Inveresk Research
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Inveresk Research Employees
Novan Therapeutics April 2015 - Present
Novan Therapeutics December 2013 - Present
Novan Therapeutics (contracted through Novella Clinical Resourcing) January 2013 - December 2013
FHI 360 August 2006 - December 2012
Self-employed March 2003 - August 2006
Nobex Corporation October 2001 - March 2003
Inveresk Research August 1998 - October 2001
UNC Hospitals June 1993 - August 1998
Piedmont Medical Center January 1990 - June 1993
Carolinas Medical Center June 1988 - December 1989
Skills
CTMS, Clinical Operations, Capacity Building, electronic data capture, Clinical Monitoring, Project Management, MS Project, Protocol, Procedure Manuals, PowerPoint, Project Planning, Photoshop, Public Health, International Project..., Nursing, Infectious Diseases, Clinical Trials, Communication Skills, EDC, Training, Subject Matter Experts, Clinical Research, Data Management, GCP, Clinical Development, Clinical Data Management, IRB, Medical Writing, ICH-GCP, Diabetes
Education
University of North Carolina at Chapel Hill 2003 — 2007
MPH, Public Health Leadership
University of North Carolina at Chapel Hill 1984 — 1988
BSN, Nursing
Novartis May 2015 - Present
GSK November 2005 - April 2015
GlaxoSmithKline June 2012 - December 2013
KEMRI / UNM June 2011 - January 2012
Inveresk Research July 2004 - November 2005
Roper St. Francis Healthcare February 1993 - July 2004
Genentech 1997 - 1999
Skills
SOP development, Clinical Research, Clinical Trials, mentoring, Healthcare, Healthcare Management, ICH-GCP, Development & delivery..., Cardiology, Diabetes, Emergency Management, Emergency Nursing, International Project..., Malaria, Infectious Diseases, Problem Solving, Goal Oriented, Change Management, Flexibility, Rheumatology, Endocrinology, Tropical Diseases, Neurology, Pharmacology, GCP, Sop, Therapeutic Areas, Clinical Development, Oncology, Trial Management, Medical Devices, Pharmaceutical Industry, Clinical Data Management, Regulatory Submissions, IRB, Phase I, Protocol, CRO, CRF design, Vaccines, Clinical Monitoring, Nursing, EDC, Clinical Operations, CTMS, Hospitals, Patient Recruitment, Hematology, Regulatory Affairs, Clinical Study Design
Education
Medical University of South Carolina 2003 — 2004
BSN, Nursing
Regents College 1991 — 1992
AASN, Nursing
Delaware Technical and Community College 1989 — 1990
LPN, Nursing
Astellas Pharma Global Development Inc. December 2013 - Present
Astellas Pharma Global Development Inc. April 2010 - November 2013
GSK June 2005 - March 2010
GSK November 2003 - May 2005
Inveresk Research February 2002 - May 2003
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, Oncology, GCP, Biotechnology, CRO, CTMS, Lifesciences, GMP, Sop, Pharmacovigilance, Drug Development, Regulatory Affairs, Cardiology, Validation, ICH-GCP, Clinical Research
Education
North Carolina State University 2001 — 2005
Doctor of Philosophy (PhD), Statistics
Dongguk University 1991 — 2000
Master's degree, Statistics
E*TRADE Financial April 2013 - Present
E*TRADE Financial Corporation February 2011 - April 2013
E*TRADE Financial Corporation September 2009 - February 2011
E*TRADE Financial December 2007 - September 2009
Freddie Mac May 2007 - December 2007
Dean & Company Strategy Consulting 2006 - 2007
IBM 2004 - 2006
Inveresk Research 2002 - 2004
Skills
Financial Modeling, SAS, Risk Management, Financial Analysis, Project Management, Business Analysis, Data Analysis, Process Improvement, Analytics, Forecasting
Education
University of South Carolina-Columbia 1997 — 2001
BS, Statistics
Merck November 2014 - Present
Genentech November 2006 - October 2014
Genentech April 2006 - November 2006
Genentech August 2004 - April 2006
Kforce Inc. June 2003 - August 2004
ICON plc April 2002 - June 2003
Inveresk Research May 2000 - April 2002
Inveresk Research October 1996 - May 2000
UCSF January 1995 - January 1996
Skills
Pharmaceutical Industry, Clinical Trials, ICH-GCP, CTMS, CRO, GCP, Biotechnology, Oncology, Drug Development, Clinical Monitoring, Clinical Research, Clinical Development, Lifesciences, EDC, Training, Therapeutic Areas, Biopharmaceuticals, Life Sciences
Education
Faculty of Medicine, Edinburgh University, Scotland 1989 — 1994
Ph.D., Research into alternate treatments for Type I diabetes
Liverpool John Moores University 1985 — 1989
Bachelor of Science (BSc), Clinical Biochemistry
Adam Hervey 2008 - Present
Pehr Space March 2006 - Present
Adam Hervey January 2004 - Present
Pehr Label 1997 - Present
Gathr August 2011 - January 2013
Glen Echo Entertainment April 2011 - January 2013
AOL 1999 - 2000
Inveresk Research 1998 - 1999
Lucasfilm 1997 - 1998
Skills
Film
Education
Sonoma State University 1994 — 1999
BA, Economics
ProTrials Research March 2004 - Present
Inveresk Research May 2000 - March 2004
Duke University Medical Center August 1996 - January 2001
Skills
EDC, Clinical Trials, Clinical Monitoring, Clinical Data Management, Protocol, Clinical Study Design, Neurology, Phase I, Pharmacovigilance, Immunology, Ophthalmology, Dermatology
Education
University of North Carolina at Chapel Hill 1992 — 1996
BSN, Nursing
Watkins Mill High School 1988 — 1992
Quintiles, Inc 2006 - Present
Quintiles, Inc.. April 2006 - January 2009
Inveresk 2003 - 2004
Inveresk Research 2003 - 2004
Charles River/Inveresk/PharmaResearch 1999 - 2004
