Novella Clinical, Inc.
Industry: Company
DescriptionFounded: 1998 Parent organization: IQVIA Subsidiary: Novella Clinical Resourcing, Ltd.
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Novella Clinical, Inc. Employees
Premier Research February 2015 - Present
Clinipace Worldwide October 2014 - February 2015
Novella Clinical, Inc. August 2013 - October 2014
RTI International July 2007 - August 2013
Beaumont Family Chiropractic September 2005 - July 2007
Skills
Forecasting, Budgets, Leadership, Finance, Project Management, Accounting, Contract Management, Invoicing, Process Scheduler, Team Management, PeopleSoft, Cognos, Deltek, SAP Business ByDesign, Costpoint, Oracle, CRO, Clinical Trials, Profit Analysis
Education
University of Phoenix 2005 — 2009
Bachelor of Science, Business - Accounting
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
PRA Health Sciences June 2011 - Present
Novella Clinical, Inc. December 2008 - June 2011
PPD August 2007 - December 2008
PPD May 2006 - July 2007
Shanklin and Nichols, LLP July 2002 - April 2006
Howard Stallings From & Hutson July 2001 - June 2002
Skills
Clinical Research, Contract Negotiation, Budget Negotiation, CRO, Clinical Trials, Pharmaceutical Industry, Biotechnology, Negotiation
Education
University of North Carolina at Wilmington 1997 — 2001
BA, Criminal Justice/Spanish
Novella Clinical November 2013 - Present
Novella Clinical, Inc. July 2009 - October 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" July 2008 - July 2009
Accentuate Staffing June 2006 - June 2008
Ruthi Postow Staffing June 2005 - June 2006
Skills
CRO, CTMS, EDC, Clinical Trials, Clinical Research, Training, GCP, Human Resources, Pharmaceutical Industry, Clinical Development, ICH-GCP, Sop, Clinical Monitoring, Clinical Data Management, Software Documentation, Management, Oncology, SOP
Education
University of North Carolina at Chapel Hill 2001 — 2005
BA, Communication Studies
North Mecklenburg High School 1998 — 2001
NSTAR Global Services January 2015 - Present
Novella Clinical, Inc. October 2014 - January 2015
DOCS Global May 2012 - August 2014
Summary January 2014 - January 2014
Skill Set Summary January 2013 - January 2014
KYMA TECHNOLOGIES, INC January 2011 - August 2011
Pittard Perry & Crone (Currently Carr, Riggs & Ingram) January 2008 - November 2009
BONHAM & COMPANY-CPA August 2007 - December 2007
Williams Adams & Company, CPAs (formally Williams Brown Parsons & CO) November 2004 - May 2007
ChevronTexaco August 1996 - November 2004
Skills
PeopleSoft, QuickBooks, Oracle, Solomon, SAP, Microsoft Office, Excel, OMNI, Creative Solutions..., FAS Asset, Go Systems, ProSystems tax, Lacert, Mas 90, Sage Master Builder, Peachtree, Word, PowerPoint, Access, US GAAP, GAAS, Government Contracts, Fund Accounting, White Papers, Internet Research, Tax Preparation, Corporate Tax, Sales Tax, Property Tax, payroll tax returns, Payroll Processing, Financial Analysis, Financial Reporting, Financial Accounting, General Ledger, Balance Sheet Review, Account Reconciliation, P&L Analysis, Operating Budgets, Flash, Cash Flow Forecasting, Accounts Receivable, Accounts Payable, Accounting, Financial Statements, Accruals, Bank Reconciliation, Auditing, Project...
