at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions January 2012 - December 2014
Pharmanet February 2003 - October 2011
MEXEX July 1998 - January 2001
Covance June 1996 - July 1998
Skills
Process Improvement, Quality Assurance, GCP, CRO, Auditing, Clinical Development, EDC, Regulatory Submissions, Clinical Research, CTMS, 21 CFR Part 11, Regulatory Affairs, FDA, Quality System, Quality Auditing, CAPA, Sop, Data Management, Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, GLP, Biopharmaceuticals, Pharmaceutics, GMP, Drug Development, Biotechnology, Clinical Data Management, Vaccines, SOP
Education
Penn State University
BS, Chemical Engineering
Aptiv Solutions January 2012 - December 2014
Pharmanet February 2003 - October 2011
MEXEX July 1998 - January 2001
Covance June 1996 - July 1998
Skills
Process Improvement, Quality Assurance, GCP, CRO, Auditing, Clinical Development, EDC, Regulatory Submissions, Clinical Research, CTMS, 21 CFR Part 11, Regulatory Affairs, FDA, Quality System, Quality Auditing, CAPA, Sop, Data Management, Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, GLP, Biopharmaceuticals, Pharmaceutics, GMP, Drug Development, Biotechnology, Clinical Data Management, Vaccines, SOP
Education
Penn State University
BS, Chemical Engineering
Dan Diaz Dan Diaz's Aptiv Solutions Experience January 2013 - May 2013
Job TIE Consulting Services bringing together Technology, Innovation and Excellence
Industry Pharmaceuticals
Experience
TIE Consulting Services September 2015 - Present
SPRI Clinical Trials June 2013 - September 2015
Aptiv Solutions January 2013 - May 2013
Consultant, CRO and Investigator Solutions October 2012 - May 2013
Beardsworth Consulting Group Inc. January 2007 - October 2012
MDS Pharma Services, Late Stage Development 2004 - 2006
PPD 1998 - 2004
HillTop Research 1996 - 1998
IMTCI 1994 - 1996
Marion Merrell Dow 1986 - 1994
Skills
CRO, Clinical Development, CTMS, Clinical Trials, Pharmaceutical Industry, Oncology, Clinical Monitoring, Drug Development, Endocrinology, Technology Transfer, Drug Discovery, Regulatory Submissions, FDA, Data Management, Vaccines, Validation, Biotechnology, Business Development, Commercialization, Consulting, EDC, Urology, Regulatory Affairs, Pharmaceutics, GCP, Clinical Research, Account Management, Protocol, ICH-GCP, Medical Writing, Infectious Diseases, 21 CFR Part 11, CRM, Sales Operations, Sop, Neurology, Diabetes, Medical Devices, Biopharmaceuticals, Lifesciences, Cross-functional Team..., Pharmacology, Clinical Operations, Therapeutic Areas, Cardiology, Pharmacovigilance, Sales, New Business Development, Clinical Data Management, Dermatology
Education
University of Central Missouri 1982 — 1986
Bachelor’s Degree, Business Administration
Kirkwood High School 1978 — 1982
TIE Consulting Services September 2015 - Present
SPRI Clinical Trials June 2013 - September 2015
Aptiv Solutions January 2013 - May 2013
Consultant, CRO and Investigator Solutions October 2012 - May 2013
Beardsworth Consulting Group Inc. January 2007 - October 2012
MDS Pharma Services, Late Stage Development 2004 - 2006
PPD 1998 - 2004
HillTop Research 1996 - 1998
IMTCI 1994 - 1996
Marion Merrell Dow 1986 - 1994
Skills
CRO, Clinical Development, CTMS, Clinical Trials, Pharmaceutical Industry, Oncology, Clinical Monitoring, Drug Development, Endocrinology, Technology Transfer, Drug Discovery, Regulatory Submissions, FDA, Data Management, Vaccines, Validation, Biotechnology, Business Development, Commercialization, Consulting, EDC, Urology, Regulatory Affairs, Pharmaceutics, GCP, Clinical Research, Account Management, Protocol, ICH-GCP, Medical Writing, Infectious Diseases, 21 CFR Part 11, CRM, Sales Operations, Sop, Neurology, Diabetes, Medical Devices, Biopharmaceuticals, Lifesciences, Cross-functional Team..., Pharmacology, Clinical Operations, Therapeutic Areas, Cardiology, Pharmacovigilance, Sales, New Business Development, Clinical Data Management, Dermatology
Education
University of Central Missouri 1982 — 1986
Bachelor’s Degree, Business Administration
Kirkwood High School 1978 — 1982
Kristen Henderson Kristen Henderson's Aptiv Solutions Experience November 2012 - August 2013
Job at
Industry Oil & Energy
Experience
Subseaology, LLC May 2014 - Present
Medical Metrics, Inc. September 2013 - April 2014
Aptiv Solutions November 2012 - August 2013
The University of Texas Health Science Center at Houston August 2011 - October 2012
Baylor College of Medicine November 2010 - August 2011
Quintiles November 2009 - October 2010
Quintiles October 2008 - November 2009
ABC Laboratories 2006 - 2008
Skills
Clinical Trials, GCP, Clinical Monitoring, IRB, Clinical Research, Infectious Diseases, Medical Devices, GLP, Sop, CRO, FDA, Pharmaceutics, SOP, Vaccines
Education
University of Florida 2009 — 2010
Master of Science (M.S.), Pharmacy
Missouri State University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
Subseaology, LLC May 2014 - Present
Medical Metrics, Inc. September 2013 - April 2014
Aptiv Solutions November 2012 - August 2013
The University of Texas Health Science Center at Houston August 2011 - October 2012
Baylor College of Medicine November 2010 - August 2011
Quintiles November 2009 - October 2010
Quintiles October 2008 - November 2009
ABC Laboratories 2006 - 2008
Skills
Clinical Trials, GCP, Clinical Monitoring, IRB, Clinical Research, Infectious Diseases, Medical Devices, GLP, Sop, CRO, FDA, Pharmaceutics, SOP, Vaccines
Education
University of Florida 2009 — 2010
Master of Science (M.S.), Pharmacy
Missouri State University 2001 — 2005
Bachelor of Science (B.S.), Biology, General
Melanie Crystal's Aptiv Solutions Experience October 2013 - September 2014
Job Director, Project Management at ICON plc
Industry Biotechnology
Experience
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
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
Julie Scott, RN, BSN, MBA's Aptiv Solutions Experience November 2011 - Present
Job CRA II at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions November 2011 - Present
PPD May 2010 - October 2011
Advanced Liver Therapies February 2007 - May 2010
Skills
GCP, CRO, Clinical Research, Protocol, Sop, Clinical Monitoring, CTMS, EDC, ICH-GCP, Clinical Trials, Clinical Development, Oncology, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry, Infectious Diseases, Cardiology, Endocrinology
Education
Texas Woman's University 2008 — 2009
MBA, Business
Aptiv Solutions November 2011 - Present
PPD May 2010 - October 2011
Advanced Liver Therapies February 2007 - May 2010
Skills
GCP, CRO, Clinical Research, Protocol, Sop, Clinical Monitoring, CTMS, EDC, ICH-GCP, Clinical Trials, Clinical Development, Oncology, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry, Infectious Diseases, Cardiology, Endocrinology
Education
Texas Woman's University 2008 — 2009
MBA, Business
Philip Lavin PhD Philip Lavin PhD's Aptiv Solutions Experience October 2010 - July 2013
Job Principal Consultant at Lavin Consulting LLC
Industry Pharmaceuticals
Experience
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
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
Louis Delouiser, PMP, CSM Louis Delouiser, PMP, CSM's Aptiv Solutions Experience November 2011 - June 2012
Job Managing Director, Technology at NeoSystems Corp
Industry Information Technology and Services
Experience
NeoSystems Corp February 2014 - Present
NeoSystems Corp January 2013 - Present
Merlin International June 2012 - December 2012
Merlin International, Inc. June 2012 - December 2012
Aptiv Solutions November 2011 - June 2012
Aptiv Solutions 2011 - 2012
Mission Essential Personnel, LLC March 2010 - November 2011
Deltek, Inc. October 2007 - March 2010
konvrgence, inc. February 2003 - October 2007
Lucent 2004 - 2005
Skills
PMP, Certified Scrum Master..., SQL database design, Deltek Costpoint, Web Services Integration, SharePoint 2010, Cognos, DBA, Taleo Recruiting,..., Salesforce.com, SQL Reporting, Performance Point, Governance and..., Disaster Recovery, Oracle, Weblogic, VMWare, Deltek Cobra &..., Deltek Time, Expense..., .NET Framework and..., Web Development, JD Edwards, Sterling Commerce EDI, Microsoft Dynamics, Epicor, Microsoft CRM, ITIL, Solution Architecture, Strategic Planning, Technology..., Call center start-up, Call Center..., Salesforce.com System..., Call Center Development, Costpoint, Compliance, Time Management, Deltek, Performance Tuning, SharePoint, Integration, Project Management, Business Intelligence, Microsoft SQL Server, Enterprise Architecture, ERP, Databases, T-SQL, XML, Change Management
Education
Hamilton Business College
Business & MIS
Marycrest College
Computer Information Systems; Philosophy
University of Iowa
Information Systems, Music Performance
Western Illinois University
Music Performance
NeoSystems Corp February 2014 - Present
NeoSystems Corp January 2013 - Present
Merlin International June 2012 - December 2012
Merlin International, Inc. June 2012 - December 2012
Aptiv Solutions November 2011 - June 2012
Aptiv Solutions 2011 - 2012
Mission Essential Personnel, LLC March 2010 - November 2011
Deltek, Inc. October 2007 - March 2010
konvrgence, inc. February 2003 - October 2007
Lucent 2004 - 2005
Skills
PMP, Certified Scrum Master..., SQL database design, Deltek Costpoint, Web Services Integration, SharePoint 2010, Cognos, DBA, Taleo Recruiting,..., Salesforce.com, SQL Reporting, Performance Point, Governance and..., Disaster Recovery, Oracle, Weblogic, VMWare, Deltek Cobra &..., Deltek Time, Expense..., .NET Framework and..., Web Development, JD Edwards, Sterling Commerce EDI, Microsoft Dynamics, Epicor, Microsoft CRM, ITIL, Solution Architecture, Strategic Planning, Technology..., Call center start-up, Call Center..., Salesforce.com System..., Call Center Development, Costpoint, Compliance, Time Management, Deltek, Performance Tuning, SharePoint, Integration, Project Management, Business Intelligence, Microsoft SQL Server, Enterprise Architecture, ERP, Databases, T-SQL, XML, Change Management
Education
Hamilton Business College
Business & MIS
Marycrest College
Computer Information Systems; Philosophy
University of Iowa
Information Systems, Music Performance
Western Illinois University
Music Performance
Patti Durkan's Aptiv Solutions Experience August 2013 - July 2014
Job Data Services Project Manager at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
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
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
Thomas McCray Harris Thomas McCray Harris's Aptiv Solutions Experience July 2012 - Present
Job Medical Writer at AptivSolutions
Industry Pharmaceuticals
Experience
Aptiv Solutions July 2012 - Present
PAREXEL October 2010 - June 2012
The Biomedical Artisan November 2009 - November 2010
AAIPharma 2007 - 2009
GlaxoSmithKline 2004 - 2007
Becton Dickinson Technologies 2002 - 2004
Nobex Corporation 1996 - 2002
Burroughs Wellcome 1994 - 1995
Burroughs Wellcome 1991 - 1994
Burroughs Wellcome 1986 - 1991
Skills
Clinical Research, FDA, Medical Writing, Clinical Trials, Biotechnology, Pharmacology, Clinical Development, Infectious Diseases, Lifesciences, Medical Devices, Medical Terminology, Scientific Writing, ICH guidelines, Freelance Writing, Regulatory Requirements, EMEA, GLP, GCP, GMP, MHRA, Drug Delivery, Drug Development, Pre-clinical Studies, IACUC, Bloodborne Pathogens, Laboratory Animal..., Laboratory Safety, Editing, Peer Reviews, Protocol, ICF, CSRs, IND, Investigator Brochures, Narrative, Technical Presentations, Study Reports, Publications, CNS disorders, Cardiovascular Disease, Gastrointestinal..., Obstetrics, Pulmonary Diseases, Oncology, Autoimmune Diseases, Inflammation, Pain Management, Psychopharmacology, Research Design, Innovation
Education
East Carolina University 1978 — 1985
BS, Biology
Aptiv Solutions July 2012 - Present
PAREXEL October 2010 - June 2012
The Biomedical Artisan November 2009 - November 2010
AAIPharma 2007 - 2009
GlaxoSmithKline 2004 - 2007
Becton Dickinson Technologies 2002 - 2004
Nobex Corporation 1996 - 2002
Burroughs Wellcome 1994 - 1995
Burroughs Wellcome 1991 - 1994
Burroughs Wellcome 1986 - 1991
Skills
Clinical Research, FDA, Medical Writing, Clinical Trials, Biotechnology, Pharmacology, Clinical Development, Infectious Diseases, Lifesciences, Medical Devices, Medical Terminology, Scientific Writing, ICH guidelines, Freelance Writing, Regulatory Requirements, EMEA, GLP, GCP, GMP, MHRA, Drug Delivery, Drug Development, Pre-clinical Studies, IACUC, Bloodborne Pathogens, Laboratory Animal..., Laboratory Safety, Editing, Peer Reviews, Protocol, ICF, CSRs, IND, Investigator Brochures, Narrative, Technical Presentations, Study Reports, Publications, CNS disorders, Cardiovascular Disease, Gastrointestinal..., Obstetrics, Pulmonary Diseases, Oncology, Autoimmune Diseases, Inflammation, Pain Management, Psychopharmacology, Research Design, Innovation
Education
East Carolina University 1978 — 1985
BS, Biology
Michelle Greenberg, BSN, RN Michelle Greenberg, BSN, RN's Aptiv Solutions Experience September 2011 - October 2013
Job Senior Manager, Clinician at Pfizer
Industry Pharmaceuticals
Experience
Pfizer September 2014 - Present
inVentiv Health Clinical October 2013 - September 2014
Aptiv Solutions September 2011 - October 2013
Aptiv Solutions January 2011 - September 2011
Inova Health System June 2010 - January 2011
The EMMES Corporation July 2007 - June 2010
UF Health Jacksonville October 2000 - June 2007
Maxim Healthcare Services July 2000 - February 2005
Nursefinders July 2000 - October 2000
Prince William Health System May 1999 - July 2000
Skills
Clinical Trials, Clinical Trial..., MedDRA, Regulatory Submissions, Site Selection, Project Closeout, Nursing, pediatrics, Infectious Diseases, Vaccines, Neurology, EDC, Data Management, Quality Assurance, Compliance Audits, Regulatory Affairs, Certified Clinical..., Research Project..., SAE, Clinical Research, Registered Nurse, Clinical Monitoring, IRB, Patient Safety, Management, CRO, CRF design, ACRP, Oracle Clinical, Patient Recruitment, Clinical Site Management, Cardiology, eCRF, GCP, Protocol, Sop, Pharmaceutical Industry, ICH-GCP, Clinical Data Management, Pharmacovigilance, Drug Safety, Regulatory Requirements, Immunology, 21 CFR Part 11, Clinical Development, Quality Auditing, Oncology, Clinical Operations, Therapeutic Areas, Neuroscience
Education
George Mason University 2010 — 2012
Bachelor of Science in Nursing
Northern Virginia Community College 1996 — 1999
Associate in Applied Science - Nursing
Pfizer September 2014 - Present
inVentiv Health Clinical October 2013 - September 2014
Aptiv Solutions September 2011 - October 2013
Aptiv Solutions January 2011 - September 2011
Inova Health System June 2010 - January 2011
The EMMES Corporation July 2007 - June 2010
UF Health Jacksonville October 2000 - June 2007
Maxim Healthcare Services July 2000 - February 2005
Nursefinders July 2000 - October 2000
Prince William Health System May 1999 - July 2000
Skills
Clinical Trials, Clinical Trial..., MedDRA, Regulatory Submissions, Site Selection, Project Closeout, Nursing, pediatrics, Infectious Diseases, Vaccines, Neurology, EDC, Data Management, Quality Assurance, Compliance Audits, Regulatory Affairs, Certified Clinical..., Research Project..., SAE, Clinical Research, Registered Nurse, Clinical Monitoring, IRB, Patient Safety, Management, CRO, CRF design, ACRP, Oracle Clinical, Patient Recruitment, Clinical Site Management, Cardiology, eCRF, GCP, Protocol, Sop, Pharmaceutical Industry, ICH-GCP, Clinical Data Management, Pharmacovigilance, Drug Safety, Regulatory Requirements, Immunology, 21 CFR Part 11, Clinical Development, Quality Auditing, Oncology, Clinical Operations, Therapeutic Areas, Neuroscience
Education
George Mason University 2010 — 2012
Bachelor of Science in Nursing
Northern Virginia Community College 1996 — 1999
Associate in Applied Science - Nursing
Matthew Bush's Aptiv Solutions Experience December 2012 - December 2013
Job Director, Business Development at PPD
Industry Research
Experience
PPD May 2014 - Present
Aptiv Solutions December 2012 - December 2013
PRA Health Sciences August 2006 - November 2012
United BioSource Corporation January 2006 - August 2006
Skills
Business Development, Pharmaceutical Industry, Clinical Trials, CRO, Strategy, Oncology, Biotechnology, Clinical Development, Product Management, Program Management
Education
Babson College - Franklin W. Olin Graduate School of Business 2009 — 2011
MBA, Entrepreneurship
Bentley University 1988 — 1993
MS, Marketing
PPD May 2014 - Present
Aptiv Solutions December 2012 - December 2013
PRA Health Sciences August 2006 - November 2012
United BioSource Corporation January 2006 - August 2006
Skills
Business Development, Pharmaceutical Industry, Clinical Trials, CRO, Strategy, Oncology, Biotechnology, Clinical Development, Product Management, Program Management
Education
Babson College - Franklin W. Olin Graduate School of Business 2009 — 2011
MBA, Entrepreneurship
Bentley University 1988 — 1993
MS, Marketing
Nina Chandra's Aptiv Solutions Experience March 2011 - November 2013
Job Clinical Project Manager at Medstar
Industry Research
Experience
MedStar Health November 2013 - Present
Network of South Asian Professionals January 2014 - Present
Network of South Asian Professionals February 2012 - December 2013
Aptiv Solutions March 2011 - November 2013
Meredith College August 2009 - December 2009
Skills
GCP, Adobe Acrobat, Outlook, TMF, Clinical Research, Pharmaceuticals, Data Management, Cardiology, Diabetes, SOP, EDC, FDA, ICH-GCP, Microsoft Office, Science, Corporate Communications, PCR, Gel Electrophoresis, CRO, Pharmaceutical Industry, Sop
Education
Meredith College 2005 — 2010
B.A, Biological Sciences
MedStar Health November 2013 - Present
Network of South Asian Professionals January 2014 - Present
Network of South Asian Professionals February 2012 - December 2013
Aptiv Solutions March 2011 - November 2013
Meredith College August 2009 - December 2009
Skills
GCP, Adobe Acrobat, Outlook, TMF, Clinical Research, Pharmaceuticals, Data Management, Cardiology, Diabetes, SOP, EDC, FDA, ICH-GCP, Microsoft Office, Science, Corporate Communications, PCR, Gel Electrophoresis, CRO, Pharmaceutical Industry, Sop
Education
Meredith College 2005 — 2010
B.A, Biological Sciences
Tara Earnhardt's Aptiv Solutions Experience January 2012 - December 2012
Job Manager, Accounting & Finance at INNO Clinical Outcomes LLC
Industry Research
Experience
INNO Clinical Outcomes LLC July 2014 - Present
Clinipace Worldwide May 2014 - July 2014
Trio Clinical Resourcing, LLC an Aptiv Solutions company January 2013 - May 2014
Aptiv Solutions January 2012 - December 2012
Aptiv Solutions September 2010 - December 2011
Trio Clinical Research, LLC February 2006 - September 2010
Trio Clinical Research, LLC May 2004 - February 2006
SRG Woolf Group June 2003 - May 2004
SRG Woolf Group April 2000 - June 2003
Storr Office Enviroments October 1996 - April 2000
Education
Wake Technical Community College 1999 — 2002
AA, Accounting
DeSales University 1992 — 1994
Certificate, Accounting
Allentown Business School 1990 — 1991
Certificate, General Business
Shippensburg University of Pennsylvania 1986 — 1990
BA, Sociology/Anthropology
Allentown Central Catholic H.S. 1982 — 1986
High School, College Prep
INNO Clinical Outcomes LLC July 2014 - Present
Clinipace Worldwide May 2014 - July 2014
Trio Clinical Resourcing, LLC an Aptiv Solutions company January 2013 - May 2014
Aptiv Solutions January 2012 - December 2012
Aptiv Solutions September 2010 - December 2011
Trio Clinical Research, LLC February 2006 - September 2010
Trio Clinical Research, LLC May 2004 - February 2006
SRG Woolf Group June 2003 - May 2004
SRG Woolf Group April 2000 - June 2003
Storr Office Enviroments October 1996 - April 2000
Education
Wake Technical Community College 1999 — 2002
AA, Accounting
DeSales University 1992 — 1994
Certificate, Accounting
Allentown Business School 1990 — 1991
Certificate, General Business
Shippensburg University of Pennsylvania 1986 — 1990
BA, Sociology/Anthropology
Allentown Central Catholic H.S. 1982 — 1986
High School, College Prep
Greg Dodds Greg Dodds's Aptiv Solutions Experience 2011 - 2012
Job Director, Business Development at Vince & Associates
Industry Pharmaceuticals
Experience
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Vince & Associates 2012 - Present
Aptiv Solutions 2011 - 2012
Integrium 2009 - 2011
Clinsys Clinical Research 2004 - 2009
Target Research Associates 2004 - 2009
PAREXEL 1997 - 2000
SMG Marketing Group 1993 - 1997
Skills
Clinical Development, CRO, Clinical Trials, Pharmaceutical Industry, Medical Devices, Business Development, Proposal Writing, New Business Development
Education
Northwestern University
M.S., Managerial Economics and Decision Science
St. Vincent College
B.S., Economics
Ronald Lazor Ronald Lazor's Aptiv Solutions Experience September 2012 - Present
Job Cognos Reporting Software Developer II at Aptiv Solutions/Budget & Planning Professional
Industry Financial Services
Experience
Aptiv Solutions September 2012 - Present
Computer Sciences Corporation, NPS May 1996 - July 2012
Arthur Andersen Office of Government Services January 1994 - December 1995
Tarmac America, Inc January 1993 - November 1994
Accounting Firm and Kaiser Permanente January 1993 - November 1994
Realty World Corporation December 1988 - November 1990
Robert Half/Accountemps February 1988 - November 1988
Imagematrix, Inc September 1987 - February 1988
MTech Corp January 1982 - March 1987
Penrod Drilling Company September 1981 - December 1981
Skills
Financial Modeling, Financial Reporting, Budget, Public Speaking, Forecasting, Dashboard, Project Management, Cognos, MS Excel, Budgets, OLAP, Microsoft Excel, Analysis, Essbase, Data Warehousing, Business Intelligence..., Analytics, Finance, Variance Analysis, Business Intelligence, TM1, Business Analysis, Management
Education
Hempfield Area
Indiana University of Pennsylvania
BS, Accounting
Aptiv Solutions September 2012 - Present
Computer Sciences Corporation, NPS May 1996 - July 2012
Arthur Andersen Office of Government Services January 1994 - December 1995
Tarmac America, Inc January 1993 - November 1994
Accounting Firm and Kaiser Permanente January 1993 - November 1994
Realty World Corporation December 1988 - November 1990
Robert Half/Accountemps February 1988 - November 1988
Imagematrix, Inc September 1987 - February 1988
MTech Corp January 1982 - March 1987
Penrod Drilling Company September 1981 - December 1981
Skills
Financial Modeling, Financial Reporting, Budget, Public Speaking, Forecasting, Dashboard, Project Management, Cognos, MS Excel, Budgets, OLAP, Microsoft Excel, Analysis, Essbase, Data Warehousing, Business Intelligence..., Analytics, Finance, Variance Analysis, Business Intelligence, TM1, Business Analysis, Management
Education
Hempfield Area
Indiana University of Pennsylvania
BS, Accounting
Patricia Swiech Patricia Swiech's Aptiv Solutions Experience February 2012 - November 2012
Job Learning Design Specialist at Boston Scientific
Industry Information Technology and Services
Experience
Boston Scientific April 2014 - Present
athenahealth, Inc. October 2012 - April 2014
Aptiv Solutions February 2012 - November 2012
Fidelity Investments June 2010 - January 2012
EMC Corporation May 2000 - February 2010
Knowledge Impact (formally Professional Development Group) 1999 - 2000
Commerce Insurance Company 1989 - 1999
Skills
Microsoft Office, Adobe Acrobat, Articulate Presenter, Centra Symposium, SharePoint, SnagIt, WebEx, Lotus SameTime, Information Mapping, Instructional Design, ADDIE, Blended Learning, Learning Management, Learning Management..., SCORM, Technical Training, Captivate, Project Management, Software Documentation, Training, Presenter, Technical Documentation
Education
University of Massachusetts Boston
BS.Ed, Education
Boston Scientific April 2014 - Present
athenahealth, Inc. October 2012 - April 2014
Aptiv Solutions February 2012 - November 2012
Fidelity Investments June 2010 - January 2012
EMC Corporation May 2000 - February 2010
Knowledge Impact (formally Professional Development Group) 1999 - 2000
Commerce Insurance Company 1989 - 1999
Skills
Microsoft Office, Adobe Acrobat, Articulate Presenter, Centra Symposium, SharePoint, SnagIt, WebEx, Lotus SameTime, Information Mapping, Instructional Design, ADDIE, Blended Learning, Learning Management, Learning Management..., SCORM, Technical Training, Captivate, Project Management, Software Documentation, Training, Presenter, Technical Documentation
Education
University of Massachusetts Boston
BS.Ed, Education
Michael B. Bless Michael B. Bless's Aptiv Solutions Experience April 2011 - July 2013
Job Quality Assurance Consultant (GCP)
Industry Pharmaceuticals
Experience
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)
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)
Crystal Fletcher Crystal Fletcher's Aptiv Solutions Experience September 2012 - October 2014
Job Sr. Manager, Development Administration at Sunovion Pharmaceuticals Inc.
