PAREXEL Company
Industry: Pharmaceutical company
DescriptionPAREXEL International is a global provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. Headquarters: Waltham, Massachusetts, United States CEO: Jamie Macdonald (15 Mar 2018–) Number of employees: 19,000 Founder: Josef H. von Rickenbach Founded: 1982 Subsidiaries: ClinPhone Inc, ClinPhone Ltd,
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PAREXEL Employees
Employee
Years
Job
Industry
Anna Speight Anna Speight's PAREXEL Experience March 2015 - Present
Job Data Operations Lead at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GSK February 1997 - March 2015
PPD July 1995 - July 1996
Skills
Clinical Data Management, Project Management, Vendor Management, Vendor Relations, Clinical Research, Clinical Trials, Respiratory Products, Clinical Development, Pharmaceutical Industry, SOP, Drug Development
Education
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor's degree, Business/Corporate Communications
Hoggard High School
PAREXEL March 2015 - Present
GSK February 1997 - March 2015
PPD July 1995 - July 1996
Skills
Clinical Data Management, Project Management, Vendor Management, Vendor Relations, Clinical Research, Clinical Trials, Respiratory Products, Clinical Development, Pharmaceutical Industry, SOP, Drug Development
Education
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor's degree, Business/Corporate Communications
Hoggard High School
Kelly Shepard, BS, MBA Kelly Shepard, BS, MBA's PAREXEL Experience April 2012 - September 2012
Job Sr. Clinical Trial Specialist at UBC An Express Scripts Company
Industry Pharmaceuticals
Experience
UBC - An Express Scripts Company September 2015 - Present
United BioSource Corporation September 2013 - Present
Beckloff Associates March 2013 - June 2013
Vince and Associates Clinical Research September 2012 - January 2013
PAREXEL April 2012 - September 2012
Aerotek Scientific November 2010 - December 2011
Quintiles 2001 - 2010
Skills
Regulatory Affairs, Clinical Research, CRO, FDA, Biotechnology, ICH-GCP, Quality Assurance, Sop, Clinical Data Management, Regulatory Requirements, Drug Development, Oncology, Therapeutic Areas, EDC, Software Documentation, Pharmaceutics, GCP, CTMS, 21 CFR Part 11, Medical Devices, Clinical Development, Clinical Operations, Cardiology, Lifesciences, Quality Control, GLP, Immunology, Vaccines, Computer System..., Change Control, SOP, Life Sciences, Pharmaceutical Industry, Clinical Trials, Regulatory Submissions
Education
University of Missouri-Kansas City
Master of Business Administration (MBA), Business Administration and Management, General
UBC - An Express Scripts Company September 2015 - Present
United BioSource Corporation September 2013 - Present
Beckloff Associates March 2013 - June 2013
Vince and Associates Clinical Research September 2012 - January 2013
PAREXEL April 2012 - September 2012
Aerotek Scientific November 2010 - December 2011
Quintiles 2001 - 2010
Skills
Regulatory Affairs, Clinical Research, CRO, FDA, Biotechnology, ICH-GCP, Quality Assurance, Sop, Clinical Data Management, Regulatory Requirements, Drug Development, Oncology, Therapeutic Areas, EDC, Software Documentation, Pharmaceutics, GCP, CTMS, 21 CFR Part 11, Medical Devices, Clinical Development, Clinical Operations, Cardiology, Lifesciences, Quality Control, GLP, Immunology, Vaccines, Computer System..., Change Control, SOP, Life Sciences, Pharmaceutical Industry, Clinical Trials, Regulatory Submissions
Education
University of Missouri-Kansas City
Master of Business Administration (MBA), Business Administration and Management, General
Erik Phillips's PAREXEL Experience June 2014 - Present
Job Financial Analyst II, Financial Planning & Analysis at PAREXEL
Industry Financial Services
Experience
PAREXEL June 2014 - Present
PAREXEL October 2012 - June 2014
Genworth Financial October 2011 - September 2012
American Hospital Association June 2010 - August 2010
Skills
Data Analysis, Microsoft Excel, Healthcare, Financial Analysis, Process Improvement, Leadership, Analysis, Microsoft Office, Forecasting, Performance Management, Valuation, Financial Modeling, Investments, Investment Strategies, Healthcare Management, Strategy, Corporate Finance, Due Diligence, Cash Flow Forecasting, Cash Flow Analysis, Competitive Analysis
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Health Management and Policy
PAREXEL June 2014 - Present
PAREXEL October 2012 - June 2014
Genworth Financial October 2011 - September 2012
American Hospital Association June 2010 - August 2010
Skills
Data Analysis, Microsoft Excel, Healthcare, Financial Analysis, Process Improvement, Leadership, Analysis, Microsoft Office, Forecasting, Performance Management, Valuation, Financial Modeling, Investments, Investment Strategies, Healthcare Management, Strategy, Corporate Finance, Due Diligence, Cash Flow Forecasting, Cash Flow Analysis, Competitive Analysis
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Health Management and Policy
Kalisha A. Watkins Kalisha A. Watkins's PAREXEL Experience January 2015 - Present
Job Associate Manager, Clinical Operations Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL January 2015 - Present
PAREXEL November 2014 - January 2015
PAREXEL March 2012 - October 2014
Merz Pharmaceuticals, LLC November 2010 - March 2012
GlaxoSmithKline November 2008 - November 2010
Novella Clinical October 2006 - November 2008
Novella Clinical February 2006 - October 2006
PPD January 2005 - February 2006
GeneCare Medical Genetics Center February 2005 - September 2005
Skills
Clinical Trial..., Clinical Monitoring, GCP, Clinical Research, Clinical Trials, Project Management, Supply Chain, EDC, cGMP, CTMS, Oracle, GMP, Inform, Medidata, Negotiation, FDA, Sop, Quality Assurance, Regulatory Affairs, Software Documentation, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Therapeutic Areas, Oncology, Drug Development, Pharmacovigilance, Protocol, Diabetes, ICH-GCP, SOP
Education
University of North Carolina at Chapel Hill 2008 — 2010
Master's Degree
University of North Carolina at Greensboro
B.A. Degree
PAREXEL January 2015 - Present
PAREXEL November 2014 - January 2015
PAREXEL March 2012 - October 2014
Merz Pharmaceuticals, LLC November 2010 - March 2012
GlaxoSmithKline November 2008 - November 2010
Novella Clinical October 2006 - November 2008
Novella Clinical February 2006 - October 2006
PPD January 2005 - February 2006
GeneCare Medical Genetics Center February 2005 - September 2005
Skills
Clinical Trial..., Clinical Monitoring, GCP, Clinical Research, Clinical Trials, Project Management, Supply Chain, EDC, cGMP, CTMS, Oracle, GMP, Inform, Medidata, Negotiation, FDA, Sop, Quality Assurance, Regulatory Affairs, Software Documentation, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Therapeutic Areas, Oncology, Drug Development, Pharmacovigilance, Protocol, Diabetes, ICH-GCP, SOP
Education
University of North Carolina at Chapel Hill 2008 — 2010
Master's Degree
University of North Carolina at Greensboro
B.A. Degree
Bella Jenkins Sessoms, MPH Bella Jenkins Sessoms, MPH's PAREXEL Experience February 2013 - Present
Job Director, Business Operations at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL February 2013 - Present
PAREXEL International December 2011 - Present
Duke Clinical Research Institute April 2011 - December 2011
PAREXEL International April 2010 - April 2011
PAREXEL International June 2008 - April 2010
PAREXEL International October 2006 - June 2008
PharmaNet June 2006 - October 2006
Family Health International June 2004 - June 2006
Family Health International June 2002 - June 2006
Family Health International January 2001 - July 2002
Skills
Clinical Research, Proposal Writing, RFP, Strategic Partnerships, Contract Negotiation, Contract Management, Proposal Review, Training Personnel, Personnel Training, Personnel Supervision, Pharmaceutical Industry, Clinical Trials, CRO, Management, Project Management
Education
University of North Carolina at Chapel Hill 2007 — 2009
MPH, Health Policy and Management
University of North Carolina at Chapel Hill 1995 — 1999
BSPH, Health Administration
PAREXEL February 2013 - Present
PAREXEL International December 2011 - Present
Duke Clinical Research Institute April 2011 - December 2011
PAREXEL International April 2010 - April 2011
PAREXEL International June 2008 - April 2010
PAREXEL International October 2006 - June 2008
PharmaNet June 2006 - October 2006
Family Health International June 2004 - June 2006
Family Health International June 2002 - June 2006
Family Health International January 2001 - July 2002
Skills
Clinical Research, Proposal Writing, RFP, Strategic Partnerships, Contract Negotiation, Contract Management, Proposal Review, Training Personnel, Personnel Training, Personnel Supervision, Pharmaceutical Industry, Clinical Trials, CRO, Management, Project Management
Education
University of North Carolina at Chapel Hill 2007 — 2009
MPH, Health Policy and Management
University of North Carolina at Chapel Hill 1995 — 1999
BSPH, Health Administration
Linda Briley Linda Briley's PAREXEL Experience March 2015 - Present
Job Medical Research Scientist at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline June 1996 - February 2015
University of North Carolina at Chapel Hill 1991 - 1996
University of North Carolina at Chapel Hill 1985 - 1991
Skills
Molecular Biology, Genetics, Pharmacogenetics, Drug Discovery, Biomarkers, Clinical Development, Pharmaceutical Industry, Pharmacogenomics, Clinical Trials, Lifesciences, Biotechnology, Infectious Diseases, Personalized Medicine, Oncology, Immunology, Translational Medicine, Pharmacology, Biomarker Discovery, Drug Development, Genomics, Pharmacokinetics, DNA, Life Sciences
Education
University of North Carolina at Chapel Hill 1981 — 1985
B.S., Zoology
PAREXEL March 2015 - Present
GlaxoSmithKline June 1996 - February 2015
University of North Carolina at Chapel Hill 1991 - 1996
University of North Carolina at Chapel Hill 1985 - 1991
Skills
Molecular Biology, Genetics, Pharmacogenetics, Drug Discovery, Biomarkers, Clinical Development, Pharmaceutical Industry, Pharmacogenomics, Clinical Trials, Lifesciences, Biotechnology, Infectious Diseases, Personalized Medicine, Oncology, Immunology, Translational Medicine, Pharmacology, Biomarker Discovery, Drug Development, Genomics, Pharmacokinetics, DNA, Life Sciences
Education
University of North Carolina at Chapel Hill 1981 — 1985
B.S., Zoology
Brianna Creedon Brianna Creedon's PAREXEL Experience June 2013 - December 2014
Job Client Human Resources Consultant at Arthur J. Gallagher
Industry Human Resources
Experience
NRECA June 2015 - Present
Arthur J. Gallagher & Co. January 2015 - June 2015
PAREXEL June 2013 - December 2014
PAREXEL February 2013 - June 2013
Brookstone September 2012 - January 2013
Brookstone June 2012 - September 2012
Hannaford Bros. Co. February 2008 - June 2012
Under Armour September 2010 - January 2012
Brookstone May 2011 - August 2011
Brookstone June 2008 - August 2008
Skills
Customer Service, Time Management, New Hire Orientations, Public Relations, Onboarding, Microsoft Excel, Facebook, Microsoft Word, PowerPoint, Social Media, Event Planning, Event Management, Retail, Lotus Notes, Microsoft Powerpoint, IP, Organized self-starter, Organized Multi-tasker
Education
University of New Hampshire 2008 — 2012
Bachelor of Arts (B.A.), Psychology
Bishop Guertin High School 2004 — 2008
NRECA June 2015 - Present
Arthur J. Gallagher & Co. January 2015 - June 2015
PAREXEL June 2013 - December 2014
PAREXEL February 2013 - June 2013
Brookstone September 2012 - January 2013
Brookstone June 2012 - September 2012
Hannaford Bros. Co. February 2008 - June 2012
Under Armour September 2010 - January 2012
Brookstone May 2011 - August 2011
Brookstone June 2008 - August 2008
Skills
Customer Service, Time Management, New Hire Orientations, Public Relations, Onboarding, Microsoft Excel, Facebook, Microsoft Word, PowerPoint, Social Media, Event Planning, Event Management, Retail, Lotus Notes, Microsoft Powerpoint, IP, Organized self-starter, Organized Multi-tasker
Education
University of New Hampshire 2008 — 2012
Bachelor of Arts (B.A.), Psychology
Bishop Guertin High School 2004 — 2008
Heath Hair Heath Hair's PAREXEL Experience March 2015 - Present
Job Project Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline May 2010 - March 2015
GlaxoSmithKline November 2012 - December 2014
GlaxoSmithKline March 2009 - June 2010
GlaxoSmithKline September 2007 - June 2010
GlaxoSmithKline October 2007 - May 2010
GlaxoSmithKline September 2001 - September 2007
PharmaLinkFHI 2000 - 2001
Minidoc 1999 - 2000
Quintiles 1997 - 1999
Skills
Clinical Operations, Clinical Trials, Pharmaceutical Industry, Clinical Development, Facilitation, CTMS, EDC, CRO, Peer Mentoring, GCP, ICH-GCP, Drug Development, Clinical Research, Clinical Monitoring, Oncology, Infectious Diseases, Therapeutic Areas, Protocol, Clinical Study Design, Clinical Data Management, Inform, Clinical Planning, Project Management
Education
University of North Carolina at Chapel Hill 1995 — 1997
MA, Exercise Physiology
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor of Arts (B.A.), Economics
PAREXEL March 2015 - Present
GlaxoSmithKline May 2010 - March 2015
GlaxoSmithKline November 2012 - December 2014
GlaxoSmithKline March 2009 - June 2010
GlaxoSmithKline September 2007 - June 2010
GlaxoSmithKline October 2007 - May 2010
GlaxoSmithKline September 2001 - September 2007
PharmaLinkFHI 2000 - 2001
Minidoc 1999 - 2000
Quintiles 1997 - 1999
Skills
Clinical Operations, Clinical Trials, Pharmaceutical Industry, Clinical Development, Facilitation, CTMS, EDC, CRO, Peer Mentoring, GCP, ICH-GCP, Drug Development, Clinical Research, Clinical Monitoring, Oncology, Infectious Diseases, Therapeutic Areas, Protocol, Clinical Study Design, Clinical Data Management, Inform, Clinical Planning, Project Management
Education
University of North Carolina at Chapel Hill 1995 — 1997
MA, Exercise Physiology
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor of Arts (B.A.), Economics
Joe Cunningham's PAREXEL Experience 1998 - 2000
Job Principal Vice President of Business Development at Praxis Life Sciences.