PharmaResearch Corporation 1999 - 2003
PHARMARESEARCH Corporation - Morrisville, NC USA 1999 - 2003
Skills
CRO, CTMS, GCP, ICH-GCP, Oncology, Clinical Research, Biotechnology, Therapeutic Areas, Project Management, Lifesciences, Drug Development, Immunology, Clinical Development, Clinical Trials, EDC, Pharmaceutical Industry
Education
Marshall University 1978 — 1984
ViiV Healthcare August 2014 - Present
GlaxoSmithKline May 2005 - Present
Trio Clinical Resourcing September 2004 - May 2005
i3 Research March 2004 - September 2004
Inveresk Research October 2003 - February 2004
PharmaResearch, Inc November 2002 - September 2003
PharmaResearch, Inc. September 1999 - October 2002
PharmaResearch, Inc. February 1999 - August 1999
Healthfield Hospice, Inc. November 1996 - February 1999
Grady Health System August 1996 - November 1996
Skills
Clinical Trials, Clinical Monitoring, Clinical Development, GCP, Clinical Trial..., CRO, Clinical Research, Protocol Development, Infectious Diseases, ICH-GCP, Nursing, Inform
Education
Emory University 1993 — 1995
Bachelors of Science, Nursing
Boehringer Ingelheim November 2013 - Present
ICON plc December 2011 - November 2013
ICON Clinical Research October 2005 - July 2011
PharmaLinkFHI November 2000 - October 2005
Novella Clinical (formerly PharmaLinkFHI) 2000 - 2005
Inveresk Research 1995 - 2000
Skills
EDC, Clinical Trials, Clinical Operations, CRO, Management, CTMS, GCP, Clinical Development, Clinical Monitoring, ICH-GCP, Pharmaceutical Industry, Oncology, Clinical Data Management, Therapeutic Areas, Regulatory Submissions
Education
Metropolitian State College of Denver 1990 — 1994
Bachelor's degree, Business Administration and Management, General
Metropolitan State University of Denver 1990 — 1993
BS, Business Management
Community Research Initiative of New England April 2009 - June 2014
Community Research Initiative of New England April 2008 - April 2010
Inveresk Research 1999 - 2001
Skills
Clinical Trials, Regulatory Affairs, Nonprofits, Program Management, Editing, Research, Strategic Planning, Biotechnology
Education
Emory University
Bachelor of Science (BS), Biology, General
Emory University (Rollins School of Public Health)
Masters of Public Health, Occupational and Environmental Health
INC Research February 2012 - Present
INC Research July 2011 - March 2013
INC Research September 2006 - July 2011
Charles River Laboratories January 2006 - September 2006
Charles River Laboratories September 2004 - January 2006
Inveresk Research January 2003 - September 2004
PharmaResearch Corporation March 2002 - January 2003
Education
University of North Carolina at Chapel Hill 1992 — 1996
Bachelors of Science, Biology
Xceleron Inc October 2011 - Present
Intertek August 2008 - January 2011
WIL Research Holding Company, Inc. March 2006 - July 2008
Synomics Pharmaceutical Services October 2004 - February 2006
ClinTrials BioResearch (CTBR) 1997 - 2004
ClinTrials BioResearch (CTBR) March 1996 - April 1997
Huntingdon Life Sciences January 1993 - March 1996
Inveresk Research July 1989 - January 1993
Skills
Due Diligence, Competitive Analysis, Corporate Development, Key Account Management, Mergers, Biotechnology, Pharmaceutical Industry, CRO, Lifesciences, Medical Devices, Clinical Development, Drug Development, Business Planning, Strategy, FDA, R&D, Strategic Planning, Management, Drug Discovery, Venture Capital, Market Research, Pharmaceutics, Technology Transfer, Business Development, Business Strategy, Toxicology, Cross-functional Team..., GLP, Mergers & Acquisitions, Team Building, Regulatory Affairs, Clinical Trials, Biopharmaceuticals, Regulatory Submissions, Sop, Oncology
Education
Imperial College London 1979 — 1983
BSc Hons., Biochemistry (Applied Biochemistry & Biotechnology)
PPD October 2011 - Present
Talecris Biotherapeutics January 2010 - September 2011
Kendle International February 2003 - December 2009
Inveresk Research 2003 - 2006
Blue Cross and Blue Shield of North Carolina 1988 - 1997
Skills
Pharmacovigilance, CRO, Clinical Trials, Drug Safety, EDC, GCP, ICH-GCP, Oncology, Therapeutic Areas, Clinical Monitoring
Education
University of North Carolina at Charlotte 1978 — 1983
BSN, Nursing
Pharmaceutical professional working in the clinical trial research and Pharma Industry. January 2014 - Present
On sabbatical August 2012 - November 2013
Pfizer 2007 - 2012
Pfizer May 2007 - August 2007
PRO Unlimited May 2005 - May 2007
Cardiovascular Research Foundation February 2005 - April 2005
Inveresk Research 2000 - 2004
CENCEC 1994 - 2000
Skills
Clinical Trials, CRO, CTMS, GCP, Clinical Research, ICH-GCP, Pharmaceutical Industry, Clinical Monitoring, Oncology, Clinical Development, Project Management, Clinical Operations, Sop, Therapeutic Areas, Drug Development, EDC, Vaccines, Regulatory Submissions, FDA, Clinical Data Management, Diabetes, Infectious Diseases, TMF, Feasibility-Clinical..., Feasibility Studies, CAPA, Pharmacovigilance, Biotechnology, Data Management, Endocrinology, Cardiology, Protocol, Strategic Planning, Strategic Financial..., Respiratory Therapy, Epidemiology, Analysis, Multilingual, Strategic Negotiations, Contract Management, Trainers, Cerebrovascular Disease, Medical devices, Ophthalmology, sexual health medication, Resources allocation..., Multicultural, Contract Negotiation, Neurology, Obesity/Overweight...