Industry Biotechnology
Experience
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
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
Jim Box Jim Box's Aptiv Solutions Experience October 2011 - May 2013
Job Solutions Architect for Health & Life Sciences at SAS
Industry Computer Software
Experience
SAS June 2015 - Present
SAS May 2014 - June 2015
Aptiv Solutions October 2011 - May 2013
SRA International November 2010 - September 2011
Quanticate June 2010 - November 2010
RTP Product Development Guild May 2009 - September 2010
Health Decisions June 2008 - March 2009
Health Decisions July 2005 - May 2008
Health Decisions August 2004 - September 2005
RTI International February 2003 - August 2004
Skills
Statistics, Statistical Programming, IT Management, SAS, Data Management, Data Analysis, Excel, R, Management, SAS programming, Statistical Modeling, Statistical Data..., Clinical Trials, Databases, Microsoft Excel, JMP, Business Intelligence, Business Development, Analysis, Business Analysis, Biostatistics, CRO, Time Series Analysis, Survival Analysis, Leadership, Data Mining, Linear Algebra, Analytics
Education
North Carolina State University - Institute for Advanced Analytics 2013 — 2014
Master of Science in Analytics (MSA), Advanced Analytics
North Carolina State University 2008 — 2010
MBA, Operations & Services Innovation
Duke University 1996 — 1997
MS, Statistics
Florida Institute of Technology 1991 — 1994
MS, Systems Management
California State University-Chico 1986 — 1990
BS, Mathematics
SAS June 2015 - Present
SAS May 2014 - June 2015
Aptiv Solutions October 2011 - May 2013
SRA International November 2010 - September 2011
Quanticate June 2010 - November 2010
RTP Product Development Guild May 2009 - September 2010
Health Decisions June 2008 - March 2009
Health Decisions July 2005 - May 2008
Health Decisions August 2004 - September 2005
RTI International February 2003 - August 2004
Skills
Statistics, Statistical Programming, IT Management, SAS, Data Management, Data Analysis, Excel, R, Management, SAS programming, Statistical Modeling, Statistical Data..., Clinical Trials, Databases, Microsoft Excel, JMP, Business Intelligence, Business Development, Analysis, Business Analysis, Biostatistics, CRO, Time Series Analysis, Survival Analysis, Leadership, Data Mining, Linear Algebra, Analytics
Education
North Carolina State University - Institute for Advanced Analytics 2013 — 2014
Master of Science in Analytics (MSA), Advanced Analytics
North Carolina State University 2008 — 2010
MBA, Operations & Services Innovation
Duke University 1996 — 1997
MS, Statistics
Florida Institute of Technology 1991 — 1994
MS, Systems Management
California State University-Chico 1986 — 1990
BS, Mathematics
Vinita Roy Vinita Roy's Aptiv Solutions Experience October 2010 - April 2014
Job Clinical Development Execution Outsourcing Solutions
Industry Biotechnology
Experience
Covance April 2014 - Present
Aptiv Solutions October 2010 - April 2014
PRA International 2005 - September 2010
Absorption Systems August 2003 - December 2005
Rhodia Inc. 1995 - 1999
Skills
CRO, Clinical Trials, Oncology, Clinical Development, FDA, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Drug Development, Solutions Provider
Education
The University of Texas at Austin 1998 — 1999
MBA, Business Administration
The University of Texas at Austin - The Red McCombs School of Business 1997 — 1999
Master of Business Administration (MBA)
Covance April 2014 - Present
Aptiv Solutions October 2010 - April 2014
PRA International 2005 - September 2010
Absorption Systems August 2003 - December 2005
Rhodia Inc. 1995 - 1999
Skills
CRO, Clinical Trials, Oncology, Clinical Development, FDA, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Drug Development, Solutions Provider
Education
The University of Texas at Austin 1998 — 1999
MBA, Business Administration
The University of Texas at Austin - The Red McCombs School of Business 1997 — 1999
Master of Business Administration (MBA)
Lesley Keays Lesley Keays's Aptiv Solutions Experience March 2011 - December 2011
Job Branding | Communications | Strategy
Industry Marketing and Advertising
Experience
Lydon Communications December 2011 - Present
GaltNeedleTech February 2014 - September 2015
Aptiv Solutions March 2011 - December 2011
Facet Solutions August 2008 - January 2010
NDO Surgical, Inc. January 2008 - March 2008
NDO Surgical, Inc. March 2005 - January 2008
PAREXEL International January 2003 - February 2005
PAREXEL International January 2001 - January 2003
PAREXEL International December 1997 - December 2000
Skills
Corporate Communications, Public Relations, Integrated Marketing, Marketing, Social Media, Strategic Communications, Pharmaceutical Industry, Management, Marketing Communications, Project Management, Internal Communications, Marketing Strategy, Biotechnology, Leadership, Clinical Research, Creative Direction, Medical Devices, Cross-functional Team..., Entrepreneurship, Marketing Management, Writing, Training, Program Management, Publishing, Copy Editing, Email Marketing, Newsletters, Online Marketing, Trade Shows, Media Relations, Budgets, Market Planning, Brand Development, Photography, Resume Writing, Copywriting, Messaging, Corporate Branding, Social Media Marketing, Competitive Analysis, Press Releases, Salesforce.com, Constant Contact, Content Writing, Nonprofits, Proofreading, National Association of..., Content Development, Content Management, Strategic Partnerships
Education
Providence College 1989 — 1992
B.A., English
Wheaton College 1988 — 1989
Liberal Arts
Lydon Communications December 2011 - Present
GaltNeedleTech February 2014 - September 2015
Aptiv Solutions March 2011 - December 2011
Facet Solutions August 2008 - January 2010
NDO Surgical, Inc. January 2008 - March 2008
NDO Surgical, Inc. March 2005 - January 2008
PAREXEL International January 2003 - February 2005
PAREXEL International January 2001 - January 2003
PAREXEL International December 1997 - December 2000
Skills
Corporate Communications, Public Relations, Integrated Marketing, Marketing, Social Media, Strategic Communications, Pharmaceutical Industry, Management, Marketing Communications, Project Management, Internal Communications, Marketing Strategy, Biotechnology, Leadership, Clinical Research, Creative Direction, Medical Devices, Cross-functional Team..., Entrepreneurship, Marketing Management, Writing, Training, Program Management, Publishing, Copy Editing, Email Marketing, Newsletters, Online Marketing, Trade Shows, Media Relations, Budgets, Market Planning, Brand Development, Photography, Resume Writing, Copywriting, Messaging, Corporate Branding, Social Media Marketing, Competitive Analysis, Press Releases, Salesforce.com, Constant Contact, Content Writing, Nonprofits, Proofreading, National Association of..., Content Development, Content Management, Strategic Partnerships
Education
Providence College 1989 — 1992
B.A., English
Wheaton College 1988 — 1989
Liberal Arts
Amy Rueckheim Amy Rueckheim's Aptiv Solutions Experience May 2010 - August 2012
Job Clinical Risk Manager at inVentiv Health Clinical
Industry Pharmaceuticals
Experience
inVentiv Health November 2014 - Present
ICON plc September 2014 - November 2014
ICON Clinical Research August 2012 - September 2014
Aptiv Solutions May 2010 - August 2012
Pharm-Olam International May 2007 - April 2010
Skills
Clinical Research, Oncology, Clinical Trials, Infectious Diseases, Contract Negotiation, Urology, Women's Health, Vaccines, Pediatrics, Allergy, First In Man, SWAT, Remote Monitoring, Clinical Monitoring, EDC, Early Phase, SDV, Pulmonology, Dermatology, Genitourinary, Immunology, ICH-GCP, Clinical Development, Clinical Trial..., Therapeutic areas, GCP, Rheumatology, Pharmaceuticals, Hematology, Regulatory Submissions, Regulatory Affairs, CTMS, SOP, Clinical, Medical Writing, Rheumatoid Arthritis, Research, Quality Assurance, Cross-functional Team..., Compliance, Patient Recruitment, Sop, Clinical Data Management, Therapeutic Areas, Clinical Operations, Pharmaceutical Industry, Pharmacovigilance, Oracle Clinical, Protocol
Education
Texas State University 2004 — 2006
University of Phoenix 2000 — 2003
Bachelor of Science
inVentiv Health November 2014 - Present
ICON plc September 2014 - November 2014
ICON Clinical Research August 2012 - September 2014
Aptiv Solutions May 2010 - August 2012
Pharm-Olam International May 2007 - April 2010
Skills
Clinical Research, Oncology, Clinical Trials, Infectious Diseases, Contract Negotiation, Urology, Women's Health, Vaccines, Pediatrics, Allergy, First In Man, SWAT, Remote Monitoring, Clinical Monitoring, EDC, Early Phase, SDV, Pulmonology, Dermatology, Genitourinary, Immunology, ICH-GCP, Clinical Development, Clinical Trial..., Therapeutic areas, GCP, Rheumatology, Pharmaceuticals, Hematology, Regulatory Submissions, Regulatory Affairs, CTMS, SOP, Clinical, Medical Writing, Rheumatoid Arthritis, Research, Quality Assurance, Cross-functional Team..., Compliance, Patient Recruitment, Sop, Clinical Data Management, Therapeutic Areas, Clinical Operations, Pharmaceutical Industry, Pharmacovigilance, Oracle Clinical, Protocol
Education
Texas State University 2004 — 2006
University of Phoenix 2000 — 2003
Bachelor of Science
Vlad Dragalin Vlad Dragalin's Aptiv Solutions Experience February 2011 - May 2014
Job Vice President, Scientific Fellow at Janssen, Pharmaceutical Companies of Johnson and Johnson
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson May 2014 - Present
Aptiv Solutions February 2011 - May 2014
Quintiles Transnational April 2010 - February 2011
Pfizer October 2009 - April 2010
Wyeth Research 2006 - October 2009
GSK 1999 - 2006
University of Rochester Medical Center 1997 - May 1999
Skills
Statistical Modeling, Clinical Trials, Adaptive Design, Leadership, Research, CRO, Clinical Development, Oncology, Pharmaceutical Industry, SAS, Drug Development, Regulatory Submissions, Regulatory Affairs, FDA, Protocol, Clinical Research, GCP, Clinical Data Management, Clinical Study Design, Statistics, Biostatistics
Education
Steklov Mathematical Institute 1985 — 1988
PhD, Probability and Mathematical Statistics
1976 — 1981
MSc, Applied Mathematics
Janssen, Pharmaceutical Companies of Johnson and Johnson May 2014 - Present
Aptiv Solutions February 2011 - May 2014
Quintiles Transnational April 2010 - February 2011
Pfizer October 2009 - April 2010
Wyeth Research 2006 - October 2009
GSK 1999 - 2006
University of Rochester Medical Center 1997 - May 1999
Skills
Statistical Modeling, Clinical Trials, Adaptive Design, Leadership, Research, CRO, Clinical Development, Oncology, Pharmaceutical Industry, SAS, Drug Development, Regulatory Submissions, Regulatory Affairs, FDA, Protocol, Clinical Research, GCP, Clinical Data Management, Clinical Study Design, Statistics, Biostatistics
Education
Steklov Mathematical Institute 1985 — 1988
PhD, Probability and Mathematical Statistics
1976 — 1981
MSc, Applied Mathematics
Sheri E. Rosenberg Sheri E. Rosenberg's Aptiv Solutions Experience August 2010 - December 2014
Job Clinical Outcome Associate at ICON plc
Industry Pharmaceuticals
Experience
ICON plc January 2015 - Present
Aptiv Solutions August 2010 - December 2014
KAI Research, Inc January 2003 - March 2010
KAI Research, Inc May 2001 - December 2002
Chestnut Lodge Hospital June 1999 - April 2001
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, EDC, Clinical Monitoring, ICH-GCP
Education
University of Maryland Baltimore 1997 — 1998
Bachelor of Science (B.S.), Nursing
University of Maryland College Park 1985 — 1989
Bachelor of Arts (B.A.), Sociology
ICON plc January 2015 - Present
Aptiv Solutions August 2010 - December 2014
KAI Research, Inc January 2003 - March 2010
KAI Research, Inc May 2001 - December 2002
Chestnut Lodge Hospital June 1999 - April 2001
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, EDC, Clinical Monitoring, ICH-GCP
Education
University of Maryland Baltimore 1997 — 1998
Bachelor of Science (B.S.), Nursing
University of Maryland College Park 1985 — 1989
Bachelor of Arts (B.A.), Sociology
Angela Silverman Angela Silverman's Aptiv Solutions Experience August 2011 - May 2014
Job Clinical Operations Manager, ICON plc; Nurse Practitioner at Mercy Health Clinic
Industry Pharmaceuticals
Experience
ICON plc May 2014 - Present
Mercy Health Clinic July 2012 - Present
Aptiv Solutions August 2011 - May 2014
MedStar Health 2007 - 2013
MedStar Health 2007 - 2011
MedStar Health 2006 - 2011
MedStar Health 2000 - 2011
MedStar Health 2003 - 2006
MedStar Health 1984 - 2003
Skills
Clinical Operations, Clinical Research, Clinical Trials, GCP, CTMS, ICH-GCP, CRO, Oncology, Clinical Monitoring, EDC, Regulatory Submissions, SOP, Clinical Development, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, Drug Development, Cardiology, Protocol, FDA
Education
The Catholic University of America
Master's degree, Cardiovascular Nursing, Certified Adult Nurse Practitioner
ICON plc May 2014 - Present
Mercy Health Clinic July 2012 - Present
Aptiv Solutions August 2011 - May 2014
MedStar Health 2007 - 2013
MedStar Health 2007 - 2011
MedStar Health 2006 - 2011
MedStar Health 2000 - 2011
MedStar Health 2003 - 2006
MedStar Health 1984 - 2003
Skills
Clinical Operations, Clinical Research, Clinical Trials, GCP, CTMS, ICH-GCP, CRO, Oncology, Clinical Monitoring, EDC, Regulatory Submissions, SOP, Clinical Development, Clinical Data Management, Pharmacovigilance, Regulatory Affairs, Drug Development, Cardiology, Protocol, FDA
Education
The Catholic University of America
Master's degree, Cardiovascular Nursing, Certified Adult Nurse Practitioner
Keisha Davis Keisha Davis's Aptiv Solutions Experience October 2011 - May 2014
Job Clinical Research Associate at ICON plc
Industry Pharmaceuticals
Experience
ICON plc May 2014 - Present
Aptiv Solutions October 2011 - May 2014
SRA International August 2007 - September 2011
Constella Group, LLC 2004 - July 2007
Resource Solutions, Inc. (RSI) November 2001 - 2004
Skills
Central Nervous System, Therapeutic Areas, Endocrinology, Infectious Diseases, Urology, Ophthalmology, EDC, Clinical Research, Drug Development, CRO, ICH-GCP, GCP, CTMS, Clinical Trials, Clinical Monitoring, Clinical Development, Protocol, Clinical Data Management, Oncology, Pharmaceutical Industry
Education
Durham Technical Community College 2005 — 2006
Certificate, Certified Nursing Assistant (CNA)
Durham Technical Community College 2005 — 2005
CNA I, Certified Nursing Assistant I
George Mason University 1993 — 2001
Psychology / Business Administration
Kaplan University
Health Sciences with a Nutrition emphasis
ICON plc May 2014 - Present
Aptiv Solutions October 2011 - May 2014
SRA International August 2007 - September 2011
Constella Group, LLC 2004 - July 2007
Resource Solutions, Inc. (RSI) November 2001 - 2004
Skills
Central Nervous System, Therapeutic Areas, Endocrinology, Infectious Diseases, Urology, Ophthalmology, EDC, Clinical Research, Drug Development, CRO, ICH-GCP, GCP, CTMS, Clinical Trials, Clinical Monitoring, Clinical Development, Protocol, Clinical Data Management, Oncology, Pharmaceutical Industry
Education
Durham Technical Community College 2005 — 2006
Certificate, Certified Nursing Assistant (CNA)
Durham Technical Community College 2005 — 2005
CNA I, Certified Nursing Assistant I
George Mason University 1993 — 2001
Psychology / Business Administration
Kaplan University
Health Sciences with a Nutrition emphasis
Aleksandr Sirosh's Aptiv Solutions Experience September 2010 - May 2012
Job Regional CTM at Boehringer Ingelheim RCV
Industry Pharmaceuticals
Experience
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
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
Chip Carnathan Chip Carnathan's Aptiv Solutions Experience October 2010 - January 2012
Job Director of Regulatory Affairs at Impact Pharmaceutical Services
Industry Biotechnology
Experience
Impact Pharmaceutical Services February 2014 - Present
Independent Consultant January 2012 - Present
Aptiv Solutions October 2010 - January 2012
Independent Consultant June 2010 - October 2010
Argos Therapeutics July 2009 - June 2010
SRA International November 2005 - April 2009
Origin USA LLC May 2003 - November 2005
Napro Biotherapeutics 2001 - 2005
IAVI 1999 - 2001
Atrix Laboratories January 1998 - October 1999
Skills
Vaccines, Clinical Development, Drug Development, IND, Toxicology, Biologics, Pharmacology, Biotechnology, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Submissions, Medical Writing, Sop, GCP, Infectious Diseases, Clinical Research, Lifesciences, CRO, Therapeutic Areas, R&D, Regulatory Requirements, FDA, In Vivo, Clinical Study Design, GLP, Pharmaceutics, Immunology, Technology Transfer, Drug Discovery, Biopharmaceuticals, Life Sciences, SOP
Education
University of Massachusetts, Amherst 1976 — 1981
MS, PhD, Reproductive Pharmacology/Physiology
Northeastern University 1971 — 1974
BSc, Psychology
Impact Pharmaceutical Services February 2014 - Present
Independent Consultant January 2012 - Present
Aptiv Solutions October 2010 - January 2012
Independent Consultant June 2010 - October 2010
Argos Therapeutics July 2009 - June 2010
SRA International November 2005 - April 2009
Origin USA LLC May 2003 - November 2005
Napro Biotherapeutics 2001 - 2005
IAVI 1999 - 2001
Atrix Laboratories January 1998 - October 1999
Skills
Vaccines, Clinical Development, Drug Development, IND, Toxicology, Biologics, Pharmacology, Biotechnology, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Submissions, Medical Writing, Sop, GCP, Infectious Diseases, Clinical Research, Lifesciences, CRO, Therapeutic Areas, R&D, Regulatory Requirements, FDA, In Vivo, Clinical Study Design, GLP, Pharmaceutics, Immunology, Technology Transfer, Drug Discovery, Biopharmaceuticals, Life Sciences, SOP
Education
University of Massachusetts, Amherst 1976 — 1981
MS, PhD, Reproductive Pharmacology/Physiology
Northeastern University 1971 — 1974
BSc, Psychology
Bridget LaBean's Aptiv Solutions Experience February 2010 - September 2011
Job Sr. CRA at ICON plc
Industry Pharmaceuticals
Experience
ICON plc 2012 - Present
ICON plc 2011 - 2012
Aptiv Solutions February 2010 - September 2011
ICON Clinical Research 2007 - 2010
Tyson Foods April 2005 - July 2007
Skills
CRO, Vaccines, Clinical Research, Endocrinology, Protocol, ICH-GCP, GCP, EDC, CTMS, Clinical Monitoring, Clinical Development, Clinical Operations, Clinical Research...