Industry Pharmaceuticals
Experience
Praxis Life Sciences February 2015 - Present
Compliance Implementation Services CIS June 2010 - February 2015
Exploria SPS June 2009 - July 2010
Skura Corporation June 2008 - June 2009
Almac Clinical Technologies January 2007 - June 2008
FindingCures January 2004 - January 2007
First Consulting Group 2003 - 2004
Parexel 1998 - 2000
Omnicare Clinical Research 1995 - 1997
Omnicare Clinical Research 1995 - 1997
Skills
Pharmaceutical Industry, Biotechnology, Quality Assurance, Project Management, Process Improvement, FDA, Lifesciences, Medical Devices, Training, Strategic Planning, Business Development, Business Strategy, Account Management, Cross-functional Team..., Strategy, Life Sciences, Product Launch, Healthcare, Management, Sales Management
Education
University of Missouri-Rolla 1983 — 1986
BS, Economics
Phillips University 1981 — 1983
Praxis Life Sciences February 2015 - Present
Compliance Implementation Services CIS June 2010 - February 2015
Exploria SPS June 2009 - July 2010
Skura Corporation June 2008 - June 2009
Almac Clinical Technologies January 2007 - June 2008
FindingCures January 2004 - January 2007
First Consulting Group 2003 - 2004
Parexel 1998 - 2000
Omnicare Clinical Research 1995 - 1997
Omnicare Clinical Research 1995 - 1997
Skills
Pharmaceutical Industry, Biotechnology, Quality Assurance, Project Management, Process Improvement, FDA, Lifesciences, Medical Devices, Training, Strategic Planning, Business Development, Business Strategy, Account Management, Cross-functional Team..., Strategy, Life Sciences, Product Launch, Healthcare, Management, Sales Management
Education
University of Missouri-Rolla 1983 — 1986
BS, Economics
Phillips University 1981 — 1983
Candace Anderson's PAREXEL Experience April 2012 - Present
Job Clinical Monitoring Associate at PAREXEL
Industry Pharmaceuticals
Experience
SYNCStudio July 2013 - Present
PAREXEL April 2012 - Present
PRA International November 2010 - March 2012
Novella Clinical, Inc. July 2009 - November 2010
Bell Partners Real Estate & Investments March 2008 - July 2009
Collabera 2007 - 2008
Skills
Clinical Research, Training, Clinical Monitoring, ICH guidelines, Clinical Trials, EDC, Clinical Study Start-Up, CTMS, CRO, ICH-GCP, GCP, Therapeutic Areas, Oncology, Regulatory Submissions, Infectious Diseases, Pharmaceutical Industry, Protocol
Education
UNC Chapel Hill 2002 — 2006
Bachelor of Arts (B.A.), Business/Corporate Communications, English
SYNCStudio July 2013 - Present
PAREXEL April 2012 - Present
PRA International November 2010 - March 2012
Novella Clinical, Inc. July 2009 - November 2010
Bell Partners Real Estate & Investments March 2008 - July 2009
Collabera 2007 - 2008
Skills
Clinical Research, Training, Clinical Monitoring, ICH guidelines, Clinical Trials, EDC, Clinical Study Start-Up, CTMS, CRO, ICH-GCP, GCP, Therapeutic Areas, Oncology, Regulatory Submissions, Infectious Diseases, Pharmaceutical Industry, Protocol
Education
UNC Chapel Hill 2002 — 2006
Bachelor of Arts (B.A.), Business/Corporate Communications, English
Gina Morris Gina Morris's PAREXEL Experience July 2010 - September 2011
Job Senior CRA
Industry Pharmaceuticals
Experience
Celgene November 2011 - Present
PAREXEL July 2010 - September 2011
AstraZeneca/RPS September 2007 - September 2009
AstraZeneca May 2004 - September 2007
PAREXEL International February 2002 - May 2004
PRA International May 2000 - February 2002
Skills
Clinical Monitoring, CTMS, ICH-GCP, GCP, EDC, Therapeutic Areas, CRO, Clinical Trials, Oncology, Clinical Development, Clinical Operations, Clinical Research, Hematology
Education
University of Missouri-Columbia 1996 — 1999
BS, Nursing
Celgene November 2011 - Present
PAREXEL July 2010 - September 2011
AstraZeneca/RPS September 2007 - September 2009
AstraZeneca May 2004 - September 2007
PAREXEL International February 2002 - May 2004
PRA International May 2000 - February 2002
Skills
Clinical Monitoring, CTMS, ICH-GCP, GCP, EDC, Therapeutic Areas, CRO, Clinical Trials, Oncology, Clinical Development, Clinical Operations, Clinical Research, Hematology
Education
University of Missouri-Columbia 1996 — 1999
BS, Nursing
Prachi Mahajani Prachi Mahajani's PAREXEL Experience January 2015 - July 2015
Job Clinical Research Associate at Covance
Industry Pharmaceuticals
Experience
Covance July 2015 - Present
PAREXEL January 2015 - July 2015
PAREXEL September 2013 - January 2015
Galaxy Diagnotics, Inc. October 2011 - August 2013
On Assignment July 2011 - October 2011
Wake Forest University May 2011 - August 2011
University Village January 2011 - May 2011
UNC Greensboro August 2010 - May 2011
Skills
Microsoft Office, QuickBooks, SPSS, Grant Writing, Data Entry, Analysis, Software Documentation, Sop, Quality Assurance
Education
University of North Carolina at Wilmington 2011 — 2013
Master of Science (M.S.), Gerontology
University of North Carolina at Greensboro 2007 — 2011
Bachelor's degree, Human Biology
Covance July 2015 - Present
PAREXEL January 2015 - July 2015
PAREXEL September 2013 - January 2015
Galaxy Diagnotics, Inc. October 2011 - August 2013
On Assignment July 2011 - October 2011
Wake Forest University May 2011 - August 2011
University Village January 2011 - May 2011
UNC Greensboro August 2010 - May 2011
Skills
Microsoft Office, QuickBooks, SPSS, Grant Writing, Data Entry, Analysis, Software Documentation, Sop, Quality Assurance
Education
University of North Carolina at Wilmington 2011 — 2013
Master of Science (M.S.), Gerontology
University of North Carolina at Greensboro 2007 — 2011
Bachelor's degree, Human Biology
Blake Precythe Blake Precythe's PAREXEL Experience July 2014 - Present
Job CMA at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2014 - Present
PPD July 2013 - July 2014
Walgreens October 2011 - July 2013
State Employees Association of North Carolina May 2011 - August 2011
Skills
People-oriented, Communication Skills, Passionate about work, Organization, Microsoft Office, Time Management, People Skills, Critical Thinking, Social Media, Telephone Skills, Customer Satisfaction, Data Entry, Cashiering, Sales, Customer Service
Education
University of North Carolina at Charlotte 2007 — 2011
Bachelor of Arts, Political Science
PAREXEL July 2014 - Present
PPD July 2013 - July 2014
Walgreens October 2011 - July 2013
State Employees Association of North Carolina May 2011 - August 2011
Skills
People-oriented, Communication Skills, Passionate about work, Organization, Microsoft Office, Time Management, People Skills, Critical Thinking, Social Media, Telephone Skills, Customer Satisfaction, Data Entry, Cashiering, Sales, Customer Service
Education
University of North Carolina at Charlotte 2007 — 2011
Bachelor of Arts, Political Science
Chris Speck Chris Speck's PAREXEL Experience August 2006 - Present
Job Principal Programmer at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL August 2006 - Present
WCPE 2009 - 2013
FPG Child Development Institute 2004 - 2006
Skills
CDISC, Statistical Programming, Clinical Trials, SAS programming, Data Management, CRO, SDTM, Validation, Biostatistics, EDC, Oracle Clinical, 21 CFR Part 11, SAS, Clinical Data Management, Pharmaceutical Industry, GCP, Clinical Development, SAS Base, CTMS, ICH-GCP
Education
University of North Carolina at Chapel Hill 2002 — 2004
MIS, Database development
Duke University
Duke University
PAREXEL August 2006 - Present
WCPE 2009 - 2013
FPG Child Development Institute 2004 - 2006
Skills
CDISC, Statistical Programming, Clinical Trials, SAS programming, Data Management, CRO, SDTM, Validation, Biostatistics, EDC, Oracle Clinical, 21 CFR Part 11, SAS, Clinical Data Management, Pharmaceutical Industry, GCP, Clinical Development, SAS Base, CTMS, ICH-GCP
Education
University of North Carolina at Chapel Hill 2002 — 2004
MIS, Database development
Duke University
Duke University
Tom Kerby Tom Kerby's PAREXEL Experience January 2006 - January 2007
Job Owner of TK Consulting, LLC Clinical Data Management Solutions
Industry Biotechnology
Experience
TK Consulting, LLC June 2013 - Present
DOCS September 2010 - Present
Quintiles January 2007 - August 2010
PAREXEL January 2006 - January 2007
Kendle International December 2004 - January 2007
PharmaResearch January 2001 - December 2004
Education
University of North Carolina at Chapel Hill 1988 — 1992
Bachelor of Arts (B.A.), Cpmmunications and Psychology
Chapel Hill High
TK Consulting, LLC June 2013 - Present
DOCS September 2010 - Present
Quintiles January 2007 - August 2010
PAREXEL January 2006 - January 2007
Kendle International December 2004 - January 2007
PharmaResearch January 2001 - December 2004
Education
University of North Carolina at Chapel Hill 1988 — 1992
Bachelor of Arts (B.A.), Cpmmunications and Psychology
Chapel Hill High
Samantha Conley Samantha Conley's PAREXEL Experience April 2005 - May 2007
Job Procurement, Supplier Diversity & Spend Analytics Manager at Infor
Industry Computer Software
Experience
Infor February 2014 - Present
Vertex Pharmaceuticals March 2012 - February 2014
Iron Mountain May 2007 - March 2012
PAREXEL April 2005 - May 2007
New Boston Fund June 2002 - April 2005
Skills
Procurement, Data Analysis, Spend Analysis, Supplier Diversity, OBIEE, OBI, Strategic Sourcing, Analytics, Dashboarding, KPI Dashboards, Performance Dashboards, Excel Dashboards, Microsoft Excel
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics 1998 — 2002
BS, Business Administration
Infor February 2014 - Present
Vertex Pharmaceuticals March 2012 - February 2014
Iron Mountain May 2007 - March 2012
PAREXEL April 2005 - May 2007
New Boston Fund June 2002 - April 2005
Skills
Procurement, Data Analysis, Spend Analysis, Supplier Diversity, OBIEE, OBI, Strategic Sourcing, Analytics, Dashboarding, KPI Dashboards, Performance Dashboards, Excel Dashboards, Microsoft Excel
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics 1998 — 2002
BS, Business Administration
Katie Cooper Katie Cooper's PAREXEL Experience March 2015 - Present
Job Associate Project Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
PAREXEL May 2014 - February 2015
PAREXEL November 2012 - May 2014
PAREXEL September 2011 - November 2012
North Carolina Disability Determination Services September 2010 - September 2011
Skills
Microsoft Office, Excel, Organizing, Outlook, PowerPoint, Customer Relations, Problem Solving, Training, Microsoft Excel, Clinical Research, Quality Assurance, Software Documentation, Customer Service, Research, CRO, EDC, Data Analysis, Clinical Trials, GCP
Education
University of North Carolina at Chapel Hill 2006 — 2010
Bachelor of Arts (B.A.), Political Science and Government
PAREXEL March 2015 - Present
PAREXEL May 2014 - February 2015
PAREXEL November 2012 - May 2014
PAREXEL September 2011 - November 2012
North Carolina Disability Determination Services September 2010 - September 2011
Skills
Microsoft Office, Excel, Organizing, Outlook, PowerPoint, Customer Relations, Problem Solving, Training, Microsoft Excel, Clinical Research, Quality Assurance, Software Documentation, Customer Service, Research, CRO, EDC, Data Analysis, Clinical Trials, GCP
Education
University of North Carolina at Chapel Hill 2006 — 2010
Bachelor of Arts (B.A.), Political Science and Government
Grace Kirchgessner Grace Kirchgessner's PAREXEL Experience 2015 - Present
Job Project Leadership at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL 2015 - Present
GlaxoSmithKline 2011 - 2015
GSK 2008 - 2011
GlaxoSmithKline 2001 - 2008
Cisco Systems 2000 - 2001
Skills
Project Management, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Drug Development, CTMS, Clinical Research, Regulatory Submissions, Cross-functional Team..., CRO, Infectious Diseases, Process Improvement, SOP
Education
University of North Carolina at Chapel Hill
BA, Economics
PAREXEL 2015 - Present
GlaxoSmithKline 2011 - 2015
GSK 2008 - 2011
GlaxoSmithKline 2001 - 2008
Cisco Systems 2000 - 2001
Skills
Project Management, Pharmaceutical Industry, Clinical Trials, Clinical Development, GCP, Drug Development, CTMS, Clinical Research, Regulatory Submissions, Cross-functional Team..., CRO, Infectious Diseases, Process Improvement, SOP
Education
University of North Carolina at Chapel Hill
BA, Economics
Maria Oyaski Maria Oyaski's PAREXEL Experience September 2004 - January 2005
Job Regulatory Affairs Scientist: Cellular immunotherapy, IVDs
Industry Biotechnology
Experience
Heat Biologics October 2014 - Present
Argos Therapeutics September 2011 - October 2014
Argos Therapeutics July 2010 - September 2011
BioMerieux July 2007 - June 2010
PPD May 2006 - July 2007
Durham Technical Community College January 2006 - May 2006
Polaris Clinical Research Associates 2005 - 2006
PAREXEL September 2004 - January 2005
PPD May 2002 - September 2004
PPD December 2000 - May 2002
Skills
Regulatory Writing, Regulatory Strategy, Medical Writing, Autologous cellular..., In-vitro diagnostics..., Regulatory Submissions, FDA, Regulatory Affairs, eCTD, Strategy, Clinical Research, NDA, Clinical Trials, Pharmacovigilance, Oncology, Pharmaceutical Industry, Writing, IVD, Cell Therapy, GCP
Education
University of Pennsylvania
MS, Molecular and Cellular Biology
University of North Carolina at Chapel Hill
University of Pittsburgh
BS, MA, Biological Sciences; History and Philosophy of Science
Heat Biologics October 2014 - Present
Argos Therapeutics September 2011 - October 2014
Argos Therapeutics July 2010 - September 2011
BioMerieux July 2007 - June 2010
PPD May 2006 - July 2007
Durham Technical Community College January 2006 - May 2006
Polaris Clinical Research Associates 2005 - 2006
PAREXEL September 2004 - January 2005
PPD May 2002 - September 2004
PPD December 2000 - May 2002
Skills
Regulatory Writing, Regulatory Strategy, Medical Writing, Autologous cellular..., In-vitro diagnostics..., Regulatory Submissions, FDA, Regulatory Affairs, eCTD, Strategy, Clinical Research, NDA, Clinical Trials, Pharmacovigilance, Oncology, Pharmaceutical Industry, Writing, IVD, Cell Therapy, GCP
Education
University of Pennsylvania
MS, Molecular and Cellular Biology
University of North Carolina at Chapel Hill
University of Pittsburgh
BS, MA, Biological Sciences; History and Philosophy of Science
Brandon Doyle Brandon Doyle's PAREXEL Experience January 2013 - April 2014
Job Clinical Research Manager currently seeking new opportunities
Industry Research
Experience
Currently seeking new opportunities March 2015 - Present
Memorial Sloan-Kettering Cancer Center April 2014 - October 2014
PAREXEL January 2013 - April 2014
Minnesota Veterans Medical Research & Education Foundation March 2012 - December 2012
University of Minnesota- Department of Medicine August 2009 - March 2012
University of Minnesota- Transdiciplanary Tobacco Use Research Center, Department of Medicine June 2008 - August 2009
University of Minnesota- Cancer Center June 2005 - August 2009
University of Minnesota- Minnesota Center for Twin and Family Research May 2001 - May 2005
University of Minnesota January 2000 - January 2002
Skills
Protocol Writing, IRB, Patient Recruitment, Study Design, Clinical Research, Qualitative Research, SPSS, Market Research, PowerPoint, Microsoft Office, FDA, SOP, Clinical Trials, Protocol Development, Data Analysis, GCP, Excel, Research, Leadership, Clinical Study Design, CTMS, Protocol, Sop, CRO, Healthcare, Oncology, Management, EDC, Clinical Development, Microsoft Excel
Education
University of Minnesota - Carlson School of Management 2005 — 2008
MBA, Marketing and Management
University of Minnesota 1996 — 2002
Bachelor of Arts, Sociology and Psychology
Currently seeking new opportunities March 2015 - Present
Memorial Sloan-Kettering Cancer Center April 2014 - October 2014
PAREXEL January 2013 - April 2014
Minnesota Veterans Medical Research & Education Foundation March 2012 - December 2012
University of Minnesota- Department of Medicine August 2009 - March 2012
University of Minnesota- Transdiciplanary Tobacco Use Research Center, Department of Medicine June 2008 - August 2009
University of Minnesota- Cancer Center June 2005 - August 2009
University of Minnesota- Minnesota Center for Twin and Family Research May 2001 - May 2005
University of Minnesota January 2000 - January 2002
Skills
Protocol Writing, IRB, Patient Recruitment, Study Design, Clinical Research, Qualitative Research, SPSS, Market Research, PowerPoint, Microsoft Office, FDA, SOP, Clinical Trials, Protocol Development, Data Analysis, GCP, Excel, Research, Leadership, Clinical Study Design, CTMS, Protocol, Sop, CRO, Healthcare, Oncology, Management, EDC, Clinical Development, Microsoft Excel
Education
University of Minnesota - Carlson School of Management 2005 — 2008
MBA, Marketing and Management
University of Minnesota 1996 — 2002
Bachelor of Arts, Sociology and Psychology
Ashley Tointon Ashley Tointon's PAREXEL Experience March 2010 - October 2013
Job Principal Consultant at Accelerate Clinical Enrollment LLC
Industry Pharmaceuticals
Experience
Accelerate Clinical Enrollment LLC March 2015 - Present
ePharmaSolutions October 2013 - December 2014
PAREXEL March 2010 - October 2013
MMG 2009 - 2010
Inclinix July 2007 - May 2009
GSK November 2003 - April 2006
GSK October 1997 - November 2003
Skills
Project Management, Regulations, Pharmaceutical Industry, Clinical Trials, Cross-functional Team..., Process Improvement, Program Management, CRO, Contract Negotiation, Management, Budgets, Change Management, Marketing, Training, FDA, Therapeutic Areas, Clinical Research, Clinical Development, GCP, CTMS, Sop, EDC, Oncology, ICH-GCP, Clinical Data Management, Medical Writing, Protocol, SOP
Education
University of North Carolina at Chapel Hill
Bachelor of Arts (BA), Communications
University of North Carolina at Chapel Hill
Bachelor's degree, Communication and Media Studies
Accelerate Clinical Enrollment LLC March 2015 - Present
ePharmaSolutions October 2013 - December 2014
PAREXEL March 2010 - October 2013
MMG 2009 - 2010
Inclinix July 2007 - May 2009
GSK November 2003 - April 2006
GSK October 1997 - November 2003
Skills
Project Management, Regulations, Pharmaceutical Industry, Clinical Trials, Cross-functional Team..., Process Improvement, Program Management, CRO, Contract Negotiation, Management, Budgets, Change Management, Marketing, Training, FDA, Therapeutic Areas, Clinical Research, Clinical Development, GCP, CTMS, Sop, EDC, Oncology, ICH-GCP, Clinical Data Management, Medical Writing, Protocol, SOP
Education
University of North Carolina at Chapel Hill
Bachelor of Arts (BA), Communications
University of North Carolina at Chapel Hill
Bachelor's degree, Communication and Media Studies
Brian Kaputa's PAREXEL Experience April 2013 - Present
Job IT and PMO Manager
Industry Medical Devices
Experience
PAREXEL April 2013 - Present
Visa June 2011 - January 2013
Medtronic August 2008 - May 2011
Medtronic June 2007 - July 2008
Medtronic September 2005 - May 2007
Paymentech 2003 - 2005
The Kestrel Group 1998 - 2002
The Kestrel Group 1995 - 1998
Kmart Corporation July 1993 - August 1994
Skills
Cross-functional Team..., Process Improvement, Medical Devices, Payments, Project Management, Project Portfolio..., Lean Manufacturing, Agile Methodologies, Six Sigma, FDA, Management, Operations Management, Management Consulting, Labels, System Deployment, 21 CFR Part 11, Strategy, SDLC, Business Analysis, IT Strategy, Program Management
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics 1994 — 1996
MBA, Operations
West Virginia University 1989 — 1993
BS, Business Administration (HR, IT emphasis)
PAREXEL April 2013 - Present
Visa June 2011 - January 2013
Medtronic August 2008 - May 2011
Medtronic June 2007 - July 2008
Medtronic September 2005 - May 2007
Paymentech 2003 - 2005
The Kestrel Group 1998 - 2002
The Kestrel Group 1995 - 1998
Kmart Corporation July 1993 - August 1994
Skills
Cross-functional Team..., Process Improvement, Medical Devices, Payments, Project Management, Project Portfolio..., Lean Manufacturing, Agile Methodologies, Six Sigma, FDA, Management, Operations Management, Management Consulting, Labels, System Deployment, 21 CFR Part 11, Strategy, SDLC, Business Analysis, IT Strategy, Program Management
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics 1994 — 1996
MBA, Operations
West Virginia University 1989 — 1993
BS, Business Administration (HR, IT emphasis)
Jason Parish, CCRP Jason Parish, CCRP's PAREXEL Experience June 2011 - January 2012
Job CRAClinical Monitoring at Quintiles
Industry Pharmaceuticals
Experience
Quintiles April 2014 - Present
Quintiles January 2012 - April 2014
PAREXEL June 2011 - January 2012
INC Research October 2010 - June 2011
INC Research October 2008 - October 2010
University of North Carolina at Chapel Hill December 2007 - October 2008
University of North Carolina at Chapel Hill July 2007 - December 2007
St. Joseph County Intermediate School District September 2006 - May 2007
Aflac July 2005 - August 2006
Skills
Clinical Trials, GCP, CTMS, IRB, ICH-GCP, Clinical Research, Clinical Monitoring, Sop, Protocol, EDC, Clinical Development, CRO, Regulatory Submissions, Oncology
Education
University of Michigan 2001 — 2005
Bachelor of Science, Statistics
Quintiles April 2014 - Present
Quintiles January 2012 - April 2014
PAREXEL June 2011 - January 2012
INC Research October 2010 - June 2011
INC Research October 2008 - October 2010