Education
University of Phoenix 2009 — 2011
MBA, Master's in Business Administration
University of Phoenix 1999 — 2003
BS/Accounting, Business Administration, Management and Operations
Novella Clinical, Inc. November 2013 - Present
Salix Pharmaceuticals November 2011 - August 2013
Celgene October 2007 - November 2011
RSI and Constella Group 2001 - 2007
CTSS of Durham March 1999 - June 2001
Duke Clinical Research Institute (DCRI) December 1990 - July 1999
Skills
Regulatory Requirements, Technical Expertise, CTMS, Application Testing, Clinical Research, Group Presentations, Troubleshooting, Training New Hires, Comittee Participant..., PowerPoint, Problem Solving, Outlook, Excel, Microsoft Office, Clinical Trials, Word, Mentoring, SOP, Negotiation, Biotechnology, Endocrinology, Neurology, Oncology, Cardiology, Diabetes, Contract Negotiation, EDC, Budget Preparation, Budget Tracking, Organizational..., Site Management, Protocol Review, Meeting Planning, Training, Guidance Documents, Macro, Sop, ICH-GCP, Regulatory Affairs, FDA, Therapeutic Areas, Protocol, Clinical Development, Clinical Data Management, Pharmaceutical Industry, Inform, Infectious Diseases, Hematology, Medical Writing, Pharmacovigilance
Education
University of Phoenix 2009 — 2011
MBA, Business Management
University of Phoenix 2005 — 2009
BS/BM, Business
Novella Clinical July 2015 - Present
Novella Clinical, Inc. June 2014 - August 2014
Northwestern Mutual August 2013 - May 2014
Genesco February 2012 - January 2014
Massage Envy April 2013 - August 2013
Valentunana Curso de Ingles July 2011 - August 2011
American Eagle Outfitters November 2010 - February 2011
Cirrus Pharmaceuticals June 2010 - December 2010
Skills
Facebook, Teamwork, Microsoft Office, PowerPoint, Microsoft Word, Research, Salesforce.com, Financial Services, Sales, Public Speaking, Microsoft Excel, Social Media, Mathematics
Education
Universitat de València 2014 — 2015
Finance
University of North Carolina at Wilmington 2012 — 2015
Bachelor’s Degree, Business Administration with a concentration in Finance and a minor in Spanish, 3.73
Catalyst Clinical Resourcing, LLC May 2013 - Present
Novella Clinical, Inc. October 2011 - December 2012
Novella Clinical Resourcing 2005 - October 2011
The Woolf Group 1995 - 2002
ClinTrials Research 1992 - 1995
Skills
Clinical Staffing, Marketing Strategy, Physician Network..., Leadership, Outsourcing, Marketing
Education
University of Minnesota-Twin Cities
BA
Novella Clinical, Inc. March 2015 - Present
Novella Clinical, Inc. February 2015 - March 2015
Novella Clinical, Inc. September 2011 - January 2015
Quintiles December 2009 - September 2011
PPD August 2008 - November 2009
Arcade Marketing April 2003 - May 2008
Health Care Services Group September 2002 - March 2003
Skills
Pharmacovigilance, Narrative Writing, Workflow Management, Contract Research..., Clinical Trials, Clinical Research, Drug Safety, Medical Devices, Inform, ARISg, 21 CFR Part 11, MedDRA, EDC, GCP, CRO, ICH-GCP, Narrative
Education
University of North Carolina at Wilmington 1998 — 2002
Bachelor of Science, Biology
Grifols November 2014 - Present
INC Research March 2012 - November 2014
Novella Clinical, Inc. July 2009 - March 2012
Skills
Regulatory Affairs, Medical Writing, Regulatory Submissions, Regulatory Documentation, Clinical Trials, GCP, ICH-GCP, Oncology, Regulatory Requirements, Life Sciences, Protocol, Pharmacology, CRO
Education
UNC Chapel Hill 2003 — 2009
Doctor of Philosophy (PhD), Pharmacology
University of Maryland Eastern Shore 1999 — 2003
Bachelor's degree, Biology, General
Novella Clinical, Inc. November 2014 - Present
Compliance Implementation Services CIS December 2013 - April 2014
Compliance Implementation Services CIS March 2013 - December 2013
Wrigley July 2010 - January 2013
CVS Pharmacy May 2009 - May 2010
The Wilmington Post, LLC August 2008 - May 2009
Rite Aid Pharmacy September 2006 - September 2008
Hayes Barton Pharmacy March 2003 - August 2005
Skills
Retail, Sales, Management, Marketing, Selling, CRM, Salesforce.com, Employee Training, Customer Service, Long-term Customer..., B2B, Inventory Management, Market Research, Business Development
Education
University of North Carolina at Wilmington 2005 — 2009
BSBA, Marketing, Minor- Spanish
Broughton High School 2001 — 2005