Education
Vrije Universiteit Brussel 1998 — 2000
Master's degree, Medical and pharmaceutical research
University of Havana 1989 — 1994
Licentiate in Pharmaceutical Sciencies degree, Pharmaceutical Sciences
Verastem September 2012 - Present
Myriad Genetics September 2009 - Present
Phanstiel Enterprises, LLC January 2008 - Present
WellPoint, Inc. December 1996 - December 2007
Inveresk Research April 2002 - October 2004
Coopers & Lybrand July 1985 - November 1996
Skills
Strategic Planning, Mergers
Education
Golden Gate University
BA
PPD October 2011 - Present
PharPoint Research, Inc. January 2011 - September 2011
i3 Statprobe July 2010 - January 2011
AAIPharma December 2006 - August 2009
Inveresk Research September 2004 - September 2005
Skills
Clinical Trials, Microsoft Word, Biostatistics, Microsoft Excel, Clinical Data Management, SAS, Pharmaceutical Industry, Clinical Research, GCP, Regulatory Submissions
Education
University of North Carolina at Wilmington 2000 — 2005
Masters, Applied Mathematics
Inveresk Research/Acquired by INC Research in 2011 June 2011 - May 2012
INC Research October 2010 - June 2011
INC Research April 2010 - October 2010
INC Research August 2008 - April 2010
Duke University Medical Center May 2005 - August 2008
Inveresk Research December 2004 - February 2005
Inveresk Research November 2001 - November 2004
Duke University Medical Center January 2000 - October 2001
Duke University Medical Center December 1997 - December 2000
Carolina Learning Services Neuro-Rehab Facility March 1994 - December 1997
Skills
Personnel Management, Organizational..., Performance Management, Leadership, Management, Program Management, Clinical Trials, GCP, ICH-GCP, Training, EDC, Protocol, Clinical Research, Sop, Clinical Monitoring
Education
Elon University 1990 — 1994
BA, Human Services / Psychology
Array BioPharma April 2013 - Present
Array BioPharma April 2010 - April 2013
Array BioPharma September 2008 - April 2010
Abraxis BioScience, Inc. September 2004 - September 2008
Inveresk Research 2004 - 2007
ClinTrials Research 2000 - 2004
Triangle Laboratories, Inc. 1991 - 1997
Skills
Clinical Development, CTMS, EDC, CRO, Clinical Trials, GCP, Oncology, Clinical Monitoring, Therapeutic Areas, Drug Development, Pharmaceutical Industry, Biotechnology, Clinical Research, Phase I, ICH-GCP, Infectious Diseases, Clinical Operations
Education
North Carolina State University 1990 — 1995
MS, Biology
inVentiv Health Clinical February 2015 - April 2015
Duke University Health System January 2012 - April 2014
Miller Medical Research, LLC August 2010 - November 2012
Orange County Health Department March 2011 - July 2011
Garretson Firm Resolution Group, Inc. August 2010 - July 2011
Inveresk Research January 2000 - August 2002
Duke University Medical Center July 1996 - January 2000
Skills
Clinical Research, Critical Care, ICU, Medical Records, Public Health, Nursing, Hospitals, Patient Safety, Healthcare, Medicine, Clinical Trials, HIPAA, Patient Advocacy
Education
Duke University 2010 — 2010
Legal Nurse Consultant Certificate Program
Clemson University 1992 — 1996
BSN, Nursing
Forest Laboratories January 2013 - Present
Ibis Medical Writing August 2006 - Present
Gilead Sciences April 2007 - December 2010
Kendle International 2005 - 2007
Inveresk Research 2003 - 2006
PharmaResearch Corporation April 2002 - 2003
SRI International May 2000 - February 2002
Onyx Pharmaceuticals September 1999 - April 2000
Skills
Medical Writing, Protocol Development, IND, Clinical Development, Toxicology, Regulatory Submissions, Pharmacology, Manuscripts, Clinical Trials, Protocol, Clinical Study Design, FDA, Pharmacokinetics, Immunology, Manuscript, Sop, Vaccines, Clinical Research, Drug Development, SOP, Pharmaceutical Industry, CRO, GCP
Education
State University of New York College at Buffalo 1995 — 1998
MA, Pharmacology
Cornell University 1988 — 1993
BA, Biology
Cardlytics, Inc. April 2015 - Present
Cardlytics, Inc. October 2012 - Present
LBi US June 2012 - October 2012
Pier 1 Imports October 2005 - March 2012
Gronski Financial Alliance April 2001 - September 2002
Inveresk Research October 1999 - May 2001
Skills
Customer Service, Microsoft Excel, Microsoft Office, Accounting, Forecasting, Management, Leadership
Education
Kennesaw State University - Michael J. Coles College of Business
Bachelors of Business Administration, Accounting
Quintiles September 2013 - Present
Covance June 2007 - Present
Covance, Canada June 2007 - September 2013
PPD January 2004 - May 2007
Inveresk Research March 2002 - June 2003
Quintiles UK May 1996 - April 2002
Quintiles October 1995 - March 1996
Skills
Clinical Monitoring, Attention To Detail, Organizational...
Education
Loyola University New Orleans 1974 — 1978
B.S., Biology
UnitedHealth Group 2005 - Present
The Woolf Group 2002 - 2004
Inveresk Research 1999 - 2002
CSI 1997 - 1999
Skills
Clinical Research, Healthcare, Recruiting, Training, Clinical Trials, GCP, Oncology, Human Resources, Personnel Management, Management, EDC, Applicant Tracking..., Talent Acquisition, Clinical Monitoring, Leadership
Education
North Carolina State University 1993 — 1996
Research Pharmaceutical Services October 2013 - Present
Quintiles May 2013 - November 2013
Chiltern International July 2012 - April 2013
Roche - K-Force Alliance February 2009 - July 2012
Rho, Inc. July 2006 - February 2009
Charles River Laboratories July 2002 - July 2006
Inveresk Research July 2002 - July 2006
Skills
Clinical Trials, Phase I, Clinical Monitoring, EDC, CRO, CTMS, GCP, ICH-GCP, Therapeutic Areas, Clinical Development, Clinical Data Management, Oncology, Protocol, Ophthalmology, Endocrinology, Clinical Operations, Clinical Research, Dermatology, Diabetes, Pain Management, Oracle Clinical, Pediatrics, Pharmaceutics, Rheumatology, Trial Management, Urology