University of North Carolina at Chapel Hill December 2007 - October 2008
University of North Carolina at Chapel Hill July 2007 - December 2007
St. Joseph County Intermediate School District September 2006 - May 2007
Aflac July 2005 - August 2006
Skills
Clinical Trials, GCP, CTMS, IRB, ICH-GCP, Clinical Research, Clinical Monitoring, Sop, Protocol, EDC, Clinical Development, CRO, Regulatory Submissions, Oncology
Education
University of Michigan 2001 — 2005
Bachelor of Science, Statistics
Janette Baribeau Janette Baribeau's PAREXEL Experience January 1999 - November 1999
Job Water Operator at Clearwater Operations
Industry Leisure, Travel & Tourism
Experience
Clearwater Operations March 2015 - Present
Skinny Skis November 2010 - May 2015
Jackson Hole Mountain Resort December 2000 - August 2010
USDA Forest Service June 2006 - September 2006
USDA Forest Service July 2005 - November 2005
NH Department of Environmental Services June 2000 - December 2000
Attitash Bear Peak (now Attitash Mountain Resort) November 1999 - April 2000
PAREXEL January 1999 - November 1999
Borregaard September 1998 - December 1998
Skills
Public Speaking, Customer Service, Microsoft Office, Research, Water Resources, Data Management, Surveying, Field Work, Trimble GPS, Hydrology, Equipment Installation, Problem Solving, Rosgen Method to Stream..., NEPA, Environmental..., Team-oriented, Employee Training, Highly detail oriented, Back Office, Front Office, Sales, Time Management, Data Collection, Community Outreach, Event Management, Social Media
Education
University of New Hampshire 1994 — 1998
BS, Water Resources Management
Clearwater Operations March 2015 - Present
Skinny Skis November 2010 - May 2015
Jackson Hole Mountain Resort December 2000 - August 2010
USDA Forest Service June 2006 - September 2006
USDA Forest Service July 2005 - November 2005
NH Department of Environmental Services June 2000 - December 2000
Attitash Bear Peak (now Attitash Mountain Resort) November 1999 - April 2000
PAREXEL January 1999 - November 1999
Borregaard September 1998 - December 1998
Skills
Public Speaking, Customer Service, Microsoft Office, Research, Water Resources, Data Management, Surveying, Field Work, Trimble GPS, Hydrology, Equipment Installation, Problem Solving, Rosgen Method to Stream..., NEPA, Environmental..., Team-oriented, Employee Training, Highly detail oriented, Back Office, Front Office, Sales, Time Management, Data Collection, Community Outreach, Event Management, Social Media
Education
University of New Hampshire 1994 — 1998
BS, Water Resources Management
S Clayton Shapiro S Clayton Shapiro's PAREXEL Experience March 2010 - Present
Job Sr CRA at PAREXEL
Industry Research
Experience
PAREXEL March 2010 - Present
RPS May 2009 - February 2010
Clinsys Clinical Research June 2004 - February 2009
Volt Technical Service July 2002 - June 2004
MDS Pharma Services-Phoenix International October 1999 - July 2002
Baylor College of Medicine December 1998 - October 1999
HCRN/Montrose Clinic May 1996 - November 1998
Education
Minnesota Intercollegiate Nursing Consortium 1988 — 1990
Nursing, Nursing
University of Missouri-Kansas City 1986 — 1987
BA, BS, biology Chemistry
University of Missouri-Kansas City School of Medicine 1982 — 1987
Medicine
Francis Howel High School 1978 — 1982
HS grad
PAREXEL March 2010 - Present
RPS May 2009 - February 2010
Clinsys Clinical Research June 2004 - February 2009
Volt Technical Service July 2002 - June 2004
MDS Pharma Services-Phoenix International October 1999 - July 2002
Baylor College of Medicine December 1998 - October 1999
HCRN/Montrose Clinic May 1996 - November 1998
Education
Minnesota Intercollegiate Nursing Consortium 1988 — 1990
Nursing, Nursing
University of Missouri-Kansas City 1986 — 1987
BA, BS, biology Chemistry
University of Missouri-Kansas City School of Medicine 1982 — 1987
Medicine
Francis Howel High School 1978 — 1982
HS grad
Becky Pruitt Becky Pruitt's PAREXEL Experience 1996 - 2001
Job PRO License and Translation Coordinator
Industry Pharmaceuticals
Experience
A10 Solutions on contract to GlaxoSmithKline March 2013 - September 2013
GlaxoSmithKline 2001 - July 2011
PAREXEL 1996 - 2001
Research Triangle Institute (RTI) 1989 - 1996
Skills
Case Report Form Design, Clinical Data Management, Data Standards, PRO Design, SAE Reconciliation, CRF and PRO Translations, Coding Adverse Events..., EDC, Phase I Studies, CRF design, Infectious Diseases, Clinical Trials, Protocol, Oncology, Clinical Research
Education
University of North Carolina at Chapel Hill
BA, Biology
A10 Solutions on contract to GlaxoSmithKline March 2013 - September 2013
GlaxoSmithKline 2001 - July 2011
PAREXEL 1996 - 2001
Research Triangle Institute (RTI) 1989 - 1996
Skills
Case Report Form Design, Clinical Data Management, Data Standards, PRO Design, SAE Reconciliation, CRF and PRO Translations, Coding Adverse Events..., EDC, Phase I Studies, CRF design, Infectious Diseases, Clinical Trials, Protocol, Oncology, Clinical Research
Education
University of North Carolina at Chapel Hill
BA, Biology
Melissa Cabrera's PAREXEL Experience May 2015 - Present
Job Senior Site Intelligence Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL May 2015 - Present
Skills
CRO, Clinical Trials, Analysis, Government, ICH-GCP, Data Analysis, Research, GCP, ArcGIS, Criminal Justice, Access, Enforcement, Statistics, Protocol, FDA, Laboratory, Data Management, Databases, Evidence, Therapeutic Areas, Management, Training
Education
University of New Haven 2001 — 2002
MS, Forensic Science
Wake Forest University 1996 — 2000
BS, Biology
PAREXEL May 2015 - Present
Skills
CRO, Clinical Trials, Analysis, Government, ICH-GCP, Data Analysis, Research, GCP, ArcGIS, Criminal Justice, Access, Enforcement, Statistics, Protocol, FDA, Laboratory, Data Management, Databases, Evidence, Therapeutic Areas, Management, Training
Education
University of New Haven 2001 — 2002
MS, Forensic Science
Wake Forest University 1996 — 2000
BS, Biology
Elizabeth Kristine Yates Elizabeth Kristine Yates's PAREXEL Experience 2000 - 2001
Job Owner, Yates Clinical Research Consulting
Industry Research
Experience
Yates Clinical Research Consulting 2014 - Present
UCB Biosciences, Inc. January 2003 - December 2013
Pathway Clinical Research Group, Inc. 2003 - 2013
ReSearch Pharmaceutical Services 2001 - 2009
PAREXEL 2000 - 2001
PAREXEL 1998 - 2000
Skills
Clinical Development, Clinical Trials, CRO, CTMS, Sop, FDA, Clinical Data Management, Pharmaceutics, Clinical Research, Clinical Study Design, GCP, EDC, Clinical Monitoring, Protocol, Pharmaceutical Industry, Neurology, Gastroenterology, Rheumatology, Therapeutic Areas, Regulatory Affairs, IND, Pharmaceuticals, Research Project..., Phase I, ICH-GCP, Oracle Clinical, Medical Writing, Dermatology, Project Management, SOP
Education
University of North Carolina at Chapel Hill 1992 — 1997
Biology, Biology/Chemisty/RECR
Cardinal Gibbons High School, Raleigh, NC 1988 — 1992
HS Diploma
Our Lady of Lourdes - Raleigh 1980 — 1988
Yates Clinical Research Consulting 2014 - Present
UCB Biosciences, Inc. January 2003 - December 2013
Pathway Clinical Research Group, Inc. 2003 - 2013
ReSearch Pharmaceutical Services 2001 - 2009
PAREXEL 2000 - 2001
PAREXEL 1998 - 2000
Skills
Clinical Development, Clinical Trials, CRO, CTMS, Sop, FDA, Clinical Data Management, Pharmaceutics, Clinical Research, Clinical Study Design, GCP, EDC, Clinical Monitoring, Protocol, Pharmaceutical Industry, Neurology, Gastroenterology, Rheumatology, Therapeutic Areas, Regulatory Affairs, IND, Pharmaceuticals, Research Project..., Phase I, ICH-GCP, Oracle Clinical, Medical Writing, Dermatology, Project Management, SOP
Education
University of North Carolina at Chapel Hill 1992 — 1997
Biology, Biology/Chemisty/RECR
Cardinal Gibbons High School, Raleigh, NC 1988 — 1992
HS Diploma
Our Lady of Lourdes - Raleigh 1980 — 1988
Chandan Gavai Chandan Gavai's PAREXEL Experience July 2007 - March 2008
Job Sr. Programmer Analyst at Broadridge Financial Services
Industry Financial Services
Experience
Broadridge Financial Services July 2011 - Present
L-1 Identity Solutions April 2009 - June 2011
Imagitas May 2008 - March 2009
PAREXEL July 2007 - March 2008
HP March 2007 - June 2007
GTL Limited 2005 - 2006
Skills
Validation, SQL, Testing, Scrum
Education
University of Mumbai 1995 — 2005
Broadridge Financial Services July 2011 - Present
L-1 Identity Solutions April 2009 - June 2011
Imagitas May 2008 - March 2009
PAREXEL July 2007 - March 2008
HP March 2007 - June 2007
GTL Limited 2005 - 2006
Skills
Validation, SQL, Testing, Scrum
Education
University of Mumbai 1995 — 2005
Denise Shortino Denise Shortino's PAREXEL Experience March 2015 - Present
Job Director Statistics at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline 2012 - March 2015
GSK 2002 - 2012
GSK 1990 - 2002
Skills
Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, CTMS, Oncology, Drug Development, GCP, Biostatistics, Biotechnology, Life Sciences, Clinical Research, Regulatory Submissions, Infectious Diseases
Education
University of North Carolina at Chapel Hill
MS, Biostatistics
Virginia Polytechnic Institute and State University
Bachelor's Degree
PAREXEL March 2015 - Present
GlaxoSmithKline 2012 - March 2015
GSK 2002 - 2012
GSK 1990 - 2002
Skills
Pharmaceutical Industry, Clinical Development, CRO, Clinical Trials, CTMS, Oncology, Drug Development, GCP, Biostatistics, Biotechnology, Life Sciences, Clinical Research, Regulatory Submissions, Infectious Diseases
Education
University of North Carolina at Chapel Hill
MS, Biostatistics
Virginia Polytechnic Institute and State University
Bachelor's Degree
Kelly (Neel) Henkel's PAREXEL Experience July 2014 - Present
Job MBA, PMP, Entrepreneur
Industry Pharmaceuticals
Experience
PAREXEL July 2014 - Present
J&K Construction March 2009 - Present
Mary Kay Inc. April 2011 - January 2015
INC Research May 2012 - March 2014
PRA International December 2010 - March 2012
Quintiles September 2008 - December 2010
Quintiles October 2005 - December 2010
Quintiles August 2002 - October 2008
Ingenix June 2000 - February 2002
POZEN June 1999 - June 2000
Skills
CRO, Clinical Trials, Clinical Development, Cross-functional Team..., CTMS, EDC, Clinical Research, GCP, ICH-GCP, Pharmaceutical Industry, Software Documentation, Clinical Monitoring, Project Management, FDA, Leadership, Oncology, Data Management, Quality Assurance, MS Project, Process Improvement, SOP, Certified Project..., Certified Aerobics..., Proficient in MS..., Biotechnology, Informatics, Construction Management
Education
South Caldwell 1988 — 1991
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science (B.S.), Biology-Minor Chemistry
Strayer College 2010 — 2013
Master of Business Administration (M.B.A.), Project Management
PAREXEL July 2014 - Present
J&K Construction March 2009 - Present
Mary Kay Inc. April 2011 - January 2015
INC Research May 2012 - March 2014
PRA International December 2010 - March 2012
Quintiles September 2008 - December 2010
Quintiles October 2005 - December 2010
Quintiles August 2002 - October 2008
Ingenix June 2000 - February 2002
POZEN June 1999 - June 2000
Skills
CRO, Clinical Trials, Clinical Development, Cross-functional Team..., CTMS, EDC, Clinical Research, GCP, ICH-GCP, Pharmaceutical Industry, Software Documentation, Clinical Monitoring, Project Management, FDA, Leadership, Oncology, Data Management, Quality Assurance, MS Project, Process Improvement, SOP, Certified Project..., Certified Aerobics..., Proficient in MS..., Biotechnology, Informatics, Construction Management
Education
South Caldwell 1988 — 1991
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science (B.S.), Biology-Minor Chemistry
Strayer College 2010 — 2013
Master of Business Administration (M.B.A.), Project Management
Kristy Gura Kristy Gura's PAREXEL Experience August 2014 - December 2014
Job Territory Manager
Industry Pharmaceuticals
Experience
Arbor Pharmaceuticals December 2014 - Present
PAREXEL August 2014 - December 2014
Clinipace Worldwide October 2013 - August 2014
Complete Nutrition July 2011 - August 2013
UNC Health Care-Neurosciences Hospital-Memory Disorders Clinic May 2010 - February 2011
UNC-CH-FPG Child Development Institute May 2010 - February 2011
UNC-CH School of Social Work April 2010 - February 2011
University of North Carolina at Chapel Hill September 2008 - May 2010
Cary Family YMCA May 2004 - August 2009
Skills
Management, Clinical Trials, Sales, Clinical Data Management, Clinical Research, Literature Reviews, Site Visits, Research Development, IRB, SPSS, New Client Acquisitions, Maintaining Strong..., Marketing, Data Analysis, Leadership, Research, Customer Service
Education
University of North Carolina at Chapel Hill 2006 — 2010
Bachelor of Arts (B.A.), Psychology
Arbor Pharmaceuticals December 2014 - Present
PAREXEL August 2014 - December 2014
Clinipace Worldwide October 2013 - August 2014
Complete Nutrition July 2011 - August 2013
UNC Health Care-Neurosciences Hospital-Memory Disorders Clinic May 2010 - February 2011
UNC-CH-FPG Child Development Institute May 2010 - February 2011
UNC-CH School of Social Work April 2010 - February 2011
University of North Carolina at Chapel Hill September 2008 - May 2010
Cary Family YMCA May 2004 - August 2009
Skills
Management, Clinical Trials, Sales, Clinical Data Management, Clinical Research, Literature Reviews, Site Visits, Research Development, IRB, SPSS, New Client Acquisitions, Maintaining Strong..., Marketing, Data Analysis, Leadership, Research, Customer Service
Education
University of North Carolina at Chapel Hill 2006 — 2010
Bachelor of Arts (B.A.), Psychology
Meka Hargrove Meka Hargrove's PAREXEL Experience April 2012 - January 2014
Job Senior Feasibility & Site Specialist at ICON plc
Industry Pharmaceuticals
Experience
ICON plc February 2014 - Present
PAREXEL April 2012 - January 2014
PharmaNet/i3 October 2010 - April 2012
Quintiles, Inc July 2009 - October 2010
Quintiles January 2008 - July 2009
Quintiles January 2007 - January 2008
Quintiles July 2006 - January 2007
Carolina Population Center 2004 - 2006
School Success Profile 1999 - 2004
Skills
Clinical Monitoring, Biotechnology, CTMS, Clinical Trials, CRO, Cross-functional Team..., Pharmaceutical Industry, Clinical Research, Clinical Development, EDC, ICH-GCP, Leadership, GCP, Neuroscience, Feasibility Studies, Vaccines, Therapeutic Areas, Patient Recruitment, Regulatory Submissions, Protocol, Diabetes, Regulatory Affairs, Infectious Diseases, Oncology, Research, Rheumatology, FDA, Sop, Clinical Operations, Healthcare, Clinical Data Management, Medical Writing, IRB, Drug Development
Education
University of North Carolina at Chapel Hill
BA, Psychology
University of North Carolina at Chapel Hill
MSW, Social Work
ICON plc February 2014 - Present
PAREXEL April 2012 - January 2014
PharmaNet/i3 October 2010 - April 2012
Quintiles, Inc July 2009 - October 2010
Quintiles January 2008 - July 2009
Quintiles January 2007 - January 2008
Quintiles July 2006 - January 2007
Carolina Population Center 2004 - 2006
School Success Profile 1999 - 2004
Skills
Clinical Monitoring, Biotechnology, CTMS, Clinical Trials, CRO, Cross-functional Team..., Pharmaceutical Industry, Clinical Research, Clinical Development, EDC, ICH-GCP, Leadership, GCP, Neuroscience, Feasibility Studies, Vaccines, Therapeutic Areas, Patient Recruitment, Regulatory Submissions, Protocol, Diabetes, Regulatory Affairs, Infectious Diseases, Oncology, Research, Rheumatology, FDA, Sop, Clinical Operations, Healthcare, Clinical Data Management, Medical Writing, IRB, Drug Development
Education
University of North Carolina at Chapel Hill
BA, Psychology
University of North Carolina at Chapel Hill
MSW, Social Work
Ginger Johnson Ginger Johnson's PAREXEL Experience November 2012 - Present
Job Senior CRA at PAREXEL
Industry Pharmaceuticals
Christopher Swayngim Christopher Swayngim's PAREXEL Experience October 2012 - December 2012
Job Senior Site Start Up Manager, Premier Research Group International
Industry Pharmaceuticals
Experience
PAREXEL October 2012 - December 2012
PAREXEL February 2012 - October 2012
PPD March 2010 - July 2010
PPD March 2008 - March 2010
PPD February 2007 - March 2008
Skills
Clinical Trials, GCP, Clinical Research, CTMS, IRB, ICH-GCP, FDA, CRO, Diabetes, Life Sciences, Regulatory Requirements
Education
Cape Fear Community College 2008 — 2011
NA, Anatomy & Physiology, Microbiology, Nursing, Clinical Research Overview
University of North Carolina at Asheville 1993 — 1998
BA, Sociology, Liberal Arts
PAREXEL October 2012 - December 2012
PAREXEL February 2012 - October 2012
PPD March 2010 - July 2010
PPD March 2008 - March 2010
PPD February 2007 - March 2008
Skills
Clinical Trials, GCP, Clinical Research, CTMS, IRB, ICH-GCP, FDA, CRO, Diabetes, Life Sciences, Regulatory Requirements
Education
Cape Fear Community College 2008 — 2011
NA, Anatomy & Physiology, Microbiology, Nursing, Clinical Research Overview
University of North Carolina at Asheville 1993 — 1998
BA, Sociology, Liberal Arts
Tracy Newbold Tracy Newbold's PAREXEL Experience 1999 - 2001
Job Director, Program Management at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics 2013 - Present
United Therapeutics 2013 - Present
United Therapeutics May 2011 - March 2013
Pfizer (formerly King Pharmaceuticals) August 2006 - April 2011
Family Health International December 2004 - July 2006
University of Washington September 2003 - December 2004
Quintiles 2001 - 2003
PAREXEL 1999 - 2001
Skills
Clinical Monitoring, Project Management, Quality Control, Clinical Development, Clinical Study Design, Clinical Trials, Contract Negotiation, Data Management, FDA, IND, Leadership, Infectious Diseases, Pharmaceutical Industry, Program Management, Protocol, Sop, Training, Team Management, Clinical Research, SOP, Biotechnology, GCP
Education
University of North Carolina at Chapel Hill 1986 — 1990
B.A., Journalism & RTVMP
United Therapeutics 2013 - Present
United Therapeutics 2013 - Present
United Therapeutics May 2011 - March 2013
Pfizer (formerly King Pharmaceuticals) August 2006 - April 2011
Family Health International December 2004 - July 2006
University of Washington September 2003 - December 2004
Quintiles 2001 - 2003
PAREXEL 1999 - 2001
Skills
Clinical Monitoring, Project Management, Quality Control, Clinical Development, Clinical Study Design, Clinical Trials, Contract Negotiation, Data Management, FDA, IND, Leadership, Infectious Diseases, Pharmaceutical Industry, Program Management, Protocol, Sop, Training, Team Management, Clinical Research, SOP, Biotechnology, GCP
Education
University of North Carolina at Chapel Hill 1986 — 1990
B.A., Journalism & RTVMP
Bonnie Whitehead's PAREXEL Experience July 2014 - February 2015
Job Regulatory and Start Up Specialist at Quintiles Transnational
Industry Pharmaceuticals
Experience
PAREXEL July 2014 - February 2015
PPD January 2014 - July 2014
Step Up Ministry July 2011 - December 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - April 2012
Polaris Compliance Consultants, Inc February 2011 - February 2011
BioCryst Pharmaceuticals Inc November 2009 - April 2010
Purdue University August 2006 - October 2009
GlaxoSmithKline August 2001 - August 2006
Quintiles Transnational December 2000 - March 2001
Skills
Medical Writing, Pharmacovigilance, Research Project..., CTMS, GCP, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Research, Oncology, Urology, Clinical Monitoring, Medicine, Sop, Lifesciences, Clinical Data Management, Clinical Pharmacology, Project Management, Drug Development, Protocol, Pharmaceutical Industry, CRO, FDA, Pharmacokinetics, IND, Pharmaceutics, Infectious Diseases, Vaccines, Cancer, Biotechnology, Regulatory Affairs, Immunology, GLP, Clinical Study Design, Pharmacology, EDC, Drug Safety, ICH-GCP, Regulatory Submissions, Diabetes, Phase I, Biomarkers, Assay Development, SOP
Education
University of North Carolina at Chapel Hill 1978 — 1979
MAT, Biology
Randolph College
Bachelor of Arts (no BS offered), Biology
PAREXEL July 2014 - February 2015
PPD January 2014 - July 2014
Step Up Ministry July 2011 - December 2013
Drug Safety Alliance October 2012 - December 2012
Quintiles November 2011 - April 2012
Polaris Compliance Consultants, Inc February 2011 - February 2011
BioCryst Pharmaceuticals Inc November 2009 - April 2010
Purdue University August 2006 - October 2009
GlaxoSmithKline August 2001 - August 2006
Quintiles Transnational December 2000 - March 2001
Skills
Medical Writing, Pharmacovigilance, Research Project..., CTMS, GCP, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Research, Oncology, Urology, Clinical Monitoring, Medicine, Sop, Lifesciences, Clinical Data Management, Clinical Pharmacology, Project Management, Drug Development, Protocol, Pharmaceutical Industry, CRO, FDA, Pharmacokinetics, IND, Pharmaceutics, Infectious Diseases, Vaccines, Cancer, Biotechnology, Regulatory Affairs, Immunology, GLP, Clinical Study Design, Pharmacology, EDC, Drug Safety, ICH-GCP, Regulatory Submissions, Diabetes, Phase I, Biomarkers, Assay Development, SOP
Education
University of North Carolina at Chapel Hill 1978 — 1979
MAT, Biology
Randolph College
Bachelor of Arts (no BS offered), Biology
Brian Rourke, CPA, CIA's PAREXEL Experience September 2012 - July 2014
Job Senior Internal Audit at Keurig Green Mountain, Inc.