PPD October 2014 - Present
WITN-7 January 2014 - October 2014
Tutt Media Group October 2010 - October 2014
Novella Clinical, Inc. March 2010 - October 2010
PPD January 2007 - March 2010
Skills
SOP, Quality Assurance, Mentoring, Training, Clinical Trials, FDA, Project Management, Editing, Networking, Microsoft Office
Education
Univeristy of North Carolina at Wilmington 2015 — 2018
Master’s Degree, Clnical Research and Product Development
University of North Carolina at Wilmington 2002 — 2004
Bachelor's Degree, Film
University of North Carolina at Wilmington 2002 — 2004
Minor in English
Novella Clinical, Inc. October 2011 - Present
Clinsys Clinical Research February 2011 - October 2011
Quintiles November 2009 - March 2011
Quintiles April 2009 - October 2009
Quintiles August 2006 - March 2009
Thomson Learning, Inc. July 2003 - August 2006
Red Hat June 2002 - July 2003
SAS April 2001 - May 2002
The Dialog Corporation January 2001 - March 2001
West Group, Inc. August 1998 - January 2001
Skills
Project Management, Business Development, Process Improvement, Clinical Trials, Management, Proposal Writing, CRO, Budgets, Analysis, Training, Marketing, Project Planning, Sales, Sales Operations, GCP, Strategy
Education
University of North Carolina at Chapel Hill 1988 — 1992
BAs, Psychology and Anthropology
Novella Clinical July 2012 - Present
Novella Clinical, Inc. December 2007 - June 2012
Skills
CTMS, CRO, Clinical Development, Clinical Trials, FDA, Medical Devices, Project Management
Education
University of Iowa 1992 — 1996
BS, Physiology and Business Administration
Novella Clinical, Inc. April 2014 - Present
Novella Clinical, Inc. September 2012 - March 2014
MD Clinical Monitor, LLC April 2010 - September 2012
Hematology Oncology Consultants Inc 2011 - 2012
Ohio State University Medical Center September 2007 - February 2010
InVasc Therapeutics, Inc May 2007 - April 2009
VA Ann Arbor Healthcare System September 2003 - August 2006
University of Michigan October 2002 - 2003
Delta Medical Search Associates August 1998 - May 2000
State of Ohio January 1996 - January 1998
Skills
Clinical Trials, Clinical Research, Oncology, GCP, Clinical Development, Healthcare, Clinical Monitoring, Diabetes, Hospitals, Cardiology, Healthcare Management, Drug Development, Hematology, Protocol, Research, CTMS, IRB, Nursing, CRO, Clinical Data Management, ICH-GCP
Education
Franklin University, Graduate School of Business 1996 — 1998
Masters of Business Administration, Health Services Administration
University of Pennsylvania 1994 — 1995
Bachelors of Science, Biology
Trocaire College 1991 — 1993
Associates of Applied Sciences, Medical Laboratory Technology
Rungta Vidya Bhavan 1975 — 1985
Novella Clinical, Inc. May 2014 - Present
Novella Clinical, Inc. March 2012 - May 2014
Novella Clinical, Inc. December 2010 - March 2012
INC Research (Kendle) December 2009 - 2010
Skills
GCP, CTMS, Project Management, Clinical Research, Clinical Trials, Regulatory Affairs, Clinical Monitoring, ICH-GCP, Therapeutic Areas, CRO, Clinical Data Management, Oncology, EDC, Clinical Development, Pharmaceutical Industry
Education
University of North Carolina at Wilmington 2006 — 2015
Master of Science (M.S.), Clinical Research, Project Management, 4.0 GPA
Richmond Ambulance Authority June 2015 - Present
UREMS November 2013 - Present
CarMax May 2015 - July 2015
University of Richmond August 2013 - May 2014
Novella Clinical, Inc. May 2013 - August 2013
University of Richmond August 2012 - May 2013
Novella Clinical, Inc. July 2012 - August 2012
Kramden Institute June 2009 - August 2010
Skills
Event Planning, Microsoft Office, Social Media, PowerPoint, Windows, Microsoft Excel, Project Management, Customer Service, Strategic Planning, Public Speaking, Research, Open Office, Active Directory, Help Desk Support, Fundraising, Microsoft Word, Leadership
Education
University of Richmond 2012 — 2016
Bachelor of Arts (B.A.), PPEL and Leadership Studies
University of Iringa 2014 — 2014
Study Abroad, Management of Community Development Programs
Armand Hammer United World College of the American West 2010 — 2012
IB Diploma, English A1 HL, Economics HL, History HL, Environmental Systems SL, Spanish B SL, Math SL
Cary Academy 2005 — 2010
High School, General