Education
University of Alabama 2007 — 2008
Master of Science, Nurse Case Management, Health Professions and Related Clinical Sciences, Other
Auburn University at Montgomery 2000 — 2002
Bachelor of Science, Nursing
PPD September 2014 - Present
Covance June 2011 - September 2014
Sarah Cannon Research Institute April 2008 - June 2011
Cato Research April 2005 - February 2008
PPD April 2004 - April 2005
Inveresk Research December 2003 - April 2004
Inveresk Research January 2003 - December 2003
Inveresk Research August 2001 - December 2003
Skills
GCP, Clinical Trials, IRB, FDA, Regulatory Affairs, CRO, Protocol, Clinical Research, Regulatory Submissions, Material Review Board, Customer Service, Regulatory Requirements, Sop, Drug Development, Medical Writing, Clinical Data Management, CTMS, Biotechnology, EDC, Clinical Development, IND, Pharmaceutical Industry, ICH-GCP, Oncology, eCTD, Data Management, Lifesciences, Therapeutic Areas, 21 CFR Part 11, CRF design, Clinical Monitoring, Validation, Infectious Diseases, Vaccines, Pharmacovigilance, GLP, Management, Clinical Operations, Medical Devices
Education
University of Maine 1996 — 2000
B.S., Biology/Pre-Medical Studies
Lewiston High School 1992 — 1996
PPD April 2015 - Present
PPD February 2012 - March 2015
PPD September 2010 - February 2012
Chiltern International October 2008 - January 2011
PPD December 2006 - October 2008
PPD November 2005 - November 2006
Charles River Laboratories August 2004 - October 2005
Inveresk Research April 2002 - August 2004
PharmaResearch Corporation July 2001 - April 2002
Skills
EDC, ICH-GCP, Quality Assurance, Clinical Trials, CTMS, CRO, GCP, Pharmaceutical Industry, Clinical Development, Clinical Research, Clinical Monitoring, Oncology, SOP, 21 CFR Part 11, Biotechnology, Clinical Data Management, Clinical Operations, Data Management, Computer System..., Drug Development, FDA, Regulatory Affairs, Regulatory Submissions, Sop, Therapeutic Areas, Validation
Education
Slippery Rock University of Pennsylvania 1994 — 1996
Athletic Administration
Springfield College 1991 — 1994
BS, General Studies
Bay Path University 1990 — 1991
AS, Business Administration
PPD August 2011 - Present
Kendle January 2006 - August 2011
Charles River Laboratories 2004 - 2006
PharmaResearch 2001 - 2006
Inveresk Research 2003 - 2004
PharmaResearch Corporation 1998 - 2001
Creative Choice Homes 1997 - 1998
Skills
Quality Assurance
Education
University of North Carolina at Wilmington 1987 — 1991
BA, Philosophy, Eastern Religion
Hendersonville
PRA Health Sciences August 2015 - Present
InterMune May 2012 - July 2015
Gilead Sciences September 2010 - May 2012
Genentech Pharmaceutical May 2010 - September 2010
Duke Comprehensive Cancer Center July 2009 - February 2010
Quintiles, Inc August 2006 - February 2009
Drug Safety Alliance January 2005 - August 2006
Inveresk Research August 2001 - November 2004
Inveresk Research August 2001 - August 2004
Quintiles, Inc February 2000 - August 2001
Skills
FDA, Clinical Research, Clinical Trials, Oncology, CRO, GCP, Pharmacovigilance, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Pharmaceutical Industry, SOP, Clinical Development, CTMS, Drug Safety, Biotechnology
Education
University of North Carolina at Chapel Hill
BSN, Nursing
Triangle Research Labs February 2012 - July 2012
Aptiv Solutions February 2009 - January 2012
Nuvilex February 2007 - January 2009
Aptuit January 2006 - December 2006
CRF, Inc. January 2005 - December 2005
Inveresk Research January 2001 - December 2003
Inceutica 1999 - 2001
AAI 1991 - 1999
Skills
CRO, Pharmaceutical Industry, Biotechnology, Clinical Trials, Clinical Development, Oncology, Lifesciences, CTMS, Medical Devices, Clinical Research, GCP, Sales, Sales Management, Marketing, Business Development, CMC development, Analytical Chemistry, MBA, adaptive clinical trials, Strategic Sales Plans, Key Account Management, Team Leadership, Regulatory Affairs, Cross-functional Team..., Strategy, New Business Development, FDA, Business Strategy, Management, Leadership, Sales Operations, Drug Development, Commercialization, Product Development, Technology Transfer, Biopharmaceuticals, Marketing Management, R&D, Therapeutic Areas, Drug Discovery, Infectious Diseases, Diabetes, EDC, IND
Education
Duke University - The Fuqua School of Business 1998 — 1999
MBA
Montclair State University 1983 — 1987
BS, Chemistry
Shire Pharmaceuticals January 2015 - Present
Medivation January 2013 - January 2015
PAREXEL International June 2010 - January 2013
University of North Carolina, Chapel Hill August 2007 - June 2010
Wyeth Research January 2007 - August 2007
Genentech July 2005 - December 2006
Eli Lilly January 2004 - June 2005
Inveresk Research July 2002 - December 2003
Skills
Biostatistics, Clinical Trials, Oncology, SAS, Survival Analysis, Clinical Research, Statistical Programming, Clinical Development, CDISC, Cancer, Multivariate Analysis, Clinical Data Management, CRO, Neuroscience, Immunology, Bayesian statistics, Bid Defence, Autoimmune Diseases, Adaptive Design, NDA, Protocol Development, Leadership, Management, Protocol, Pharmaceutical Industry, Statistics, GCP, Biotechnology, EDC, Data Analysis, Life Sciences, SAS Programming, Drug Development
Education
University of North Carolina at Chapel Hill
Doctor of Philosophy (PhD), Biostatistics
North Carolina State University
Master's degree, Statistics
University of Dhaka, Institute of Business Administration
Master of Business Administration (M.B.A.)