Industry Accounting
Experience
Keurig Green Mountain, Inc. November 2014 - Present
GT Advanced Technologies July 2014 - November 2014
PAREXEL September 2012 - July 2014
The Corporate Finance Group July 2010 - September 2012
MFA - Moody, Famiglietti & Andronico, LLP November 2009 - July 2010
Ernst & Young August 2008 - October 2009
Skills
Internal Controls, Auditing, Internal Audit, Sarbanes-Oxley Act, Financial Accounting, Revenue Recognition, Certified Public..., Assurance, External Audit, Sarbanes-Oxley, SOX 404, CPA, SEC reporting, Consulting, Oracle, SAP, GEAC, SOX Compliancy, Lotus Notes, Microsoft Excel, Technical Accounting..., Essbase, Hyperion HFM, FCPA, Fraud Detection, Fraud Prevention
Education
University of New Hampshire 2007 — 2008
Masters, Accounting
University of New Hampshire -- Peter T. Paul College of Business and Economics 2003 — 2007
Bachelor, Accounting
Keurig Green Mountain, Inc. November 2014 - Present
GT Advanced Technologies July 2014 - November 2014
PAREXEL September 2012 - July 2014
The Corporate Finance Group July 2010 - September 2012
MFA - Moody, Famiglietti & Andronico, LLP November 2009 - July 2010
Ernst & Young August 2008 - October 2009
Skills
Internal Controls, Auditing, Internal Audit, Sarbanes-Oxley Act, Financial Accounting, Revenue Recognition, Certified Public..., Assurance, External Audit, Sarbanes-Oxley, SOX 404, CPA, SEC reporting, Consulting, Oracle, SAP, GEAC, SOX Compliancy, Lotus Notes, Microsoft Excel, Technical Accounting..., Essbase, Hyperion HFM, FCPA, Fraud Detection, Fraud Prevention
Education
University of New Hampshire 2007 — 2008
Masters, Accounting
University of New Hampshire -- Peter T. Paul College of Business and Economics 2003 — 2007
Bachelor, Accounting
Shannon Gooding Shannon Gooding's PAREXEL Experience March 2015 - Present
Job Data Operations Lead at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GSK December 1992 - March 2015
Skills
Clinical Trials, Pharmaceutical Industry, GCP, CRO, Oncology, Clinical Research, SOP, Clinical Development, EDC, ICH-GCP
Education
University of North Carolina at Chapel Hill
Bachelor’s Degree, Mathematical Sciences
PAREXEL March 2015 - Present
GSK December 1992 - March 2015
Skills
Clinical Trials, Pharmaceutical Industry, GCP, CRO, Oncology, Clinical Research, SOP, Clinical Development, EDC, ICH-GCP
Education
University of North Carolina at Chapel Hill
Bachelor’s Degree, Mathematical Sciences
Carolyn Latham Carolyn Latham's PAREXEL Experience January 2013 - Present
Job Cardiac Nurse Educator, Care Specialist
Industry Pharmaceuticals
Experience
InVentiv Health August 2014 - Present
PAREXEL January 2013 - Present
Your Home Advantage Inc November 2011 - January 2013
Publicis Selling Solutions - Specialty Pharmaceutical August 2010 - November 2011
Oncotech/Exiqon Diagnostics September 2009 - July 2010
Alabama Allergy & Asthma Center March 2009 - August 2009
Certified Astham Nurse Educator February 2002 - August 2005
Alabama Allergy & Asthma Center January 2000 - January 2002
Ginsburg Dermatology & Aesthetic Laser Center January 1999 - January 2000
Skills
Healthcare, Healthcare Management, Strategic Planning, Process Improvement, Hospitals, Customer Service, Operations Management, Team Building, Healthcare Information..., Project Management, Budgets, Change Management, Microsoft Office, EMR, Program Management, Nurse Educator
Education
University of North Alabama
Bachelor of Science, Nursing
Wallace State Community College
Associate Degree, Nursing
InVentiv Health August 2014 - Present
PAREXEL January 2013 - Present
Your Home Advantage Inc November 2011 - January 2013
Publicis Selling Solutions - Specialty Pharmaceutical August 2010 - November 2011
Oncotech/Exiqon Diagnostics September 2009 - July 2010
Alabama Allergy & Asthma Center March 2009 - August 2009
Certified Astham Nurse Educator February 2002 - August 2005
Alabama Allergy & Asthma Center January 2000 - January 2002
Ginsburg Dermatology & Aesthetic Laser Center January 1999 - January 2000
Skills
Healthcare, Healthcare Management, Strategic Planning, Process Improvement, Hospitals, Customer Service, Operations Management, Team Building, Healthcare Information..., Project Management, Budgets, Change Management, Microsoft Office, EMR, Program Management, Nurse Educator
Education
University of North Alabama
Bachelor of Science, Nursing
Wallace State Community College
Associate Degree, Nursing
Emily Moran Emily Moran's PAREXEL Experience March 2014 - July 2015
Job Learning Coach at College for America at Southern New Hampshire University
Industry Hospital & Health Care
Experience
College for America at Southern New Hampshire University August 2015 - Present
PAREXEL March 2014 - July 2015
PAREXEL April 2012 - February 2014
Breakfast Hill Chiropractic, P.L.L.C. November 2011 - August 2012
Enterprise Consulting Solutions, Inc August 2011 - November 2011
Dartmouth-Hitchcock Community Group Practice June 2010 - August 2010
St. Joseph Hospital 2006 - 2007
Skills
Clinical Research, Social Networking, Customer Service, Public Speaking, EMR, Marketing, Time Management, Training, Data Analysis
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Healthcare Management and Policy
University of New Hampshire 2007 — 2011
Bachelor of Science (B.S.), Healthcare Management and Policy
College for America at Southern New Hampshire University August 2015 - Present
PAREXEL March 2014 - July 2015
PAREXEL April 2012 - February 2014
Breakfast Hill Chiropractic, P.L.L.C. November 2011 - August 2012
Enterprise Consulting Solutions, Inc August 2011 - November 2011
Dartmouth-Hitchcock Community Group Practice June 2010 - August 2010
St. Joseph Hospital 2006 - 2007
Skills
Clinical Research, Social Networking, Customer Service, Public Speaking, EMR, Marketing, Time Management, Training, Data Analysis
Education
University of New Hampshire 2007 — 2011
Bachelor of Science, Healthcare Management and Policy
University of New Hampshire 2007 — 2011
Bachelor of Science (B.S.), Healthcare Management and Policy
Tamara Buie Hayes, BA, CCRP's PAREXEL Experience November 2012 - August 2013
Job Senior Specialist, Regulatory Compliance at Worldwide Clinical Trials
Industry Research
Experience
Worldwide Clinical Trials August 2013 - Present
PAREXEL November 2012 - August 2013
PAREXEL May 2011 - November 2012
Duke University Medical Center, Duke Insomnia and Sleep Research Program July 2007 - May 2011
Skills
Extensive expertise in..., Expert knowledge in..., Extensive Site..., Project management, extensive knowledge in..., Extensive knowledge..., Expert knowledge of the..., Clinical Monitoring, Clinical Trials, GCP, Project Management, Software Documentation, Clinical Research, IRB, Protocol, CTMS, EDC, ICH-GCP, Therapeutic Areas, CRO, Clinical Development, Sop, Regulatory Submissions, Informed Consent, Regulatory Affairs, Clinical Study Design, Clinical Operations, Trial Management, ICH guidelines, 21 CFR Part 11, Drug Safety, Regulatory Requirements, Neurology, Medidata, SOP development, IND, Pharmaceutical Industry, Clinical Data Management, FDA, Drug Development, Pharmacovigilance, SOP
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
Hillside High School 1989 — 1993
High School Diploma- Honors, College Prep
Worldwide Clinical Trials August 2013 - Present
PAREXEL November 2012 - August 2013
PAREXEL May 2011 - November 2012
Duke University Medical Center, Duke Insomnia and Sleep Research Program July 2007 - May 2011
Skills
Extensive expertise in..., Expert knowledge in..., Extensive Site..., Project management, extensive knowledge in..., Extensive knowledge..., Expert knowledge of the..., Clinical Monitoring, Clinical Trials, GCP, Project Management, Software Documentation, Clinical Research, IRB, Protocol, CTMS, EDC, ICH-GCP, Therapeutic Areas, CRO, Clinical Development, Sop, Regulatory Submissions, Informed Consent, Regulatory Affairs, Clinical Study Design, Clinical Operations, Trial Management, ICH guidelines, 21 CFR Part 11, Drug Safety, Regulatory Requirements, Neurology, Medidata, SOP development, IND, Pharmaceutical Industry, Clinical Data Management, FDA, Drug Development, Pharmacovigilance, SOP
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
Hillside High School 1989 — 1993
High School Diploma- Honors, College Prep
Ellen (Ellen Hunsicker) Penningroth, BSN, RN Ellen (Ellen Hunsicker) Penningroth, BSN, RN's PAREXEL Experience June 2014 - December 2014
Job Seeking New Opportunity
Industry Hospital & Health Care
Experience
Seeking New Opportunity in Chicago NAET practitionerNAET2010 - 2015
PAREXEL June 2014 - December 2014
St Jude Medical 2012 - 2013
Medtronic 2012 - 2013
MGI Pharma 2006 - 2007
Amgen 2005 - 2006
Pfizer May 1998 - August 2004
Pharmacia May 1998 - August 2004
Quintiles September 1996 - April 1998
The University of Iowa Health Care September 1994 - May 1996
Skills
Pharmaceutical Industry, Medical Devices, Clinical Research, ICH-GCP, Microsoft Excel, Electronic Data..., Training, Microsoft Word, Customer Service, PowerPoint, Windows, Outlook, Teaching, Public Speaking, Negotiation, Oracle Clinical, Territory Development, Informed Consent..., Budget Negotiation, Electronic Databases, Medical Terminology, Holistic Health, Community Development, GCP, Clinical Trials, Clinical Monitoring, Oncology, Protocol, FDA, Cardiology
Education
University of Minnesota-Twin Cities 1992 — 1994
Bachelor of Science (BS), Nursing, 3.7
Northwestern 1985 — 1989
Bachelor of Science (BS), Education and Social Policy, Organizational Behavior, Health Care, 3.4
Seeking New Opportunity in Chicago NAET practitionerNAET2010 - 2015
PAREXEL June 2014 - December 2014
St Jude Medical 2012 - 2013
Medtronic 2012 - 2013
MGI Pharma 2006 - 2007
Amgen 2005 - 2006
Pfizer May 1998 - August 2004
Pharmacia May 1998 - August 2004
Quintiles September 1996 - April 1998
The University of Iowa Health Care September 1994 - May 1996
Skills
Pharmaceutical Industry, Medical Devices, Clinical Research, ICH-GCP, Microsoft Excel, Electronic Data..., Training, Microsoft Word, Customer Service, PowerPoint, Windows, Outlook, Teaching, Public Speaking, Negotiation, Oracle Clinical, Territory Development, Informed Consent..., Budget Negotiation, Electronic Databases, Medical Terminology, Holistic Health, Community Development, GCP, Clinical Trials, Clinical Monitoring, Oncology, Protocol, FDA, Cardiology
Education
University of Minnesota-Twin Cities 1992 — 1994
Bachelor of Science (BS), Nursing, 3.7
Northwestern 1985 — 1989
Bachelor of Science (BS), Education and Social Policy, Organizational Behavior, Health Care, 3.4
Carlie Porterfield's PAREXEL Experience December 2014 - Present
Job Clinical Research Associate
Industry Pharmaceuticals
Experience
PAREXEL December 2014 - Present
PPD April 2012 - December 2014
PPD July 2010 - April 2012
PPD April 2009 - July 2010
PPD August 2007 - April 2009
Skills
ICH-GCP, Clinical Trials, Clinical Monitoring, Clinical Research, Protocol, Research, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Medidata, Inform, OC-RDC, Diabetes, HIV
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Arts (B.A.), Chemistry
PAREXEL December 2014 - Present
PPD April 2012 - December 2014
PPD July 2010 - April 2012
PPD April 2009 - July 2010
PPD August 2007 - April 2009
Skills
ICH-GCP, Clinical Trials, Clinical Monitoring, Clinical Research, Protocol, Research, Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Medidata, Inform, OC-RDC, Diabetes, HIV
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Arts (B.A.), Chemistry
Heather Kirkeby's PAREXEL Experience December 2013 - Present
Job Portfolio Director at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL December 2013 - Present
PAREXEL September 2012 - December 2013
PAREXEL November 2010 - September 2012
PAREXEL October 2008 - November 2010
PAREXEL November 2006 - October 2008
Medifacts International October 2004 - November 2006
3M Pharmaceuticals 2000 - 2001
Searle September 1999 - September 2000
Clinical Cardiovascular Research 1997 - 1999
Skills
Project Management, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, CRO, GCP, EDC, Oncology
Education
University of Minnesota - Carlson School of Management 1992 — 1993
BS, Business
University of Minnesota-Duluth 1988 — 1992
BS, Business
PAREXEL December 2013 - Present
PAREXEL September 2012 - December 2013
PAREXEL November 2010 - September 2012
PAREXEL October 2008 - November 2010
PAREXEL November 2006 - October 2008
Medifacts International October 2004 - November 2006
3M Pharmaceuticals 2000 - 2001
Searle September 1999 - September 2000
Clinical Cardiovascular Research 1997 - 1999
Skills
Project Management, Clinical Trials, Clinical Research, Clinical Development, Pharmaceutical Industry, CRO, GCP, EDC, Oncology
Education
University of Minnesota - Carlson School of Management 1992 — 1993
BS, Business
University of Minnesota-Duluth 1988 — 1992
BS, Business
Kelly Fillbrandt Swartz Kelly Fillbrandt Swartz's PAREXEL Experience January 2015 - August 2015
Job Associate Director, Statistical Programming at inVentiv Health Clinical
Industry Research
Experience
inVentiv Health Clinical August 2015 - Present
PAREXEL January 2015 - August 2015
PAREXEL May 2013 - December 2014
PAREXEL November 2011 - April 2013
PAREXEL July 2010 - October 2011
Premier Research Group December 2008 - July 2010
PPD February 2005 - December 2008
HealthPartners Research Foundation March 1999 - September 2004
GreenTree Financial November 1997 - February 1999
MarketResponse Intl July 1996 - October 1997
Skills
Clinical Trials, CDISC, CRO, SAS, Clinical Research, FDA, EDC, Clinical Data Management, Medical Devices, Sop, Clinical Development, ICH-GCP, Oracle Clinical, Biotechnology, Regulatory Affairs, CTMS, GCP, 21 CFR Part 11, Data Management, Project Management
Education
University of Minnesota-Twin Cities
Bachelor of Science, Economics with Math Emphasis
inVentiv Health Clinical August 2015 - Present
PAREXEL January 2015 - August 2015
PAREXEL May 2013 - December 2014
PAREXEL November 2011 - April 2013
PAREXEL July 2010 - October 2011
Premier Research Group December 2008 - July 2010
PPD February 2005 - December 2008
HealthPartners Research Foundation March 1999 - September 2004
GreenTree Financial November 1997 - February 1999
MarketResponse Intl July 1996 - October 1997
Skills
Clinical Trials, CDISC, CRO, SAS, Clinical Research, FDA, EDC, Clinical Data Management, Medical Devices, Sop, Clinical Development, ICH-GCP, Oracle Clinical, Biotechnology, Regulatory Affairs, CTMS, GCP, 21 CFR Part 11, Data Management, Project Management
Education
University of Minnesota-Twin Cities
Bachelor of Science, Economics with Math Emphasis
Diane Black Diane Black's PAREXEL Experience November 2012 - Present
Job Project Specialist at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL November 2012 - Present
PAREXEL April 2010 - November 2012
PAREXEL January 1998 - April 2010
Skills
EDC, Clinical Data Management, CRO, CTMS, ICH-GCP, GCP, Clinical Trials, Pharmaceutical Industry, Protocol, Inform, Oracle Clinical, Budgets, Therapeutic Areas, Process Improvement
Education
University of North Carolina at Chapel Hill 1985 — 1990
PAREXEL November 2012 - Present
PAREXEL April 2010 - November 2012
PAREXEL January 1998 - April 2010
Skills
EDC, Clinical Data Management, CRO, CTMS, ICH-GCP, GCP, Clinical Trials, Pharmaceutical Industry, Protocol, Inform, Oracle Clinical, Budgets, Therapeutic Areas, Process Improvement
Education
University of North Carolina at Chapel Hill 1985 — 1990
Kaitlin Bournival Kaitlin Bournival's PAREXEL Experience November 2008 - January 2012
Job Customer Account Executive Premier Care at Comcast Cable
Industry Telecommunications
Experience
Comcast Cable November 2013 - Present
Comcast Business Class July 2012 - November 2013
PAREXEL November 2008 - January 2012
PAREXEL International June 2007 - November 2008
Workout Club & Wellness Center May 2004 - June 2007
Skills
Microsoft Office, Customer Service, Outlook, PowerPoint, Microsoft Excel, Customer Satisfaction, Microsoft Word, Call Center, Windows 7, Sales
Education
University of New Hampshire 2002 — 2006
B.A, Communications
University of New Hampshire-Manchester 2002 — 2006
Commuinications, Media and Communications
Comcast Cable November 2013 - Present
Comcast Business Class July 2012 - November 2013
PAREXEL November 2008 - January 2012
PAREXEL International June 2007 - November 2008
Workout Club & Wellness Center May 2004 - June 2007
Skills
Microsoft Office, Customer Service, Outlook, PowerPoint, Microsoft Excel, Customer Satisfaction, Microsoft Word, Call Center, Windows 7, Sales
Education
University of New Hampshire 2002 — 2006
B.A, Communications
University of New Hampshire-Manchester 2002 — 2006
Commuinications, Media and Communications
Greg Dombal Greg Dombal's PAREXEL Experience October 2003 - April 2004
Job Chief Operating Officer at Halloran Consulting Group, Inc.