Education
Northwestern State University 2000 — 2004
Bachelors, Biology
ICON plc 2012 - Present
ICON plc 2011 - 2012
Aptiv Solutions February 2010 - September 2011
ICON Clinical Research 2007 - 2010
Tyson Foods April 2005 - July 2007
Skills
CRO, Vaccines, Clinical Research, Endocrinology, Protocol, ICH-GCP, GCP, EDC, CTMS, Clinical Monitoring, Clinical Development, Clinical Operations, Clinical Research...
Education
Northwestern State University 2000 — 2004
Bachelors, Biology
Kevin Prybol Kevin Prybol's Aptiv Solutions Experience April 2013 - July 2013
Job Statistician/Predictive Modeler/Product Developer
Industry Research
Experience
Community Care of North Carolina (CCNC) August 2014 - Present
Alabama College of Osteopathic Medicine August 2013 - May 2014
Aptiv Solutions April 2013 - July 2013
Duke University April 2012 - April 2013
Duke University May 2011 - April 2013
Kaplan June 2009 - April 2013
Fulton County Department of Health and Wellness January 2011 - May 2011
Skills
R, SAS, Python, Apache Spark, Data Analysis, Clinical Research, Biostatistics, Public Health, Predictive Modeling, Clinical Trials, Tableau, SQL, SPSS, Epidemiology, Literature Reviews, Scientific Writing, Data Management, IRB, Statistics, Research, GCP, Metabolomics, HL7, RapidMiner, Machine Learning, Data Mining, Data Validation, MySQL
Education
Georgia State University 2010 — 2014
MPH, Biostatistics
University of Miami 2004 — 2008
B.S., Biology
Community Care of North Carolina (CCNC) August 2014 - Present
Alabama College of Osteopathic Medicine August 2013 - May 2014
Aptiv Solutions April 2013 - July 2013
Duke University April 2012 - April 2013
Duke University May 2011 - April 2013
Kaplan June 2009 - April 2013
Fulton County Department of Health and Wellness January 2011 - May 2011
Skills
R, SAS, Python, Apache Spark, Data Analysis, Clinical Research, Biostatistics, Public Health, Predictive Modeling, Clinical Trials, Tableau, SQL, SPSS, Epidemiology, Literature Reviews, Scientific Writing, Data Management, IRB, Statistics, Research, GCP, Metabolomics, HL7, RapidMiner, Machine Learning, Data Mining, Data Validation, MySQL
Education
Georgia State University 2010 — 2014
MPH, Biostatistics
University of Miami 2004 — 2008
B.S., Biology
Cynthia Nolte Cynthia Nolte's Aptiv Solutions Experience April 1995 - Present
Job Senior Director at ICON plc
Industry Medical Devices
Experience
ICON plc September 2014 - Present
Aptiv Solutions April 1995 - Present
Organogenesis 1989 - 1995
Education
Boston University
Ph.D., Biochemistry
Wheaton College (MA) 1978 — 1981
BA, Biology
ICON plc September 2014 - Present
Aptiv Solutions April 1995 - Present
Organogenesis 1989 - 1995
Education
Boston University
Ph.D., Biochemistry
Wheaton College (MA) 1978 — 1981
BA, Biology
Gene Resnick Gene Resnick's Aptiv Solutions Experience January 2011 - May 2014
Job Senior Medical Consultant at ICON plc
Industry Pharmaceuticals
Experience
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
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
Heidi Deets Heidi Deets's Aptiv Solutions Experience September 2010 - April 2013
Job Clinical Team Manager at Theorem Clinical Research
Industry Pharmaceuticals
Experience
Theorem Clinical Research July 2014 - Present
PRA International April 2013 - June 2014
Aptiv Solutions September 2010 - April 2013
sanofi-aventis April 2008 - March 2010
sanofi-aventis July 2007 - April 2008
ICON Clinical Research November 2000 - July 2007
Skills
Clinical Trials, Oncology, Infectious Diseases, Vaccines, Endocrinology, Clinical Operations, Hypertension, In Vitro, Assay Development, CTMS, CRO, GCP, Clinical Monitoring, EDC, Clinical Development, Phase I, Clinical Research, ICH-GCP
Education
Eastern Illinois University 1994 — 1998
Bachelor of Science, Zoology
Theorem Clinical Research July 2014 - Present
PRA International April 2013 - June 2014
Aptiv Solutions September 2010 - April 2013
sanofi-aventis April 2008 - March 2010
sanofi-aventis July 2007 - April 2008
ICON Clinical Research November 2000 - July 2007
Skills
Clinical Trials, Oncology, Infectious Diseases, Vaccines, Endocrinology, Clinical Operations, Hypertension, In Vitro, Assay Development, CTMS, CRO, GCP, Clinical Monitoring, EDC, Clinical Development, Phase I, Clinical Research, ICH-GCP
Education
Eastern Illinois University 1994 — 1998
Bachelor of Science, Zoology
Rosina Robinson's Aptiv Solutions Experience July 1992 - Present
Job Principal True North Regulatory Consultants, LLC
Industry Medical Devices
Experience
True North Regulatory Consultants, LLC July 2011 - Present
Aptiv Solutions July 1992 - Present
Medical Device Consultants, Inc. July 1992 - July 2011
Northeastern University, School of Professional and Continuing Studies 2005 - 2007
Northeastern University 2002 - 2007
Independent Regulatory Consultant 1991 - 1992
Haemonetics 1979 - 1985
Education
Bridgewater State University 1986 — 1986
MEd, Heatlth promotion
True North Regulatory Consultants, LLC July 2011 - Present
Aptiv Solutions July 1992 - Present
Medical Device Consultants, Inc. July 1992 - July 2011
Northeastern University, School of Professional and Continuing Studies 2005 - 2007
Northeastern University 2002 - 2007
Independent Regulatory Consultant 1991 - 1992
Haemonetics 1979 - 1985
Education
Bridgewater State University 1986 — 1986
MEd, Heatlth promotion
Ann Fogarty, SPHR, SHRM-SCP's Aptiv Solutions Experience October 2011 - December 2014
Job Director of Human Resources at HealthDrive Corporation
Industry Human Resources
Experience
HealthDrive Corporation January 2015 - Present
Aptiv Solutions October 2011 - December 2014
UNFI June 2008 - October 2011
National Grid Inc April 2007 - April 2010
Girl Scouts of Eastern Massachusetts 1994 - 2009
Hitachi Computer Products (America) Inc January 1990 - January 1995
Fanning Personnel January 1989 - January 1990
Skills
Deferred Compensation, Employee Relations, HRIS, Recruiting, Onboarding, Performance Management, Talent Management, Employee Benefits, Organizational..., Talent Acquisition, Employee Engagement, Sourcing, PeopleSoft, Human Resources, Personnel Management, Benefits Administration, Employment Law, Payroll, Training, Interviews, Applicant Tracking..., Leadership
Education
Bridgewater State College 1984 — 1988
BS, Elementary Education, Cum Laude
Bentley University 1990 — 1992
HR Mgmt Certificate, Human Resources Management
Assumption College 2011 — 2011
HR Certification, Human Resources
HealthDrive Corporation January 2015 - Present
Aptiv Solutions October 2011 - December 2014
UNFI June 2008 - October 2011
National Grid Inc April 2007 - April 2010
Girl Scouts of Eastern Massachusetts 1994 - 2009
Hitachi Computer Products (America) Inc January 1990 - January 1995
Fanning Personnel January 1989 - January 1990
Skills
Deferred Compensation, Employee Relations, HRIS, Recruiting, Onboarding, Performance Management, Talent Management, Employee Benefits, Organizational..., Talent Acquisition, Employee Engagement, Sourcing, PeopleSoft, Human Resources, Personnel Management, Benefits Administration, Employment Law, Payroll, Training, Interviews, Applicant Tracking..., Leadership
Education
Bridgewater State College 1984 — 1988
BS, Elementary Education, Cum Laude
Bentley University 1990 — 1992
HR Mgmt Certificate, Human Resources Management
Assumption College 2011 — 2011
HR Certification, Human Resources
Karen Gwozdowski Gauvin Karen Gwozdowski Gauvin's Aptiv Solutions Experience February 2010 - May 2011
Job QA Regulatory Compliance Manager at CVS Caremark Corporation
Industry Consumer Goods
Experience
CVS Caremark Corporation October 2012 - Present
Boston Biomedical Associates May 2011 - October 2012
Aptiv Solutions February 2010 - May 2011
Oxford Immunotec September 2008 - January 2010
Hologic, Inc. (formerly Cytyc Corp.) July 2007 - September 2008
Stryker Biotech July 2005 - June 2007
Davol November 2002 - July 2005
Skills
Medical Devices, FDA, Regulatory Affairs, GCP, ISO 13485, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, PMA, IND, CAPA, 21 CFR Part 11, Sop, Biotechnology, Clinical Research, CTMS, Lifesciences, Validation, GMP, Post Market Surveillance, Quality Auditing, ISO 14971, Software Documentation, Quality Assurance, Clinical Development, Regulatory Requirements, Pharmacovigilance, Cross-functional Team...
Education
University of Massachusetts, Amherst 2000 — 2002
MPH, Epidemiology
Clark University 1995 — 1999
BA, Biology/Microbiology
CVS Caremark Corporation October 2012 - Present
Boston Biomedical Associates May 2011 - October 2012
Aptiv Solutions February 2010 - May 2011
Oxford Immunotec September 2008 - January 2010
Hologic, Inc. (formerly Cytyc Corp.) July 2007 - September 2008
Stryker Biotech July 2005 - June 2007
Davol November 2002 - July 2005
Skills
Medical Devices, FDA, Regulatory Affairs, GCP, ISO 13485, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, PMA, IND, CAPA, 21 CFR Part 11, Sop, Biotechnology, Clinical Research, CTMS, Lifesciences, Validation, GMP, Post Market Surveillance, Quality Auditing, ISO 14971, Software Documentation, Quality Assurance, Clinical Development, Regulatory Requirements, Pharmacovigilance, Cross-functional Team...
Education
University of Massachusetts, Amherst 2000 — 2002
MPH, Epidemiology
Clark University 1995 — 1999
BA, Biology/Microbiology
Hollee Sloop's Aptiv Solutions Experience August 2013 - March 2014
Job Clinical Data Specialist III at Duke Clinical Research Institute
Industry Pharmaceuticals
Experience
Duke Clinical Research Institute November 2014 - Present
Chiltern March 2014 - October 2014
Aptiv Solutions August 2013 - March 2014
Rho August 2011 - August 2013
Rho December 2010 - August 2011
University of North Carolina at Chapel Hill November 2007 - December 2010
University of North Carolina at Chapel Hill February 2010 - October 2010
Planned Parenthood of Central North Carolina August 2009 - December 2009
Skills
Data Management, Clinical Trials, EDC, Validation, Clinical Research, GCP, Databases, CRO, Sop, CRF design, Autoimmune Diseases, Medidata RAVE, eClinical OS, Inform, SOP, Pharmaceutical Industry, Clinical Data Management, Medidata, Protocol
Education
University of North Carolina at Chapel Hill 2006 — 2010
BA, Psychology
Duke Clinical Research Institute November 2014 - Present
Chiltern March 2014 - October 2014
Aptiv Solutions August 2013 - March 2014
Rho August 2011 - August 2013
Rho December 2010 - August 2011
University of North Carolina at Chapel Hill November 2007 - December 2010
University of North Carolina at Chapel Hill February 2010 - October 2010
Planned Parenthood of Central North Carolina August 2009 - December 2009
Skills
Data Management, Clinical Trials, EDC, Validation, Clinical Research, GCP, Databases, CRO, Sop, CRF design, Autoimmune Diseases, Medidata RAVE, eClinical OS, Inform, SOP, Pharmaceutical Industry, Clinical Data Management, Medidata, Protocol
Education
University of North Carolina at Chapel Hill 2006 — 2010
BA, Psychology
Thomas Bunker Thomas Bunker's Aptiv Solutions Experience July 2013 - May 2014
Job IT Support Analyst at ICON plc
Industry Information Technology and Services
Experience
ICON plc May 2014 - Present
Aptiv Solutions July 2013 - May 2014
United Stationers February 1998 - April 2013
Skills
A+ Certified, Network+ Certified
Education
Illinois State University
Chemistry
College of DuPage
Associates Degree, Data Processing & Programming
ICON plc May 2014 - Present
Aptiv Solutions July 2013 - May 2014
United Stationers February 1998 - April 2013
Skills
A+ Certified, Network+ Certified
Education
Illinois State University
Chemistry
College of DuPage
Associates Degree, Data Processing & Programming
Luis Gutierrez's Aptiv Solutions Experience May 2012 - June 2014
Job President & CEO at Theranostics Health, Inc.
Industry Biotechnology
Experience
Theranostics Health, Inc October 2014 - Present
Aptiv Solutions May 2012 - June 2014
MedAssurant (now Inovalon) August 2010 - May 2012
Covance January 2007 - August 2010
Covance Market Access Services Inc. September 1998 - December 2006
Covance Health Economics and Outcomes Services Inc. July 1996 - August 1998
Health Technology Associates Inc. June 1991 - June 1996
Merck June 1990 - August 1990
Lewin and Associates (now The Lewin Group) June 1986 - August 1989
Skills
Clinical Research, Biotechnology, Lifesciences, Clinical Trials, Oncology, Pharmaceutical Industry, Healthcare, Medical Devices, Cross-functional Team..., Business Development, CRO, Informatics, Clinical Development, Strategic Planning, Health Economics, Leadership, Vaccines, Strategy, Market Access, Life Sciences
Education
Stanford University Graduate School of Business 1989 — 1991
MBA
Harvard University 1982 — 1986
BA, Biological Anthropology
Theranostics Health, Inc October 2014 - Present
Aptiv Solutions May 2012 - June 2014
MedAssurant (now Inovalon) August 2010 - May 2012
Covance January 2007 - August 2010
Covance Market Access Services Inc. September 1998 - December 2006
Covance Health Economics and Outcomes Services Inc. July 1996 - August 1998
Health Technology Associates Inc. June 1991 - June 1996
Merck June 1990 - August 1990
Lewin and Associates (now The Lewin Group) June 1986 - August 1989
Skills
Clinical Research, Biotechnology, Lifesciences, Clinical Trials, Oncology, Pharmaceutical Industry, Healthcare, Medical Devices, Cross-functional Team..., Business Development, CRO, Informatics, Clinical Development, Strategic Planning, Health Economics, Leadership, Vaccines, Strategy, Market Access, Life Sciences
Education
Stanford University Graduate School of Business 1989 — 1991
MBA
Harvard University 1982 — 1986
BA, Biological Anthropology
Jill Anne Robinson's Aptiv Solutions Experience September 2012 - January 2013
Job Clinical Research Associate (CRA) at Covance Inc
Industry Research
Experience
Covance Inc August 2014 - Present
Fresenius Medical Care September 2013 - January 2014
Outcomes Health Information Solutions February 2013 - April 2013
Aptiv Solutions September 2012 - January 2013
Covance Inc January 2010 - May 2012
Quintiles March 2008 - October 2009
ICON Clinical Research September 2006 - June 2007
ClinForce, LLC 2007 - 2007
Praxis 2005 - 2006
University of Kentucky, Department of Surgery 2001 - 2005
Skills
EDC, GCP, Clinical Trials, CRO, ICH-GCP, Patient Recruitment, Clinical Data Management, Clinical Research..., Clinical Monitoring, CTMS, Oracle Clinical, Inform, Clinical Research, Medidata, Protocol, Clinical Development, Therapeutic Areas, Oncology
Education
University of Kentucky
Bachelor of Health Sciences, Clinical Laboratory Sciences
University of Kentucky
Bachelor of Science, Animal Sciences
Covance Inc August 2014 - Present
Fresenius Medical Care September 2013 - January 2014
Outcomes Health Information Solutions February 2013 - April 2013
Aptiv Solutions September 2012 - January 2013
Covance Inc January 2010 - May 2012
Quintiles March 2008 - October 2009
ICON Clinical Research September 2006 - June 2007
ClinForce, LLC 2007 - 2007
Praxis 2005 - 2006
University of Kentucky, Department of Surgery 2001 - 2005
Skills
EDC, GCP, Clinical Trials, CRO, ICH-GCP, Patient Recruitment, Clinical Data Management, Clinical Research..., Clinical Monitoring, CTMS, Oracle Clinical, Inform, Clinical Research, Medidata, Protocol, Clinical Development, Therapeutic Areas, Oncology
Education
University of Kentucky
Bachelor of Health Sciences, Clinical Laboratory Sciences
University of Kentucky
Bachelor of Science, Animal Sciences
Angelina Barfield Angelina Barfield's Aptiv Solutions Experience 2011 - 2011
Job Contract or Freelance Regulatory or Pharmacovigilance Services
Industry Pharmaceuticals
Experience
A. Barfield Pharmacovigilance Consulting, LLC May 2011 - Present
United Therapeutics February 2009 - May 2011
Aptiv Solutions 2011 - 2011
Aptiv Solutions 2011 - 2011
Rho, Inc. February 2007 - February 2009
Trimeris October 2005 - February 2007
King Pharmaceuticals February 2003 - September 2005
GlaxoSmithKline June 1996 - February 2003
SRG Woolf Group 1996 - 2000
Clintrials 1992 - 1995
Education
East Carolina University 1985 — 1989
BS Nursing, Nursing
A. Barfield Pharmacovigilance Consulting, LLC May 2011 - Present
United Therapeutics February 2009 - May 2011
Aptiv Solutions 2011 - 2011
Aptiv Solutions 2011 - 2011
Rho, Inc. February 2007 - February 2009
Trimeris October 2005 - February 2007
King Pharmaceuticals February 2003 - September 2005
GlaxoSmithKline June 1996 - February 2003
SRG Woolf Group 1996 - 2000
Clintrials 1992 - 1995
Education
East Carolina University 1985 — 1989
BS Nursing, Nursing
Kurt Mussina Kurt Mussina's Aptiv Solutions Experience February 2009 - January 2012
Job
Industry Pharmaceuticals
Experience
Triangle Research Labs February 2012 - July 2012
Aptiv Solutions February 2009 - January 2012
Nuvilex February 2007 - January 2009
Aptuit January 2006 - December 2006
CRF, Inc. January 2005 - December 2005
Inveresk Research January 2001 - December 2003
Inceutica 1999 - 2001
AAI 1991 - 1999
Skills
CRO, Pharmaceutical Industry, Biotechnology, Clinical Trials, Clinical Development, Oncology, Lifesciences, CTMS, Medical Devices, Clinical Research, GCP, Sales, Sales Management, Marketing, Business Development, CMC development, Analytical Chemistry, MBA, adaptive clinical trials, Strategic Sales Plans, Key Account Management, Team Leadership, Regulatory Affairs, Cross-functional Team..., Strategy, New Business Development, FDA, Business Strategy, Management, Leadership, Sales Operations, Drug Development, Commercialization, Product Development, Technology Transfer, Biopharmaceuticals, Marketing Management, R&D, Therapeutic Areas, Drug Discovery, Infectious Diseases, Diabetes, EDC, IND
Education
Duke University - The Fuqua School of Business 1998 — 1999
MBA
Montclair State University 1983 — 1987
BS, Chemistry
Triangle Research Labs February 2012 - July 2012
Aptiv Solutions February 2009 - January 2012
Nuvilex February 2007 - January 2009
Aptuit January 2006 - December 2006
CRF, Inc. January 2005 - December 2005
Inveresk Research January 2001 - December 2003
Inceutica 1999 - 2001
AAI 1991 - 1999
Skills
CRO, Pharmaceutical Industry, Biotechnology, Clinical Trials, Clinical Development, Oncology, Lifesciences, CTMS, Medical Devices, Clinical Research, GCP, Sales, Sales Management, Marketing, Business Development, CMC development, Analytical Chemistry, MBA, adaptive clinical trials, Strategic Sales Plans, Key Account Management, Team Leadership, Regulatory Affairs, Cross-functional Team..., Strategy, New Business Development, FDA, Business Strategy, Management, Leadership, Sales Operations, Drug Development, Commercialization, Product Development, Technology Transfer, Biopharmaceuticals, Marketing Management, R&D, Therapeutic Areas, Drug Discovery, Infectious Diseases, Diabetes, EDC, IND
Education
Duke University - The Fuqua School of Business 1998 — 1999
MBA
Montclair State University 1983 — 1987
BS, Chemistry
Linda McCarthy Linda McCarthy's Aptiv Solutions Experience November 2004 - November 2007
Job Senior Project Accountant
Industry Accounting
Experience
Premier Research May 2015 - Present
Radius Product Development September 2013 - April 2015
Aptiv Solutions, an ICON plc company November 2007 - July 2013
Aptiv Solutions November 2004 - November 2007
PAREXEL October 2000 - October 2004
PAREXEL September 1996 - October 2000
Skills
Financial Analysis, Proposal Writing, Budgeting, Financial Reporting, Revenue Recognition, Revenue Forecasting, Billing, Accounts Receivable, Budgets, Invoicing, Forecasting, Auditing, Clinical Trials, CRO, Management, CTMS, Clinical Research, Sarbanes-Oxley Act, Clinical Development, Project Management, Change Management, GCP, Accounting, Variance Analysis, Accruals, Internal Audit, Account Reconciliation, Training, Mergers & Acquisitions, Process Improvement, Data Analysis, Acquisition Integration, Costpoint, Software Documentation, Cross-functional Team..., Data Management, Project Planning, Pharmaceutical Industry, Contract Negotiation, Contract Management, Integration, Analysis, EDC
Education
University of Massachusetts Lowell 2014 — 2018
Pursuing Bachelor of Business Administration, Business Administration and Management, General
Johnson & Wales University
Associate of Science
Premier Research May 2015 - Present
Radius Product Development September 2013 - April 2015
Aptiv Solutions, an ICON plc company November 2007 - July 2013
Aptiv Solutions November 2004 - November 2007
PAREXEL October 2000 - October 2004
PAREXEL September 1996 - October 2000
Skills
Financial Analysis, Proposal Writing, Budgeting, Financial Reporting, Revenue Recognition, Revenue Forecasting, Billing, Accounts Receivable, Budgets, Invoicing, Forecasting, Auditing, Clinical Trials, CRO, Management, CTMS, Clinical Research, Sarbanes-Oxley Act, Clinical Development, Project Management, Change Management, GCP, Accounting, Variance Analysis, Accruals, Internal Audit, Account Reconciliation, Training, Mergers & Acquisitions, Process Improvement, Data Analysis, Acquisition Integration, Costpoint, Software Documentation, Cross-functional Team..., Data Management, Project Planning, Pharmaceutical Industry, Contract Negotiation, Contract Management, Integration, Analysis, EDC
Education
University of Massachusetts Lowell 2014 — 2018
Pursuing Bachelor of Business Administration, Business Administration and Management, General
Johnson & Wales University
Associate of Science
Lauren Barabas's Aptiv Solutions Experience November 2009 - June 2011
Job Program Coordinator at UMass Medical School
Industry Hospital & Health Care
Experience
UMass Medical School October 2014 - Present
TJX January 2013 - September 2014
UMass Medical School September 2012 - January 2013
AstraZeneca June 2011 - April 2012
Aptiv Solutions November 2009 - June 2011
Charles River Laboratories May 2008 - October 2009
Skills
Project Planning, Project Management, Microsoft Office, GLP, Compliance, Drug Discovery, Biotechnology, Pharmaceutical Industry, Coordination, TMF, Clinical Trials, GCP, CRO, Management, Sop, Cross-functional Team..., Pharmacology
Education
Fitchburg State University 2009 — 2011
Masters, Business Administration
Fitchburg State University 2003 — 2007
Bachelors, Biology, Criminal Justice
UMass Medical School October 2014 - Present
TJX January 2013 - September 2014
UMass Medical School September 2012 - January 2013
AstraZeneca June 2011 - April 2012
Aptiv Solutions November 2009 - June 2011
Charles River Laboratories May 2008 - October 2009
Skills
Project Planning, Project Management, Microsoft Office, GLP, Compliance, Drug Discovery, Biotechnology, Pharmaceutical Industry, Coordination, TMF, Clinical Trials, GCP, CRO, Management, Sop, Cross-functional Team..., Pharmacology
Education
Fitchburg State University 2009 — 2011
Masters, Business Administration
Fitchburg State University 2003 — 2007
Bachelors, Biology, Criminal Justice
Joan Berenato Joan Berenato's Aptiv Solutions Experience December 2010 - July 2014
Job Sr. Clinical Recruiter at Planet Pharma
Industry Pharmaceuticals
Experience
Planet Pharma August 2014 - Present
Aptiv Solutions December 2010 - July 2014
Delta Pharma June 2010 - November 2010
Precept Life Sciences July 2009 - May 2010
Devon Consulting 2002 - 2009
Devon Consulting 1995 - 2002
Devon Consulting 1989 - 1995
Skills
Medical Writing, Data Management, Medical Affairs, Regulations, Talent Acquisition, Project Managers, Applicant Tracking..., Sourcing, Recruiting, Internet Recruiting, Temporary Placement, Training, Sop, Management, Clinical Development, Technical Recruiting, Clinical Monitoring, Medical Devices, Executive Search, Onboarding, Staffing Services, SOP, EDC, Clinical Trials, Pharmaceutical Industry, CRO, GCP, CTMS, Biotechnology
Education
Temple University - Fox School of Business and Management
Bachelor, Business Administration
Planet Pharma August 2014 - Present
Aptiv Solutions December 2010 - July 2014
Delta Pharma June 2010 - November 2010
Precept Life Sciences July 2009 - May 2010
Devon Consulting 2002 - 2009
Devon Consulting 1995 - 2002
Devon Consulting 1989 - 1995
Skills
Medical Writing, Data Management, Medical Affairs, Regulations, Talent Acquisition, Project Managers, Applicant Tracking..., Sourcing, Recruiting, Internet Recruiting, Temporary Placement, Training, Sop, Management, Clinical Development, Technical Recruiting, Clinical Monitoring, Medical Devices, Executive Search, Onboarding, Staffing Services, SOP, EDC, Clinical Trials, Pharmaceutical Industry, CRO, GCP, CTMS, Biotechnology
Education
Temple University - Fox School of Business and Management
Bachelor, Business Administration
Sherry Volk Sherry Volk's Aptiv Solutions Experience August 2011 - October 2014
Job Sr. Clinical Data Lead at ICON
Industry Biotechnology
Experience
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
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
Patricia Monteforte Patricia Monteforte's Aptiv Solutions Experience 2013 - 2014
Job Entrepreneur, Executive Management, Strategy and Execution
Industry Pharmaceuticals
Experience
Trio Clinical Resourcing, an Aptiv Solutions company 2013 - 2014
Aptiv Solutions 2013 - 2014
INC Research 2006 - 2013
INC Research 2006 - 2009
Pharmaceutical Resource Corporation (PRC) 1992 - 2006
Pharmaceutical Staffing Solutions, Inc. 1992 - 2006
Skills
Pharmaceutical Industry, Clinical Development, Pharmaceutics, Oncology, Leadership, Medical Affairs, Management, Vaccines, Biotechnology, CTMS, CRO, Operations Management, Entrepreneurship, Medical Devices, Dermatology, Infectious Diseases
Education
Franklin & Marshall College
Bachelor's degree, Biology/Biological Sciences, General
Dartmouth College - The Tuck School of Business at Dartmouth
The Tuck Executive Program, Participation Sponsored by Johnson & Johnson, Building a High-Performing Business
Committee of 200 Entrepreneur Mentorship Program 2004 — 2005
Trio Clinical Resourcing, an Aptiv Solutions company 2013 - 2014
Aptiv Solutions 2013 - 2014
INC Research 2006 - 2013
INC Research 2006 - 2009
Pharmaceutical Resource Corporation (PRC) 1992 - 2006
Pharmaceutical Staffing Solutions, Inc. 1992 - 2006
Skills
Pharmaceutical Industry, Clinical Development, Pharmaceutics, Oncology, Leadership, Medical Affairs, Management, Vaccines, Biotechnology, CTMS, CRO, Operations Management, Entrepreneurship, Medical Devices, Dermatology, Infectious Diseases
Education
Franklin & Marshall College
Bachelor's degree, Biology/Biological Sciences, General
Dartmouth College - The Tuck School of Business at Dartmouth
The Tuck Executive Program, Participation Sponsored by Johnson & Johnson, Building a High-Performing Business
Committee of 200 Entrepreneur Mentorship Program 2004 — 2005
Sandy (Hjulstrom) Namin Sandy (Hjulstrom) Namin's Aptiv Solutions Experience September 2010 - June 2012
Job Application Developer III (contract) at Genzyme, a Sanofi company
Industry Biotechnology
Experience
Perficient April 2014 - May 2015
BioPharm Systems, Inc. August 2013 - March 2014
Veristat, Inc. June 2012 - October 2012
Aptiv Solutions September 2010 - June 2012
Averion International Corporation November 2006 - September 2010
Allmerica Financial 1979 - 2004
Skills
EDC, Clinical Trials, CDISC, CRO, GCP, Oracle PL/SQL..., SDLC, IVR, Java, VBA, Crystal Reports, Oracle Forms, SAS Base, Databases, Data Analysis, Lifesciences, 21 CFR Part 11, Validation, Oracle
Education
University of Maryland University College 2004 — 2006
M.S., Biotechnology Studies / Bioinformatics
UMass Lowell 2004 — 2004
Department of Computer Science
Clark University 1975 — 1979
B.A., Mathematics
Perficient April 2014 - May 2015
BioPharm Systems, Inc. August 2013 - March 2014
Veristat, Inc. June 2012 - October 2012
Aptiv Solutions September 2010 - June 2012
Averion International Corporation November 2006 - September 2010
Allmerica Financial 1979 - 2004
Skills
EDC, Clinical Trials, CDISC, CRO, GCP, Oracle PL/SQL..., SDLC, IVR, Java, VBA, Crystal Reports, Oracle Forms, SAS Base, Databases, Data Analysis, Lifesciences, 21 CFR Part 11, Validation, Oracle
Education
University of Maryland University College 2004 — 2006
M.S., Biotechnology Studies / Bioinformatics
UMass Lowell 2004 — 2004
Department of Computer Science
Clark University 1975 — 1979
B.A., Mathematics
Kathy Hassig, MS, PMP's Aptiv Solutions Experience November 2001 - August 2012
Job Senior Director, Project Delivery at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences July 2015 - Present
PRA International August 2012 - June 2015
Aptiv Solutions November 2001 - August 2012
Quintiles August 1999 - November 2001
North Carolina Clinical Research January 1995 - August 1999
Skills
Project Execution, Cross-functional Team..., Mentoring Of Staff, Clinical Trials, CRO, ICH-GCP, Project Management, Clinical Development, Drug Development, GCP, Clinical Research, Clinical Monitoring, Oncology, Vaccines, Medical Devices, Protocol, Therapeutic Areas, EDC, CTMS, Biotechnology, Pharmaceutical Industry, Endocrinology, Regulatory Submissions, Clinical Operations, Pharmacovigilance, FDA, Clinical Data Management, Medical Writing, Sop, Lifesciences, Oracle Clinical, GLP, Inform, Data Management, IND, Regulatory Requirements, Immunology, Validation, Clinical Study Design, Biopharmaceuticals, Regulatory Affairs, Diabetes, 21 CFR Part 11
Education
Campbell University 2001 — 2004
MS, Clinical Research
State University of New York College at Geneseo 1990 — 1994
BS, Biology
PRA Health Sciences July 2015 - Present
PRA International August 2012 - June 2015
Aptiv Solutions November 2001 - August 2012
Quintiles August 1999 - November 2001
North Carolina Clinical Research January 1995 - August 1999
Skills
Project Execution, Cross-functional Team..., Mentoring Of Staff, Clinical Trials, CRO, ICH-GCP, Project Management, Clinical Development, Drug Development, GCP, Clinical Research, Clinical Monitoring, Oncology, Vaccines, Medical Devices, Protocol, Therapeutic Areas, EDC, CTMS, Biotechnology, Pharmaceutical Industry, Endocrinology, Regulatory Submissions, Clinical Operations, Pharmacovigilance, FDA, Clinical Data Management, Medical Writing, Sop, Lifesciences, Oracle Clinical, GLP, Inform, Data Management, IND, Regulatory Requirements, Immunology, Validation, Clinical Study Design, Biopharmaceuticals, Regulatory Affairs, Diabetes, 21 CFR Part 11
Education
Campbell University 2001 — 2004
MS, Clinical Research
State University of New York College at Geneseo 1990 — 1994
BS, Biology
Blake Roland Blake Roland's Aptiv Solutions Experience October 2011 - April 2014
Job Senior Biostatistician at PharPoint Research, Inc.
Industry Information Technology and Services
Experience
PharPoint Research, Inc. May 2014 - Present
Aptiv Solutions October 2011 - April 2014
SRA International September 2008 - September 2011
GlaxoSmithKline May 2006 - June 2008
Skills
Clinical Trials, SAS, CRO, Biostatistics, EDC, Clinical Data Management, GCP, Data Management, R, Clinical Development, Protocol, Pharmaceutical Industry, Statistical Programming, ICH-GCP, Regulatory Submissions, CTMS
Education
North Carolina State University 2004 — 2006
Masters, Statistics
University of North Carolina at Wilmington 2000 — 2004
BS, Mathematics
PharPoint Research, Inc. May 2014 - Present
Aptiv Solutions October 2011 - April 2014
SRA International September 2008 - September 2011
GlaxoSmithKline May 2006 - June 2008
Skills
Clinical Trials, SAS, CRO, Biostatistics, EDC, Clinical Data Management, GCP, Data Management, R, Clinical Development, Protocol, Pharmaceutical Industry, Statistical Programming, ICH-GCP, Regulatory Submissions, CTMS
Education
North Carolina State University 2004 — 2006
Masters, Statistics
University of North Carolina at Wilmington 2000 — 2004
BS, Mathematics
Michelle Gerardi Michelle Gerardi's Aptiv Solutions Experience December 2013 - July 2014
Job Sr. Recruiter at Chiltern
Industry Pharmaceuticals
Experience
Chiltern November 2014 - Present
Chiltern September 2014 - November 2014
Aptiv Solutions December 2013 - July 2014
Aptiv Solutions December 2007 - November 2013
Sun Life Financial May 2005 - November 2007
Venturi Staffing Partners 1998 - 2005
Cross Country TravCorps 1996 - 1998
MB Consultants 1995 - 1996
Skills
CRO, Clinical Research, GCP, Talent Acquisition, Medical Devices, Vendor Management, Interviews, Pharmacovigilance, Clinical Trials, Training, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Human Resources, Recruiting, CTMS, Applicant Tracking..., Oncology, Project Management, Business Development, Talent Management
Education
Stonehill College 1992 — 1996
Chiltern November 2014 - Present
Chiltern September 2014 - November 2014
Aptiv Solutions December 2013 - July 2014
Aptiv Solutions December 2007 - November 2013
Sun Life Financial May 2005 - November 2007
Venturi Staffing Partners 1998 - 2005
Cross Country TravCorps 1996 - 1998
MB Consultants 1995 - 1996
Skills
CRO, Clinical Research, GCP, Talent Acquisition, Medical Devices, Vendor Management, Interviews, Pharmacovigilance, Clinical Trials, Training, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Human Resources, Recruiting, CTMS, Applicant Tracking..., Oncology, Project Management, Business Development, Talent Management
Education
Stonehill College 1992 — 1996
Lauren Berning Lauren Berning's Aptiv Solutions Experience October 2010 - March 2012
Job Clinical Research Associate II at TissueGene, Inc.