University of Dhaka
Bachelor's degree, Statistics
Chiltern July 2015 - Present
Chiltern International February 2014 - June 2015
Chiltern International July 2012 - January 2014
Chiltern International May 2010 - June 2012
ZeeCRO Inc. (formerly AAIPharma Inc.) July 2007 - April 2010
Kendle International June 2006 - June 2007
Charles River Laboratories October 2004 - May 2006
Inveresk Research August 2002 - October 2004
Chesapeake Biological Labs November 2001 - June 2002
Excellus BCBS June 2000 - October 2001
Skills
CTMS, EDC, ePro, IVR, Clinical, PMI, Clinical Trial..., Clinical Trials, ICH-GCP, Clinical Research, GCP, CRO, PMP, CRF design, IRT, Consulting, SOP development, TMF, Social Media, Technical Writing, Ophthalmology, Oncology, Macular Degeneration, Dry Eye, Uveitis, Ocular Disease, Glaucoma, Diabetic Retinopathy, NSCLC, Hematologic Malignancies, Lymphoma, Pancreatic Cancer, Clinical Monitoring, Pharmaceutical Industry, Clinical Development, GMP, Lifesciences, Data Management, Pharmacovigilance, Sop, FDA, Drug Development, Biopharmaceuticals, Biotechnology, Regulatory Affairs, Life Sciences, SOP
Education
Rochester Institute of Technology
BS, Biotechnology (Highest Honors)
Rochester Institute of Technology - Saunders College of Business
MBA, Technology Management
Delozier Consulting, Inc. June 2006 - Present
Medpace 2014 - 2015
Medpace 2014 - 2015
PAREXEL February 2005 - June 2006
Inveresk Research May 2003 - February 2005
PharmaResearch Corporation 2003 - 2004
GlaxoSmithKline June 1999 - May 2003
Skills
Microsoft Office, Clinical Research, Clinical Trials, FDA, Protocol, EDC, Validation, Clinical Monitoring, CTMS, Clinical Data Management, ICH-GCP, Oncology, GCP, Clinical Development
Education
Campbell University 2001 — 2004
MS, Clinical Research
North Carolina State University 1991 — 1996
BS, BA, Biochemistry, Chemistry
Octapharma Plasma, Inc. March 2014 - Present
Belk February 2013 - March 2014
Perficient May 2010 - February 2013
ClearTrial April 2009 - September 2009
Abbott Laboratories March 2008 - April 2009
Inforte August 2005 - March 2008
Inveresk Research February 2001 - August 2005
The Graydon Corporation October 1998 - October 2000
Skills
Requirements Gathering, Business Analysis, Requirements Analysis, Siebel, Testing, Agile Methodologies, SDLC, Technical Writing, Computer System..., FDA, Healthcare Information..., Training Delivery, Cross-functional Team..., Process Definition
Education
Meredith College 1993 — 1997
BA
Independent Contractor April 2013 - Present
PAREXEL May 2012 - April 2013
PAREXEL International March 2010 - April 2012
Chiltern International April 2008 - March 2010
Chiltern August 2007 - March 2008
INC Research September 2006 - August 2007
Inclinix (formerly PharmaTech Solutions) March 2006 - August 2006
Charles River Laboratories August 2005 - April 2006
Inveresk Research August 2004 - June 2005
Inveresk Research July 2003 - July 2004
Skills
CRO, Clinical Trials, EDC, CTMS, GCP, Clinical Monitoring, ICH-GCP, Clinical Development, Pharmaceutical Industry, Clinical Research, Therapeutic Areas, Clinical Data Management, Infectious Diseases, Regulatory Submissions, Trial Management, Protocol, Sop
Education
University of North Carolina at Wilmington 1998 — 2000
Bachelor of Arts (BA), Biology, General
Delgado Community College 1992 — 1993
Certification, Respiratory Care Therapy/Therapist
Immune Tolerance Network September 2013 - March 2014
Immune Tolerance Network November 2012 - June 2013
Immune Tolerance Network November 2002 - August 2007
Elan Pharmaceuticals 2000 - 2002
Inveresk Research 1998 - 2000
Quintiles 1997 - 1998
Commonwealth Research Center, Harvard Medical School September 1992 - August 1994
Skills
Clinical Monitoring, Protocol, Drug Development, ICH-GCP, Pharmaceutical Industry, GCP, CTMS, Biopharmaceuticals, Protocol Development
Education
Cornell University 1988 — 1992
BS, Psychology
Cell Therapeutics, Inc. October 2011 - June 2013
i3 Research October 2009 - July 2011
Kendle International, Inc April 2004 - June 2009
Charles River Laboratories April 2005 - July 2006
Inveresk Research April 2001 - April 2005
PRA International August 1998 - April 2001
Skills
Clinical Trials, CTMS, Clinical Trial..., ICH-GCP, CRO, Clinical Monitoring, GCP, EDC, Oncology, Clinical Development, Therapeutic Areas, Biotechnology, Clinical Operations, Oracle Clinical, CRF design, Medidata, Cancer, Clinical Research, Clinical Data Management, Drug Development, Pharmaceutical Industry, Life Sciences
Education
University of Central Oklahoma 1992 — 1996
BS, Biology
ICON plc April 2014 - Present
ICON plc November 2011 - March 2014
ICON Clinical Research, Inc. August 2006 - November 2011
BioNumerik Pharmaceuticals May 2006 - August 2006
Bionumerik Pharmaceuticals April 2005 - May 2006
Inveresk Research 2004 - 2005
GlaxoSmithKline March 2004 - July 2004
Target Research Associates 2000 - 2004
Spectrum Pharmaceutical Research Corp. August 2000 - November 2000
ILEX Oncology March 2000 - August 2000
Skills
ICH-GCP, Clinical Trials, CRO, Clinical Development, FDA, Pharmaceutical Industry, Protocol, Clinical Research, CRF design, Training, Clinical Study Design, Vendor Management, Informed Consent, Drug Safety, GCP, EDC, Clinical Monitoring, Clinical Research..., Oncology, Research, Regulatory Affairs, 21 CFR Part 11, Clinical Operations, Quality Control, CTMS, Sop, Pharmacovigilance, Data Management, Clinical Data Management, Therapeutic Areas, Regulatory Requirements, Phase I, Regulatory Submissions, Project Management, Biotechnology, Quality Assurance, Oracle Clinical, Inform, SOP development, IRB, Diabetes, Cancer, Regulatory Documentation, eCRF, Quality Auditing, MedDRA, Medidata, LIMS, CAPA, Dermatology