Industry Biotechnology
Experience
Halloran Consulting Group, Inc. January 2008 - Present
Halloran Consulting Group January 2008 - November 2012
ArQule April 2004 - December 2007
Parexel October 2003 - April 2004
Antigenics January 2001 - October 2003
Genzyme January 1999 - January 2001
DepoTech July 1995 - December 1998
Burroughs Wellcome May 1994 - July 1995
Skills
Biotechnology, Clinical Development, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, Oncology, Lifesciences, FDA, Drug Development, Clinical Research, CRO, Medical Devices, Clinical Operations, Commercialization, GCP, GMP, CTMS, Biopharmaceuticals, Sop, Regulatory Submissions, EDC, Validation, Drug Discovery, Infectious Diseases, 21 CFR Part 11, CAPA, Medical Writing, Quality System, Vaccines, Technology Transfer, R&D, Protocol, Data Management, Pharmacovigilance, ICH-GCP, Clinical Monitoring, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor of Science, Biology
Halloran Consulting Group, Inc. January 2008 - Present
Halloran Consulting Group January 2008 - November 2012
ArQule April 2004 - December 2007
Parexel October 2003 - April 2004
Antigenics January 2001 - October 2003
Genzyme January 1999 - January 2001
DepoTech July 1995 - December 1998
Burroughs Wellcome May 1994 - July 1995
Skills
Biotechnology, Clinical Development, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, Oncology, Lifesciences, FDA, Drug Development, Clinical Research, CRO, Medical Devices, Clinical Operations, Commercialization, GCP, GMP, CTMS, Biopharmaceuticals, Sop, Regulatory Submissions, EDC, Validation, Drug Discovery, Infectious Diseases, 21 CFR Part 11, CAPA, Medical Writing, Quality System, Vaccines, Technology Transfer, R&D, Protocol, Data Management, Pharmacovigilance, ICH-GCP, Clinical Monitoring, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill 1990 — 1994
Bachelor of Science, Biology
Donna Backshall Donna Backshall's PAREXEL Experience March 2015 - Present
Job
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline October 2006 - February 2015
GlaxoSmithKline March 2002 - September 2006
Skills
Bioinformatics, Drug Discovery, Genetics, Biotechnology, Lifesciences, Drug Development, Genomics, Pharmaceutical Industry, Biomarkers, Life Sciences, Pharmacogenomics, Informatics, Oracle Database..., Data Management, Clinical Data Management, Personalized Medicine, Clinical Trials, Data Mining, Corporate Training, Technical Writing, Microsoft Excel, Data Sciences, Communications, Clinical Research
Education
University of North Carolina at Chapel Hill 1982 — 1986
Wake Technical Community College 2004 — 2004
Certification, High Performance Computing: Bioinformatics
PAREXEL March 2015 - Present
GlaxoSmithKline October 2006 - February 2015
GlaxoSmithKline March 2002 - September 2006
Skills
Bioinformatics, Drug Discovery, Genetics, Biotechnology, Lifesciences, Drug Development, Genomics, Pharmaceutical Industry, Biomarkers, Life Sciences, Pharmacogenomics, Informatics, Oracle Database..., Data Management, Clinical Data Management, Personalized Medicine, Clinical Trials, Data Mining, Corporate Training, Technical Writing, Microsoft Excel, Data Sciences, Communications, Clinical Research
Education
University of North Carolina at Chapel Hill 1982 — 1986
Wake Technical Community College 2004 — 2004
Certification, High Performance Computing: Bioinformatics
Christine Gardner Christine Gardner's PAREXEL Experience September 2015 - Present
Job Senior Clinical Research Associate
Industry Pharmaceuticals
Experience
PAREXEL September 2015 - Present
Quintiles January 2009 - May 2015
Quintiles August 2007 - January 2009
Quintiles December 2006 - April 2007
Quintiles December 2004 - December 2006
Cliniforce June 2004 - December 2004
AAIPharma Services Corp. May 2003 - June 2004
CANCER CENTERS OF NORTH CAROLINA (AFFILIATE OF US ONCOLOGY) July 2002 - May 2003
Homemaker June 1996 - July 2002
BCBSNC February 1988 - May 1996
Skills
Clinical Monitoring, CTMS, GCP, ICH-GCP, CRO, Clinical Trials, EDC, Oncology, Clinical Development, Therapeutic Areas, Clinical Data Management, Clinical Research, Regulatory Submissions
Education
University of Tennessee-Knoxville 1980 — 1985
Bachelor's degree, Registered Nursing/Registered Nurse
University of North Carolina at Chapel Hill
RN Refresher Program - 2002
PAREXEL September 2015 - Present
Quintiles January 2009 - May 2015
Quintiles August 2007 - January 2009
Quintiles December 2006 - April 2007
Quintiles December 2004 - December 2006
Cliniforce June 2004 - December 2004
AAIPharma Services Corp. May 2003 - June 2004
CANCER CENTERS OF NORTH CAROLINA (AFFILIATE OF US ONCOLOGY) July 2002 - May 2003
Homemaker June 1996 - July 2002
BCBSNC February 1988 - May 1996
Skills
Clinical Monitoring, CTMS, GCP, ICH-GCP, CRO, Clinical Trials, EDC, Oncology, Clinical Development, Therapeutic Areas, Clinical Data Management, Clinical Research, Regulatory Submissions
Education
University of Tennessee-Knoxville 1980 — 1985
Bachelor's degree, Registered Nursing/Registered Nurse
University of North Carolina at Chapel Hill
RN Refresher Program - 2002
Jasper Harris, MHA Jasper Harris, MHA's PAREXEL Experience May 2003 - August 2003
Job Sr. Clinical Informatics Analyst at BCBSNC
Industry Pharmaceuticals
Experience
BCBSNC June 2013 - Present
PRA International August 2011 - May 2013
Blue Cross Blue Shield January 2004 - August 2011
University of North Carolina at Chapel Hill October 2003 - July 2004
University of North Carolina at Chapel Hill July 2001 - March 2004
PAREXEL May 2003 - August 2003
FRESHERS INC July 1999 - November 2001
University of North Carolina at Chapel Hill September 1999 - July 2001
University of North Carolina at Chapel Hill June 1998 - August 1998
Skills
SAS, Statistics, SQL, Clinical Trials, Data Mining, Crystal Ball, Crystal Reports, Business Objects, Public Speaking, Excel, PowerPoint, Teradata, Health Insurance, Healthcare, Pay for Performance, Program Evaluation, Data Analysis, Medical Home, Managed Care, R, HEDIS, Public Health, Analytics, Access, Biostatistics, Informatics, Clinical Research, Microsoft Excel
Education
University of North Carolina at Chapel Hill 2007 — 2010
MHA, Healthcare Administration
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Science, Public Health; Biostatistics, Minor: Information Systems and Library Science
BCBSNC June 2013 - Present
PRA International August 2011 - May 2013
Blue Cross Blue Shield January 2004 - August 2011
University of North Carolina at Chapel Hill October 2003 - July 2004
University of North Carolina at Chapel Hill July 2001 - March 2004
PAREXEL May 2003 - August 2003
FRESHERS INC July 1999 - November 2001
University of North Carolina at Chapel Hill September 1999 - July 2001
University of North Carolina at Chapel Hill June 1998 - August 1998
Skills
SAS, Statistics, SQL, Clinical Trials, Data Mining, Crystal Ball, Crystal Reports, Business Objects, Public Speaking, Excel, PowerPoint, Teradata, Health Insurance, Healthcare, Pay for Performance, Program Evaluation, Data Analysis, Medical Home, Managed Care, R, HEDIS, Public Health, Analytics, Access, Biostatistics, Informatics, Clinical Research, Microsoft Excel
Education
University of North Carolina at Chapel Hill 2007 — 2010
MHA, Healthcare Administration
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Science, Public Health; Biostatistics, Minor: Information Systems and Library Science
Frank Brusky Frank Brusky's PAREXEL Experience 2011 - Present
Job Principal Support Analyst
Industry Pharmaceuticals
Experience
PAREXEL 2011 - Present
PAREXEL 2006 - 2011
PAREXEL 2003 - 2006
PAREXEL 2001 - 2003
PAREXEL 1997 - 2001
Vanstar 1996 - 1997
Skills
IT Solutions, IT Strategy, IT Service Management, Enterprise Software, Project Management, Software Documentation, Process Improvement, ITIL, Microsoft Office, IT Infrastructure..., Technical Documentation, Pharmaceutical Industry, 21 CFR Part 11
Education
University of New Hampshire
Bachelor of Arts (B.A.), Political Science and Government
PAREXEL 2011 - Present
PAREXEL 2006 - 2011
PAREXEL 2003 - 2006
PAREXEL 2001 - 2003
PAREXEL 1997 - 2001
Vanstar 1996 - 1997
Skills
IT Solutions, IT Strategy, IT Service Management, Enterprise Software, Project Management, Software Documentation, Process Improvement, ITIL, Microsoft Office, IT Infrastructure..., Technical Documentation, Pharmaceutical Industry, 21 CFR Part 11
Education
University of New Hampshire
Bachelor of Arts (B.A.), Political Science and Government
Mark Stuntz Mark Stuntz's PAREXEL Experience August 2013 - May 2014
Job Senior Research Associate at Deerfield Management
Industry Market Research
Experience
Deerfield Management February 2015 - Present
GlobalData June 2014 - February 2015
PAREXEL August 2013 - May 2014
Yale School of Public Health August 2011 - June 2013
Battelle June 2009 - May 2011
GlaxoSmithKline January 2008 - May 2009
Skills
Epidemiology, Data Analysis, Public Health, Infectious Diseases, SAS, Statistics, Global Health, Qualitative Research, Biostatistics, Stata, Literature Reviews, Drug Discovery, SPSS, Program Evaluation, Report Writing, Technical Writing
Education
Yale School of Public Health 2011 — 2013
MPH, Epidemiology of Microbial Diseases
University of North Carolina at Chapel Hill 2002 — 2006
BA, Psychology
Deerfield Management February 2015 - Present
GlobalData June 2014 - February 2015
PAREXEL August 2013 - May 2014
Yale School of Public Health August 2011 - June 2013
Battelle June 2009 - May 2011
GlaxoSmithKline January 2008 - May 2009
Skills
Epidemiology, Data Analysis, Public Health, Infectious Diseases, SAS, Statistics, Global Health, Qualitative Research, Biostatistics, Stata, Literature Reviews, Drug Discovery, SPSS, Program Evaluation, Report Writing, Technical Writing
Education
Yale School of Public Health 2011 — 2013
MPH, Epidemiology of Microbial Diseases
University of North Carolina at Chapel Hill 2002 — 2006
BA, Psychology
Sally Choe's PAREXEL Experience June 2011 - Present
Job Senior Director at PAREXEL
Industry Pharmaceuticals
Margaret Hueckel's PAREXEL Experience May 2004 - December 2006
Job Clinical Data Manager at Worldwide Clinical Trials
Industry Pharmaceuticals
Experience
Worldwide Clinical Trials April 2014 - Present
Duke University August 1992 - Present
Ockham March 2013 - September 2013
Cmed Clinical Services November 2011 - March 2013
Premier Research Group August 2010 - April 2011
ICON July 2007 - March 2010
PPD January 2007 - June 2007
PAREXEL May 2004 - December 2006
PAREXEL August 2001 - May 2004
Duke Clinical Research Institute January 2000 - July 2001
Skills
CDISC, Oracle Clinical, Clinical Data Management, EDC, GCP, CRO, Medidata, CRF design, Clinical Trials, CTMS, ICH-GCP, Inform, Data Management, Lifesciences, Clinical Development, Pharmaceutical Industry, Oncology, Quality Assurance, 21 CFR Part 11, Clinical Research, Biostatistics, Medical Writing
Education
University of North Carolina at Chapel Hill
MSLS
University of Warsaw
MA, Literature
Worldwide Clinical Trials April 2014 - Present
Duke University August 1992 - Present
Ockham March 2013 - September 2013
Cmed Clinical Services November 2011 - March 2013
Premier Research Group August 2010 - April 2011
ICON July 2007 - March 2010
PPD January 2007 - June 2007
PAREXEL May 2004 - December 2006
PAREXEL August 2001 - May 2004
Duke Clinical Research Institute January 2000 - July 2001
Skills
CDISC, Oracle Clinical, Clinical Data Management, EDC, GCP, CRO, Medidata, CRF design, Clinical Trials, CTMS, ICH-GCP, Inform, Data Management, Lifesciences, Clinical Development, Pharmaceutical Industry, Oncology, Quality Assurance, 21 CFR Part 11, Clinical Research, Biostatistics, Medical Writing
Education
University of North Carolina at Chapel Hill
MSLS
University of Warsaw
MA, Literature
Mark Riggs's PAREXEL Experience March 2015 - Present
Job Clinical Monitoring Associate at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline October 2002 - February 2015
CompuChem Environmental Corp. 1994 - 1996
Education
University of North Carolina at Asheville
Bachelor’s Degree, German Language
University of Tennessee-Knoxville
Master’s Degree, German Language and Literature
PAREXEL March 2015 - Present
GlaxoSmithKline October 2002 - February 2015
CompuChem Environmental Corp. 1994 - 1996
Education
University of North Carolina at Asheville
Bachelor’s Degree, German Language
University of Tennessee-Knoxville
Master’s Degree, German Language and Literature
Malea Goodlow Wilson's PAREXEL Experience April 2010 - Present
Job Experienced Proposal Manager Clinical and Pharmaceutical Industries
Industry Pharmaceuticals
Experience
PAREXEL April 2010 - Present
Child Abuse Prevention Association July 2012 - September 2013
Omnicare Clinical Research January 2008 - April 2010
Aptuit June 2006 - December 2007
Aptuit October 2005 - June 2006
Quintiles December 2001 - September 2005
Quintiles January 2000 - December 2001
Hoechst Marion Roussel 1996 - 1997
Skills
Proposal Writing, CRO, Clinical Development, Clinical Trials, Strategy, Biotechnology, Budgets, CRM, Pricing, GCP, Pharmaceutical Industry, Management, Marketing, Oncology, Writing, Business Development, Cross-functional Team..., Proposal Management, Budgeting, Process Improvement, Sales, Product Development, Research, Selling, EDC, Salesforce.com, Microsoft Excel, Leadership, Training, Microsoft Office, Mentoring
Education
Walden University 2010 — 2013
Master of Science (M.S.), Mental Health Counseling
University of Missouri-Kansas City - Bloch School of Business 1998 — 2001
MBA coursework
University of Missouri-Columbia 1990 — 1994
Bachelor of Science, Journalism
PAREXEL April 2010 - Present
Child Abuse Prevention Association July 2012 - September 2013
Omnicare Clinical Research January 2008 - April 2010
Aptuit June 2006 - December 2007
Aptuit October 2005 - June 2006
Quintiles December 2001 - September 2005
Quintiles January 2000 - December 2001
Hoechst Marion Roussel 1996 - 1997
Skills
Proposal Writing, CRO, Clinical Development, Clinical Trials, Strategy, Biotechnology, Budgets, CRM, Pricing, GCP, Pharmaceutical Industry, Management, Marketing, Oncology, Writing, Business Development, Cross-functional Team..., Proposal Management, Budgeting, Process Improvement, Sales, Product Development, Research, Selling, EDC, Salesforce.com, Microsoft Excel, Leadership, Training, Microsoft Office, Mentoring
Education
Walden University 2010 — 2013
Master of Science (M.S.), Mental Health Counseling
University of Missouri-Kansas City - Bloch School of Business 1998 — 2001
MBA coursework
University of Missouri-Columbia 1990 — 1994
Bachelor of Science, Journalism
Linda Baher's PAREXEL Experience 1992 - 1996
Job Director, Clinical Operations at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics December 2012 - Present
Janssen Alzheimer Immunotherapy July 2011 - November 2012
Roche Pharmaceuticals March 2010 - May 2011
Roche Pharmaceuticals August 2008 - February 2010
Roche Pharmaceuticals April 2003 - August 2008
International AIDS Vaccine Initiative December 2002 - March 2003
MedImmune 1999 - 2002
Barnett Educational Services 1996 - 1999
PAREXEL 1992 - 1996
Peace Corps 1989 - 1992
Skills
Alzheimer's disease, Influenza, Hepatitis C, Clinical Trials, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Biotechnology, CTMS, Program Management, Project Management, Protocol Development, HIV, SOP Development, ICH-GCP, Medidata, MS Project, Protocol, GCP, 21 CFR Part 11, Regulatory Submissions, FDA, Clinical Study Design, Oncology, Clinical Monitoring, Sop, Diabetes, Biopharmaceuticals, Clinical Pharmacology, Drug Development, Cardiology, Cancer, IND, Therapeutic Areas, SOP
Education
University of Minnesota-Twin Cities
Bachelor of Science
Pharmacyclics December 2012 - Present
Janssen Alzheimer Immunotherapy July 2011 - November 2012
Roche Pharmaceuticals March 2010 - May 2011
Roche Pharmaceuticals August 2008 - February 2010
Roche Pharmaceuticals April 2003 - August 2008
International AIDS Vaccine Initiative December 2002 - March 2003
MedImmune 1999 - 2002
Barnett Educational Services 1996 - 1999
PAREXEL 1992 - 1996
Peace Corps 1989 - 1992
Skills
Alzheimer's disease, Influenza, Hepatitis C, Clinical Trials, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Clinical Development, Biotechnology, CTMS, Program Management, Project Management, Protocol Development, HIV, SOP Development, ICH-GCP, Medidata, MS Project, Protocol, GCP, 21 CFR Part 11, Regulatory Submissions, FDA, Clinical Study Design, Oncology, Clinical Monitoring, Sop, Diabetes, Biopharmaceuticals, Clinical Pharmacology, Drug Development, Cardiology, Cancer, IND, Therapeutic Areas, SOP
Education
University of Minnesota-Twin Cities
Bachelor of Science
Heidi Warren's PAREXEL Experience 1997 - 2000
Job Clinical Research Administration
Industry Research
Experience
KUMC Research Institute, Inc. August 2010 - October 2013
KUMC Research Institute, Inc. May 2008 - August 2010
Quintiles February 2007 - May 2008
KUMC Research Institute, Inc. November 2000 - May 2005
Chicago Institute of Neurosurgery and Neuroresearch 2000 - 2000
PAREXEL 1997 - 2000
Skills
Project Management, ICH-GCP, Clinical Trials, Budgets, Data Management, Process Improvement, Clinical Research, Research Administration, CRF design, Time Management, EDC
Education
University of Nebraska Medical Center 1990 — 1995
Bachelor of Science - Nursing
KUMC Research Institute, Inc. August 2010 - October 2013
KUMC Research Institute, Inc. May 2008 - August 2010
Quintiles February 2007 - May 2008
KUMC Research Institute, Inc. November 2000 - May 2005
Chicago Institute of Neurosurgery and Neuroresearch 2000 - 2000
PAREXEL 1997 - 2000
Skills
Project Management, ICH-GCP, Clinical Trials, Budgets, Data Management, Process Improvement, Clinical Research, Research Administration, CRF design, Time Management, EDC
Education
University of Nebraska Medical Center 1990 — 1995
Bachelor of Science - Nursing
Anita Shanker's PAREXEL Experience February 1997 - August 1997
Job Statistician
Industry Pharmaceuticals
Experience
Health Decisions August 2004 - Present
University of North Carolina at Chapel Hill September 1999 - January 2000
Collaborative Studies Coordinating Center September 1998 - August 1999
PPD May 1998 - August 1998
PAREXEL February 1997 - August 1997
ClinTrials Research August 1996 - January 1997
Skills
Clinical Trials, SAS, Biostatistics, CRO, Statistics, SQL, Data Analysis, CDISC
Education
University of North Carolina at Chapel Hill 1992 — 1996
Bachelor's of Science in Public Health, Biotstatistics
Health Decisions August 2004 - Present
University of North Carolina at Chapel Hill September 1999 - January 2000
Collaborative Studies Coordinating Center September 1998 - August 1999
PPD May 1998 - August 1998
PAREXEL February 1997 - August 1997
ClinTrials Research August 1996 - January 1997
Skills
Clinical Trials, SAS, Biostatistics, CRO, Statistics, SQL, Data Analysis, CDISC
Education
University of North Carolina at Chapel Hill 1992 — 1996
Bachelor's of Science in Public Health, Biotstatistics
Cheryl Ford's PAREXEL Experience 2014 - 2014
Job Owner Ford Documentation Services, LLC
Industry Pharmaceuticals
Experience
Agilent Technologies, Inc. NASD Division February 2015 - Present
Ford Documentation Svcs. March 1998 - Present
Hospira Boulder 2009 - February 2014
Parexel 2014 - 2014
Biomet 2014 - 2014
Agilent Technologies Boulder July 2011 - December 2013
Amgen 2002 - 2004
NaPro 2000 - 2001
Array BioPharma 2000 - 2001
Roche Pharmaceuticals 1994 - 1998
Skills
Technical Writing, Validation, Pharmaceutical Industry, GMP, Quality System, Change Control, FDA, Project Management, Manufacturing, Sop, Biotechnology, 21 CFR Part 11, Computer System..., CAPA, Cross-functional Team..., SOP, Process Simulation
Education
University of New Hampshire 1986 — 1990
Bachelor of Arts (BA), English Language and Literature, General