Novella Clinical, Inc. December 2013 - Present
PRA International September 2011 - November 2013
Duke Clinical Research Institute April 2009 - September 2011
Duke Clinical Research Institute January 2007 - April 2009
Skills
CTMS, Inform, Clinical Monitoring, EDC, GCP, ICH-GCP, CRO, Clinical Trials, Oracle Clinical, IRB, Clinical Data Management, Clinical Development, Clinical Research, Protocol, Regulatory Submissions, Medidata, Clinical Operations, Neurology, Patient Recruitment, Pharmaceutical Industry, Oncology, SOP, Biotechnology, Regulatory Affairs
Education
University of North Carolina at Wilmington 2000 — 2004
Bachelors of Arts, Psychology
Akesis, LLC September 2013 - Present
Novella Clinical, Inc. December 2012 - September 2013
TT Pharma July 2011 - August 2012
PharmaNet Development Group, Inc. June 2010 - December 2010
PharmaNet Development Group, Inc. September 2003 - June 2010
Skills
Budget Tracking, Project Coordination, Regulatory Review, Customer Service, Administrative Support, Quality Assurance, GCP, Clinical Trial..., CRO, Clinical Research, Lotus Notes, ICH-GCP, Mentoring, Word, Excel, EDC, Data Entry, Outlook, IRB, CTMS, Microsoft Office, Endocrinology, Microsoft Excel, Budgets, Administrative..., Therapeutic Areas, Clinical Data Management, Regulations, Clinical Development, Clinical Monitoring, Oncology, Microsoft Word, Clinical Trials, Software Documentation, Regulatory Affairs, Validation, Protocol, Inform, Sop, Infectious Diseases, Oracle Clinical, Data Management, FDA, Biotechnology, Pharmacovigilance, Pharmaceutical Industry, Cardiology
Education
University of Phoenix 2008 — 2008
N/A, Communications
East Mecklenburgh High School 1994 — 1997
General studies
PPD July 2013 - Present
Novella Clinical December 2011 - July 2013
Novella Clinical, Inc. February 2011 - December 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI" October 2005 - February 2011
PPD 2001 - 2005
PPD 1999 - 2001
PPD 1990 - 1998
Skills
Clinical Research, Leadership, FDA, CTMS, Clinical Monitoring, EDC, Clinical Trials, Project Management, Clinical Development, CRO, Training, Vaccines, GCP, Therapeutic Areas, Clinical Operations, ICH-GCP, Oncology
Education
University of North Carolina at Wilmington 1984 — 1988
BS, Biology
Esri March 2014 - Present
Novella Clinical, Inc. April 2011 - March 2014
The University of North Carolina at Greensboro (UNCG) 2008 - 2010
Skills
Blackberry Enterprise..., Laptops, Citrix, Group Policy, Active Directory, Antivirus, Track It - Ticketing..., Dell Computers, Lenovo Computers, Microsoft Exchange, Windows Server, Windows 7, XP, DHCP, SCCM, Apple, Windows 8.1
Education
University of North Carolina at Greensboro 2005 — 2010
BS, Information Systems Operations Management
Novella Clinical, Inc. March 2015 - Present
Wake Forest University August 2010 - March 2015
Medical College of Georgia September 2008 - January 2010
Mississippi State University August 2008 - September 2008
Skills
Animal Models, Research, Science, Neuroscience, Cell Biology, Scientific Writing, Physiology, In Vivo, Protein Expression, Lifesciences
Education
Wake Forest University School of Medicine 2011 — 2015
PhD, Neuoscience, Pharmacology
University of Florida 2004 — 2008
Bachelor of Science (B.S.), Zoology/Animal Biology
Novella Clinical August 2015 - Present
Novella Clinical, Inc. August 2014 - August 2015
Quintiles July 2012 - January 2014
Cancer Centers of North Carolina May 2011 - May 2012
Charleston Area Medical Center Health System March 2010 - May 2011
Skills
Oncology Clinical..., Oncology, Oncology Nursing, Clinical Research, Clinical Monitoring, Clinical Trials, Registered Nurses, Protocol, ICH-GCP, CTMS, EDC, GCP, CRO, Regulatory Affairs, SOP, Clinical Data Management, Regulatory Requirements, Clinical Development, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 2002 — 2003
Bachelor of Science (B.S.), Registered Nursing/Registered Nurse
University of North Carolina at Wilmington 1995 — 2000
Bachelor of Arts (B.A.), Therapeutic Recreation/Recreational Therapy
Medidata Solutions February 2015 - Present
PAREXEL June 2014 - February 2015
MMS Holdings Inc. September 2013 - May 2014
Novella Clinical, Inc. July 2012 - September 2013
PPD March 2011 - July 2012
PPD, Inc June 2007 - March 2011
Wilmington-Wireless July 2005 - December 2006