Education
University of Phoenix [San Antonio Campus] 2006 — 2007
MBA, Master of Business Administration
Tusculum College 1989 — 1993
BA, Biology
Amgen June 2013 - Present
Amgen December 2009 - June 2013
Amgen October 2004 - February 2011
Inveresk Research May 1999 - September 2004
PPL Therapeutics May 1995 - May 1999
Skills
Biotechnology, Biopharmaceuticals, GMP, Quality Control, Quality Assurance, CAPA, Validation
Education
Liverpool John Moores University 1990 — 1994
Bsc Hons, Applied Biochemistry
Bluegrass Clinical Consulting, LLC October 2012 - Present
Argos Therapeutics, Inc. September 2011 - October 2012
Fulcrum Pharma January 2010 - September 2011
Biopharmaceutical Company, Seattle WA July 2009 - January 2010
Erimos January 2007 - June 2009
Omnicare Clinical Research October 2004 - January 2007
Inveresk Research December 1998 - October 2003
ClinTrials Research 1995 - 1998
ClinTrials Research 1992 - 1995
Skills
Program Management, Clinical Development, Pharmaceutical Industry, CRO, Clinical Trials, CTMS, GCP, Clinical Research, Drug Development, Oncology, ICH-GCP, Biotechnology, Sop, Biopharmaceuticals, Clinical Operations, Regulatory Affairs, FDA, Gastroenterology, Rheumatology, EDC, Therapeutic Areas, Pharmaceutics, SOP
Education
University of Mississippi 1984 — 1988
INC Research January 2014 - Present
INC Research April 2012 - December 2013
INC Research March 2011 - March 2012
PRA International December 2008 - November 2010
i3 Innovus December 2007 - December 2008
ppd 2004 - 2007
PharmaResearch 1998 - 2004
Inveresk Research 1998 - 2004
Skills
Clinical Trials, GCP, CTMS, Clinical Monitoring, Oncology, Pharmaceutical Industry, Therapeutic Areas, Infectious Diseases, Neurology, Clinical Development, Sop, Biotechnology, Endocrinology, Data Management, Cardiology, Vaccines
Education
Davidson College
University of South Carolina-Columbia
MSW, Social Work
Inveresk Research January 2000 - June 2002
Interpath Communications January 1998 - January 2000
MCI WorldCom January 1993 - January 1997
Skills
People Management, Microsoft Office, Office Management, Payroll, Corporate Communications, Event Planning, Event Management, Corporate Events, Contract Management, Administration, Non-profit Leadership
Education
Pace University-Pleasantville/Briarcliff Campus 1988 — 1991
Wasserstein Perella NYC, Accounting (Intern) permanent position 1990-1992
Bayer June 2013 - Present
inVentiv Health Clinical September 2012 - July 2013
Pfizer (Kforce Inc.; PharmaNet-i3; InVentiv) April 2006 - September 2012
Inveresk Research/ Charles River Laboratories September 2004 - April 2006
Inveresk Research March 2003 - September 2004
Radiant Research February 1997 - March 2003
Hybritech Incorporated/ Beckman Inc. June 1993 - February 1997
Loma Linda University Medical Center May 1992 - May 1993
Skills
Clinical Monitoring, GCP, Clinical Trials, CTMS, CRO, EDC, ICH-GCP, Therapeutic Areas, Clinical Development, Clinical Research, Clinical Data Management, Oncology, Endocrinology, Infectious Diseases, Pharmaceutical Industry, Diabetes, Phase I, Cardiology, Oracle Clinical, Rheumatology
Education
Palomar College
ADN, Nursing/Registered Nurse
Jacksonville University
Nursing Science
San Diego State University-California State University
Health Services/Allied Health/Health Sciences, General
UCB Pharma 2011 - Present
Schwarz Biosciences (a member of the UCB Group) 2007 - May 2011
Schwarz Biosciences 2004 - 2007
Inveresk Research 1999 - 2004
ClinTrials Research Inc 1996 - 1999
Radian International 1987 - 1996
Skills
CDISC, Statistical Programming, SDTM, Drug Development, Biotechnology, Statistics, NDA, Electronic Submissions, CRO, Clinical Trials, SAS programming, Clinical Data Management, Pharmaceutical Industry, SAS, Regulatory Submissions, Clinical Development, Biostatistics, EDC
Education
University of Warwick 1989 — 1990
Postgraduate Diploma, Statistics
Meredith College 1983 — 1987
BS / BA, Mathematics / Chemistry, French
INC Research April 2011 - Present
Kendle International 2006 - March 2011
Charles River Laboratories 2004 - 2006
Inveresk Research 2004 - 2006
Skills
Clinical Monitoring, EDC, GCP, Clinical Research, Clinical Trials, Clinical Trial..., ICH-GCP
Education
University of Sherbrooke 1993 — 1995
Liceul C. Negruzzi, Iasi
Higher Education 2011 - Present
Confidential May 2011 - September 2011
Confidential June 2008 - May 2011
Abraxis BioScience November 2006 - June 2008
Kendle International February 2001 - November 2006
Charles River Laboratories 2004 - 2006
Inveresk Research 2001 - 2004
BASF 2000 - 2001
Tascor 1996 - 1999
The Vanguard Group 1984 - 1992
Skills
Employee Relations, Training, Employment-based..., Change Management, Compensation & Benefit, Organizational..., Problem Solving, Strategic Planning, HR Policies, Employee Handbooks, Employee Training, New Hire Orientations, Full Life Cycle..., Recruiting, Personnel Management, Human Resources, Onboarding, Talent Management, Leadership, Hiring, Talent Acquisition, Succession Planning, Deferred Compensation, Performance Management, Workforce Planning, HRIS, Employee Benefits, Benefits Administration, Interviews, Temporary Placement, Applicant Tracking...
Education
Ashford University
Bachelor of Arts (BA), Psychology
North Carolina Central University
Business Adminstration
Crosspointe Church May 2012 - June 2014
self April 2008 - April 2012
Amkor Technology April 2005 - April 2007
Charles River Laboratories November 2004 - April 2005
Inveresk Research October 2000 - November 2004
Analysts International Corporation (AIC) February 1999 - October 2000
Analysts International Corporation (AIC) September 1998 - February 1999
Analysts International Corporation (AIC) September 1996 - September 1998
Adecco January 1995 - September 1996
Skills
Employee Relations, Training, Sales, Recruiting, Program Management, Operations Management, Management, Interviews, Human Resources, HRIS, HR Policies, Event Planning, Employee Benefits, Process Improvement, Team Building, Customer Service, Leadership, Microsoft Office, Public Speaking
Education
Elon University 1990 — 1994
BA, Corporate Communications
INC Research October 2006 - July 2008
Kendle International August 2006 - October 2006
Charles River Laboratories July 2005 - August 2006
Inveresk Research July 2001 - July 2005
ClinTrials Research June 1996 - July 2001
Education
Meredith College 1990 — 1996
BS, Business Administration (management concentration)
PPD April 2013 - Present
PPD August 2007 - March 2013
Inveresk 1996 - 2007
Kendle International 1996 - 2007
Charles River Laboratories 2004 - 2005
Inveresk Research 1998 - 2003
Clintrials 1996 - 1999
ClinTrials Resarch 1996 - 1998
Skills
CRO, CTMS, Clinical Trials, Clinical Research, ICH-GCP, Change Management
Education
Medical University of South Carolina 1991 — 1993
B.S., Health Information Administration
California State University San Marcos March 2015 - Present
Quartesian October 2010 - Present
California State University San Marcos September 2006 - Present
West Coast Clinical Trials June 2009 - March 2010
PharmaNet Development Group, Inc. February 2002 - May 2009
Inveresk Research 2000 - 2002
Phoenix International Life Sciences 1993 - 2000
Hoechst-Roussel Pharmaceuticals June 1986 - April 1993
Hoechst-Roussel Pharmaceuticals June 1986 - April 1993
Education
Uniformed Services University of the Health Sciences - F Edward Hebert SOM 1980 — 1984
Ph.D., Pharmacology
State University of New York College at Plattsburgh 1978 — 1980
M.S., Physiology
State University of New York College at Plattsburgh 1974 — 1978
B.S., Biochem/Biophysics
INC Research, LLC. 1996 - Present
Kendle International August 2006 - July 2011
Charles River Laboratories Clinical Services October 2004 - August 2006
Inveresk Research 1999 - 2004
ClinTrials Research June 1996 - October 1999
Monarch Staffing March 1992 - May 1996
Graham & Associates May 1984 - February 1992
Skills
Accounts Payable, Accounts Receivable, Payroll, General Ledger, Financial Reporting, Accounting, Auditing, Cash Management, Human Resources, Management, Sarbanes-Oxley Act, CRO
Education
Appalachian State University 1980 — 1983
BSBA, Information Systems
bioMerieux April 2006 - Present
RTI Health Solutions March 2004 - March 2006
Inveresk Research January 2001 - March 2004
Skills
HTML, XML, FDA, Medical Devices, Technical Communication, Manuals, Sop, Technical Writing, Quality Assurance, Clinical Trials, Software Documentation, Validation, Technical Documentation, Editing, GMP, 21 CFR Part 11, SOP
Education
North Carolina State University 2004 — 2007
MS, Technical Communication
University of North Carolina at Chapel Hill 1992 — 1996
BA, English
INNO Clinical Outcomes LLC September 2014 - Present
PAREXEL December 2009 - September 2014
DCRI 2004 - December 2009
SCIREX Corporation 2004 - 2005
Inveresk Research 2002 - 2004
PPD 2001 - 2002
Battelle- Centers for Public Health Research and Evaluation 1999 - 2001
East Carolina University School of Medicine, Department of Surgical Oncology 1998 - 1999
Skills
GCP, CTMS, Clinical Monitoring, Clinical Trials, Therapeutic Areas, EDC, Clinical Development, Clinical Data Management, Sop, Regulatory Submissions, CRO, ICH-GCP
Education
East Carolina University
Bachelor of Science (B.S.), Biology and Anthropology
Bayer HealthCare Pharmaceuticals Inc. July 2012 - Present
Novartis March 2011 - July 2012
Novartis September 2008 - February 2011
Novartis September 2007 - September 2008
Eisai Medical Research Inc. October 2005 - September 2007
OSI Pharmaceuticals Inc. August 2001 - October 2005
OSI Pharmaceuticals Inc. March 2001 - June 2001
Novartis Pharmaceuticals Canada Inc. February 1997 - February 2001
Ciba-Geigy Canada Inc. September 1996 - February 1997
Inveresk Research January 1995 - April 1996
Education
University of Plymouth 1981 — 1984
BS Combined Studies (Sciences), Chemistry and Applied Biology
Novella Clinical, Inc. August 2009 - Present
Self Employed July 2007 - Present
Helm Publishing, Inc 2007 - 2011
POZEN February 2008 - June 2009
GlaxoSmithKline January 2004 - February 2005
Inveresk Research August 2000 - January 2004
Eckerd 1999 - 2000
CVS Pharmacy 1997 - 1999
Duke University Medical Center 1990 - 1994
Skills
Clinical Research, Clinical, Data Management, Clinical Trials, Pharmaceuticals, Clinical Monitoring, Data Entry, EDC, CRO, Writing, Medical Devices, Books, Oncology, GCP, Infectious Diseases, Cardiology, Clinical Data Management, Inform, Pharmaceutical Industry, Therapeutic Areas, Regulatory Affairs, Clinical Development, ICH-GCP, Neurology, FDA, Drug Development, Diabetes, Regulatory Submissions, Biotechnology, Pharmacovigilance, Immunology, Regulatory Requirements, Protocol
Education
University of North Carolina at Chapel Hill 1980 — 1985
BS, Pharmacy
Chemware May 2005 - Present
Inveresk Research August 2004 - May 2005
Ajilon Consulting - GSK onsite May 2003 - July 2004
Headway Corporate Resources August 2002 - May 2003
Skills
Cloud Computing, Active Directory, Virtualization, DNS, VMware ESX, System Administration, RHEV, VMware Server, VMware, IPSec, pfSense, Exchange 2010/2007/2003, Exchange Support, Exchange ActiveSync, Oracle RDBMS, Microsoft Office 2007, Microsoft Cluster, DataCore, SAN, FTPS, Backup Exec, Windows Server, Windows NT, DHCP, IPv4, LAN-WAN, PPTP, RDP, Microsoft Exchange, Network Administration, NuGenesis, Instrument Interfacing, Weblogic Administration, Oracle, Enterprise Software, Linux, Help Desk Support, Databases, Microsoft Office, SQL, Microsoft SQL Server
Education
Data Innovations 2006 — 2006
RS232 Instrument Interfacing
Wake Technical Community College 2002 — 2003
MSCE Windows 2000
Houston Community College 1997 — 1999
Computer Information Systems
VTC
Quintiles November 2009 - Present
King Pharmaceuticals November 2008 - November 2009
ZARS Pharma November 2006 - October 2008
Kendle International December 2001 - October 2006
Inveresk Research February 2002 - June 2005
Skills
Clinical Monitoring, Clinical Research, CRO, CTMS, Clinical Trials, GCP, Clinical Data Management, Regulatory Submissions, PowerPoint, MS Project, Team Leadership, Customer Service, Leadership Development, Endocrinology, Public Relations, Pharmaceutical Industry, Oncology, Clinical Development, Neurology, Project Management, Line Management, PDF editing, Clinical review of...