Agilent Technologies, Inc. NASD Division February 2015 - Present
Ford Documentation Svcs. March 1998 - Present
Hospira Boulder 2009 - February 2014
Parexel 2014 - 2014
Biomet 2014 - 2014
Agilent Technologies Boulder July 2011 - December 2013
Amgen 2002 - 2004
NaPro 2000 - 2001
Array BioPharma 2000 - 2001
Roche Pharmaceuticals 1994 - 1998
Skills
Technical Writing, Validation, Pharmaceutical Industry, GMP, Quality System, Change Control, FDA, Project Management, Manufacturing, Sop, Biotechnology, 21 CFR Part 11, Computer System..., CAPA, Cross-functional Team..., SOP, Process Simulation
Education
University of New Hampshire 1986 — 1990
Bachelor of Arts (BA), English Language and Literature, General
Adam Morgan's PAREXEL Experience 1994 - 1998
Job Director Data Management at ACADIA Pharmaceuticals
Industry Biotechnology
Experience
ACADIA Pharmaceuticals September 2013 - Present
Ardea Biosciences August 2012 - Present
Ardea Biosciences December 2011 - August 2012
Spectrum Pharmaceuticals January 2009 - February 2010
Favrille Inc. September 2006 - June 2008
Elan Pharmaceuticals 2005 - 2006
La Jolla Pharmaceutical Company October 2002 - March 2005
Advanced Tissue Sciences June 1999 - October 2002
Idec Pharmaceuticals April 1998 - June 1999
Parexel 1994 - 1998
Skills
FDA, CRO, EDC, Software Documentation, Validation, Oncology, Sop, GCP, SOP, Biotechnology
Education
University of New Hampshire 1988 — 1992
BA, Zoology/PreMed
ACADIA Pharmaceuticals September 2013 - Present
Ardea Biosciences August 2012 - Present
Ardea Biosciences December 2011 - August 2012
Spectrum Pharmaceuticals January 2009 - February 2010
Favrille Inc. September 2006 - June 2008
Elan Pharmaceuticals 2005 - 2006
La Jolla Pharmaceutical Company October 2002 - March 2005
Advanced Tissue Sciences June 1999 - October 2002
Idec Pharmaceuticals April 1998 - June 1999
Parexel 1994 - 1998
Skills
FDA, CRO, EDC, Software Documentation, Validation, Oncology, Sop, GCP, SOP, Biotechnology
Education
University of New Hampshire 1988 — 1992
BA, Zoology/PreMed
Jeff Sigman's PAREXEL Experience 1997 - 1998
Job Executive Director, Global Medical Affairs Operations at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics August 2013 - Present
United Therapeutics January 2013 - July 2013
United Therapeutics April 1998 - December 2012
PAREXEL 1997 - 1998
University of North Carolina at Chapel Hill 1986 - 1996
Orange County Emergency Medical Services 1986 - 1996
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Clinical Study Design, Drug Development, Biotechnology, Medical Affairs, Clinical Research, CRO, Clinical Operations, GCP, Oncology
Education
University of North Carolina at Chapel Hill
BA, Chemistry
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
Executive Development Institute
United Therapeutics August 2013 - Present
United Therapeutics January 2013 - July 2013
United Therapeutics April 1998 - December 2012
PAREXEL 1997 - 1998
University of North Carolina at Chapel Hill 1986 - 1996
Orange County Emergency Medical Services 1986 - 1996
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, Clinical Study Design, Drug Development, Biotechnology, Medical Affairs, Clinical Research, CRO, Clinical Operations, GCP, Oncology
Education
University of North Carolina at Chapel Hill
BA, Chemistry
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
Executive Development Institute
Lisa Hatch's PAREXEL Experience September 1991 - September 1998
Job Project Leader at Duke Clinical Research Institute
Industry Pharmaceuticals
Experience
Duke Clinical Research Institute January 2010 - May 2015
Novella Clinical October 2007 - October 2009
Sanofi-Aventis January 2006 - April 2007
PRA International January 2005 - November 2005
Pfizer Global R & D August 2001 - June 2004
The Woolf Group October 1998 - March 2001
Parexel September 1991 - September 1998
ICI Pharmaceuticals January 1985 - September 1991
Skills
Clinical Trials, Clinical Research, Oncology, Pharmaceuticals, Clinical, Clinical Monitoring, Clinical Development, CRO, GCP, Clinical Trial..., Phase I, EDC, Infectious Diseases, SOP, ICH-GCP, Clinical Data Management, Therapeutic Areas, Drug Development, Biotechnology, Regulatory Submissions, FDA, Data Management, Regulatory Affairs
Education
University of Michigan 1980 — 1982
MPH, Epidemiology
Virginia Polytechnic Institute and State University 1976 — 1980
BS, Biology
Duke Clinical Research Institute January 2010 - May 2015
Novella Clinical October 2007 - October 2009
Sanofi-Aventis January 2006 - April 2007
PRA International January 2005 - November 2005
Pfizer Global R & D August 2001 - June 2004
The Woolf Group October 1998 - March 2001
Parexel September 1991 - September 1998
ICI Pharmaceuticals January 1985 - September 1991
Skills
Clinical Trials, Clinical Research, Oncology, Pharmaceuticals, Clinical, Clinical Monitoring, Clinical Development, CRO, GCP, Clinical Trial..., Phase I, EDC, Infectious Diseases, SOP, ICH-GCP, Clinical Data Management, Therapeutic Areas, Drug Development, Biotechnology, Regulatory Submissions, FDA, Data Management, Regulatory Affairs
Education
University of Michigan 1980 — 1982
MPH, Epidemiology
Virginia Polytechnic Institute and State University 1976 — 1980
BS, Biology
Anita Nelsen's PAREXEL Experience March 2015 - Present
Job Director, Clinical Research Services
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GSK April 2014 - February 2015
GSK June 2011 - April 2014
GlaxoSmithKline October 2009 - May 2011
GlaxoSmithKline July 2008 - October 2009
GSK April 2004 - July 2008
GSK May 2002 - April 2004
GSK May 2001 - May 2002
GlaxoWellcome April 1997 - May 2001
Glaxo Wellcome December 1995 - April 1997
Skills
Lifesciences, Clinical Development, Drug Discovery, Pharmaceutical Industry, Clinical Research, Biotechnology, Drug Development, Strategy, Clinical Trials, Informatics, Life Sciences, CRO, CTMS, Oncology, Infectious Diseases, GCP, Genetics, Genomics, DNA, Biomarkers
Education
University of North Carolina at Chapel Hill 1984 — 1988
Biology
PAREXEL March 2015 - Present
GSK April 2014 - February 2015
GSK June 2011 - April 2014
GlaxoSmithKline October 2009 - May 2011
GlaxoSmithKline July 2008 - October 2009
GSK April 2004 - July 2008
GSK May 2002 - April 2004
GSK May 2001 - May 2002
GlaxoWellcome April 1997 - May 2001
Glaxo Wellcome December 1995 - April 1997
Skills
Lifesciences, Clinical Development, Drug Discovery, Pharmaceutical Industry, Clinical Research, Biotechnology, Drug Development, Strategy, Clinical Trials, Informatics, Life Sciences, CRO, CTMS, Oncology, Infectious Diseases, GCP, Genetics, Genomics, DNA, Biomarkers
Education
University of North Carolina at Chapel Hill 1984 — 1988
Biology
Laura Coker, CCRP's PAREXEL Experience March 2015 - Present
Job Clinical Monitoring Associate at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
Carolinas Healthcare System-Levine Cancer Institute January 2012 - February 2015
UAB Hospital January 2011 - January 2012
Carolinas Healthcare System/Blumenthal Cancer Center May 2008 - January 2011
Carolinas Healthcare System/Blumenthal Cancer Center August 2006 - May 2008
Skills
Clinical Research, Public Health, Clinical Trials, Healthcare, Phase I, Oncology Clinical..., Gynecologic Oncology, Pediatric..., Regulatory Affairs, Regulatory Requirements, TAO, Electronic Data..., ICH-GCP, Quality Assurance, Cancer Research, Medical Terminology, Process Improvement, Regulatory Submissions, EMR, EDC, CTMS, CRO, Clinical Monitoring, Oncology, Management, Hospitals, Pharmaceutical Industry
Education
University of North Carolina at Charlotte
Bachelor's Degree, Biology/Biological Sciences, General
PAREXEL March 2015 - Present
Carolinas Healthcare System-Levine Cancer Institute January 2012 - February 2015
UAB Hospital January 2011 - January 2012
Carolinas Healthcare System/Blumenthal Cancer Center May 2008 - January 2011
Carolinas Healthcare System/Blumenthal Cancer Center August 2006 - May 2008
Skills
Clinical Research, Public Health, Clinical Trials, Healthcare, Phase I, Oncology Clinical..., Gynecologic Oncology, Pediatric..., Regulatory Affairs, Regulatory Requirements, TAO, Electronic Data..., ICH-GCP, Quality Assurance, Cancer Research, Medical Terminology, Process Improvement, Regulatory Submissions, EMR, EDC, CTMS, CRO, Clinical Monitoring, Oncology, Management, Hospitals, Pharmaceutical Industry
Education
University of North Carolina at Charlotte
Bachelor's Degree, Biology/Biological Sciences, General
Lorien Armour's PAREXEL Experience 2005 - 2005
Job CMC Regulatory Consultant
Industry Pharmaceuticals
Experience
Armour CMC Regulatory Consulting, LLC July 2005 - Present
InsideOut Body Therapies May 2010 - Present
GlaxoSmithKline November 1998 - January 2005
PAREXEL 2005 - 2005
ALZA Corporation 1995 - 1998
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Interactions, Regulatory Submissions, FDA, Quality Assurance, Training, Clinical Development, Drug Development, GMP, Drug Discovery, Technology Transfer, Sop, Change Control, Clinical Trials, Biopharmaceuticals
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science (B.S.)
Armour CMC Regulatory Consulting, LLC July 2005 - Present
InsideOut Body Therapies May 2010 - Present
GlaxoSmithKline November 1998 - January 2005
PAREXEL 2005 - 2005
ALZA Corporation 1995 - 1998
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Interactions, Regulatory Submissions, FDA, Quality Assurance, Training, Clinical Development, Drug Development, GMP, Drug Discovery, Technology Transfer, Sop, Change Control, Clinical Trials, Biopharmaceuticals
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Science (B.S.)
Jennifer Minai's PAREXEL Experience August 2011 - August 2013
Job at
Industry Accounting
Experience
Atterocor, Inc. July 2014 - Present
Atterocor, Inc. August 2013 - July 2014
PAREXEL August 2011 - August 2013
Ernst & Young October 2000 - August 2011
Skills
Sarbanes-Oxley Act, SEC filings, Internal Controls, Auditing, Financial Reporting, Revenue Recognition, GAAP, External Audit, Assurance, Accounting, Sarbanes-Oxley
Education
University of Michigan - Stephen M. Ross School of Business 1999 — 2000
Master of Accounting, Accounting
University of Michigan - Stephen M. Ross School of Business 1997 — 1999
Bachelor of Business Administration (BBA), Finance and Accounting
Atterocor, Inc. July 2014 - Present
Atterocor, Inc. August 2013 - July 2014
PAREXEL August 2011 - August 2013
Ernst & Young October 2000 - August 2011
Skills
Sarbanes-Oxley Act, SEC filings, Internal Controls, Auditing, Financial Reporting, Revenue Recognition, GAAP, External Audit, Assurance, Accounting, Sarbanes-Oxley
Education
University of Michigan - Stephen M. Ross School of Business 1999 — 2000
Master of Accounting, Accounting
University of Michigan - Stephen M. Ross School of Business 1997 — 1999
Bachelor of Business Administration (BBA), Finance and Accounting
Hani Alkhaldi's PAREXEL Experience November 2014 - Present
Job Site Intelligence Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL November 2014 - Present
PAREXEL November 2011 - November 2014
Dell Sports Inc May 2006 - May 2011
Education
University of North Carolina at Chapel Hill 1997 — 2002
BS, Computer Science
PAREXEL November 2014 - Present
PAREXEL November 2011 - November 2014
Dell Sports Inc May 2006 - May 2011
Education
University of North Carolina at Chapel Hill 1997 — 2002
BS, Computer Science
Justin Pennington, RAC's PAREXEL Experience September 2011 - March 2014
Job Regulatory and Quality Assurance Professional
Industry Pharmaceuticals
Experience
Pennington Pharmaceutical Services LLC May 2010 - Present
Quintiles October 2014 - Present
PharMed Management Group June 2014 - Present
Advanced Biomedical Consulting (ABC), LLC September 2011 - Present
PAREXEL September 2011 - March 2014
DDN Pharmaceutical Logistics January 2008 - April 2010
Cypress Pharmaceutical, Inc. August 2006 - December 2007
Hawthorn Pharmaceuticals, Inc. August 2006 - December 2007
Eurofins Scientific June 2005 - July 2006
Skills
GMP, Quality Assurance, Regulatory Submissions, Sop, Pharmaceutical Industry, Quality System, Biopharmaceuticals, FDA, CAPA, Regulatory Affairs, Pharmaceutics, Quality Control, Lifesciences, Commercialization, Regulatory Requirements, Medical Devices, GxP, Biotechnology, Strategy
Education
University of Mississippi 2000 — 2005
Bachelor of Arts (B.A.), Biochemistry
University of Mississippi 2000 — 2005
Bachelor of Arts (B.A.), Psychology
Pennington Pharmaceutical Services LLC May 2010 - Present
Quintiles October 2014 - Present
PharMed Management Group June 2014 - Present
Advanced Biomedical Consulting (ABC), LLC September 2011 - Present
PAREXEL September 2011 - March 2014
DDN Pharmaceutical Logistics January 2008 - April 2010
Cypress Pharmaceutical, Inc. August 2006 - December 2007
Hawthorn Pharmaceuticals, Inc. August 2006 - December 2007
Eurofins Scientific June 2005 - July 2006
Skills
GMP, Quality Assurance, Regulatory Submissions, Sop, Pharmaceutical Industry, Quality System, Biopharmaceuticals, FDA, CAPA, Regulatory Affairs, Pharmaceutics, Quality Control, Lifesciences, Commercialization, Regulatory Requirements, Medical Devices, GxP, Biotechnology, Strategy
Education
University of Mississippi 2000 — 2005
Bachelor of Arts (B.A.), Biochemistry
University of Mississippi 2000 — 2005
Bachelor of Arts (B.A.), Psychology
Elizabeth (Sneade) Rouse's PAREXEL Experience Senior Clinical Data AssociateKendle InternationalOctober 2004 - April 2011
Job Senior Clinical Data Analyst at Parexel
Industry Pharmaceuticals
Experience
PAREXEL Senior Clinical Data AssociateKendle InternationalOctober 2004 - April 2011
Kendle International October 2004 - September 2008
GlaxoSmithKline September 2002 - September 2008
LabCorp May 2001 - September 2002
Duke University Hospital August 2000 - May 2001
Skills
Clinical Research, Clinical Trials, Molecular Biology, Medicine, CRO, GCP, Clinical Data Management, EDC, Life Sciences, Biotechnology
Education
University of North Carolina at Chapel Hill 1999 — 2001
clinical laboratory science, Clinical Laboratory Science/Medical Technology/Technologist
Durham Technical Community College
Certificate, Clinical Data Management
Wake Technical Community College
A.S., Associate of Science
PAREXEL Senior Clinical Data AssociateKendle InternationalOctober 2004 - April 2011
Kendle International October 2004 - September 2008
GlaxoSmithKline September 2002 - September 2008
LabCorp May 2001 - September 2002
Duke University Hospital August 2000 - May 2001
Skills
Clinical Research, Clinical Trials, Molecular Biology, Medicine, CRO, GCP, Clinical Data Management, EDC, Life Sciences, Biotechnology
Education
University of North Carolina at Chapel Hill 1999 — 2001
clinical laboratory science, Clinical Laboratory Science/Medical Technology/Technologist
Durham Technical Community College
Certificate, Clinical Data Management
Wake Technical Community College
A.S., Associate of Science
Valerie Murray's PAREXEL Experience 1998 - 1999
Job Director at Quintiles
Industry Pharmaceuticals
Experience
Quintiles September 2002 - Present
Cromedica 1999 - 2002
Parexel 1998 - 1999
Chrysalis 1997 - 1998
Emory Alzheimers Disease Center 1992 - 1995
Emory University Hospital 1991 - 1995
Skills
CRO, Clinical Development, Training, Clinical Trials, Pharmaceutical Industry, GCP, EDC, ICH-GCP, Clinical Monitoring, Oncology, Regulatory Submissions
Education
University of North Carolina at Chapel Hill
Quintiles September 2002 - Present
Cromedica 1999 - 2002
Parexel 1998 - 1999
Chrysalis 1997 - 1998
Emory Alzheimers Disease Center 1992 - 1995
Emory University Hospital 1991 - 1995
Skills
CRO, Clinical Development, Training, Clinical Trials, Pharmaceutical Industry, GCP, EDC, ICH-GCP, Clinical Monitoring, Oncology, Regulatory Submissions
Education
University of North Carolina at Chapel Hill
Elizabeth Moore's PAREXEL Experience 1996 - 1999
Job Senior Director, Clinical Operations
Industry Pharmaceuticals
Experience
United Therapeutics September 2010 - 2015
Icagen, Inc July 2005 - September 2010
PharmaNet 2001 - 2005
Quintiles 1999 - 2001
PAREXEL 1996 - 1999
Burroughs Welcome Company 1986 - 1996
Burroughs Wellcome Co. 1986 - 1996
Skills
Clinical Trials, Clinical Development, Clinical Trial..., CRO, GCP, Pharmaceuticals, Clinical Monitoring, Regulatory Affairs, Protocol Development, Medical Writing, Neurology, Regulatory Submissions, Vendor Management, Hematology, Program Management, Make Things Happen, Clinical Research, Pharmaceutical Industry, CTMS, ICH-GCP, Protocol, Training, Team Building, Team Leadership, Cross-functional Team..., Process Improvement, EDC, Biotechnology, Global Management, Oncology, Clinical Operations, Pain Management
Education
NCSU 1980 — 1982
MS, Zoology
University of North Carolina at Chapel Hill 1975 — 1979
BS, Zoology
United Therapeutics September 2010 - 2015
Icagen, Inc July 2005 - September 2010
PharmaNet 2001 - 2005
Quintiles 1999 - 2001
PAREXEL 1996 - 1999
Burroughs Welcome Company 1986 - 1996
Burroughs Wellcome Co. 1986 - 1996
Skills
Clinical Trials, Clinical Development, Clinical Trial..., CRO, GCP, Pharmaceuticals, Clinical Monitoring, Regulatory Affairs, Protocol Development, Medical Writing, Neurology, Regulatory Submissions, Vendor Management, Hematology, Program Management, Make Things Happen, Clinical Research, Pharmaceutical Industry, CTMS, ICH-GCP, Protocol, Training, Team Building, Team Leadership, Cross-functional Team..., Process Improvement, EDC, Biotechnology, Global Management, Oncology, Clinical Operations, Pain Management
Education
NCSU 1980 — 1982
MS, Zoology
University of North Carolina at Chapel Hill 1975 — 1979
BS, Zoology
Sheryl Georgoulias's PAREXEL Experience August 2014 - Present
Job Associate Manager, Clinical Operations Leaders at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL August 2014 - Present
PAREXEL March 2012 - Present
PharmaNet/i3 March 2007 - March 2012
Rho, Inc. 2003 - 2007
Skills
Clinical Trials, Sop, Clinical Monitoring, EDC, Clinical Research, Protocol, Oncology, Clinical Development, Pharmaceutical Industry, CRO, CTMS, GCP, ICH-GCP, SOP, Clinical Data Management, Therapeutic Areas
Education
University of North Carolina at Chapel Hill 1998 — 2003
B.S., Biology, Psychology
PAREXEL August 2014 - Present
PAREXEL March 2012 - Present
PharmaNet/i3 March 2007 - March 2012
Rho, Inc. 2003 - 2007
Skills
Clinical Trials, Sop, Clinical Monitoring, EDC, Clinical Research, Protocol, Oncology, Clinical Development, Pharmaceutical Industry, CRO, CTMS, GCP, ICH-GCP, SOP, Clinical Data Management, Therapeutic Areas
Education
University of North Carolina at Chapel Hill 1998 — 2003
B.S., Biology, Psychology
Amy Cutrell's PAREXEL Experience March 2015 - September 2015
Job Director Statistics at ViiV Healthcare
Industry Pharmaceuticals
Experience
ViiV Healthcare September 2015 - Present
PAREXEL March 2015 - September 2015
GSK 1988 - March 2015
Skills
Clinical Development, Clinical Research, Biostatistics, GCP, Clinical Trials, Oncology, Medical Writing, Medical Affairs, Drug Development, Infectious Diseases, CRO, Pharmaceutical Industry, Therapeutic Areas, Pharmacology, Biotechnology, CTMS
Education
University of North Carolina at Chapel Hill 1987 — 1989
MS, Biostatistics
Chapel Hill
ViiV Healthcare September 2015 - Present
PAREXEL March 2015 - September 2015
GSK 1988 - March 2015
Skills
Clinical Development, Clinical Research, Biostatistics, GCP, Clinical Trials, Oncology, Medical Writing, Medical Affairs, Drug Development, Infectious Diseases, CRO, Pharmaceutical Industry, Therapeutic Areas, Pharmacology, Biotechnology, CTMS
Education
University of North Carolina at Chapel Hill 1987 — 1989
MS, Biostatistics
Chapel Hill
Martin Tochacek's PAREXEL Experience September 2013 - Present
Job Senior Project Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL September 2013 - Present
PAREXEL November 2012 - September 2013