Industry Pharmaceuticals
Experience
TissueGene, Inc. September 2015 - Present
GlycoMimetics May 2015 - August 2015
GlycoMimetics March 2012 - May 2015
Aptiv Solutions October 2010 - March 2012
Skills
GCP, Clinical Trials, Clinical Research, Pharmaceuticals, SOP, FDA, ICH-GCP, Sop, Biotechnology, Clinical Monitoring, Pharmacovigilance, Clinical Development, CRO, Pharmaceutical Industry
Education
New Mexico State University
Bachelor of Arts, Chemistry
TissueGene, Inc. September 2015 - Present
GlycoMimetics May 2015 - August 2015
GlycoMimetics March 2012 - May 2015
Aptiv Solutions October 2010 - March 2012
Skills
GCP, Clinical Trials, Clinical Research, Pharmaceuticals, SOP, FDA, ICH-GCP, Sop, Biotechnology, Clinical Monitoring, Pharmacovigilance, Clinical Development, CRO, Pharmaceutical Industry
Education
New Mexico State University
Bachelor of Arts, Chemistry
Denise Satterfield, MBA Denise Satterfield, MBA's Aptiv Solutions Experience December 2010 - April 2012
Job Senior Business Development Associate at Duke Clinical Research Institute
Industry Research
Experience
Duke Clinical Research Institute August 2014 - Present
Duke Clinical Research Institute April 2013 - July 2014
Duke Clinical Research Institute May 2012 - March 2013
Aptiv Solutions December 2010 - April 2012
Trio Clinical Resourcing May 2008 - December 2010
Trio Clinical Resourcing October 2006 - April 2008
Duke University September 2004 - October 2006
Skills
Excel, Microsoft Office, Budgeting, Salesforce, SAP, Quickbooks, ADP Payroll, Sales Support, Accounts Payable, Accounts Receivable, Account Reconciliation, Budget Tracking, Change Orders, Proposal Generation, Proposal Coordination, Proposal Review, Payroll Administration, Project Finance, Financial Analysis, Budgets, Pharmaceutical Industry, Proposal Writing, CRO, Clinical Research, Clinical Development, Management, Clinical Trials, Sales Operations, Contract Negotiation, CRM, CTMS, Human Resources, Business Development, GCP, Oncology, EDC, Clinical Data Management, Therapeutic Areas, Biotechnology, Data Management
Education
East Carolina University 2009 — 2012
MBA, Finance
University of North Carolina at Chapel Hill 1999 — 2003
BA, International Studies and Political Science
Duke Clinical Research Institute August 2014 - Present
Duke Clinical Research Institute April 2013 - July 2014
Duke Clinical Research Institute May 2012 - March 2013
Aptiv Solutions December 2010 - April 2012
Trio Clinical Resourcing May 2008 - December 2010
Trio Clinical Resourcing October 2006 - April 2008
Duke University September 2004 - October 2006
Skills
Excel, Microsoft Office, Budgeting, Salesforce, SAP, Quickbooks, ADP Payroll, Sales Support, Accounts Payable, Accounts Receivable, Account Reconciliation, Budget Tracking, Change Orders, Proposal Generation, Proposal Coordination, Proposal Review, Payroll Administration, Project Finance, Financial Analysis, Budgets, Pharmaceutical Industry, Proposal Writing, CRO, Clinical Research, Clinical Development, Management, Clinical Trials, Sales Operations, Contract Negotiation, CRM, CTMS, Human Resources, Business Development, GCP, Oncology, EDC, Clinical Data Management, Therapeutic Areas, Biotechnology, Data Management
Education
East Carolina University 2009 — 2012
MBA, Finance
University of North Carolina at Chapel Hill 1999 — 2003
BA, International Studies and Political Science
Saba Refai (Ali), CCRP's Aptiv Solutions Experience March 2010 - January 2013
Job Senior CRA at ReSearch Pharmaceutical Services
Industry Research
Experience
PRA Health Sciences January 2013 - Present
Aptiv Solutions March 2010 - January 2013
Caligeo Clinical CRO April 2007 - March 2010
Allergan June 2005 - March 2007
Galderma November 2002 - June 2005
Innovex, Inc October 2000 - September 2002
Gillette Company January 2000 - October 2000
Brigham and Women's Hospital October 1998 - December 1999
Skills
R&D, ENT, Oncology, Clinical Trials, Clinical Research, Therapeutic Areas, ICH-GCP, Infectious Diseases, Dermatology, Protocol, Neurology, FDA, Pharmaceutical Industry, CRO
Education
Brandeis University 1994 — 1997
B.S., Neuroscience, Psychology
PRA Health Sciences January 2013 - Present
Aptiv Solutions March 2010 - January 2013
Caligeo Clinical CRO April 2007 - March 2010
Allergan June 2005 - March 2007
Galderma November 2002 - June 2005
Innovex, Inc October 2000 - September 2002
Gillette Company January 2000 - October 2000
Brigham and Women's Hospital October 1998 - December 1999
Skills
R&D, ENT, Oncology, Clinical Trials, Clinical Research, Therapeutic Areas, ICH-GCP, Infectious Diseases, Dermatology, Protocol, Neurology, FDA, Pharmaceutical Industry, CRO
Education
Brandeis University 1994 — 1997
B.S., Neuroscience, Psychology
Tift Tounsley Tift Tounsley's Aptiv Solutions Experience April 2011 - August 2012
Job Principal CRA at PPD
Industry Pharmaceuticals
Experience
PPD March 2013 - Present
Tift J. Tounsley, Inc. August 2012 - March 2013
Aptiv Solutions April 2011 - August 2012
Tift J. Tounsley, Inc October 2010 - April 2011
Premier Research Group, Ltd August 2007 - October 2010
PPD, Inc April 2005 - August 2007
PPD, Inc April 2004 - April 2005
Skills
Oncology, Hypertension, Rheumatoid Arthritis, Restless Leg Syndrome, Parkinsons Disease, CRO, Clinical Research, ICH-GCP, CTMS, Phase I, Contract CRA, Phase Forward InForm, eCRF
Education
University of North Carolina at Wilmington 1991 — 1995
Bachelor of Arts, Psychology
Cape Fear Community College
PPD March 2013 - Present
Tift J. Tounsley, Inc. August 2012 - March 2013
Aptiv Solutions April 2011 - August 2012
Tift J. Tounsley, Inc October 2010 - April 2011
Premier Research Group, Ltd August 2007 - October 2010
PPD, Inc April 2005 - August 2007
PPD, Inc April 2004 - April 2005
Skills
Oncology, Hypertension, Rheumatoid Arthritis, Restless Leg Syndrome, Parkinsons Disease, CRO, Clinical Research, ICH-GCP, CTMS, Phase I, Contract CRA, Phase Forward InForm, eCRF
Education
University of North Carolina at Wilmington 1991 — 1995
Bachelor of Arts, Psychology
Cape Fear Community College
Jeanette Jeudy's Aptiv Solutions Experience June 2012 - Present
Job Sr. CPC, Aptiv Solutions Company, Pharmaceuticals Industry
Industry Research
Experience
Aptiv Solutions June 2012 - Present
Quintiles August 2007 - October 2012
PPD August 2006 - August 2007
Skills
Sop, Pharmaceutical Industry, Clinical Research, Validation, Regulatory Affairs, FDA, GMP, Medical Devices, EDC, CRO, Quality Assurance, CTMS, GCP, ICH-GCP, Clinical Monitoring, Clinical Development, Clinical Trials, Oncology, Protocol, SOP, Regulatory Submissions
Education
Gardner-Webb University 2005 — 2006
Bachelor of Science (BS), Health Science
Aptiv Solutions June 2012 - Present
Quintiles August 2007 - October 2012
PPD August 2006 - August 2007
Skills
Sop, Pharmaceutical Industry, Clinical Research, Validation, Regulatory Affairs, FDA, GMP, Medical Devices, EDC, CRO, Quality Assurance, CTMS, GCP, ICH-GCP, Clinical Monitoring, Clinical Development, Clinical Trials, Oncology, Protocol, SOP, Regulatory Submissions
Education
Gardner-Webb University 2005 — 2006
Bachelor of Science (BS), Health Science
Kimberly Edgerton's Aptiv Solutions Experience February 2008 - September 2012
Job Regulatory Affairs Manager at Synthon
Industry Pharmaceuticals
Experience
Synthon September 2012 - Present
Aptiv Solutions February 2008 - September 2012
Teleflex Medical January 2005 - February 2008
BIOPHARM RESOURCES FOR KING PHARMACEUTICALS 2004 - 2005
RANDSTAD NORTH AMERICA 2002 - 2004
THE WOOLF GROUP, INC January 2000 - January 2002
CLINTRIALS RESEARCH, INC January 1998 - January 2000
Clintrial research 1998 - 1998
Skills
Regulatory Submissions, FDA, Regulatory Affairs, IND, ISO 13485, Pharmaceutical Industry, Medical Devices, Clinical Development, Biotechnology, Clinical Trials, CRO
Education
North Carolina Central University 1991 — 1994
BA, Political Science/Public Administration
Durham Technical Community College 1987 — 1989
Associate in Applied Science, Paralegal Technology
UNC-Charlotte 1983 — 1985
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Synthon September 2012 - Present
Aptiv Solutions February 2008 - September 2012
Teleflex Medical January 2005 - February 2008
BIOPHARM RESOURCES FOR KING PHARMACEUTICALS 2004 - 2005
RANDSTAD NORTH AMERICA 2002 - 2004
THE WOOLF GROUP, INC January 2000 - January 2002
CLINTRIALS RESEARCH, INC January 1998 - January 2000
Clintrial research 1998 - 1998
Skills
Regulatory Submissions, FDA, Regulatory Affairs, IND, ISO 13485, Pharmaceutical Industry, Medical Devices, Clinical Development, Biotechnology, Clinical Trials, CRO
Education
North Carolina Central University 1991 — 1994
BA, Political Science/Public Administration
Durham Technical Community College 1987 — 1989
Associate in Applied Science, Paralegal Technology
UNC-Charlotte 1983 — 1985
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Allison (Salvi) Gorman's Aptiv Solutions Experience January 2012 - May 2014
Job Project Manager at ICON plc
Industry Research
Experience
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
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
Victoria Braidotti, RN's Aptiv Solutions Experience October 2011 - May 2012
Job Clinical Data Reviewer
Industry Research
Experience
Aptiv Solutions October 2011 - May 2012
Green Key Resources 2012 - 2012
Bayer Pharmaceuticals May 2011 - October 2011
Akos Limited May 2007 - December 2010
NYU Medical Center February 2006 - May 2007
Slim-Fast 2002 - 2004
Skills
Oncology, Project Management, Medical Writing, Clinical Research, GCP, Clinical Trials, CRO, CTMS, Clinical Data Management, Clinical Development, EDC, Pharmacovigilance, Drug Safety, Regulatory Submissions
Education
State University of New York Downstate Medical Center College of Medicine 2004 — 2005
BS, Nursing
State University of New York at Oswego 1992 — 1997
BA, Art History
Aptiv Solutions October 2011 - May 2012
Green Key Resources 2012 - 2012
Bayer Pharmaceuticals May 2011 - October 2011
Akos Limited May 2007 - December 2010
NYU Medical Center February 2006 - May 2007
Slim-Fast 2002 - 2004
Skills
Oncology, Project Management, Medical Writing, Clinical Research, GCP, Clinical Trials, CRO, CTMS, Clinical Data Management, Clinical Development, EDC, Pharmacovigilance, Drug Safety, Regulatory Submissions
Education
State University of New York Downstate Medical Center College of Medicine 2004 — 2005
BS, Nursing
State University of New York at Oswego 1992 — 1997
BA, Art History
Aaron Tonkin's Aptiv Solutions Experience December 2013 - September 2014
Job Manager, Sales Support at Premier Research
Industry Biotechnology
Experience
Premier Research April 2015 - Present
ICON plc September 2014 - February 2015
Aptiv Solutions December 2013 - September 2014
Aptiv Solutions February 2012 - December 2013
Aptiv Solutions January 2007 - January 2012
The Institute for Health and Social Policy 2004 - 2006
Skills
Contract Negotiation, Budgeting, Financial Analysis, Excel, Microsoft Office, Clinical Trials, Proposal Writing, VBA, Salesforce.com, Salesforce.com..., Metrics Reporting, Financial Metrics, Business Analysis, Business Development, MS Excel Pivot Tables, Management, SharePoint, Budgets, Process Improvement
Education
The University of Akron
BS, Business Administration/Finance
Premier Research April 2015 - Present
ICON plc September 2014 - February 2015
Aptiv Solutions December 2013 - September 2014
Aptiv Solutions February 2012 - December 2013
Aptiv Solutions January 2007 - January 2012
The Institute for Health and Social Policy 2004 - 2006
Skills
Contract Negotiation, Budgeting, Financial Analysis, Excel, Microsoft Office, Clinical Trials, Proposal Writing, VBA, Salesforce.com, Salesforce.com..., Metrics Reporting, Financial Metrics, Business Analysis, Business Development, MS Excel Pivot Tables, Management, SharePoint, Budgets, Process Improvement
Education
The University of Akron
BS, Business Administration/Finance
Sarah Carter DuHaime's Aptiv Solutions Experience April 2013 - April 2014
Job Senior Proposal Development Associate at ICON plc
Industry Pharmaceuticals
Experience
Aptiv Solutions, an ICON plc company May 2014 - December 2014
Aptiv Solutions April 2013 - April 2014
Quintiles February 2011 - April 2013
Quintiles October 2008 - February 2011
Scene Change Inc. November 2006 - October 2008
Jones Apparel Group February 1996 - October 2006
Schering-Plough 1995 - 1996
EMI Records 1993 - 1995
Bristol-Myers Squibb 1992 - 1993
Standard Management Company 1990 - 1992
Skills
Cross-functional Team..., Retail, Process Improvement, Apparel, Trend Analysis, Management, Fashion, Forecasting, Sportswear, Technical Design, Budgets, Real Estate, Product Development, Start-ups, Social Media, Microsoft Office, Negotiation, Marketing Strategy, Clinical Development, Clinical Trials, Clinical Research, Project Management, Project Coordination, Project Finance, MS Project, Salesforce.com, Microsoft Excel, Adobe Acrobat, Adobe Creative Suite, PLM Tools, Proposal Writing, Pharmaceutical Industry, CRO, Business Development, Strategy, Strategic Planning, Marketing, Analysis
Education
Rutgers, The State University of New Jersey-Newark 2003 — 2013
MBA
Franklin University
Bachelor of Applied Science (BASc), Business Administration and Management, General
Aptiv Solutions, an ICON plc company May 2014 - December 2014
Aptiv Solutions April 2013 - April 2014
Quintiles February 2011 - April 2013
Quintiles October 2008 - February 2011
Scene Change Inc. November 2006 - October 2008
Jones Apparel Group February 1996 - October 2006
Schering-Plough 1995 - 1996
EMI Records 1993 - 1995
Bristol-Myers Squibb 1992 - 1993
Standard Management Company 1990 - 1992
Skills
Cross-functional Team..., Retail, Process Improvement, Apparel, Trend Analysis, Management, Fashion, Forecasting, Sportswear, Technical Design, Budgets, Real Estate, Product Development, Start-ups, Social Media, Microsoft Office, Negotiation, Marketing Strategy, Clinical Development, Clinical Trials, Clinical Research, Project Management, Project Coordination, Project Finance, MS Project, Salesforce.com, Microsoft Excel, Adobe Acrobat, Adobe Creative Suite, PLM Tools, Proposal Writing, Pharmaceutical Industry, CRO, Business Development, Strategy, Strategic Planning, Marketing, Analysis
Education
Rutgers, The State University of New Jersey-Newark 2003 — 2013
MBA
Franklin University
Bachelor of Applied Science (BASc), Business Administration and Management, General
Marija Ribar, DMD, MBA's Aptiv Solutions Experience December 2012 - January 2014
Job Senior Director, Global Program Management, DOCS
Industry Pharmaceuticals
Experience
DOCS January 2014 - Present
Aptiv Solutions December 2012 - January 2014
Aptiv Solutions July 2011 - December 2012
Aptiv Solutions, an ICON plc company October 2008 - July 2011
Fulcrum Pharma Developments, Inc. January 2006 - October 2008
Health Center "Novi Beograd" June 2000 - 2004
Skills
Clinical Research, Clinical Development, Cross-functional Team..., Drug Development, Contract Negotiation, Program Management, Pharmaceutical Industry, Biotechnology, Clinical Trials, Oncology, Lifesciences, FDA, CRO, Regulatory Submissions, R&D, IND, Infectious Diseases, Medical Devices, Management, Drug Discovery, CTMS, Validation, Therapeutic Areas
Education
North Carolina State University - College of Management 2005 — 2008
MBA, BioPharma Management
Univerzitet u Beogradu 1993 — 2000
Doctor of Dental Medicine
DOCS January 2014 - Present
Aptiv Solutions December 2012 - January 2014
Aptiv Solutions July 2011 - December 2012
Aptiv Solutions, an ICON plc company October 2008 - July 2011
Fulcrum Pharma Developments, Inc. January 2006 - October 2008
Health Center "Novi Beograd" June 2000 - 2004
Skills
Clinical Research, Clinical Development, Cross-functional Team..., Drug Development, Contract Negotiation, Program Management, Pharmaceutical Industry, Biotechnology, Clinical Trials, Oncology, Lifesciences, FDA, CRO, Regulatory Submissions, R&D, IND, Infectious Diseases, Medical Devices, Management, Drug Discovery, CTMS, Validation, Therapeutic Areas
Education
North Carolina State University - College of Management 2005 — 2008
MBA, BioPharma Management
Univerzitet u Beogradu 1993 — 2000
Doctor of Dental Medicine
Kelly Hross's Aptiv Solutions Experience October 2004 - May 2012
Job Manager, ICON Clinical Research
Industry Pharmaceuticals
Experience
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
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
Victoria Pursel's Aptiv Solutions Experience June 2008 - Present
Job Senior Director Clinical Operations at ICON
Industry Pharmaceuticals
Experience
ICON plc May 2014 - Present
Aptiv Solutions June 2008 - Present
MRA July 1999 - June 2008
Skills
Clinical Research, GCP, Clinical Operations, CTMS, CRO, Clinical Monitoring, Infectious Diseases, Protocol, EDC, Regulatory Submissions, FDA, Talent Management, Clinical Development, Clinical Data Management, Cardiology, Biotechnology, Management, Drug Development, Clinical Trials, Medical Devices, Therapeutic Areas, ICH-GCP, Regulatory Affairs, Pharmaceutical Industry, Oncology, Pharmacovigilance, Sop, SOP
Education
Columbia University in the City of New York 1996 — 1999
MS
New York University 1994 — 1996
BS, Nursing
Muhlenberg College
BA, History
ICON plc May 2014 - Present
Aptiv Solutions June 2008 - Present
MRA July 1999 - June 2008
Skills
Clinical Research, GCP, Clinical Operations, CTMS, CRO, Clinical Monitoring, Infectious Diseases, Protocol, EDC, Regulatory Submissions, FDA, Talent Management, Clinical Development, Clinical Data Management, Cardiology, Biotechnology, Management, Drug Development, Clinical Trials, Medical Devices, Therapeutic Areas, ICH-GCP, Regulatory Affairs, Pharmaceutical Industry, Oncology, Pharmacovigilance, Sop, SOP
Education
Columbia University in the City of New York 1996 — 1999
MS
New York University 1994 — 1996
BS, Nursing
Muhlenberg College
BA, History
LeKeisha Whitworth's Aptiv Solutions Experience 2008 - August 2012
Job Sr. Data Manager at Novartis
Industry Pharmaceuticals
Experience
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
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
Gail O'Mullan's Aptiv Solutions Experience April 2010 - May 2014
Job Consultant at GOM Consulting
Industry Biotechnology
Experience
Aptiv Solutions April 2010 - May 2014
CR Group February 2008 - April 2010
PRA International February 2003 - December 2007
Sanofi November 1999 - September 2002
BP January 1994 - December 1999
Skills
Recruiting, Strategy, Human Resources, HRIS, Personnel Management, Leadership, Training, Program Management, Mergers & Acquisitions, Succession Planning, Strategic Planning, Employment Law, Budgets, Deferred Compensation, Talent Management, Talent Acquisition, CRO
Education
Texas Tech University 1985 — 1988
Master of Business Administration (MBA), Business
Texas Tech University School of Law 1985 — 1988
Doctor of Jurisprudence, Law
Aptiv Solutions April 2010 - May 2014
CR Group February 2008 - April 2010
PRA International February 2003 - December 2007
Sanofi November 1999 - September 2002
BP January 1994 - December 1999
Skills
Recruiting, Strategy, Human Resources, HRIS, Personnel Management, Leadership, Training, Program Management, Mergers & Acquisitions, Succession Planning, Strategic Planning, Employment Law, Budgets, Deferred Compensation, Talent Management, Talent Acquisition, CRO
Education
Texas Tech University 1985 — 1988
Master of Business Administration (MBA), Business
Texas Tech University School of Law 1985 — 1988
Doctor of Jurisprudence, Law
Christine Romanski's Aptiv Solutions Experience January 2008 - Present
Job Clinical Research Associate
Industry Research
Experience
Aptiv Solutions January 2008 - Present
J. Tyson and Associates January 2005 - January 2008
Education
Florida Atlantic University 1999 — 2001
Bachelor of Science in Nursing
Aptiv Solutions January 2008 - Present
J. Tyson and Associates January 2005 - January 2008
Education
Florida Atlantic University 1999 — 2001
Bachelor of Science in Nursing
Yvette Reza's Aptiv Solutions Experience October 2011 - Present
Job Sr CRA at ICON plc
Industry Research
Experience
ICON plc (formerly Aptiv Solutions) October 2014 - Present
Aptiv Solutions October 2011 - Present
SRA International September 2008 - October 2011
Skills
CRO, CTMS, Clinical Trials, ICH-GCP, Clinical Research, Oncology, EDC, GCP, Clinical Monitoring, Clinical Development
Education
The University of Texas at El Paso
ICON plc (formerly Aptiv Solutions) October 2014 - Present
Aptiv Solutions October 2011 - Present
SRA International September 2008 - October 2011
Skills
CRO, CTMS, Clinical Trials, ICH-GCP, Clinical Research, Oncology, EDC, GCP, Clinical Monitoring, Clinical Development
Education
The University of Texas at El Paso
Pat Donnelly's Aptiv Solutions Experience March 2008 - June 2014
Job Chairman & CEO at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions March 2008 - June 2014
PRA International 1994 - 2006
Skills
Clinical Development, Cardiology, CRO, CTMS, Clinical Research, Pharmaceutical Industry, Biopharmaceuticals, Clinical Trials, Infectious Diseases, Oncology, Sop, Drug Development, Clinical Monitoring, Regulatory Submissions, Regulatory Affairs, GCP, Biotechnology, SOP, Pharmacovigilance, Lifesciences, Drug Discovery, FDA, Technology Transfer
Education
Penn State University 1982 — 1984
MBA, Business
University of Missouri-Columbia, College of Business 1976 — 1980
BS, Business
Aptiv Solutions March 2008 - June 2014
PRA International 1994 - 2006
Skills
Clinical Development, Cardiology, CRO, CTMS, Clinical Research, Pharmaceutical Industry, Biopharmaceuticals, Clinical Trials, Infectious Diseases, Oncology, Sop, Drug Development, Clinical Monitoring, Regulatory Submissions, Regulatory Affairs, GCP, Biotechnology, SOP, Pharmacovigilance, Lifesciences, Drug Discovery, FDA, Technology Transfer
Education
Penn State University 1982 — 1984
MBA, Business
University of Missouri-Columbia, College of Business 1976 — 1980
BS, Business
Helen Mayfield, RAC's Aptiv Solutions Experience August 2010 - March 2014
Job Consultant at PAREXEL
Industry Biotechnology
Experience
PAREXEL July 2015 - Present
Integra LifeSciences March 2015 - Present
OncoSec Medical Inc March 2014 - March 2015
Aptiv Solutions August 2010 - March 2014
Victory Pharma August 2009 - April 2010
Amylin Pharmaceuticals September 2006 - November 2008
Biogen Idec 2000 - 2006
Allergan October 1999 - April 2000
Techniclone 1997 - 1999
Skills
GMP, Validation, Regulatory Affairs, ISO 13485, NDA, IND, Biotechnology, SOP, Combination Products, CMC, V&V, Medical Devices, Regulatory Submissions, Biologics, Life Sciences, Chromatography, Pharmaceutical Industry, Monoclonal Antibodies, FDA, Aseptic Processing
Education
San Diego State University-California State University
M.S., Regulatory Affairs
University of California, Irvine
B.S., Chemistry & Biology
PAREXEL July 2015 - Present
Integra LifeSciences March 2015 - Present
OncoSec Medical Inc March 2014 - March 2015
Aptiv Solutions August 2010 - March 2014
Victory Pharma August 2009 - April 2010
Amylin Pharmaceuticals September 2006 - November 2008
Biogen Idec 2000 - 2006
Allergan October 1999 - April 2000
Techniclone 1997 - 1999
Skills
GMP, Validation, Regulatory Affairs, ISO 13485, NDA, IND, Biotechnology, SOP, Combination Products, CMC, V&V, Medical Devices, Regulatory Submissions, Biologics, Life Sciences, Chromatography, Pharmaceutical Industry, Monoclonal Antibodies, FDA, Aseptic Processing
Education
San Diego State University-California State University
M.S., Regulatory Affairs
University of California, Irvine
B.S., Chemistry & Biology
Phil Dehazya's Aptiv Solutions Experience November 2010 - Present
Job Program Director, Oncology Business Unit at Aptiv Solutions
Industry Research
Experience
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)
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)
Beth Moeller's Aptiv Solutions Experience July 2012 - May 2014
Job Director Sales Operations
Industry Pharmaceuticals
Experience
ICON plc May 2014 - Present
Aptiv Solutions July 2012 - May 2014
Aptiv Solutions 2011 - July 2012
MannKind Corporation September 2003 - April 2011
Hughes Aircraft Company 1987 - 1997
Data General 1982 - 1987
Skills
Pharmaceutical Industry
Education
Anna Maria College 1978 — 1982
Anna Maria College 1978 — 1982
Accounting
ICON plc May 2014 - Present
Aptiv Solutions July 2012 - May 2014
Aptiv Solutions 2011 - July 2012
MannKind Corporation September 2003 - April 2011
Hughes Aircraft Company 1987 - 1997
Data General 1982 - 1987
Skills
Pharmaceutical Industry
Education
Anna Maria College 1978 — 1982
Anna Maria College 1978 — 1982
Accounting
Peter Gonze's Aptiv Solutions Experience August 2008 - January 2013
Job Independent Consultant at CorInsights
Industry Biotechnology
Experience
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
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
Neal Hebert's Aptiv Solutions Experience June 2010 - July 2012
Job Sr. Clinical Research Consultant at ProTrials Research Inc.