Skills
Clinical Trials, CTMS, Oncology, GCP, Pharmaceutical Industry, CRO, Clinical Monitoring, Microsoft Excel, Customer Service, Budgets, Budget Proposals, Contract Negotiation, Financial Analysis, Financial Reporting, Financial Risk, Financial Forecasting, RFP, Process Improvement, ICH-GCP, EDC
Education
University of North Carolina at Wilmington 2004 — 2007
Bachelor of Science, Business Administration; Finance
Novella Clinical, Inc. February 2015 - Present
PPD April 2014 - March 2015
PPD January 2013 - April 2014
PPD December 2011 - December 2012
Tarheel Physicians Supply May 2011 - August 2011
Skills
Salesforce.com, CTMS, Sales Prospecting, Budget Development, Proposal Generation, Proposal Coordination, Sales Support Tools, PowerPoint, Team Building, Entrepreneurship, Regulatory Documentation, Microsoft Office, Business Analysis, Phone Skills, Excel, Facebook, Twitter, Outlook, Cascade, Livelink
Education
Cameron School of Business 2010 — 2012
University of North Carolina at Wilmington 2010 — 2012
Bachelor of Science, Business Administration; Management and Leadership
Novella Clinical, Inc. January 2014 - Present
Novella Clinical, Inc. March 2011 - January 2014
Novella Clinical, Inc. November 2008 - March 2011
Accentuate Staffing June 2006 - November 2008
Skills
EDC, Clinical Trials, CTMS, Project Management, CRO, Clinical Research, Budgets, Human Resources
Education
University of North Carolina at Chapel Hill 2003 — 2007
BA, Communication Studies
Novella Clinical, Inc. February 2013 - Present
Novella Clinical, Inc. March 2012 - February 2013
Novella Clinical, Inc. December 2010 - March 2012
Novella Clinical, Inc. July 2009 - December 2010
Novella Clinical, Inc. July 2008 - July 2009
INC Research January 2008 - July 2008
GSK June 2004 - January 2008
Wake Research Associates March 2003 - December 2003
Skills
CRO, CTMS, Clinical Monitoring, EDC, ICH-GCP, Clinical Data Management, Inform, Clinical Trial..., Dermatology, Oncology, SOP, Regulatory Affairs, Cardiology, Quality Assurance, Auditing, Mentoring, PowerPoint, Excel, Outlook, Customer Service, Pharmaceuticals, Problem Solving, Strategic Planning, Budgeting, Healthcare, Access, Start-ups Management, Project Closeout, IP reconciliation, Device Studies, Post Marketing Trial..., Query Resolution, Staff Retention, Resourcing Strategies, Study Coordination, Infectious Diseases, Regulatory Submissions
Education
University of North Carolina at Chapel Hill 1999 — 2001
Master of Public Health (M.P.H.), Health/Health Care Administration/Management
M.S. University 1991 — 1995
Educational Psychology
Novella Clinical, Inc. July 2014 - Present
University of North Carolina at Chapel Hill March 2012 - February 2014
INC Research February 2010 - February 2012
INC Research October 2008 - February 2010
INC Research February 2008 - October 2008
INC Research February 2007 - February 2008
INC Research June 2006 - February 2007
University of North Carolina May 2004 - June 2006
GlaxoSmithKline February 2002 - May 2004
Associates in Internal Medicine February 2000 - January 2001
Skills
Clinical Trials, CTMS, Oncology, ICH-GCP, Sop, Infectious Diseases, Clinical Monitoring, FDA, Therapeutic Areas, Project Management, Clinical Research, GCP, Biotechnology, Clinical Operations, Drug Development, Lifesciences, CRO, Data Management, EDC, Regulatory Submissions, IRB, Clinical Data Management, Diabetes, Epidemiology, Neurology, Pharmaceutical Industry, Biostatistics, Protocol, Immunology, Regulatory Affairs, Laboratory, Cardiology, Neuroscience, Cancer, Phase I, Public Health, Pharmacovigilance, Oncology Clinical..., Pharmacology, Pharmacokinetics
Education
University of North Carolina 2002 — 2004
B.A, Biology
University of North Carolina at Chapel Hill 2002 — 2004
Bachelors, Biology, General
Potter Financial Group September 2014 - Present
Novella Clinical, Inc. January 2003 - June 2014
Novella Clinical, 2003 - June 2014
Clinical Research Organization May 2006 - February 2012
Skills
Long Term Care Insurance, Retirement Planning, CRO, Human Resources, Pharmaceutical Industry, Clinical Trials, Clinical Development, CTMS, EDC, Sop, GCP, Biotechnology, Regulatory Affairs, Software Documentation, Project Management, Data Management, Talent Acquisition, Applicant Tracking...
Education
University of North Carolina at Wilmington 1985 — 1990
Bachelor of Science (BS), Social Work
Northern High
Northern High
Novella Clinical July 2015 - Present
Novella Clinical, Inc. August 2009 - July 2015
Constella Group May 2006 - December 2008
IBM June 1999 - May 2006
McMillan, Pate & Company, L.L.P. September 1997 - June 1999
Dixon Hughes Goodman LLP July 1996 - September 1997
Skills
Financial Reporting, Auditing, Accounting, Financial Analysis, Account Reconciliation, Forecasting, Variance Analysis, Revenue Recognition, Consolidation, General Ledger, Process Improvement, Budgets, Fixed Assets, Financial Accounting, Accounts Payable, Financial Statements, Tax, Accruals, Accounts Receivable, US GAAP, Payroll, CPA, QuickBooks, Internal Controls, Access, Cost Accounting, Internal Audit, Financial Audits, Fixed Asset Management, Cash, Deltek, Spreadsheets, Statutory Accounting, Corporate Tax, Mergers, Accountants, Expenses, External Audit, Journal Entries, GAAP, Tax Preparation, SEC filings, Sarbanes-Oxley, Hyperion Enterprise, Cash Flow, Managerial Finance, Cash Management, SAP, Sarbanes-Oxley Act, Hyperion
Education
University of North Carolina at Wilmington 1994 — 1996
MSA, Accountancy
University of North Carolina at Chapel Hill 1988 — 1992
Biology, BA
Novella Clinical, Inc. April 2007 - Present
EDS Group January 2006 - April 2007
Levolor Home Fashions - Newell Rubbermaid November 1999 - January 2006
Skills
Landlord, USSF Soccer Referee, Disaster Recovery, System Administration, Oracle, Database Design, SQL, Databases, Landlords, Unix, Microsoft SQL Server
Education
John Wesley College 1996 — 1997
Bachelor's degree, Business Administration and Management, General
University of North Carolina at Greensboro
Adams Consulting Services, LLC March 2013 - Present
Novella Clinical, Inc. August 2012 - March 2013
Ockham Development Group (an ASG Company) February 2010 - August 2012
Kendle International, Inc December 2007 - February 2010
PharmaNet Development Group, Inc. 2005 - 2007
Inversek Research 2002 - 2004
Cancer and Leukemia Group B Duke University 2000 - 2002
Corning Incorporated 1998 - 2000
Skills
ICH-GCP, Oracle Clinical, CRO, EDC, CDISC, CRF design, Clinical Data Management, Clinical Trials, GCP, CTMS, Medidata, Clinical Development, Data Management, Inform, Clinical Monitoring
Education
University of North Carolina at Wilmington 1995 — 1998
Bachelor's, Chemistry
Novella Clinical, Inc. August 2004 - Present
PPD 1997 - 2004
Zeneca 1989 - 1997
Skills
Oncology, Clinical Development, CRO, Pharmaceutical Industry, Clinical Trials, CTMS, EDC, Medical Devices, Regulatory Affairs, Infectious Diseases, 21 CFR Part 11, Vaccines, GCP, Regulatory Submissions, Neurology, Drug Development, Biotechnology, Medical Writing, Lifesciences, Leadership, Cardiology, FDA, Clinical Monitoring, Pharmacovigilance, Hematology, Sop
Education
University of North Carolina at Chapel Hill 1980 — 1984
Bachelor of Arts (B.A.), Economics
Novella Clinical, Inc. February 2010 - Present
OSI Pharmaceuticals 1999 - 2010
Somatogen 1995 - 1997
Skills
Clinical Trials, CRO, Oncology, EDC, Clinical Development, Pharmaceutical Industry
Education
University of Missouri-Saint Louis
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
INC Research November 2011 - Present
Quintiles Transnational June 2010 - January 2011
NOVELLA CLINICAL February 2009 - June 2010
Novella Clinical, Inc. 2009 - 2010
PPD April 2007 - September 2008
UNC HEALTHCARE February 2005 - March 2007
LABORATORY CORPORATION OF AMERICA November 2000 - February 2005
Education
University of North Carolina at Greensboro 1995 — 2000
BS, BIOLOGY/CONCENTRATION IN BIOTECHNOLOGY
Novella Clinical, Inc. October 2012 - Present
Social & Scientific Systems January 2001 - July 2012
Skills
SAS, Clinical Trials, Epidemiology, Public Health, CRO, Clinical Research, GCP, Clinical Development, Data Analysis, CTMS, Biotechnology, Infectious Diseases, Data Management, ICH-GCP
Education
University of South Florida 1997 — 2000
Master of Public Health (MPH), Epidemiology
University of South Florida 1994 — 1997
Bachelor of Science (BS), Environmental Science and Policy
Novella Clinical July 2015 - Present
Novella Clinical, Inc. March 2014 - Present
Novella Clinical, Inc. January 2011 - March 2014
Novella Clinical May 2008 - January 2011
Omnicare May 2007 - May 2008
Constella Group 2007 - 2007
Lineberry Research Associates 2005 - 2007
Constella Group & Lineberry Research Associates 2005 - 2007
Lineberry Research Associates (now SRA) 2005 - 2007
Skills
CRO, Clinical Research, EDC, Clinical Monitoring, CTMS, Clinical Trials, GCP, ICH-GCP, Clinical Development, Pharmaceutical Industry
Education
UNC Chapel Hill 1996 — 2000
BS, Clinical Laboratory Science
University of North Carolina at Chapel Hill 1996 — 2000
BS, Clinical Laboratory Science
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
Novella Clinical, Inc. January 2013 - Present
Paragon Biomedical May 2009 - January 2013
i3 Research 2006 - 2009
ClinTrials 1997 - 1999
Health Cost Management/HDI 1989 - 1991
Skills
Business Development, Pharmaceutical Industry, EDC, FDA, CTMS, 21 CFR Part 11, CRO, Strategic Planning, Clinical Development, Oncology, Clinical Monitoring, Business Strategy, Neurology, GCP, Therapeutic Areas, Healthcare, Clinical Trials, Medical Devices, Clinical Operations, Immunology, New Business Development, Sop, Clinical Data Management, Lifesciences, Data Management, Biotechnology, Regulatory Submissions, Dermatology, Diabetes, Management, Drug Development, Medical Writing, Phase I, Cardiology, Endocrinology, ICH-GCP, Contract Negotiation, Infectious Diseases, Protocol, Pharmacovigilance, Vaccines, Regulatory Affairs, Cross-functional Team..., Clinical Research
Education
University of Dayton 1967 — 1971
B.S., Social Work, Psychology
Consultant - Data Management Medical Coding August 2014 - Present
Novella Clinical, Inc. June 2012 - July 2014
INC Research acquired Kendle International May 2011 May 2011 - June 2012
Kendle International August 2008 - May 2011
etrials Worldwide, Inc. October 2000 - August 2008
Quintiles October 1998 - October 2000
Skills
MedDRA, EDC, Inform, Data Management, DataTrak, dsNavigator, Central Coding, WHODrug Dictionary, OmniComm Trial Master, eCOS EDC, Medidata, Clinical Data Management, Regulatory Affairs, CRO, Biotechnology, Medical Coding, ICH-GCP, Computer System..., Clinical Data, Cardiology, 21 CFR Part 11, Clinical Research, Clinical Trials, Pharmacovigilance, Clinical Development, Sop, Therapeutic Areas, Oracle Clinical, CTMS, GCP, Regulatory Submissions, Oncology, Infectious Diseases, Lifesciences, CRF design, Clinical Monitoring, CDISC, Pharmaceutical Industry, FDA
Education
University of Mount Olive 2007 — 2009
BS, BA-Mgmnt Organization Development
Novella Clinical, Inc. January 2015 - Present
Novella Clinical, Inc. May 2013 - January 2015
Novella Clinical July 2012 - April 2013
Rho December 2009 - July 2012
Rho, Inc. December 2009 - February 2011
Education
University of North Carolina at Chapel Hill 2005 — 2009
Bachelor of Science, Public Health
Novella Clinical June 2015 - Present
Novella Clinical, Inc. April 2015 - June 2015
Novella Clinical, Inc. November 2013 - March 2015
Bioventus May 2013 - November 2013
Novella Clinical, Inc. May 2011 - May 2013
IBM December 2005 - April 2011
Skills
Financial Reporting, Accounting, Sarbanes-Oxley Act, Financial Analysis, Hyperion Enterprise, Account Reconciliation, Forecasting, SAP, Process Improvement, Cost Accounting, Internal Controls, Finance, Variance Analysis, Business Analysis, Financial Accounting, Management, Pharmaceutical Industry, General Ledger, Microsoft Excel, Analysis, US GAAP, Strategic Planning
Education
University of Kentucky 2004 — 2005
Master of Science, Accounting
University of Kentucky 2001 — 2004
Bachelor of Science, Accounting
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
Novella Clinical September 2015 - Present
Novella Clinical, Inc. April 2015 - August 2015
Novella Clinical, Inc. September 2013 - March 2015
Novella Clinical, Inc. September 2007 - September 2013
Tranzyme Pharma November 2006 - September 2007
PharmaLinkFHI October 2000 - November 2006
ClinTrials 1999 - 2000
Remington Davis June 1997 - June 1999
Grant Medical Center, Cardiac Step-down Unit June 1996 - August 1998
University of North Carolina, Dept. of Pathology June 1994 - May 1996
Skills
CTMS, Project Management, Oncology, GCP, CRO, Clinical Monitoring, Biotechnology, Clinical Development, Infectious Diseases, Therapeutic Areas, ICH-GCP, EDC, Regulatory Affairs, Clinical Trials, Hematology, Drug Development, Pharmaceutical Industry, Regulatory Submissions, Clinical Data Management
Education
University of North Carolina at Chapel Hill 1989 — 1994
BS, Biology
Novella Clinical, Inc. March 2010 - March 2014
Novella Clinical, Inc. August 2009 - November 2009
Trinity Research Consultants January 2009 - February 2009
A.R. Kamm Associates December 1999 - September 2000
Glaxo Wellcome 1995 - 1995
Glaxo Inc. September 1986 - January 1991
Skills
Clinical Trials, CRO, EDC, Oncology, SOP, Clinical Research, FDA, GCP, CTMS, Pharmaceutics
Education
University of North Carolina at Chapel Hill 1979 — 1983
B.S., Business Administration
Novella Clinical, Inc. December 2011 - Present
Education
Wake Technical Community College 2009 — 2011
Database Administration
University of Massachusetts, Amherst 1999 — 2003
B.A., Psychology
SynteractHCR September 2014 - Present
Novella Clinical, Inc. February 2013 - September 2014
Novella Clinical, Inc. January 2012 - February 2013
Novella Clinical, Inc. November 2010 - January 2012
Quintiles 2000 - 2002
Quintiles 1996 - 2000
Bayer (Schering AG) 1991 - 1996
Skills
Clinical Research, CRO, CTMS, EDC, Clinical Monitoring, ICH-GCP, GCP, Clinical Development, Clinical Study Design, Clinical Trials, Sop, Clinical Operations, Therapeutic Areas, Line Management, Oncology, Protocol, Clinical Data Management
Education
University of Nottingham 1982 — 1985
B.Sc, Genetics
Novella Clinical, Inc. June 2013 - Present
Novella Clinical, Inc. April 2011 - June 2013
Novartis December 2008 - April 2011
University of Pittsburgh 2004 - 2008
Skills
Oncology, CRO, Biostatistics
Education
University of Pittsburgh
Ph.D., Biostatistics
inVentiv Health Clinical January 2013 - Present
Novella Clinical, Inc. 2008 - 2010
Health Decisions 2006 - September 2008
Duke Clinical Research Institute 2002 - 2006
GlaxoSmithKline 1999 - 2002
Skills
Project Management, Protocol, Clinical Trials, Oncology, Cross-functional Team..., Clinical Research, Data Analysis, CRO
Education
Rutgers College of Engineering
Bachelor of Science (BS), Industrial Engineering
University of North Carolina at Chapel Hill
Master of Public Health (MPH), Biostatistics
Novella Clinical May 2013 - May 2015
Novella Clinical, Inc. August 2012 - April 2013
Independent Contractor-S.O.S. Monitoring Inc. June 2001 - August 2012
The Woolf Group 1996 - 2001
ClinTrials Research, INC 1995 - 1996
ClinTrials Research, Inc. 1993 - 1994
Skills
CRO, EDC, Clinical Trials, CTMS, Program Management, Pharmaceutical Industry, Oncology, Lifesciences, GCP, Data Management, Biotechnology, Cross-functional Team..., Clinical Data Management, Clinical Development, Vendor Management, Regulatory Affairs, Sop, Clinical Research, FDA, Pharmacovigilance
Education
University of North Carolina at Chapel Hill 1986 — 1990
Bachelor of Arts (B.A.), Psychology
CTI Clinical Trials and Consulting October 2011 - Present
Novella Clinical, Inc. June 2010 - September 2011
Drug Safety Alliance January 2007 - June 2010
PPD October 2004 - December 2006
PPD May 2003 - October 2004
PPD November 1999 - April 2003
SUPERVALU September 1995 - August 1999
Rite Aid August 1993 - June 1995
Rite Aid July 1989 - August 1993
Education
University of South Carolina-Columbia
BS, Pharmacy
Novella Clinical, Inc. November 2012 - Present
Monsanto 2012 - 2012
Skills
Microsoft Office, SAS
Education
University of North Carolina at Asheville 2008 — 2011
Bachelor's degree, Mathematics and Statistics
Novella Clinical, Inc. April 2001 - Present
Quintiles April 1999 - April 2001
Duke University Health System September 1998 - April 1999
Skills
CTMS, Oracle Clinical, Clinical Data Management, SharePoint, CRO, Clinical Trials, EDC, Software Documentation, ICH-GCP
Education
University of North Carolina at Greensboro 1991 — 1995
BA, Biology
Chiltern International January 2013 - Present
INC Research October 2011 - December 2012
Novella Clinical, Inc. January 2009 - June 2010
Skills
Clinical Research, Clinical Trials, CRO, Oncology, GCP, Clinical Development, ICH-GCP, CTMS, EDC, Pharmaceutical Industry, Clinical Monitoring, Clinical Data Management, Biotechnology, Infectious Diseases, Pharmacovigilance, Therapeutic Areas, Lifesciences, Diabetes, Regulatory Affairs
Education
UNC Greensboro 1995 — 2000
Bachelor of Science (B.S.), Biology with concentration in Biotechnology
University of North Carolina at Greensboro 1995 — 2000
Bachelor of Science (B.S.), Biology with concentration in Biotechnology