PAREXEL June 2010 - October 2012
Rho, Inc. January 2010 - March 2010
Duke University Medical Center July 2007 - December 2009
Duke University Medical Center February 2002 - June 2007
Skills
Rheumatology, Patient Recruitment, CRO, Clinical Trials, Molecular Biology, Clinical Development, Immunology, Clinical Project..., ICH-GCP, Oncology, Clinical Research
Education
University of Nebraska Medical Center 1996 — 2001
PhD, Biochemistry and Molecular Biology
University of St. Thomas 1991 — 1995
B.A, Biology
PAREXEL September 2013 - Present
PAREXEL November 2012 - September 2013
PAREXEL June 2010 - October 2012
Rho, Inc. January 2010 - March 2010
Duke University Medical Center July 2007 - December 2009
Duke University Medical Center February 2002 - June 2007
Skills
Rheumatology, Patient Recruitment, CRO, Clinical Trials, Molecular Biology, Clinical Development, Immunology, Clinical Project..., ICH-GCP, Oncology, Clinical Research
Education
University of Nebraska Medical Center 1996 — 2001
PhD, Biochemistry and Molecular Biology
University of St. Thomas 1991 — 1995
B.A, Biology
Jessica McClellan's PAREXEL Experience June 1999 - March 2001
Job Manager, Data Management at Novella Clinical
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. August 2008 - Present
Quintiles July 2006 - August 2008
Rho March 2001 - June 2006
PAREXEL June 1999 - March 2001
Skills
EDC, Clinical Data Management, CRO, CTMS, Oracle Clinical, GCP, ICH-GCP, CDISC, Clinical Monitoring, Medidata, SOP, CRF design, Inform, Therapeutic Areas, Clinical Trials, Clinical Development, Oncology
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor’s Degree, Biology
Novella Clinical, Inc. August 2008 - Present
Quintiles July 2006 - August 2008
Rho March 2001 - June 2006
PAREXEL June 1999 - March 2001
Skills
EDC, Clinical Data Management, CRO, CTMS, Oracle Clinical, GCP, ICH-GCP, CDISC, Clinical Monitoring, Medidata, SOP, CRF design, Inform, Therapeutic Areas, Clinical Trials, Clinical Development, Oncology
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelor’s Degree, Biology
Jason Tignor's PAREXEL Experience January 2015 - Present
Job Senior Clinical Data Analyst at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL January 2015 - Present
Ockham April 2014 - December 2014
PAREXEL May 2013 - April 2014
PRA International February 2013 - May 2013
PharmaNet/i3 May 2006 - February 2013
ClinForce 2002 - 2006
Skills
Oracle Clinical, MedDRA, Infectious Diseases, GCP, EDC, Data Management, CRO, ICH-GCP, Excel, SQL, Word, Microsoft Word, Clinical Data Management, CRF design, Microsoft Excel, Inform, CTMS, Medidata, Pharmaceutical Industry, Clinical Trials
Education
University of North Carolina at Chapel Hill 1991 — 1995
Exercise and Sports Science
PAREXEL January 2015 - Present
Ockham April 2014 - December 2014
PAREXEL May 2013 - April 2014
PRA International February 2013 - May 2013
PharmaNet/i3 May 2006 - February 2013
ClinForce 2002 - 2006
Skills
Oracle Clinical, MedDRA, Infectious Diseases, GCP, EDC, Data Management, CRO, ICH-GCP, Excel, SQL, Word, Microsoft Word, Clinical Data Management, CRF design, Microsoft Excel, Inform, CTMS, Medidata, Pharmaceutical Industry, Clinical Trials
Education
University of North Carolina at Chapel Hill 1991 — 1995
Exercise and Sports Science
Arlene Hughes's PAREXEL Experience March 2015 - Present
Job Senior Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GSK February 2010 - February 2015
GSK 1998 - February 2015
GSK 1991 - 1998
Skills
Pharmaceutical Industry, Project Management, Microsoft Office, Strategic Planning, Customer Service, Microsoft Excel, Cross-functional Team..., Strategy, Change Management, Marketing, Genetics
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (Ph.D.), Pharmacology
PAREXEL March 2015 - Present
GSK February 2010 - February 2015
GSK 1998 - February 2015
GSK 1991 - 1998
Skills
Pharmaceutical Industry, Project Management, Microsoft Office, Strategic Planning, Customer Service, Microsoft Excel, Cross-functional Team..., Strategy, Change Management, Marketing, Genetics
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (Ph.D.), Pharmacology
Valerie Welty's PAREXEL Experience March 2002 - December 2007
Job Senior Manager, Global Monitoring Operations at PAREXEL International
Industry Pharmaceuticals
Experience
PAREXEL International April 2012 - Present
PAREXEL International January 2008 - July 2010
PAREXEL March 2002 - December 2007
Skills
Clinical Monitoring, EDC, CTMS, CRO, ICH-GCP
Education
University of North Carolina at Chapel Hill 1990 — 1994
BSPH, Health Policy and Administration
PAREXEL International April 2012 - Present
PAREXEL International January 2008 - July 2010
PAREXEL March 2002 - December 2007
Skills
Clinical Monitoring, EDC, CTMS, CRO, ICH-GCP
Education
University of North Carolina at Chapel Hill 1990 — 1994
BSPH, Health Policy and Administration
Stephen Millikin's PAREXEL Experience October 1999 - June 2012
Job Retired at The Beach
Industry Wine and Spirits
Experience
The Beach June 2012 - Present
PAREXEL International October 1999 - June 2012
PAREXEL October 1999 - June 2012
Education
University of North Carolina at Chapel Hill
Bachelor of Science (BS), PharmD, Pharmacy
The Beach June 2012 - Present
PAREXEL International October 1999 - June 2012
PAREXEL October 1999 - June 2012
Education
University of North Carolina at Chapel Hill
Bachelor of Science (BS), PharmD, Pharmacy
Nichole McGhee's PAREXEL Experience February 2005 - October 2005
Job Clinical Team Leader at INC Research
Industry Pharmaceuticals
Experience
INC Research September 2012 - Present
Kforce Clinical Research, Inc. January 2011 - August 2012
Kforce Clinical Research, Inc. October 2005 - January 2011
PAREXEL February 2005 - October 2005
International Healthcare August 2004 - December 2004
PAREXEL November 1999 - August 2004
Education
University of North Carolina at Chapel Hill 1992 — 1996
BS, Biology
INC Research September 2012 - Present
Kforce Clinical Research, Inc. January 2011 - August 2012
Kforce Clinical Research, Inc. October 2005 - January 2011
PAREXEL February 2005 - October 2005
International Healthcare August 2004 - December 2004
PAREXEL November 1999 - August 2004
Education
University of North Carolina at Chapel Hill 1992 — 1996
BS, Biology
Bob Barrier's PAREXEL Experience July 2015 - Present
Job Principal Biostatistician at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2015 - Present
Quintiles August 2012 - June 2015
Novella Clinical, Inc. May 2011 - August 2012
Lilly Venture (i3 Statprobe) May 2007 - May 2011
PPD October 2005 - May 2007
Duke Comprehensive Cancer Center August 2002 - October 2005
Skills
Biostatistics, Clinical Trials, CRO, EDC, Clinical Development, CDISC, GCP, SAS programming, SAS, Oncology, CTMS, Statistical Programming, Clinical Study Design, ICH-GCP, Data Management, Infectious Diseases, Clinical Research, Pharmaceutical Industry, Medical Writing, Survival Analysis, SAS Programming
Education
University of North Carolina at Chapel Hill 2000 — 2002
M.S., Biostatistics
University of North Carolina at Chapel Hill 1991 — 1994
A.B. Ed., Mathematics Education/Mathematics
PAREXEL July 2015 - Present
Quintiles August 2012 - June 2015
Novella Clinical, Inc. May 2011 - August 2012
Lilly Venture (i3 Statprobe) May 2007 - May 2011
PPD October 2005 - May 2007
Duke Comprehensive Cancer Center August 2002 - October 2005
Skills
Biostatistics, Clinical Trials, CRO, EDC, Clinical Development, CDISC, GCP, SAS programming, SAS, Oncology, CTMS, Statistical Programming, Clinical Study Design, ICH-GCP, Data Management, Infectious Diseases, Clinical Research, Pharmaceutical Industry, Medical Writing, Survival Analysis, SAS Programming
Education
University of North Carolina at Chapel Hill 2000 — 2002
M.S., Biostatistics
University of North Carolina at Chapel Hill 1991 — 1994
A.B. Ed., Mathematics Education/Mathematics
Neil Fausz's PAREXEL Experience 2001 - 2004
Job Technology Leader/Strategic Planning/ Portfolio & Project Management/ Compliance & Validation Expert
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions June 2015 - Present
Actavis plc October 2014 - June 2015
Actavis, Inc. (Formerly Watson Pharmaceuticals Inc.) August 2011 - October 2014
Watson Pharmaceuticals March 2009 - August 2011
Andrx Pharmaceuticals May 2006 - March 2009
Washington Group International 2005 - 2006
PAREXEL 2001 - 2004
Arthur Andersen 1998 - 2001
Skills
Validation, Quality System, Computer System..., Project Management, Information Technology, Quality Management, Process Improvement, Pharmaceutical Industry, Medical Devices, Quality Assurance, Leadership, SDLC, R&D, Software Project..., Change Control, 21 CFR Part 11, FDA, Project Portfolio..., Software Quality..., Change Management, Program Management, Portfolio Management, Configuration Management, Vendor Management, Business Relationship..., Software Selection &..., Mergers, Divestitures,..., Budget Management, Technology Roadmapping, Strategic Planning, Quality Management..., Laboratory Systems, LIMS, Chromatography Data..., Cross-functional Team..., GMP, Management, SOP, Software Documentation, CAPA
Education
University of Missouri-Columbia, College of Business 1996 — 1998
BS, B&PA
University of Missouri-Columbia 1994 — 1998
BA, International Relations
Catalent Pharma Solutions June 2015 - Present
Actavis plc October 2014 - June 2015
Actavis, Inc. (Formerly Watson Pharmaceuticals Inc.) August 2011 - October 2014
Watson Pharmaceuticals March 2009 - August 2011
Andrx Pharmaceuticals May 2006 - March 2009
Washington Group International 2005 - 2006
PAREXEL 2001 - 2004
Arthur Andersen 1998 - 2001
Skills
Validation, Quality System, Computer System..., Project Management, Information Technology, Quality Management, Process Improvement, Pharmaceutical Industry, Medical Devices, Quality Assurance, Leadership, SDLC, R&D, Software Project..., Change Control, 21 CFR Part 11, FDA, Project Portfolio..., Software Quality..., Change Management, Program Management, Portfolio Management, Configuration Management, Vendor Management, Business Relationship..., Software Selection &..., Mergers, Divestitures,..., Budget Management, Technology Roadmapping, Strategic Planning, Quality Management..., Laboratory Systems, LIMS, Chromatography Data..., Cross-functional Team..., GMP, Management, SOP, Software Documentation, CAPA
Education
University of Missouri-Columbia, College of Business 1996 — 1998
BS, B&PA
University of Missouri-Columbia 1994 — 1998
BA, International Relations
Teena Cochran's PAREXEL Experience March 2015 - Present
Job Director, Global Operational Excellence at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline May 2013 - Present
NC PMI 2007 - October 2013
GlaxoSmithKline March 2011 - May 2013
GlaxoSmithKline February 2009 - March 2011
GlaxoSmithKline 1993 - 2009
Triangle Laboratories Inc. 1991 - 1993
Skills
Master Coach, Lean Six Sigma Black..., Project Management..., Negotiation, Change Management, Process Improvement, Strategic Planning, Business Analysis, Clinical Development, Six Sigma, PMP, Project Management, Business Process..., Clinical Trials, Cross-functional Team..., GCP, Program Management, Management Consulting, Software Documentation, Business Process, Management, Organizational..., Risk Management, Project Planning, FDA, Strategy, Validation, CRO, Pharmaceutical Industry, Vaccines
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 1990 — 1991
ExecMBA, Business Administration
Virginia Polytechnic Institute and State University 1973 — 1975
Masters, Biochemistry
Virginia Polytechnic Institute and State University 1971 — 1973
BS, Biochemistry
PAREXEL March 2015 - Present
GlaxoSmithKline May 2013 - Present
NC PMI 2007 - October 2013
GlaxoSmithKline March 2011 - May 2013
GlaxoSmithKline February 2009 - March 2011
GlaxoSmithKline 1993 - 2009
Triangle Laboratories Inc. 1991 - 1993
Skills
Master Coach, Lean Six Sigma Black..., Project Management..., Negotiation, Change Management, Process Improvement, Strategic Planning, Business Analysis, Clinical Development, Six Sigma, PMP, Project Management, Business Process..., Clinical Trials, Cross-functional Team..., GCP, Program Management, Management Consulting, Software Documentation, Business Process, Management, Organizational..., Risk Management, Project Planning, FDA, Strategy, Validation, CRO, Pharmaceutical Industry, Vaccines
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 1990 — 1991
ExecMBA, Business Administration
Virginia Polytechnic Institute and State University 1973 — 1975
Masters, Biochemistry
Virginia Polytechnic Institute and State University 1971 — 1973
BS, Biochemistry
Marcia Lund's PAREXEL Experience January 2003 - September 2009
Job Corporate Vice President, Global Clinical Research Services
Industry Pharmaceuticals
Experience
PAREXEL International Corporation October 2009 - Present
PAREXEL January 2003 - September 2009
PAREXEL October 1990 - December 2002
PAREXEL July 1986 - August 1990
SYNTEX Pharmaceuticals October 1978 - December 1985
Education
University of Michigan
Ph.D., Toxicology
PAREXEL International Corporation October 2009 - Present
PAREXEL January 2003 - September 2009
PAREXEL October 1990 - December 2002
PAREXEL July 1986 - August 1990
SYNTEX Pharmaceuticals October 1978 - December 1985
Education
University of Michigan
Ph.D., Toxicology
Kathi Irvin's PAREXEL Experience January 2015 - Present
Job Project Manager
Industry Pharmaceuticals
Experience
PAREXEL January 2015 - Present
ICON plc March 2014 - January 2015
UBC - An Express Scripts Company September 2013 - March 2014
Quintiles October 2012 - September 2013
Quintiles February 2005 - September 2012
INC Research March 2003 - February 2005
PRA International February 1999 - February 2003
Skills
CTMS, Clinical Monitoring, ICH-GCP, EDC, GCP, CRO, Clinical Trials, Therapeutic Areas, Clinical Development, Clinical Data Management, Inform, Oncology, Regulatory Submissions, Clinical Research, Pharmacovigilance, Protocol, Regulatory Affairs, Pharmaceutical Industry, Sop, Clinical Operations
Education
University of Missouri-Columbia 1990 — 1995
Bachelor-General Studies, Bio/Chem/Math
PAREXEL January 2015 - Present
ICON plc March 2014 - January 2015
UBC - An Express Scripts Company September 2013 - March 2014
Quintiles October 2012 - September 2013
Quintiles February 2005 - September 2012
INC Research March 2003 - February 2005
PRA International February 1999 - February 2003
Skills
CTMS, Clinical Monitoring, ICH-GCP, EDC, GCP, CRO, Clinical Trials, Therapeutic Areas, Clinical Development, Clinical Data Management, Inform, Oncology, Regulatory Submissions, Clinical Research, Pharmacovigilance, Protocol, Regulatory Affairs, Pharmaceutical Industry, Sop, Clinical Operations
Education
University of Missouri-Columbia 1990 — 1995
Bachelor-General Studies, Bio/Chem/Math
Kenita Mitchell's PAREXEL Experience 2011 - 2011
Job Exploring opportunities in Clinical Research or Business Management in RTP, NC or Hampton Roads, VA areas
Industry Pharmaceuticals
Experience
PAREXEL 2011 - 2011
Quintiles 2010 - 2010
Quintiles 2008 - 2010
AAi Pharma 2008 - 2008
INC Research 2007 - 2008
PPD 2005 - 2007
Skills
GCP, ICH-GCP, EDC
Education
Strayer University-Maryland 2004 — 2006
Masters, Business Administration
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Arts, Sociology
PAREXEL 2011 - 2011
Quintiles 2010 - 2010
Quintiles 2008 - 2010
AAi Pharma 2008 - 2008
INC Research 2007 - 2008
PPD 2005 - 2007
Skills
GCP, ICH-GCP, EDC
Education
Strayer University-Maryland 2004 — 2006
Masters, Business Administration
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Arts, Sociology
Katie Dorsey's PAREXEL Experience May 2012 - September 2013
Job Clinical Project Management Director at Quintiles
Industry Pharmaceuticals
Experience
Quintiles December 2014 - Present
Katie Dorsey Consulting February 2014 - December 2014
PAREXEL May 2012 - September 2013
Array BioPharma September 2008 - July 2011
GSK 2002 - 2008
Cato Research 1997 - 2002
Skills
Clinical Development, Clinical Research, Clinical Operations, GCP, CRO, Neuroscience, Clinical Trials, CTMS, Drug Development, Protocol, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelors
Quintiles December 2014 - Present
Katie Dorsey Consulting February 2014 - December 2014
PAREXEL May 2012 - September 2013
Array BioPharma September 2008 - July 2011
GSK 2002 - 2008
Cato Research 1997 - 2002
Skills
Clinical Development, Clinical Research, Clinical Operations, GCP, CRO, Neuroscience, Clinical Trials, CTMS, Drug Development, Protocol, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1993 — 1997
Bachelors
Kevin Wass's PAREXEL Experience July 2013 - Present
Job Clinical Logistics Leader PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2013 - Present
PAREXEL 2013 - Present
Pfizer PGRD January 2003 - November 2007
Pfizer PGRD September 1999 - January 2003
Novartis 1994 - 1999
Skills
Leadership, Management, Clinical Trials, CRO, Clinical Development, Clinical Research, Supply Chain Management, Pharmaceutical Industry, GCP, CTMS, Sop, GMP, SOP, Regulatory Affairs, FDA, Life Sciences
Education
University of Michigan
Bachelor of Science (BS), Biochemistry and Molecular Biology
PAREXEL July 2013 - Present
PAREXEL 2013 - Present
Pfizer PGRD January 2003 - November 2007
Pfizer PGRD September 1999 - January 2003
Novartis 1994 - 1999
Skills
Leadership, Management, Clinical Trials, CRO, Clinical Development, Clinical Research, Supply Chain Management, Pharmaceutical Industry, GCP, CTMS, Sop, GMP, SOP, Regulatory Affairs, FDA, Life Sciences
Education
University of Michigan
Bachelor of Science (BS), Biochemistry and Molecular Biology
Lorri Bass's PAREXEL Experience March 2015 - Present
Job External Communications at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GSK May 1996 - March 2015
Skills
Facilitation, Knowledge Management, Virtual Collaboration, Continuous Improvement, Internal Social Media..., Relationship Building, Networking, Teamwork, Stakeholder Management, Social Learning..., Learning and Development, Business Strategy, Project Management, PowerPoint, Strategy, Training & Development, Process Improvement
Education
University of Mississippi
Bachelor's Degree, Marketing
PAREXEL March 2015 - Present
GSK May 1996 - March 2015
Skills
Facilitation, Knowledge Management, Virtual Collaboration, Continuous Improvement, Internal Social Media..., Relationship Building, Networking, Teamwork, Stakeholder Management, Social Learning..., Learning and Development, Business Strategy, Project Management, PowerPoint, Strategy, Training & Development, Process Improvement
Education
University of Mississippi
Bachelor's Degree, Marketing
Kathy Lambert's PAREXEL Experience July 2014 - Present
Job Project Manager at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2014 - Present
PAREXEL August 2010 - July 2014
Circuit Technology, Inc November 2006 - August 2010
CIGNA Healthcare February 2005 - October 2006
Skills
Project Management, 21 CFR Part 11, Sop, Account Management, Customer Service, Clinical Trials, Product Development, Validation
Education
University of New Hampshire - Whittemore School of Business and Economics 2000 — 2004
Bachelor, Business Administration with Marketing Concentration
PAREXEL July 2014 - Present
PAREXEL August 2010 - July 2014
Circuit Technology, Inc November 2006 - August 2010
CIGNA Healthcare February 2005 - October 2006
Skills
Project Management, 21 CFR Part 11, Sop, Account Management, Customer Service, Clinical Trials, Product Development, Validation
Education
University of New Hampshire - Whittemore School of Business and Economics 2000 — 2004
Bachelor, Business Administration with Marketing Concentration
Amanda Teeley's PAREXEL Experience January 2008 - January 2010
Job Periodic Report Associate Team Lead at Genzyme, a sanofi company
Industry Pharmaceuticals
Experience