Industry Research
Experience
ProTrials Research August 2012 - Present
Aptiv Solutions June 2010 - July 2012
Kforce January 2009 - March 2010
Integrium, LLC February 2002 - January 2009
Covance LLC (Nashville) December 1997 - February 2002
Skills
EDC, Urology, Endocrinology, Gastroenterology, Clinical Monitoring, CTMS, CRO, ICH-GCP, MS Office, Phases 1 - 4, Pulmonary Diseases, Hypertension, Diabetes, Data Review - Queries, Device studies, Clinical Research, GCP, Clinical Trials, Oncology
Education
University of Louisiana at Lafayette 1984 — 1989
Bachelor's degree, Microbiology and Business
ProTrials Research August 2012 - Present
Aptiv Solutions June 2010 - July 2012
Kforce January 2009 - March 2010
Integrium, LLC February 2002 - January 2009
Covance LLC (Nashville) December 1997 - February 2002
Skills
EDC, Urology, Endocrinology, Gastroenterology, Clinical Monitoring, CTMS, CRO, ICH-GCP, MS Office, Phases 1 - 4, Pulmonary Diseases, Hypertension, Diabetes, Data Review - Queries, Device studies, Clinical Research, GCP, Clinical Trials, Oncology
Education
University of Louisiana at Lafayette 1984 — 1989
Bachelor's degree, Microbiology and Business
Bruce M. Wakeman's Aptiv Solutions Experience August 2012 - December 2013
Job Chief Commercial Officer at CRO Analytics
Industry Research
Experience
CRO Analytics August 2015 - Present
Worldwide Clinical Trials December 2013 - August 2015
Aptiv Solutions August 2012 - December 2013
INC Research November 2010 - August 2012
Premier Research Group September 2007 - December 2010
PRG July 2006 - September 2007
SCIREX Corporation March 2005 - June 2006
Skills
CRO, Clinical Trials, Clinical Development, Pharmaceutical Industry, Strategic Partnerships, Business Development, Team Leadership, CTMS, Clinical Monitoring, Oncology, Strategy, GCP, Biotechnology, Drug Development, Clinical Research, Leadership, Competitive Analysis, New Business Development, Data Management, Medical Devices
Education
University of North Carolina at Wilmington 1992 — 1995
BS, Business Management
CRO Analytics August 2015 - Present
Worldwide Clinical Trials December 2013 - August 2015
Aptiv Solutions August 2012 - December 2013
INC Research November 2010 - August 2012
Premier Research Group September 2007 - December 2010
PRG July 2006 - September 2007
SCIREX Corporation March 2005 - June 2006
Skills
CRO, Clinical Trials, Clinical Development, Pharmaceutical Industry, Strategic Partnerships, Business Development, Team Leadership, CTMS, Clinical Monitoring, Oncology, Strategy, GCP, Biotechnology, Drug Development, Clinical Research, Leadership, Competitive Analysis, New Business Development, Data Management, Medical Devices
Education
University of North Carolina at Wilmington 1992 — 1995
BS, Business Management
Launi Masterson, PMP's Aptiv Solutions Experience April 2012 - July 2013
Job Experienced Program and Project Manager
Industry Pharmaceuticals
Experience
INNO Clinical Outcomes August 2013 - August 2015
Aptiv Solutions April 2012 - July 2013
Trio Clinical Research July 2009 - June 2011
Trio Clinical Research October 2004 - June 2009
Trio Clinical Research February 2002 - April 2004
Kyowa Pharmaceutical, Inc. 2000 - 2001
Kyowa Pharmaceutical, Inc. 2000 - 2001
Quintiles 1997 - 2000
Skills
Clinical Trials, Clinical Monitoring, CRO, Clinical Research, Oncology, Regulatory Submissions, Clinical Operations, Protocol, Therapeutic Areas, Clinical Study Design, Drug Development, EDC, Biotechnology, Infectious Diseases, Clinical Development, CTMS, Pharmaceutics, GCP, Pharmaceutical Industry
Education
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1990
BS
INNO Clinical Outcomes August 2013 - August 2015
Aptiv Solutions April 2012 - July 2013
Trio Clinical Research July 2009 - June 2011
Trio Clinical Research October 2004 - June 2009
Trio Clinical Research February 2002 - April 2004
Kyowa Pharmaceutical, Inc. 2000 - 2001
Kyowa Pharmaceutical, Inc. 2000 - 2001
Quintiles 1997 - 2000
Skills
Clinical Trials, Clinical Monitoring, CRO, Clinical Research, Oncology, Regulatory Submissions, Clinical Operations, Protocol, Therapeutic Areas, Clinical Study Design, Drug Development, EDC, Biotechnology, Infectious Diseases, Clinical Development, CTMS, Pharmaceutics, GCP, Pharmaceutical Industry
Education
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1990
BS
Tina Wu's Aptiv Solutions Experience July 2010 - Present
Job Regulatory Project Manager
Industry Medical Devices
Experience
Novartis September 2015 - Present
ICON plc January 2015 - Present
Aptiv Solutions July 2010 - Present
clinivation, Inc. December 2008 - August 2010
Abcam May 2008 - September 2008
Boston University School of Medicine September 2002 - March 2008
Skills
Pharmacology, Regulatory Affairs, Clinical Trials, Assay Development, Biotechnology, Regulatory Submissions, Medical Writing, Drug Development, FDA, IND, Oncology, CRO, Regulatory Requirements, Medical Devices, Life Sciences, Clinical Research, Pharmaceutical Industry, Clinical Development
Education
Boston University School of Medicine 2002 — 2008
Ph.D., Pharmacology
University of California, Los Angeles 1997 — 2002
B.S., Biochemistry
Lexington high school
Novartis September 2015 - Present
ICON plc January 2015 - Present
Aptiv Solutions July 2010 - Present
clinivation, Inc. December 2008 - August 2010
Abcam May 2008 - September 2008
Boston University School of Medicine September 2002 - March 2008
Skills
Pharmacology, Regulatory Affairs, Clinical Trials, Assay Development, Biotechnology, Regulatory Submissions, Medical Writing, Drug Development, FDA, IND, Oncology, CRO, Regulatory Requirements, Medical Devices, Life Sciences, Clinical Research, Pharmaceutical Industry, Clinical Development
Education
Boston University School of Medicine 2002 — 2008
Ph.D., Pharmacology
University of California, Los Angeles 1997 — 2002
B.S., Biochemistry
Lexington high school
Tanya (Schilling) Guy's Aptiv Solutions Experience September 2008 - January 2015
Job Clinical Data Lead II at ICON plc
Industry Biotechnology
Experience
ICON plc January 2015 - Present
ICON plc January 2015 - Present
Aptiv Solutions September 2008 - January 2015
PAREXEL August 1999 - February 2006
Skills
EDC, Clinical Data Management, CRO, GCP, Validation, Therapeutic Areas, Clinical Monitoring, 21 CFR Part 11, Protocol, FDA, ICH-GCP, Drug Development, Clinical Trials, Oncology, Sop, Medidata, Biotechnology, Clinical Research, Data Management, Pharmaceutical Industry
Education
Fitchburg State College 1996 — 1998
Bacholer's of Science, Biology
Mount Wachusett Community College 1994 — 1996
Associates, Liberal Arts
ICON plc January 2015 - Present
ICON plc January 2015 - Present
Aptiv Solutions September 2008 - January 2015
PAREXEL August 1999 - February 2006
Skills
EDC, Clinical Data Management, CRO, GCP, Validation, Therapeutic Areas, Clinical Monitoring, 21 CFR Part 11, Protocol, FDA, ICH-GCP, Drug Development, Clinical Trials, Oncology, Sop, Medidata, Biotechnology, Clinical Research, Data Management, Pharmaceutical Industry
Education
Fitchburg State College 1996 — 1998
Bacholer's of Science, Biology
Mount Wachusett Community College 1994 — 1996
Associates, Liberal Arts
Carol Ann Farmer's Aptiv Solutions Experience April 2012 - May 2014
Job Financial Data Analyst at Cisco
Industry Accounting
Experience
Cisco May 2015 - Present
Credit Suisse September 2014 - April 2015
Credit Suisse May 2014 - August 2014
Aptiv Solutions April 2012 - May 2014
LPG, CPA Firm September 2011 - April 2012
Research Triangle Institute October 2006 - March 2010
IBM, Inc February 2005 - October 2006
IBM, Inc February 2001 - February 2005
IBM, Inc November 1999 - February 2001
IBM, Inc June 1997 - November 1999
Skills
Account Reconciliation, Financial Analysis, General Ledger, Cash Flow Forecasting, Inventory, Payroll, Invoicing, Accounts Receivable, Accounts Payable, Financial Statements, Bank Reconciliation, Management, Auditing, Financial Reporting, Customer Service, Analysis, Accounting
Education
Fayetteville State University 1996 — 1996
BS, Accounting
Cisco May 2015 - Present
Credit Suisse September 2014 - April 2015
Credit Suisse May 2014 - August 2014
Aptiv Solutions April 2012 - May 2014
LPG, CPA Firm September 2011 - April 2012
Research Triangle Institute October 2006 - March 2010
IBM, Inc February 2005 - October 2006
IBM, Inc February 2001 - February 2005
IBM, Inc November 1999 - February 2001
IBM, Inc June 1997 - November 1999
Skills
Account Reconciliation, Financial Analysis, General Ledger, Cash Flow Forecasting, Inventory, Payroll, Invoicing, Accounts Receivable, Accounts Payable, Financial Statements, Bank Reconciliation, Management, Auditing, Financial Reporting, Customer Service, Analysis, Accounting
Education
Fayetteville State University 1996 — 1996
BS, Accounting
Amy Howrigan's Aptiv Solutions Experience November 2010 - February 2013
Job Sr. Independent Contract CRA / Southern California
Industry Pharmaceuticals
Experience
Independent Contractor / ACHS Consulting LLC October 2013 - Present
Peregrine Pharmaceuticals February 2013 - April 2013
Aptiv Solutions November 2010 - February 2013
Valeant Pharmaceuticals International January 2006 - June 2008
Paragon Biomedical May 2003 - January 2006
Skills
EDC, CTMS, Clinical Trials, CRO, GCP, Clinical Development, Clinical Site Monitoring, Oncology, Pharmacueticals, Infectious Diseases, Diabetes, Dermatology, Neurology, Rheumatology, Monoclonal Antibodies, Pediatrics, Cardiology, External Audit, Internal Audit, Endocrinology, Phase II, Phase III, Medical Devices, Wound Care, Therapeutic Areas
Education
University of California, Berkeley 1996 — 2000
BA, Psychology, Social Work
Independent Contractor / ACHS Consulting LLC October 2013 - Present
Peregrine Pharmaceuticals February 2013 - April 2013
Aptiv Solutions November 2010 - February 2013
Valeant Pharmaceuticals International January 2006 - June 2008
Paragon Biomedical May 2003 - January 2006
Skills
EDC, CTMS, Clinical Trials, CRO, GCP, Clinical Development, Clinical Site Monitoring, Oncology, Pharmacueticals, Infectious Diseases, Diabetes, Dermatology, Neurology, Rheumatology, Monoclonal Antibodies, Pediatrics, Cardiology, External Audit, Internal Audit, Endocrinology, Phase II, Phase III, Medical Devices, Wound Care, Therapeutic Areas
Education
University of California, Berkeley 1996 — 2000
BA, Psychology, Social Work
Rita Tsang's Aptiv Solutions Experience June 2011 - Present
Job Principal Statistical Programmer at Aptiv Solutions
Industry Pharmaceuticals
Experience
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
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
Tom Belason's Aptiv Solutions Experience August 2011 - October 2014
Job TMF Specialist at Alexion Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
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
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
Vicki Anastasi's Aptiv Solutions Experience September 2007 - October 2014
Job Global Head, Medical Device & Diagnostics Research at ICON plc
Industry Medical Devices
Experience
ICON plc October 2014 - Present
Aptiv Solutions September 2007 - October 2014
MDCI, an Aptiv Solutions company September 2007 - January 2012
TissueLink Medical February 2000 - September 2007
TissueLink 2000 - 2007
Salient Surgical Technologies (TissueLink) 2000 - 2007
Gene-Trak 1993 - 1995
Gene-Trak Systems 1993 - 1995
Gene-Trak Systems (An Amoco Company) 1993 - 1995
bioMerieux July 1989 - September 1994
Skills
Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Biotechnology, Life Sciences, Cross-functional Team..., Clinical Development, Product Launch
Education
University of Connecticut 1979 — 1983
BS, Chemistry and Biochemistry
ICON plc October 2014 - Present
Aptiv Solutions September 2007 - October 2014
MDCI, an Aptiv Solutions company September 2007 - January 2012
TissueLink Medical February 2000 - September 2007
TissueLink 2000 - 2007
Salient Surgical Technologies (TissueLink) 2000 - 2007
Gene-Trak 1993 - 1995
Gene-Trak Systems 1993 - 1995
Gene-Trak Systems (An Amoco Company) 1993 - 1995
bioMerieux July 1989 - September 1994
Skills
Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Biotechnology, Life Sciences, Cross-functional Team..., Clinical Development, Product Launch
Education
University of Connecticut 1979 — 1983
BS, Chemistry and Biochemistry
Sylvia Maddox's Aptiv Solutions Experience February 2012 - June 2013
Job Clinical Data Associate III at INC Research
Industry Research
Experience
INC Research November 2013 - Present
Aptiv Solutions February 2012 - June 2013
PharPoint Research, Inc. February 2011 - January 2012
Health Decisions May 2003 - March 2011
GSK 2000 - 2003
Quintiles May 1990 - October 2000
Otsuka September 1997 - June 1998
Skills
Clinical Data Management, EDC, Data Management, 21 CFR Part 11, FDA, ICH-GCP, CRO, Clinical Trials, Pharmaceutical Industry, Medidata, Oracle Clinical, Sop, Protocol, GCP, Data Entry, Biotechnology, Oncology, Clinical Development, CTMS, CDISC, Inform, CRF design, Clinical Monitoring, Regulatory Affairs, Regulatory Submissions, Pharmacovigilance, Clinical Research, Therapeutic Areas, Validation, SOP development, SOP
Education
Sandhills Community College 1982 — 1984
AAS, Business, Computer Programming
University of North Carolina at Chapel Hill 1980 — 1981
General College
INC Research November 2013 - Present
Aptiv Solutions February 2012 - June 2013
PharPoint Research, Inc. February 2011 - January 2012
Health Decisions May 2003 - March 2011
GSK 2000 - 2003
Quintiles May 1990 - October 2000
Otsuka September 1997 - June 1998
Skills
Clinical Data Management, EDC, Data Management, 21 CFR Part 11, FDA, ICH-GCP, CRO, Clinical Trials, Pharmaceutical Industry, Medidata, Oracle Clinical, Sop, Protocol, GCP, Data Entry, Biotechnology, Oncology, Clinical Development, CTMS, CDISC, Inform, CRF design, Clinical Monitoring, Regulatory Affairs, Regulatory Submissions, Pharmacovigilance, Clinical Research, Therapeutic Areas, Validation, SOP development, SOP
Education
Sandhills Community College 1982 — 1984
AAS, Business, Computer Programming
University of North Carolina at Chapel Hill 1980 — 1981
General College
JoAnne (Anderson) Bronikowski, BSCS, RAC's Aptiv Solutions Experience October 2011 - January 2014
Job Senior Regulatory Project Manager, Medical Devices at ICON
Industry Information Technology and Services
Experience
ICON (Formerly Aptiv Solutions) January 2014 - Present
Aptiv Solutions October 2011 - January 2014
UNC Lineberger Comprehensive Cancer Center February 2012 - July 2012
Code-Refinery, LLC August 2011 - October 2011
Proventys April 2009 - July 2011
Code-Refinery, LLC. October 2008 - April 2009
LMS Medical Systems February 2004 - September 2008
VisionAIR 2002 - 2004
OXFORD GLOBAL SERVICES (@OXFORD GLOBAL SERVICES, @HILL-ROM, INC.) 2002 - 2003
LMS Medical Systems 2002 - 2002
Skills
Agile Methodologies
Education
Louisiana Tech University 1984 — 1988
B.S., Computer Science
ICON (Formerly Aptiv Solutions) January 2014 - Present
Aptiv Solutions October 2011 - January 2014
UNC Lineberger Comprehensive Cancer Center February 2012 - July 2012
Code-Refinery, LLC August 2011 - October 2011
Proventys April 2009 - July 2011
Code-Refinery, LLC. October 2008 - April 2009
LMS Medical Systems February 2004 - September 2008
VisionAIR 2002 - 2004
OXFORD GLOBAL SERVICES (@OXFORD GLOBAL SERVICES, @HILL-ROM, INC.) 2002 - 2003
LMS Medical Systems 2002 - 2002
Skills
Agile Methodologies
Education
Louisiana Tech University 1984 — 1988
B.S., Computer Science
Kofi Akomeah's Aptiv Solutions Experience 2011 - 2012
Job Finance
Industry Consumer Goods
Experience
PepsiCo 2014 - Present
PepsiCo 2012 - 2014
Aptiv Solutions 2011 - 2012
Kenan-Flagler Business School July 2009 - May 2011
Carrboro Capital February 2010 - January 2011
Becton Dickinson September 2005 - June 2009
Vision Technology Services 2004 - 2005
Skills
Financial Analysis, Financial Modeling, Due Diligence, Forecasting, Corporate Finance, Market Research, Corporate FP&A, Financial Reporting, Competitive Analysis, Management Consulting, Business Analysis, Data Analysis, Strategy, Cross-functional Team..., Project Management, Business Strategy, Valuation
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2009 — 2011
MBA
University of Maryland
BS, Computer Science
PepsiCo 2014 - Present
PepsiCo 2012 - 2014
Aptiv Solutions 2011 - 2012
Kenan-Flagler Business School July 2009 - May 2011
Carrboro Capital February 2010 - January 2011
Becton Dickinson September 2005 - June 2009
Vision Technology Services 2004 - 2005
Skills
Financial Analysis, Financial Modeling, Due Diligence, Forecasting, Corporate Finance, Market Research, Corporate FP&A, Financial Reporting, Competitive Analysis, Management Consulting, Business Analysis, Data Analysis, Strategy, Cross-functional Team..., Project Management, Business Strategy, Valuation
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2009 — 2011
MBA
University of Maryland
BS, Computer Science
Nicole Soule, CCRP's Aptiv Solutions Experience May 2010 - August 2012
Job CTM at Idera Pharmaceuticals
Industry Biotechnology
Experience
Idera Pharmaceuticals January 2015 - Present
AVEO Oncology December 2013 - December 2014
AVEO Oncology August 2012 - December 2013
Aptiv Solutions May 2010 - August 2012
Fresenius Biotech May 2008 - April 2010
Fresenius Biotech GmbH June 2005 - May 2008
Dana-Farber Cancer Institute October 2002 - June 2005
Worldcare, Inc. April 2002 - October 2002
Tufts-New England Medical Center December 2000 - April 2002
American Cancer Society January 1999 - December 2000
Skills
Clinical Research, Clinical Trials, Budgeting, EDC, CRO, Oncology, ICH-GCP, Biotechnology, Clinical Operations, GCP, Clinical Monitoring, Clinical Development, CTMS, Regulatory Affairs, FDA, Budgets, Pharmaceutical Industry
Education
Bates College 1993 — 1997
BA
Idera Pharmaceuticals January 2015 - Present
AVEO Oncology December 2013 - December 2014
AVEO Oncology August 2012 - December 2013
Aptiv Solutions May 2010 - August 2012
Fresenius Biotech May 2008 - April 2010
Fresenius Biotech GmbH June 2005 - May 2008
Dana-Farber Cancer Institute October 2002 - June 2005
Worldcare, Inc. April 2002 - October 2002
Tufts-New England Medical Center December 2000 - April 2002
American Cancer Society January 1999 - December 2000
Skills
Clinical Research, Clinical Trials, Budgeting, EDC, CRO, Oncology, ICH-GCP, Biotechnology, Clinical Operations, GCP, Clinical Monitoring, Clinical Development, CTMS, Regulatory Affairs, FDA, Budgets, Pharmaceutical Industry
Education
Bates College 1993 — 1997
BA
Winnie Hua's Aptiv Solutions Experience May 2006 - September 2012
Job Biostatistician and Statistical Programmer
Industry Medical Devices
Experience
Fresenius Medical Care September 2012 - Present
Aptiv Solutions May 2006 - September 2012
Skills
Clinical Trials, CRO, Clinical Development, Biostatistics, GCP, ICH-GCP, Biotechnology, CDISC, Clinical Study Design, Oncology, FDA, Pharmaceutical Industry, Regulatory Submissions, EDC
Education
Boston University 2003 — 2006
Master of Arts (MA), Biostatistics
University of New Hampshire 2002 — 2003
Master of Science (MS), Math: Statistics
Fresenius Medical Care September 2012 - Present
Aptiv Solutions May 2006 - September 2012
Skills
Clinical Trials, CRO, Clinical Development, Biostatistics, GCP, ICH-GCP, Biotechnology, CDISC, Clinical Study Design, Oncology, FDA, Pharmaceutical Industry, Regulatory Submissions, EDC
Education
Boston University 2003 — 2006
Master of Arts (MA), Biostatistics
University of New Hampshire 2002 — 2003
Master of Science (MS), Math: Statistics
Kerri Eckelman's Aptiv Solutions Experience January 2014 - Present
Job Senior Director Business Development at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions January 2014 - Present
Premier Research May 2013 - January 2014
PRA International July 2011 - April 2013
PRA International September 2005 - July 2011
PRA International June 2000 - September 2005
Education
The College of New Jersey
Aptiv Solutions January 2014 - Present
Premier Research May 2013 - January 2014
PRA International July 2011 - April 2013
PRA International September 2005 - July 2011
PRA International June 2000 - September 2005
Education
The College of New Jersey
Lydia Park's Aptiv Solutions Experience January 2012 - Present
Job Senior Director Project Management at ICON plc
Industry Pharmaceuticals
Experience
ICON plc April 2014 - Present
Aptiv Solutions January 2012 - Present
PRA International April 2001 - December 2011
Skills
GCP, CRO, CTMS, Clinical Trials, Clinical Development, EDC, Pharmaceutical Industry, ICH-GCP, Drug Development, Project Management, Therapeutic Areas, Oncology, Infectious Diseases, Clinical Monitoring, Regulatory Submissions, Oracle Clinical, Clinical Research, Sop, CNS disorders, Rare Diseases
Education
Texas State University 1983 — 1987
BS, Medical Records Admin
ICON plc April 2014 - Present
Aptiv Solutions January 2012 - Present
PRA International April 2001 - December 2011
Skills
GCP, CRO, CTMS, Clinical Trials, Clinical Development, EDC, Pharmaceutical Industry, ICH-GCP, Drug Development, Project Management, Therapeutic Areas, Oncology, Infectious Diseases, Clinical Monitoring, Regulatory Submissions, Oracle Clinical, Clinical Research, Sop, CNS disorders, Rare Diseases
Education
Texas State University 1983 — 1987
BS, Medical Records Admin
Carol Gaines, M.D.'s Aptiv Solutions Experience May 2014 - January 2015
Job Senior Medical Director at Aptinyx Inc (formerly Naurex Inc)
Industry Research
Experience
Aptinyx Inc (formerly Naurex Inc) February 2015 - Present
EMD Serono 2010 - Present
Aptiv Solutions May 2014 - January 2015
Abbott Labs September 2007 - May 2009
Covance May 2005 - September 2007
Skills
Pharmaceutical Industry, Neurology, Oncology, Clinical Trials, Biotechnology, Lifesciences, Medical Affairs, Medical Writing, Pharmaceutical Sales, Regulatory Affairs, Clinical Research, Hospitals, Healthcare, Medical Devices, Therapeutic Areas, Immunology, Clinical Development, Pharmaceutics, Medicine, Life Sciences, Neuroscience, Translational Medicine
Education
Medical College of Wisconsin 1978 — 1986
M.D., Neurology
Medical College of Wisconsin
Neurology
Aptinyx Inc (formerly Naurex Inc) February 2015 - Present
EMD Serono 2010 - Present
Aptiv Solutions May 2014 - January 2015
Abbott Labs September 2007 - May 2009
Covance May 2005 - September 2007
Skills
Pharmaceutical Industry, Neurology, Oncology, Clinical Trials, Biotechnology, Lifesciences, Medical Affairs, Medical Writing, Pharmaceutical Sales, Regulatory Affairs, Clinical Research, Hospitals, Healthcare, Medical Devices, Therapeutic Areas, Immunology, Clinical Development, Pharmaceutics, Medicine, Life Sciences, Neuroscience, Translational Medicine
Education
Medical College of Wisconsin 1978 — 1986
M.D., Neurology
Medical College of Wisconsin
Neurology
Kimberly Myette's Aptiv Solutions Experience August 2011 - Present
Job Proposal Developer, Aptiv Solutions
Industry Medical Devices
Experience
Aptiv Solutions August 2011 - Present
Medical Device Consultants, Inc. (acquired by Aptiv Solutions) January 2002 - August 2011
Insta Care Pharmacy 1984 - 1992
Skills
Medical Devices, Proposal Writing, Biotechnology, FDA, New Business Development, Oncology, Lifesciences
Education
Fitchburg State University 1980 — 1984
BS, Business/Marketing
Aptiv Solutions August 2011 - Present
Medical Device Consultants, Inc. (acquired by Aptiv Solutions) January 2002 - August 2011
Insta Care Pharmacy 1984 - 1992
Skills
Medical Devices, Proposal Writing, Biotechnology, FDA, New Business Development, Oncology, Lifesciences
Education
Fitchburg State University 1980 — 1984
BS, Business/Marketing
Silke Thode's Aptiv Solutions Experience September 2009 - July 2012
Job Director, Clinical Research at Advanced Bionics
Industry Pharmaceuticals
Experience
Advanced Bionics June 2015 - Present
Glaukos Corporation July 2012 - June 2015
Aptiv Solutions September 2009 - July 2012
Averion International (now part of Aptiv Solutions) June 2007 - September 2009
Integrium February 2004 - May 2007
Iconix Biosciences August 1999 - February 2004
Signal Pharmaceuticals November 1996 - July 1999
Skills
Clinical Trials, CRO, CTMS, GCP, Clinical Development, Clinical Operations, Clinical Monitoring, Clinical Research, Regulatory Submissions, FDA, ICH-GCP, Clinical Data Management, Sop, Drug Development
Education
University of Cologne 1980 — 1992
PhD, Biology
Advanced Bionics June 2015 - Present
Glaukos Corporation July 2012 - June 2015
Aptiv Solutions September 2009 - July 2012
Averion International (now part of Aptiv Solutions) June 2007 - September 2009
Integrium February 2004 - May 2007
Iconix Biosciences August 1999 - February 2004
Signal Pharmaceuticals November 1996 - July 1999
Skills
Clinical Trials, CRO, CTMS, GCP, Clinical Development, Clinical Operations, Clinical Monitoring, Clinical Research, Regulatory Submissions, FDA, ICH-GCP, Clinical Data Management, Sop, Drug Development
Education
University of Cologne 1980 — 1992
PhD, Biology
Heather Lanford's Aptiv Solutions Experience October 2011 - December 2011
Job Regulatory and Startup Line Manager, Investigator Contracts
Industry Research
Experience
Quintiles February 2013 - Present
Quintiles February 2012 - January 2013
Aptiv Solutions October 2011 - December 2011
SRA International November 2005 - September 2011
Charles River Laboratories Clinical Services November 2002 - November 2005
Education
East Carolina University - College of Business 1996 — 1999
BS, Business Administration
Quintiles February 2013 - Present
Quintiles February 2012 - January 2013
Aptiv Solutions October 2011 - December 2011
SRA International November 2005 - September 2011
Charles River Laboratories Clinical Services November 2002 - November 2005
Education
East Carolina University - College of Business 1996 — 1999
BS, Business Administration
Mary Fincher, PHR's Aptiv Solutions Experience January 2011 - August 2012
Job Clinical Resourcing Associate at Catalyst Clinical Resourcing, LLC
Industry Human Resources
Experience
Catalyst Clinical Resourcing, LLC January 2015 - Present
UNC Wellness Center October 2007 - Present
North Carolina State University August 2013 - December 2014
NC State University - University Temporary Services October 2012 - July 2013
Aptiv Solutions January 2011 - August 2012
Trio Clinical Resourcing August 2008 - December 2010
Trio Clinical Resourcing June 2007 - August 2008
Rowan Regional Medical Center May 2006 - August 2006
Skills
CRO, Microsoft Excel, Employee Relations, Microsoft Office, Recruiting, Performance Management, New Hire Orientations, Personnel Management, Human Resources, Benefits Administration, Employment Law, Employee Benefits, HRIS
Education
Appalachian State University 2002 — 2007
Business, Health Care Management
Salisbury High School
Salisbury High School
Catalyst Clinical Resourcing, LLC January 2015 - Present
UNC Wellness Center October 2007 - Present
North Carolina State University August 2013 - December 2014
NC State University - University Temporary Services October 2012 - July 2013
Aptiv Solutions January 2011 - August 2012
Trio Clinical Resourcing August 2008 - December 2010
Trio Clinical Resourcing June 2007 - August 2008
Rowan Regional Medical Center May 2006 - August 2006
Skills
CRO, Microsoft Excel, Employee Relations, Microsoft Office, Recruiting, Performance Management, New Hire Orientations, Personnel Management, Human Resources, Benefits Administration, Employment Law, Employee Benefits, HRIS
Education
Appalachian State University 2002 — 2007
Business, Health Care Management
Salisbury High School
Salisbury High School
Marcia Phillips's Aptiv Solutions Experience October 2011 - April 2013
Job Quality Assurance Manager at MedSource
Industry Pharmaceuticals
Experience
MedSource September 2015 - Present
Chiltern July 2014 - October 2014
Ockham Development Group April 2013 - July 2014
Aptiv Solutions October 2011 - April 2013
Health Decisions May 2004 - September 2011
RTI International June 2000 - May 2004
University Health Systems of Eastern Carolina Dept. of Pharmacy Services June 1996 - August 1997
Chrysalis International Corporation April 1995 - May 1996
Wildlife International Ltd April 1991 - April 1995
Integrated Laboratory Systems July 1988 - April 1991
Skills
Pharmaceutical Industry, CRO, EDC, GCP, Clinical Trials, CTMS, Clinical Development, ICH-GCP, Clinical Research, SOP
Education
East Carolina University 1998 — 2001
MA, History
New Mexico State University 1983 — 1986
MS, Wildlife Sciences; Toxicology
Penn State University 1979 — 1983
BS, Wildlife Sciences
MedSource September 2015 - Present
Chiltern July 2014 - October 2014
Ockham Development Group April 2013 - July 2014
Aptiv Solutions October 2011 - April 2013
Health Decisions May 2004 - September 2011
RTI International June 2000 - May 2004
University Health Systems of Eastern Carolina Dept. of Pharmacy Services June 1996 - August 1997
Chrysalis International Corporation April 1995 - May 1996
Wildlife International Ltd April 1991 - April 1995
Integrated Laboratory Systems July 1988 - April 1991
Skills
Pharmaceutical Industry, CRO, EDC, GCP, Clinical Trials, CTMS, Clinical Development, ICH-GCP, Clinical Research, SOP
Education
East Carolina University 1998 — 2001
MA, History
New Mexico State University 1983 — 1986
MS, Wildlife Sciences; Toxicology
Penn State University 1979 — 1983
BS, Wildlife Sciences
Charmi Dorsey's Aptiv Solutions Experience January 2013 - Present
Job Clinical Database Programmer II at Aptiv Solutions
Industry Pharmaceuticals
DeLynn Pugh's Aptiv Solutions Experience June 2006 - July 2012
Job Lead CRA at Cmed Clinical Services
Industry Pharmaceuticals
Experience
Cmed Clinical Services July 2012 - Present
Aptiv Solutions June 2006 - July 2012
Targacept, Inc. 2003 - 2004
i3 Research 2001 - 2004
All Trials Clinical Research, LLC 1999 - 2001
Skills
EDC, Clinical Development, CTMS, CRO, GCP, ICH-GCP, Clinical Trials, Clinical Data Management, Clinical Research, Therapeutic Areas, Protocol, Clinical Research..., Sop, Oracle Clinical, Regulatory Affairs, Infectious Diseases, Data Management, Patient Recruitment, FDA, Vaccines, 21 CFR Part 11, CRF design, Diabetes, IRB, Trial Management, Oncology Clinical..., Endocrinology, Medical Devices, Neurology, Immunology, Informed Consent, SOP development
Education
University of North Carolina at Greensboro 1994 — 1998
BS, Public Health
Cmed Clinical Services July 2012 - Present
Aptiv Solutions June 2006 - July 2012
Targacept, Inc. 2003 - 2004
i3 Research 2001 - 2004
All Trials Clinical Research, LLC 1999 - 2001
Skills
EDC, Clinical Development, CTMS, CRO, GCP, ICH-GCP, Clinical Trials, Clinical Data Management, Clinical Research, Therapeutic Areas, Protocol, Clinical Research..., Sop, Oracle Clinical, Regulatory Affairs, Infectious Diseases, Data Management, Patient Recruitment, FDA, Vaccines, 21 CFR Part 11, CRF design, Diabetes, IRB, Trial Management, Oncology Clinical..., Endocrinology, Medical Devices, Neurology, Immunology, Informed Consent, SOP development
Education
University of North Carolina at Greensboro 1994 — 1998
BS, Public Health
Bob Hines's Aptiv Solutions Experience 2008 - 2014
Job Corporate Controller at Thinking Phone Networks
Industry Pharmaceuticals
Experience
Thinking Phone Networks September 2015 - Present
Valeritas May 2014 - September 2015
Aptiv Solutions 2008 - 2014
Virtusa Corporation 2005 - 2007
Candela Corporation January 2003 - January 2005
Art Technology Group 2004 - 2005
Connected Corporation January 2001 - January 2003
The Hanover Group January 1998 - January 2000
ALEXANDER ARONSON & FINNING LLP January 1997 - January 1998
AFC Consolidated Reporting January 1995 - January 1998
Skills
Revenue Recognition, Budgets, Financial Analysis, Accounting, Financial Reporting, GAAP, SEC filings, Internal Controls, Accounts Receivable, Auditing, Account Reconciliation, Sarbanes-Oxley, General Ledger, Financial Modeling, Finance, Mergers & Acquisitions, Accounts Payable, Financial Statements, Internal Audit, Consolidation, Tax, Invoicing, CPA, Corporate Finance, External Audit, Cash Management, Payroll, Great Plains Software, Forecasting, Management, Sarbanes-Oxley Act, Consolidated Financial..., Cash Flow Forecasting, Due Diligence, Acquisition Integration, Analysis, Deltek, Financial Accounting, Corporate Tax, Managerial Finance, IPO, Public Companies
Education
Boston College 1991 — 1995
BA, Accounting
Boston College
B.A, Accounting
Thinking Phone Networks September 2015 - Present
Valeritas May 2014 - September 2015
Aptiv Solutions 2008 - 2014
Virtusa Corporation 2005 - 2007
Candela Corporation January 2003 - January 2005
Art Technology Group 2004 - 2005
Connected Corporation January 2001 - January 2003
The Hanover Group January 1998 - January 2000
ALEXANDER ARONSON & FINNING LLP January 1997 - January 1998
AFC Consolidated Reporting January 1995 - January 1998
Skills
Revenue Recognition, Budgets, Financial Analysis, Accounting, Financial Reporting, GAAP, SEC filings, Internal Controls, Accounts Receivable, Auditing, Account Reconciliation, Sarbanes-Oxley, General Ledger, Financial Modeling, Finance, Mergers & Acquisitions, Accounts Payable, Financial Statements, Internal Audit, Consolidation, Tax, Invoicing, CPA, Corporate Finance, External Audit, Cash Management, Payroll, Great Plains Software, Forecasting, Management, Sarbanes-Oxley Act, Consolidated Financial..., Cash Flow Forecasting, Due Diligence, Acquisition Integration, Analysis, Deltek, Financial Accounting, Corporate Tax, Managerial Finance, IPO, Public Companies
Education
Boston College 1991 — 1995
BA, Accounting
Boston College
B.A, Accounting
Cathy Frazee's Aptiv Solutions Experience December 2006 - April 2014
Job Clinical Data Coordinator III at ICON Clinical Research (formerly Aptiv Solutions)
Industry Pharmaceuticals
Experience
ICON Clinical Research (formerly Aptiv Solutions) December 2006 - Present
Aptiv Solutions December 2006 - April 2014
PAREXEL November 2005 - December 2006
ClinForce January 2004 - November 2005
GlaxoSmithKline (formerly GlaxoWellcome) September 1995 - December 2003
Skills
Clinical Data Management, CRO, Clinical Data, Clinical Trials, EDC, GCP, Oncology, Data Management, Clinical Research, Therapeutic Areas, Oracle Clinical, CTMS, Pharmaceutical Industry, ICH-GCP, SOP
Education
University of North Carolina at Wilmington 1989 — 1992
BS, Business Management
Louisburg College 1987 — 1989
AA, General Business
ICON Clinical Research (formerly Aptiv Solutions) December 2006 - Present
Aptiv Solutions December 2006 - April 2014
PAREXEL November 2005 - December 2006
ClinForce January 2004 - November 2005
GlaxoSmithKline (formerly GlaxoWellcome) September 1995 - December 2003
Skills
Clinical Data Management, CRO, Clinical Data, Clinical Trials, EDC, GCP, Oncology, Data Management, Clinical Research, Therapeutic Areas, Oracle Clinical, CTMS, Pharmaceutical Industry, ICH-GCP, SOP
Education
University of North Carolina at Wilmington 1989 — 1992
BS, Business Management
Louisburg College 1987 — 1989
AA, General Business
Jessica Crane's Aptiv Solutions Experience November 2007 - April 2014
Job Clinical Trials Manager at Spectrum Pharmaceuticals
Industry Biotechnology
Experience
Spectrum Pharmaceuticals May 2014 - Present
Aptiv Solutions November 2007 - April 2014
Integrium July 2007 - November 2007
UCI Comprehensive Cancer Center February 2007 - July 2007
UPMC June 2005 - January 2007
Skills
GCP, Oncology, Clinical Research, CRO, EDC, Clinical Study Design, Clinical Development, Therapeutic Areas, Clinical Trials, CTMS, ICH-GCP, Pharmaceutical Industry, Clinical Operations, Clinical Monitoring, Clinical Data Management, Data Management
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2010
MS, Health Sciences
University of Pittsburgh 2000 — 2005
BS, Health and Rehabilitation Sciences
Spectrum Pharmaceuticals May 2014 - Present
Aptiv Solutions November 2007 - April 2014
Integrium July 2007 - November 2007
UCI Comprehensive Cancer Center February 2007 - July 2007
UPMC June 2005 - January 2007
Skills
GCP, Oncology, Clinical Research, CRO, EDC, Clinical Study Design, Clinical Development, Therapeutic Areas, Clinical Trials, CTMS, ICH-GCP, Pharmaceutical Industry, Clinical Operations, Clinical Monitoring, Clinical Data Management, Data Management
Education
The George Washington University School of Medicine and Health Sciences 2008 — 2010
MS, Health Sciences
University of Pittsburgh 2000 — 2005
BS, Health and Rehabilitation Sciences
John Mitcheson's Aptiv Solutions Experience April 2012 - Present
Job Project Manager, Contracts and Proposals at Health Decisions
Industry Pharmaceuticals
Experience
Health Decisions October 2013 - Present
Aptiv Solutions April 2012 - Present
PharmaNet/i3 April 2010 - April 2012
Kendle International September 2007 - April 2010
Rogers Benefit Group June 2005 - September 2007
Kraze Speed Equipment August 1994 - February 2005
Stop & Shop Co, Inc June 1985 - August 1994
Skills
CRO, CTMS, Business Development, Clinical Trials, Proposal Writing, Budgets, Management, Pharmaceutical Industry, Clinical Development, ICH-GCP, EDC, Oncology, GCP, Clinical Monitoring, Biotechnology, Clinical Research
Education
Providence College
MBA, Business
Providence College
BS, Health Services Administration/Biology
Health Decisions October 2013 - Present
Aptiv Solutions April 2012 - Present
PharmaNet/i3 April 2010 - April 2012
Kendle International September 2007 - April 2010
Rogers Benefit Group June 2005 - September 2007
Kraze Speed Equipment August 1994 - February 2005
Stop & Shop Co, Inc June 1985 - August 1994
Skills
CRO, CTMS, Business Development, Clinical Trials, Proposal Writing, Budgets, Management, Pharmaceutical Industry, Clinical Development, ICH-GCP, EDC, Oncology, GCP, Clinical Monitoring, Biotechnology, Clinical Research
Education
Providence College
MBA, Business
Providence College
BS, Health Services Administration/Biology
Alicia Morrison's Aptiv Solutions Experience September 2010 - May 2014
Job Senior Clinical Trial Assistant at ICON plc
Industry Pharmaceuticals
Experience
ICON plc May 2014 - Present
Aptiv Solutions September 2010 - May 2014
PharmaNet Development Group March 2007 - September 2010
Toshiba Business Solutions October 2006 - January 2007
HTI Voice Solutions February 2004 - January 2006
Skills
GCP, Clinical Research, CRO, Clinical Trials, CTMS, EDC
Education
University of Phoenix 2009 — 2011
Associates, Healthcare Administration
ICON plc May 2014 - Present
Aptiv Solutions September 2010 - May 2014
PharmaNet Development Group March 2007 - September 2010
Toshiba Business Solutions October 2006 - January 2007
HTI Voice Solutions February 2004 - January 2006
Skills
GCP, Clinical Research, CRO, Clinical Trials, CTMS, EDC
Education
University of Phoenix 2009 — 2011
Associates, Healthcare Administration
Carol Fuller's Aptiv Solutions Experience September 2008 - January 2015
Job CDMS Programming Lead II at ICON plc
Industry Pharmaceuticals
Experience
ICON plc January 2015 - Present
Aptiv Solutions September 2008 - January 2015
Skills
CRO, Pharmaceutical Industry, EDC, SAS programming, Data Management, ICH-GCP, CTMS, Pharmacovigilance, Oracle Clinical, GCP, Clinical Data Management, Lifesciences, Oncology, CDISC, Clinical Research, CRF design, Clinical Trials, Business Analysis, Clinical Development
Education
Clark University 1989 — 1991
MBA, Marketing, Computer Science
Boston College 1981 — 1985
BS, Marketing Computer Science
Boston College 1981 — 1985
Bachelor’s Degree, Marketing and Computer Science
ICON plc January 2015 - Present
Aptiv Solutions September 2008 - January 2015
Skills
CRO, Pharmaceutical Industry, EDC, SAS programming, Data Management, ICH-GCP, CTMS, Pharmacovigilance, Oracle Clinical, GCP, Clinical Data Management, Lifesciences, Oncology, CDISC, Clinical Research, CRF design, Clinical Trials, Business Analysis, Clinical Development
Education
Clark University 1989 — 1991
MBA, Marketing, Computer Science
Boston College 1981 — 1985
BS, Marketing Computer Science
Boston College 1981 — 1985
Bachelor’s Degree, Marketing and Computer Science
Leslie Cate Hilton's Aptiv Solutions Experience July 2008 - June 2012
Job CEO/CRO Consultant
Industry Pharmaceuticals
Experience
LCH Consulting 2012 - Present
Aptiv Solutions July 2008 - June 2012
SRA International July 2008 - October 2011
Quintiles 2004 - 2008
Quintiles 2001 - 2004
nTouch Research 1998 - 2001
ClinTrials Research 1987 - 1998
Education
Virginia Tech 1980 — 1982
MS, Human Nutrition
Meredith College 1976 — 1980
BS, Biology
LCH Consulting 2012 - Present
Aptiv Solutions July 2008 - June 2012
SRA International July 2008 - October 2011
Quintiles 2004 - 2008
Quintiles 2001 - 2004
nTouch Research 1998 - 2001
ClinTrials Research 1987 - 1998
Education
Virginia Tech 1980 — 1982
MS, Human Nutrition
Meredith College 1976 — 1980
BS, Biology
Michelle Norton's Aptiv Solutions Experience August 2010 - August 2012
Job CRO / Biopharma / Device DMC CEC IPA Management / Medical Review / Pharmacovigilance
Industry Research
Experience
PAREXEL International November 2014 - August 2015
Boston Biomedical Associates July 2012 - August 2014
Aptiv Solutions August 2010 - August 2012
Skills
Medical Review, Pharmacovigilance, Medical Devices, CEC Adjudication..., DMC/DSMB Management, Biotechnology, Clinical Trials, Clinical Development, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, Oncology, EDC, CTMS, CRO, ICH-GCP, FDA, Orthopedic, Hematology, Neurovascular, Stroke, Endovascular, Peripheral Vascular, Hepatology, Endocrinology, Cardiovascular
Education
Regis College
Master’s Degree, Clinical Research & Regulartory Management
Regis College 2010 — 2012
Graduate Certificate Clinical Research Management
Regis College 2010 — 2012
Graduate Certificate in Regulatory Management
Framingham State University 2008 — 2010
BS, Nursing
PAREXEL International November 2014 - August 2015
Boston Biomedical Associates July 2012 - August 2014
Aptiv Solutions August 2010 - August 2012
Skills
Medical Review, Pharmacovigilance, Medical Devices, CEC Adjudication..., DMC/DSMB Management, Biotechnology, Clinical Trials, Clinical Development, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, Oncology, EDC, CTMS, CRO, ICH-GCP, FDA, Orthopedic, Hematology, Neurovascular, Stroke, Endovascular, Peripheral Vascular, Hepatology, Endocrinology, Cardiovascular
Education
Regis College
Master’s Degree, Clinical Research & Regulartory Management
Regis College 2010 — 2012
Graduate Certificate Clinical Research Management
Regis College 2010 — 2012
Graduate Certificate in Regulatory Management
Framingham State University 2008 — 2010
BS, Nursing
Wanda Davis's Aptiv Solutions Experience June 2011 - Present
Job Clinical Events Coordinator
Industry Pharmaceuticals
Experience
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
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
Gary Ponte's Aptiv Solutions Experience March 2010 - Present
Job Lead Clinical Research Associate at Aptiv Solutions
Industry Research
Experience
Aptiv Solutions March 2010 - Present
Metropolitan Research Associates Inc. April 2008 - March 2010
Healthcare Products Development Inc July 2005 - February 2008
Pfizer 2004 - 2005
Procter & Gamble 1992 - 1995
Skills
GCP, Clinical Monitoring, EDC, Clinical Research, ICH-GCP, CTMS, FDA, Oncology, Clinical Development, Protocol, Clinical Trials, Pharmaceutical Industry
Education
University of Bridgeport 1985 — 1989
Master of Science, Biology
Mercy College 1977 — 1981
Bachelor of Arts, Biology
Aptiv Solutions March 2010 - Present
Metropolitan Research Associates Inc. April 2008 - March 2010
Healthcare Products Development Inc July 2005 - February 2008
Pfizer 2004 - 2005
Procter & Gamble 1992 - 1995
Skills
GCP, Clinical Monitoring, EDC, Clinical Research, ICH-GCP, CTMS, FDA, Oncology, Clinical Development, Protocol, Clinical Trials, Pharmaceutical Industry
Education
University of Bridgeport 1985 — 1989
Master of Science, Biology
Mercy College 1977 — 1981
Bachelor of Arts, Biology
Amanda Barton Kopacz's Aptiv Solutions Experience March 2013 - Present
Job Clinical Research Associate at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions March 2013 - Present
The Longaberger Company July 2010 - Present
Aptiv Solutions January 2011 - March 2013
Beachbody May 2010 - October 2011
BOSTON SCIENTIFIC CORPORATION 2008 - 2010
HUSTON'S POOL SERVICE, INC January 2001 - January 2008
Skills
GCP, CRO, FDA, Clinical Trials, CTMS, EDC, Clinical Development, Management, Clinical Research, Protocol, Sop, Training, Software Documentation, Regulatory Submissions, Medical Devices
Education
College of Our Lady of the Elms 2003 — 2007
Bachelor of Science, Professional Studies NUR/SW
St. Peter Marian 1999 — 2003
High School Diploma
Aptiv Solutions March 2013 - Present
The Longaberger Company July 2010 - Present
Aptiv Solutions January 2011 - March 2013
Beachbody May 2010 - October 2011
BOSTON SCIENTIFIC CORPORATION 2008 - 2010
HUSTON'S POOL SERVICE, INC January 2001 - January 2008
Skills
GCP, CRO, FDA, Clinical Trials, CTMS, EDC, Clinical Development, Management, Clinical Research, Protocol, Sop, Training, Software Documentation, Regulatory Submissions, Medical Devices
Education
College of Our Lady of the Elms 2003 — 2007
Bachelor of Science, Professional Studies NUR/SW
St. Peter Marian 1999 — 2003
High School Diploma
Julian San Martin's Aptiv Solutions Experience 2013 - Present
Job Clinical Research Associate at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions 2013 - Present
Quintiles February 2012 - March 2013
PRA International May 2010 - January 2012
Kendle International November 2007 - March 2010
Constella Group January 2007 - September 2007
VPR GROUP January 2004 - November 2006
Skills
Clinical Monitoring, CTMS, EDC, Oracle Clinical, Medidata, Clin-Trials, Inntrax, Informant, On-Site
Education
Parker University 1998 — 2000
Doctor of Chiropractic, Attended
Florida State University 1995 — 1997
Bachelor of Science, Biology
Aptiv Solutions 2013 - Present
Quintiles February 2012 - March 2013
PRA International May 2010 - January 2012
Kendle International November 2007 - March 2010
Constella Group January 2007 - September 2007
VPR GROUP January 2004 - November 2006
Skills
Clinical Monitoring, CTMS, EDC, Oracle Clinical, Medidata, Clin-Trials, Inntrax, Informant, On-Site
Education
Parker University 1998 — 2000
Doctor of Chiropractic, Attended
Florida State University 1995 — 1997
Bachelor of Science, Biology
Laurie Robert's Aptiv Solutions Experience January 2011 - Present
Job Senior Clinical Data Manager at Aptiv Solutions
Industry
Experience
Aptiv Solutions January 2011 - Present
Aptiv Solutions 2011 - 2011
Veristat 2006 - 2010
Frontier Science/ECOG 2006 - 2007
Skills
Clinical Data Management, EDC, Clinical Trials, 21 CFR Part 11, GCP, ICH-GCP, Inform, CRF design, Data Management, CRO, Oracle Clinical
Education
Lesley University 2001 — 2003
Master of Arts (M.A.), Mental Health Counseling/Counselor
University of New Hampshire 1997 — 2001
B. A., Psychology
Aptiv Solutions January 2011 - Present
Aptiv Solutions 2011 - 2011
Veristat 2006 - 2010
Frontier Science/ECOG 2006 - 2007
Skills
Clinical Data Management, EDC, Clinical Trials, 21 CFR Part 11, GCP, ICH-GCP, Inform, CRF design, Data Management, CRO, Oracle Clinical
Education
Lesley University 2001 — 2003
Master of Arts (M.A.), Mental Health Counseling/Counselor
University of New Hampshire 1997 — 2001
B. A., Psychology
Brenda Faiola's Aptiv Solutions Experience January 2013 - July 2014
Job Toxicology Program Manager at BectonDickinson (BD)
Industry Pharmaceuticals
Experience
BectonDickinson (BD) July 2014 - Present
Aptiv Solutions January 2013 - July 2014
Aptiv Solutions September 2011 - December 2012
RTI International 2009 - 2011
GlaxoSmithKline 2003 - 2009
CIIT Centers for Health Research August 2001 - August 2003
Skills
Clinical Development, Pharmacology, Toxicology, GLP, Drug Development, Drug Metabolism, Clinical Trials, CRO, Regulatory Submissions, Drug Discovery, In Vitro, In Vivo
Education
Duke University
PhD, Immunology
Hood College
MS, Biomedical Sciences
Virginia Polytechnic Institute and State University
BS, Biochemistry and Chemisty with a Biology minor
BectonDickinson (BD) July 2014 - Present
Aptiv Solutions January 2013 - July 2014
Aptiv Solutions September 2011 - December 2012
RTI International 2009 - 2011
GlaxoSmithKline 2003 - 2009
CIIT Centers for Health Research August 2001 - August 2003
Skills
Clinical Development, Pharmacology, Toxicology, GLP, Drug Development, Drug Metabolism, Clinical Trials, CRO, Regulatory Submissions, Drug Discovery, In Vitro, In Vivo
Education
Duke University
PhD, Immunology
Hood College
MS, Biomedical Sciences
Virginia Polytechnic Institute and State University
BS, Biochemistry and Chemisty with a Biology minor
Ildiko Lang's Aptiv Solutions Experience 2010 - February 2012
Job Senior CRA at inVentiv Health Clinical
Industry Hospital & Health Care
Experience
inVentiv Health Clinical March 2014 - Present
PSI CRO Hungary February 2012 - March 2014
Aptiv Solutions 2010 - February 2012
Clinical Investigations Kft 2004 - 2010
Skills
Clinical Monitoring, GCP, EDC, ICH-GCP, CTMS, Cardiology, Clinical Research..., Therapeutic Areas, Clinical Trials, Clinical Development, CRO, Clinical Data Management, Clinical Operations, Regulatory Submissions, Oncology
Education
Eötvös Loránd Tudományegyetem 1980 — 1985
Master of Science (M.Sc.), Biology, General
inVentiv Health Clinical March 2014 - Present
PSI CRO Hungary February 2012 - March 2014
Aptiv Solutions 2010 - February 2012
Clinical Investigations Kft 2004 - 2010
Skills
Clinical Monitoring, GCP, EDC, ICH-GCP, CTMS, Cardiology, Clinical Research..., Therapeutic Areas, Clinical Trials, Clinical Development, CRO, Clinical Data Management, Clinical Operations, Regulatory Submissions, Oncology
Education
Eötvös Loránd Tudományegyetem 1980 — 1985
Master of Science (M.Sc.), Biology, General
Wande Ladipo's Aptiv Solutions Experience April 2011 - November 2012
Job Distribution Project Manager at Fisher Clinical Services
Industry Pharmaceuticals
Experience
Fisher Clinical Services September 2014 - Present
ICON plc November 2012 - August 2014
Aptiv Solutions April 2011 - November 2012
National Institute of Child Health, Office of Acquisitions July 2010 - December 2010
National Institutes of Health, Clinical Center June 2009 - August 2009
Skills
Volunteer Leadership, Foreign Languages, GCP, Clinical Trials, Clinical Research, CRO, Volunteering, CTMS, Protocol, EDC, ICH-GCP
Education
The George Washington University School of Medicine and Health Sciences 2011 — 2013
MSHS, Clinical Research Administration
The George Washington University 2008 — 2010
Bachelor of Arts, Psychology and Biology
Fisher Clinical Services September 2014 - Present
ICON plc November 2012 - August 2014
Aptiv Solutions April 2011 - November 2012
National Institute of Child Health, Office of Acquisitions July 2010 - December 2010
National Institutes of Health, Clinical Center June 2009 - August 2009
Skills
Volunteer Leadership, Foreign Languages, GCP, Clinical Trials, Clinical Research, CRO, Volunteering, CTMS, Protocol, EDC, ICH-GCP
Education
The George Washington University School of Medicine and Health Sciences 2011 — 2013
MSHS, Clinical Research Administration
The George Washington University 2008 — 2010
Bachelor of Arts, Psychology and Biology
Jennifer Mui's Aptiv Solutions Experience May 2011 - August 2012
Job Senior Accountant at Aptiv Solutions
Industry Pharmaceuticals
Experience
Aptiv Solutions May 2011 - August 2012
Aptiv Solutions February 2008 - May 2011
State Street 2005 - 2008
BJ's Wholesale Club 2004 - 2005
BJ's Wholesale Club 2003 - 2004
Skills
Financial Analysis, Financial Reporting, Budgets, Process Improvement, Accounting, Account Reconciliation, Microsoft Excel, Accounts Receivable, Revenue Recognition, Microsoft Office, Outlook, Microsoft Word
Education
Framingham State College 1999 — 2003
Bachelor of Science (B.S.), Business Administration
Aptiv Solutions May 2011 - August 2012
Aptiv Solutions February 2008 - May 2011
State Street 2005 - 2008
BJ's Wholesale Club 2004 - 2005
BJ's Wholesale Club 2003 - 2004
Skills
Financial Analysis, Financial Reporting, Budgets, Process Improvement, Accounting, Account Reconciliation, Microsoft Excel, Accounts Receivable, Revenue Recognition, Microsoft Office, Outlook, Microsoft Word
Education
Framingham State College 1999 — 2003
Bachelor of Science (B.S.), Business Administration
Gilda Schatzman's Aptiv Solutions Experience January 2013 - October 2014
Job Site Payment Manager at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Aptiv Solutions January 2013 - October 2014
ALMAC CLINICAL SERVICES May 2008 - December 2012
American Fibers and Yarn May 2007 - May 2008
Acme Architectural 2003 - 2007
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Sop, Accounting, Construction Accounting, Garment Manufacturing, 21 CFR Part 11, Drug Development, Clinical Development, CTMS, Regulatory Affairs, GCP, FDA, Biotechnology, Management, EDC, GMP, SOP
Education
Brooklyn College 1972 — 1976
Bachelor's degree, Psychology
Aptiv Solutions January 2013 - October 2014
ALMAC CLINICAL SERVICES May 2008 - December 2012
American Fibers and Yarn May 2007 - May 2008
Acme Architectural 2003 - 2007
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Sop, Accounting, Construction Accounting, Garment Manufacturing, 21 CFR Part 11, Drug Development, Clinical Development, CTMS, Regulatory Affairs, GCP, FDA, Biotechnology, Management, EDC, GMP, SOP
Education
Brooklyn College 1972 — 1976
Bachelor's degree, Psychology
Tanuj Kulkarni's Aptiv Solutions Experience October 2011 - September 2014
Job Solutions Architect at Onapath Systems, LLC
Industry Pharmaceuticals
Experience
Onepath Systems September 2014 - Present
Aptiv Solutions October 2011 - September 2014
Black Box Network Services LI Voice June 2011 - October 2011
INC Research October 2007 - June 2011
AT&T 1998 - 2000
Skills
Cisco Technologies, Data Center, MPLS, Telecommunications, Unified Communications, Networking, System Deployment, Infrastructure
Education
University of North Carolina at Greensboro 1988 — 1990
Master of Science (MS), Chemistry
St Andrews Presbyterian College 1985 — 1988
BS, Chemistry
St. Xavier's College
Onepath Systems September 2014 - Present
Aptiv Solutions October 2011 - September 2014
Black Box Network Services LI Voice June 2011 - October 2011
INC Research October 2007 - June 2011
AT&T 1998 - 2000
Skills
Cisco Technologies, Data Center, MPLS, Telecommunications, Unified Communications, Networking, System Deployment, Infrastructure
Education
University of North Carolina at Greensboro 1988 — 1990
Master of Science (MS), Chemistry
St Andrews Presbyterian College 1985 — 1988
BS, Chemistry
St. Xavier's College
Sabra Dudman's Aptiv Solutions Experience October 2011 - December 2013
Job Office Manager at Blend Therapeutics
Industry Pharmaceuticals
Experience
Blend Therapeutics May 2015 - Present
Karyopharm Therapeutics Inc. November 2014 - April 2015
Athena Capital Advisors June 2014 - October 2014
Aptiv Solutions October 2011 - December 2013
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, EDC, CTMS, ICH-GCP, Clinical Data Management, Sop, FDA, Clinical Research, Validation
Education
Roger Williams University
Computer Information Systems
Blend Therapeutics May 2015 - Present
Karyopharm Therapeutics Inc. November 2014 - April 2015
Athena Capital Advisors June 2014 - October 2014
Aptiv Solutions October 2011 - December 2013
Skills
Clinical Trials, CRO, Pharmaceutical Industry, GCP, EDC, CTMS, ICH-GCP, Clinical Data Management, Sop, FDA, Clinical Research, Validation
Education
Roger Williams University
Computer Information Systems