Education
Midland University 1983 — 1986
BS, Natural Science
Valencia College 1991 — 1993
AD, Nursing
Premier Research November 2014 - Present
PharPoint Research, Inc. May 2011 - November 2014
PPD October 2007 - May 2011
PPD May 2006 - October 2007
Inveresk Research July 2004 - February 2006
Skills
Clinical Trials, GCP, CDISC, CRO, Biostatistics, SAS, Phase I, EDC, SAS programming, Clinical Research
Education
North Carolina State University 2004 — 2006
MStat, Statistics, Biomedical Statistics Concentration
North Carolina State University 2000 — 2004
BS, Statistics
PRA Health Sciences September 2014 - Present
ICON July 2013 - September 2014
sanofi September 2002 - April 2013
Inveresk Research February 2002 - August 2002
PAREXEL August 2000 - February 2002
Phoenix International 1998 - 2000
Phoenix International 1996 - 1998
Biological Monitoring, Inc. 1996 - 1997
Virginia Tech Bacteriology Center 1993 - 1994
Skills
GCP, ICH-GCP, Clinical Trials, Clinical Monitoring, Clinical Trial..., Clinical Research, Regulatory Submissions, Oncology, Cardiology, Endocrinology, Diabetes, Neurology, Urology, Immunology
Education
TUI University 2008 — 2010
M.S., Health Sciences, Summa Cum Laude
Virginia Tech
B.S., Biology
Campbell Soup Company July 2014 - Present
Campbell Soup Company July 2009 - Present
Campbell Soup Company August 2004 - July 2009
Inveresk Research May 1996 - January 2003
Fisons Pharmaceuticals April 1994 - July 1994
Skills
Continuous Improvement, Process Improvement, Cross-functional Team..., Manufacturing, Lean Manufacturing, Supply Chain, Project Management, Data Analysis, Microsoft Excel, six sima, Homogenization, Kaizen, Troubleshooting
Education
Napier University 1995 — 1996
diploma, biological sciences
peebles high
INNO Clinical Outcomes LLC October 2013 - Present
Ockham November 2010 - September 2013
Abraxis BioScience June 2008 - May 2010
AAIPharma Services Corp. April 2007 - June 2008
Comprehensive Neuroscience, Inc January 2007 - April 2007
Duke Clinical Research Institute November 2006 - January 2007
PPD September 2004 - October 2006
Novella Clinical, Inc. November 2003 - August 2004
Inveresk Research March 1991 - October 2003
Skills
CRO, Data Management, FDA, Clinical Development, EDC, Therapeutic Areas, Regulatory Affairs, Clinical Trials, Clinical Data Management, Clinical Research, Sop, ICH-GCP, Pharmaceutical Industry, Infectious Diseases, Cardiology, Oncology, GCP, Biotechnology, Validation, Protocol, Drug Development, CTMS, Vaccines, Lifesciences, Regulatory Submissions
Education
University of Arkansas at Little Rock
Bachelor of Arts
Forest Laboratories 2007 - 2010
TAP Pharmaceuticals 2003 - 2007
Inveresk Research 1999 - 2002
Clintrials Research 1998 - 1999
Education
McMaster University 1992 — 1996
BScN, Nursing
Fujifilm Imaging Colorants Inc. April 2011 - Present
Fujifilm Imaging Colorants Ltd January 2006 - April 2011
FujiFilm Imaging Colorants (Formerly Avecia Ltd.) April 2000 - January 2006
A Marks & Co Ltd February 1994 - April 2000
Inveresk Research January 1993 - February 1994
Tioxide UK Ltd October 1987 - January 1993
Education
The University of Dundee 1980 — 1987
BSc/PhD, Chemistry
Duke University Health System May 2013 - Present
PharmaNet/i3 March 2007 - May 2013
PPD Development December 2004 - February 2007
INC Research 2002 - 2004
Inveresk Research June 2001 - April 2002
Duke Image Analysis Lab (DIAL); Duke Dept of Radiology October 1999 - June 2001
Skills
EDC
Education
Duke University
BS, Biology, General
INC Research 2012 - October 2014
Chimerix 2010 - 2012
GlaxoSmithKline 2005 - 2010
Inveresk Research 2004 - 2005
i3 Research 2001 - 2004
PPD September 1999 - January 2001
Skills
Clinical Trials, ICH-GCP, Infectious Diseases, Clinical Development, Neurology, Cardiology, Diabetes, Regulatory Submissions, FDA, Lifesciences, IRB, Cancer, Hematology, Clinical Monitoring, Oncology, Clinical Research, Endocrinology, Regulatory Affairs, Biotechnology, Neuroscience, Gastroenterology, Rheumatology, Therapeutic Areas, CTMS, EDC
Education
The Ohio State University 1984 — 1987
Master's degree, Nursing Science
University of Colorado Health Sciences Center 1981 — 1983
School Nurse Practitioner, School aged children
Montana State University-Bozeman
BSN, Nursing
INC Research August 2014 - June 2015
INC Research August 2012 - August 2014
INC Research July 2011 - August 2012
Kendle (formerly Charles River Laboratories, formerly Inveresk) February 2005 - July 2011
Inveresk Research June 2001 - February 2005
Skills
Sop, GCP, Pharmaceutical Industry, Clinical Trials, CRO, Regulatory Affairs, FDA, 21 CFR Part 11, Validation, ICH-GCP, CTMS, Clinical Development, Regulatory Submissions, EDC, GMP, Clinical Monitoring, Pharmacovigilance, Oncology, CAPA, Biotechnology, Clinical Study Design
Education
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor of Arts (B.A.), Psychology
University of North Carolina at Chapel Hill 1991 — 1995
Bachelor's degree, Psychology
Triangle Clinical Trial Mgmt September 2006 - Present
Rho 2009 - 2012
Omeros Corporation 2008 - 2011
Averion International 2007 - 2009
Medifacts International 2004 - 2006
Inveresk Research 2000 - 2004
Duke University Medical Center July 1996 - May 2000
Education
University of North Carolina at Chapel Hill 1994 — 1996
Bachelor's degree, Registered Nursing/Registered Nurse
University of North Carolina at Chapel Hill 1988 — 1992
Bachelor's degree, Biology, General