Genzyme, a sanofi company July 2014 - Present
Genzyme, a Sanofi Company March 2012 - July 2014
Genzyme April 2010 - March 2012
PAREXEL January 2008 - January 2010
Bayer HealthCare/Siemens Medical Solutions September 2007 - January 2008
Bayer HealthCare September 2004 - January 2007
Joslin Diabetes Center May 2002 - August 2002
Skills
GCP, Sop, FDA, Clinical Research, Infectious Diseases, Protocol, Clinical Trials, Regulatory Submissions, Regulatory Affairs, Oncology, Pharmaceutical Industry, ICH-GCP, CRO, Biotechnology, CTMS, GMP, ELISA, Pharmacovigilance, EDC, IND, Drug Development, 21 CFR Part 11, Medical Writing, Immunology, Medical Devices, Pharmacology, Regulatory Requirements, Diabetes, CAPA, Pharmaceutics, Drug Safety, SOP development, Process Improvement, Quality Control, MedDRA, Clinical Development, Clinical Monitoring, Laboratory, Validation, Lifesciences, Biopharmaceuticals, Molecular Biology, Management, Cross-functional Team..., Healthcare, SOP
Education
University of Michigan-Dearborn 1998 — 2003
Bachelor of Science, Biochemistry2003
University of Michigan-Dearborn 1998 — 2003
Bachelor of Arts, Psychology 2003
Genzyme, a sanofi company July 2014 - Present
Genzyme, a Sanofi Company March 2012 - July 2014
Genzyme April 2010 - March 2012
PAREXEL January 2008 - January 2010
Bayer HealthCare/Siemens Medical Solutions September 2007 - January 2008
Bayer HealthCare September 2004 - January 2007
Joslin Diabetes Center May 2002 - August 2002
Skills
GCP, Sop, FDA, Clinical Research, Infectious Diseases, Protocol, Clinical Trials, Regulatory Submissions, Regulatory Affairs, Oncology, Pharmaceutical Industry, ICH-GCP, CRO, Biotechnology, CTMS, GMP, ELISA, Pharmacovigilance, EDC, IND, Drug Development, 21 CFR Part 11, Medical Writing, Immunology, Medical Devices, Pharmacology, Regulatory Requirements, Diabetes, CAPA, Pharmaceutics, Drug Safety, SOP development, Process Improvement, Quality Control, MedDRA, Clinical Development, Clinical Monitoring, Laboratory, Validation, Lifesciences, Biopharmaceuticals, Molecular Biology, Management, Cross-functional Team..., Healthcare, SOP
Education
University of Michigan-Dearborn 1998 — 2003
Bachelor of Science, Biochemistry2003
University of Michigan-Dearborn 1998 — 2003
Bachelor of Arts, Psychology 2003
Joe Gleason's PAREXEL Experience November 2012 - October 2013
Job Data Management Professional in Pharma Industry
Industry Pharmaceuticals
Experience
Pharma Industry April 2015 - Present
INC Research February 2014 - April 2015
PAREXEL November 2012 - October 2013
Merge Healthcare March 2012 - November 2012
INC Research March 2010 - March 2012
PharmaNet Development Group, Inc. 2006 - 2009
i3 Statprobe October 2003 - November 2005
Quintiles 2002 - 2003
Skills
21 CFR Part 11, CRF design, CRO, CTMS, Clinical Data, Clinical Data Management, Clinical Development, Clinical Trials, Data Management, Databases, EDC, GCP, ICH-GCP, Inform, Oncology, Oracle Clinical, Validation
Education
University of North Carolina at Chapel Hill 1999 — 2001
BA, Management
Louisburg Colege 1997 — 1999
Associates Degree
Pharma Industry April 2015 - Present
INC Research February 2014 - April 2015
PAREXEL November 2012 - October 2013
Merge Healthcare March 2012 - November 2012
INC Research March 2010 - March 2012
PharmaNet Development Group, Inc. 2006 - 2009
i3 Statprobe October 2003 - November 2005
Quintiles 2002 - 2003
Skills
21 CFR Part 11, CRF design, CRO, CTMS, Clinical Data, Clinical Data Management, Clinical Development, Clinical Trials, Data Management, Databases, EDC, GCP, ICH-GCP, Inform, Oncology, Oracle Clinical, Validation
Education
University of North Carolina at Chapel Hill 1999 — 2001
BA, Management
Louisburg Colege 1997 — 1999
Associates Degree
Jason Snider's PAREXEL Experience January 2014 - Present
Job Clinical Ops Lead at PAREXEL
Industry Medical Devices
Experience
PAREXEL January 2014 - Present
Medtronic 2011 - January 2014
Anulex Technologies 2006 - 2011
GraftCath 2005 - 2006
CoAxia 2003 - 2005
Boston Scientific 2001 - 2003
St. Jude Medical 1999 - 2001
Skills
Clinical Trials, Medical Devices, CTMS
Education
University of Minnesota-Twin Cities 1988 — 1994
BA, Physiology
PAREXEL January 2014 - Present
Medtronic 2011 - January 2014
Anulex Technologies 2006 - 2011
GraftCath 2005 - 2006
CoAxia 2003 - 2005
Boston Scientific 2001 - 2003
St. Jude Medical 1999 - 2001
Skills
Clinical Trials, Medical Devices, CTMS
Education
University of Minnesota-Twin Cities 1988 — 1994
BA, Physiology
Chrystelle Boko, MSPH's PAREXEL Experience September 2014 - Present
Job CMA I at PAREXEL International
Industry Research
Experience
PAREXEL September 2014 - Present
Sarah Cannon Research Institute February 2014 - September 2014
UNC Charlotte August 2012 - May 2013
Novant Health Presbyterian Medical Center May 2012 - April 2013
InnerPulse September 2009 - January 2011
Wake Forest University January 2009 - May 2009
Skills
Clinical Trials, Medidata, Clinical Research, Statistics, Research, Biostatistics, Analysis, Science, Medical Devices, Protocol, Literature Reviews, Clinical Study Design, Public Health, SPSS, Stata, Data Management, Data Analysis, Data Entry, Report Writing, Data Collection, Teamwork, Qualitative Research, Editing, Clinical Development, Program Evaluation
Education
UNC Charlotte 2011 — 2013
Master of Science in Public Health, Master of Science in Public Health
Wake Forest University 2005 — 2009
BS, Health and Exercise Science
PAREXEL September 2014 - Present
Sarah Cannon Research Institute February 2014 - September 2014
UNC Charlotte August 2012 - May 2013
Novant Health Presbyterian Medical Center May 2012 - April 2013
InnerPulse September 2009 - January 2011
Wake Forest University January 2009 - May 2009
Skills
Clinical Trials, Medidata, Clinical Research, Statistics, Research, Biostatistics, Analysis, Science, Medical Devices, Protocol, Literature Reviews, Clinical Study Design, Public Health, SPSS, Stata, Data Management, Data Analysis, Data Entry, Report Writing, Data Collection, Teamwork, Qualitative Research, Editing, Clinical Development, Program Evaluation
Education
UNC Charlotte 2011 — 2013
Master of Science in Public Health, Master of Science in Public Health
Wake Forest University 2005 — 2009
BS, Health and Exercise Science
Amy Smith Remillard's PAREXEL Experience 1995 - 1998
Job Medical Writer
Industry Pharmaceuticals
Experience
Sunovion Pharmaceuticals Inc. April 2008 - June 2012
Consultant 2002 - 2006
Sepracor Pharmaceuticals 1999 - May 2002
PAREXEL 1995 - 1998
Education
University of New Hampshire
Bachelor of Science (BS), Applied Mathematics
Worcester Polytechnic Institute
Master's degree, Biostatistics
Sunovion Pharmaceuticals Inc. April 2008 - June 2012
Consultant 2002 - 2006
Sepracor Pharmaceuticals 1999 - May 2002
PAREXEL 1995 - 1998
Education
University of New Hampshire
Bachelor of Science (BS), Applied Mathematics
Worcester Polytechnic Institute
Master's degree, Biostatistics
Kim Doggett's PAREXEL Experience 2001 - 2003
Job Associate Director, Site Engagement Lead at UCB
Industry Pharmaceuticals
Experience
UCB May 2015 - Present
UCB September 2013 - May 2015
UCB June 2011 - August 2013
UCB Pharma June 2003 - June 2011
PAREXEL 2001 - 2003
Duke Clinical Research Institute 1998 - 2001
Skills
ICH-GCP, CRO, GCP, Therapeutic Areas, Clinical Development, Clinical Trials, Clinical Data Management, Neurology, Medical Writing, Hypertension, Regulatory Requirements, Pharmaceutical Industry, Sop, 21 CFR Part 11, Clinical Research, Clinical Monitoring, Project Management, Cardiovascular Disease, Regulatory Submissions, GxP, CNS disorders, Women's Health
Education
University of North Carolina at Chapel Hill 1989 — 1993
Bachelor of Science (BS), Biology, General
UCB May 2015 - Present
UCB September 2013 - May 2015
UCB June 2011 - August 2013
UCB Pharma June 2003 - June 2011
PAREXEL 2001 - 2003
Duke Clinical Research Institute 1998 - 2001
Skills
ICH-GCP, CRO, GCP, Therapeutic Areas, Clinical Development, Clinical Trials, Clinical Data Management, Neurology, Medical Writing, Hypertension, Regulatory Requirements, Pharmaceutical Industry, Sop, 21 CFR Part 11, Clinical Research, Clinical Monitoring, Project Management, Cardiovascular Disease, Regulatory Submissions, GxP, CNS disorders, Women's Health
Education
University of North Carolina at Chapel Hill 1989 — 1993
Bachelor of Science (BS), Biology, General
Jennifer Atwell's PAREXEL Experience January 2002 - September 2005
Job Sr. Clinical Project Manager at Ocera Therapeutics
Industry Biotechnology
Experience
Ocera Therapeutics, Inc. June 2014 - Present
PRA International December 2010 - February 2013
Gilead Sciences October 2005 - December 2010
PAREXEL January 2002 - September 2005
PharmaResearch Corporation January 2001 - January 2002
Duke Clinical Research Institute July 1998 - December 2000
Duke Clinical Research Institute April 1996 - July 1998
Duke University Medical Center May 1991 - April 1996
Skills
EDC, Clinical Trials, Clinical Monitoring, CRO, Clinical Development, CTMS, GCP, Clinical Research, ICH-GCP, Oncology, Infectious Diseases, Therapeutic Areas, Pharmaceutical Industry, Regulatory Submissions, Clinical Data Management, Medical Writing, Protocol, IND, Sop, Drug Development, Biotechnology, Data Management, Clinical Study Design, SOP
Education
University of North Carolina at Chapel Hill
Bachelors, Psychology
Ocera Therapeutics, Inc. June 2014 - Present
PRA International December 2010 - February 2013
Gilead Sciences October 2005 - December 2010
PAREXEL January 2002 - September 2005
PharmaResearch Corporation January 2001 - January 2002
Duke Clinical Research Institute July 1998 - December 2000
Duke Clinical Research Institute April 1996 - July 1998
Duke University Medical Center May 1991 - April 1996
Skills
EDC, Clinical Trials, Clinical Monitoring, CRO, Clinical Development, CTMS, GCP, Clinical Research, ICH-GCP, Oncology, Infectious Diseases, Therapeutic Areas, Pharmaceutical Industry, Regulatory Submissions, Clinical Data Management, Medical Writing, Protocol, IND, Sop, Drug Development, Biotechnology, Data Management, Clinical Study Design, SOP
Education
University of North Carolina at Chapel Hill
Bachelors, Psychology
Eric Nowicki's PAREXEL Experience February 2009 - Present
Job Associate Director, Biostatistics at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL February 2009 - Present
Rho 2007 - 2009
Skills
Biostatistics, Clinical Trials, Clinical Research, Epidemiology, Public Health
Education
University of North Carolina at Chapel Hill 2002 — 2010
Ph.D., Epidemiology
Tufts University 2000 — 2002
M.P.H, Epidemiology and Biostatistics
PAREXEL February 2009 - Present
Rho 2007 - 2009
Skills
Biostatistics, Clinical Trials, Clinical Research, Epidemiology, Public Health
Education
University of North Carolina at Chapel Hill 2002 — 2010
Ph.D., Epidemiology
Tufts University 2000 — 2002
M.P.H, Epidemiology and Biostatistics
Natalie Walker Freeland's PAREXEL Experience 2011 - 2012
Job Statistical Programmer
Industry Pharmaceuticals
Experience
Bogier Clinical & IT Solutions, Inc. September 2011 - Present
PAREXEL 2011 - 2012
Stat-Tech Services, LLC 2002 - 2010
Triangle Pharmaceuticals 2001 - 2002
Skills
SAS programming, SAS, Statistical Programming, CDISC, Biostatistics, Clinical Trials, CRO, Validation, ICH-GCP, Statistics, Clinical Development, Pharmaceutical Industry, Protocol, Oncology, Clinical Data Management, Regulatory Submissions, SDTM, Therapeutic Areas
Education
UNC Charlotte 1996 — 2000
Bachelor of Science (BS), Mathematics
Bogier Clinical & IT Solutions, Inc. September 2011 - Present
PAREXEL 2011 - 2012
Stat-Tech Services, LLC 2002 - 2010
Triangle Pharmaceuticals 2001 - 2002
Skills
SAS programming, SAS, Statistical Programming, CDISC, Biostatistics, Clinical Trials, CRO, Validation, ICH-GCP, Statistics, Clinical Development, Pharmaceutical Industry, Protocol, Oncology, Clinical Data Management, Regulatory Submissions, SDTM, Therapeutic Areas
Education
UNC Charlotte 1996 — 2000
Bachelor of Science (BS), Mathematics
Dawn Gillmor's PAREXEL Experience March 2015 - Present
Job Senior Project Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL March 2015 - Present
GlaxoSmithKline July 2014 - March 2015
GlaxoSmithKline 2005 - July 2014
IHC 2004 - 2005
etrials Worldwide 2000 - 2004
Skills
EDC, CRO, Clinical Data Management, CTMS, Clinical Trials, Data Management, GCP, Inform, Pharmaceutical Industry, Clinical Development, ICH-GCP, 21 CFR Part 11, Clinical Research, Sop, CDISC, Therapeutic Areas, CRF design
Education
University of North Carolina at Chapel Hill
PAREXEL March 2015 - Present
GlaxoSmithKline July 2014 - March 2015
GlaxoSmithKline 2005 - July 2014
IHC 2004 - 2005
etrials Worldwide 2000 - 2004
Skills
EDC, CRO, Clinical Data Management, CTMS, Clinical Trials, Data Management, GCP, Inform, Pharmaceutical Industry, Clinical Development, ICH-GCP, 21 CFR Part 11, Clinical Research, Sop, CDISC, Therapeutic Areas, CRF design
Education
University of North Carolina at Chapel Hill
Alison Moyer's PAREXEL Experience June 2013 - Present
Job Manager, Global Monitoring Operations at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL June 2013 - Present
Quintiles Transnational July 2010 - June 2013
Quintiles October 2004 - June 2010
Quintiles April 2003 - October 2004
Certus Interntional, Inc. 2001 - 2003
MDS Pharma Services 1999 - 2001
Skills
Microsoft Office, Photoshop, Spreadsheets, CTMS, CRO, Trial Management, Clinical Trials, Microsoft Excel, Clinical Monitoring, ICH-GCP, Clinical Research, Therapeutic Areas, SOP, Regulatory Submissions, GCP, Project Management, Clinical Development, Clinical Data Management, EDC
Education
University of Nebraska-Lincoln 1996 — 2000
Bachelor of Science, Biological Sciences
PAREXEL June 2013 - Present
Quintiles Transnational July 2010 - June 2013
Quintiles October 2004 - June 2010
Quintiles April 2003 - October 2004
Certus Interntional, Inc. 2001 - 2003
MDS Pharma Services 1999 - 2001
Skills
Microsoft Office, Photoshop, Spreadsheets, CTMS, CRO, Trial Management, Clinical Trials, Microsoft Excel, Clinical Monitoring, ICH-GCP, Clinical Research, Therapeutic Areas, SOP, Regulatory Submissions, GCP, Project Management, Clinical Development, Clinical Data Management, EDC
Education
University of Nebraska-Lincoln 1996 — 2000
Bachelor of Science, Biological Sciences
Amber Zimmerman's PAREXEL Experience September 2014 - Present
Job Project Quality Lead
Industry Research
Experience
PAREXEL September 2014 - Present
PAREXEL April 2012 - September 2014
Alcon Laboratories, Inc. 2010 - 2012
MCRC 2009 - 2010
Covance Laboratories 2008 - 2010
D. Anderson & Company 2007 - 2008
Radiant Research 2005 - 2007
Skills
CRO, Clinical Research, Clinical Trials, GCP, Clinical Development, Regulatory Submissions, ICH-GCP, Clinical Monitoring, EDC, Clinical Data Management, Therapeutic Areas, CTMS, Oncology, Protocol
Education
University of Nevada-Reno 2000 — 2004
Bachelor of Science, Biology
PAREXEL September 2014 - Present
PAREXEL April 2012 - September 2014
Alcon Laboratories, Inc. 2010 - 2012
MCRC 2009 - 2010
Covance Laboratories 2008 - 2010
D. Anderson & Company 2007 - 2008
Radiant Research 2005 - 2007
Skills
CRO, Clinical Research, Clinical Trials, GCP, Clinical Development, Regulatory Submissions, ICH-GCP, Clinical Monitoring, EDC, Clinical Data Management, Therapeutic Areas, CTMS, Oncology, Protocol
Education
University of Nevada-Reno 2000 — 2004
Bachelor of Science, Biology
Aloka Srinivasan's PAREXEL Experience June 2012 - Present
Job Principal Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL June 2012 - Present
US-Food and Drug Administration August 2003 - May 2012
Skills
Regulatory Submissions, FDA, Regulatory Affairs, Generic Programming, Drug Development, CMC, Leadership, Chemistry, Sop, GLP, GMP, Clinical Development, Regulatory Requirements, Pharmaceutics, Pharmaceutical Industry, CMC development, SOP, Technology Transfer
Education
University of Missouri-Columbia 1987 — 1993
Ph.D., 4.0
PAREXEL June 2012 - Present
US-Food and Drug Administration August 2003 - May 2012
Skills
Regulatory Submissions, FDA, Regulatory Affairs, Generic Programming, Drug Development, CMC, Leadership, Chemistry, Sop, GLP, GMP, Clinical Development, Regulatory Requirements, Pharmaceutics, Pharmaceutical Industry, CMC development, SOP, Technology Transfer
Education
University of Missouri-Columbia 1987 — 1993
Ph.D., 4.0
Bridgette Thompson's PAREXEL Experience February 2015 - Present
Job Clinical Research Associate at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL February 2015 - Present
PAREXEL July 2013 - February 2015
PAREXEL March 2012 - July 2013
PAREXEL June 2010 - March 2012
PPD August 2007 - June 2010
Skills
Clinical Development, Oncology, CRO, CTMS, Clinical Trials, Clinical Research, GCP, Data Management, Clinical Data Management, EDC, ICH-GCP, Protocol, SOP
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Arts (B.A.), Exercise and Sport Science
PAREXEL February 2015 - Present
PAREXEL July 2013 - February 2015
PAREXEL March 2012 - July 2013
PAREXEL June 2010 - March 2012
PPD August 2007 - June 2010
Skills
Clinical Development, Oncology, CRO, CTMS, Clinical Trials, Clinical Research, GCP, Data Management, Clinical Data Management, EDC, ICH-GCP, Protocol, SOP
Education
University of North Carolina at Chapel Hill 2003 — 2007
Bachelor of Arts (B.A.), Exercise and Sport Science
Remi Crawford's PAREXEL Experience February 2012 - Present
Job Clinical Monitoring Associate II at PAREXEL
Industry Research
Experience
PAREXEL February 2012 - Present
Celgene Corporation (formerly Abraxis BioScience) September 2004 - December 2011
PAREXEL October 2002 - September 2004
GlaxoSmithKline August 1999 - October 2002
Pharmaceutical Product Development April 1999 - May 1999
Quintiles September 1998 - April 1999
Pharmaceutical Product Development June 1998 - August 1998
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, CTMS, CRO, Protocol, Data Management, CRF design, Sop, EDC, Clinical Data Management, GCP, ICH-GCP, Therapeutic Areas, Clinical Development
Education
Mount Olive College
Bachelor of Business Administration (B.S.), Management and Organizational Development
PAREXEL February 2012 - Present
Celgene Corporation (formerly Abraxis BioScience) September 2004 - December 2011
PAREXEL October 2002 - September 2004
GlaxoSmithKline August 1999 - October 2002
Pharmaceutical Product Development April 1999 - May 1999
Quintiles September 1998 - April 1999
Pharmaceutical Product Development June 1998 - August 1998
Skills
Clinical Trials, Clinical Research, Clinical Monitoring, CTMS, CRO, Protocol, Data Management, CRF design, Sop, EDC, Clinical Data Management, GCP, ICH-GCP, Therapeutic Areas, Clinical Development
Education
Mount Olive College
Bachelor of Business Administration (B.S.), Management and Organizational Development
Dr. Margo Cowper's PAREXEL Experience August 2013 - May 2015
Job Clinical Pharmacist, Medication Case Manager, and Professor
Industry Higher Education
Experience
PharmMD August 2014 - Present
Mission Health May 2011 - Present
Chamberlain College of Nursing September 2014 - Present
Walden University October 2013 - Present
PAREXEL August 2013 - May 2015
Coram CVS/specialty infusion services February 2009 - August 2013
RITE AID June 2005 - October 2011
Skills
Research
Education
University of North Carolina at Chapel Hill 1999 — 2005
Doctor of Pharmacy (PharmD), Pharmacy
PharmMD August 2014 - Present
Mission Health May 2011 - Present
Chamberlain College of Nursing September 2014 - Present
Walden University October 2013 - Present
PAREXEL August 2013 - May 2015
Coram CVS/specialty infusion services February 2009 - August 2013
RITE AID June 2005 - October 2011
Skills
Research
Education
University of North Carolina at Chapel Hill 1999 — 2005
Doctor of Pharmacy (PharmD), Pharmacy
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca