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
Independent Contractor April 2004 - Present
Office of Consumer Affairs and Business Regulation September 2012 - December 2012
Hallmark Health Cancer Center February 2011 - June 2012
Golden Living September 2009 - February 2011
Beacon Hospice May 2009 - September 2009
PAREXEL November 2008 - June 2009
Visiting Nurse Service of New York May 2004 - August 2008
Kaye Scholer LLP March 2002 - March 2004
Anderson Kill & Olick, P.C. March 1998 - February 2002
Diane M. Baiano, RN, MSN-Private Practice Psychotherapy and HomeCare December 1992 - March 1998
Skills
Healthcare, Clinical Research, Nursing, Hospitals, Home Care, Healthcare Management, Clinical Trials, Oncology, Patient Safety, Critical Care, Legal Research, Legal Writing, Legal Issues, Legal Assistance, legal documents, legal discovery, professional..., professional writing, Counseling Psychology, child and family therapy, psychooncology..., hospice, Trial preparation..., Medical chronology..., Medical records..., Psychotherapy, Managed Care, Medical Records, Pediatrics, Disability Insurance, Case Management, Medicare, Inpatient, Medicaid, Pain Management, HIPAA
Education
Suffolk University Law School 2008 — 2012
JD
Columbia University in the City of New York
MSN
Seton Hall University
BSN
Covance September 2015 - Present
PAREXEL February 2014 - September 2015
PPD February 2008 - December 2009
Quintiles November 1996 - July 2006
Skills
Sop, EDC, CTMS, Clinical Monitoring, Pharmaceutics, Biotechnology, GCP, Clinical Development, Project Management, Vaccines, Regulatory Submissions, Clinical Trials, Cardiology, Medical Devices, Regulatory Affairs, Oracle Clinical, Oncology, CRO, Medical Writing, Protocol, Data Management, Lifesciences, GLP, Clinical Operations, Clinical Research, Phase I, Diabetes, ICH-GCP, Pharmaceutical Industry, Infectious Diseases, FDA, Clinical Data Management, Quality Assurance, Therapeutic Areas
Education
UCSD Extension 1999 — 2000
Professional Certificate, Clinical Trial Design and Management
Coleman College
Associate of Arts, Computer Science
Holy NamesCollege
Bachelor of Arts, Education/Psychology
inVentiv Health August 2015 - Present
PRA Health Sciences December 2012 - August 2015
PharmaNet/i3 March 2012 - September 2012
Kforce Clinical Research, Inc. September 2011 - March 2012
PAREXEL May 2011 - September 2011
Takeda Pharmaceuticals June 2008 - January 2011
TAP Pharmaceuticals May 2004 - June 2008
Skills
CTMS, Clinical Monitoring, GCP, EDC, CRO, Clinical Trials, ICH-GCP, Clinical Development, Clinical Data Management, Endocrinology, Clinical Research, Pharmaceutical Industry, Rheumatology, Regulatory Submissions, Infectious Diseases, FDA, Protocol
Education
Concordia University-Wisconsin
BA, Business & Communication
PAREXEL April 2015 - Present
Allergan February 2014 - December 2014
Allergan February 2011 - February 2014
Allergan Inc September 2005 - February 2011
Allergan November 2002 - September 2005
Allergan (France) May 1998 - November 2002
Fournier Pharma July 1992 - May 1998
Skills
EDC, Data Management, Clinical Data Management, Clinical Research, GCP, Pharmaceutical Industry, 21 CFR Part 11, Software Documentation, Medical Devices, Lifesciences, Data Trending, Risk Based Monitoring, Cross-functional Team..., Biotechnology, CRO, Clinical Development, Life Sciences, CAPA, Integration
Education
Conservatoire National des Arts et Métiers 1996 — 1998
Master's Degree (Ingénieur), Computer Sciences
Conservatoire National des Arts et Métiers 1991 — 1995
Bachelor's Degree, Computer Science
PAREXEL November 2014 - Present
Covance April 2014 - November 2014
Hospital for Special Surgery June 2012 - April 2014
Columbia University Medical Center August 2011 - June 2012
National Taipei University January 2007 - July 2007
Skills
Matlab, SAS programming, R, Stata, LaTeX, Computer Vision, Statistical Modeling, Statistical Data..., Microsoft Excel, Data Mining, SAS, Statistical Programming, Survival Analysis, Statistics
Education
Columbia University Mailman School of Public Health 2010 — 2012
Master of Science (M.S.), Biostatistics
National Taipei University 2004 — 2008
Bachelor of Engineering (B.Eng.), Computer Science
Premier Research June 2012 - December 2012
PAREXEL November 2011 - April 2012
Premier Pharmaceutical Research October 2005 - April 2011
MDS Pharma Services November 1998 - April 2001
Skills
Clinical Research..., Clinical Monitoring, Pharmaceutical Industry, Clinical Trials, Clinical Operations, CRO, ICH-GCP, Patient Safety, Data Quality Assurance, Pharmacovigilance, Regulatory Affairs, Clinical Data Management, EDC, CTMS, Infectious Diseases, CRF design, Protocol Implementation, Site Management, Regulatory Compliance, Project Management, Contract Negotiation, Contract Management, Quality Management, Operating Budgets, Patient Education, Direct Patient Care, Medical Terminology, Training Delivery, SOP development, Phase Forward InForm, Medidata-Rave, Oracle Database, Building Relationships, Thrive in..., Cross-functional Team..., Outstanding time..., Handle Multiple..., Travel Arrangements, Highly detail oriented, Highly Ambitious, Highly versatile, Report Writing, Legal Research, Diabetes
Education
University of Arizona 1987 — 1993
Bachelor of Science (BSc), Psychology
Concordia University-Irvine 2000 — 2003
Bachelor of Science (B.S.), Law
PAREXEL January 2015 - Present
Greater Baltimore Medical Center June 2013 - January 2015
Skills
Microsoft Excel, Research, PowerPoint, Microsoft Office, Public Speaking, Oncology Clinical..., Regulatory Affairs, Clinical Data Management, Clinical Trials, Study Coordination
Education
Clemson University 2010 — 2013
Bachelor's degree, Biology/Biological Sciences, General
inVentiv Health Clinical September 2015 - Present
Parexel International December 2007 - September 2015
PAREXEL February 2000 - December 2007
Worldwide Clinical Trials, Inc. June 1998 - January 2000
The University of Texas Health Science Center at Houston August 1994 - May 1998
Skills
EDC, Clinical Trials, CRO, Clinical Development, CTMS, Clinical Monitoring, Project Management, ICH-GCP, Leadership, GCP, Electronic Filing, Clinical Data Management, Sop, Clinical Research, Therapeutic Areas, Protocol, Pharmaceutical Industry, SOP
Education
Colorado Technical University-Online 2006 — 2008
Master of Business Administration (MBA), Executive Management
University of Houston-Downtown 1988 — 1994
Bachelor of Science (BS), Social Sciences
Alief Elsik High School 1984 — 1986
WEX Inc. (NYSE: WEX) March 2015 - Present
PAREXEL July 2014 - February 2015
PAREXEL October 2013 - June 2014
PAREXEL International September 2012 - September 2013
PAREXEL June 2010 - September 2012
Swiss Post Solutions January 2006 - January 2010
Forrest Solutions January 2004 - January 2006
Skills
Employee Relations, Talent Management, Training, Staff Development, Personnel Management, Talent Acquisition, Recruiting, Human Resources, Performance Management, Onboarding, Succession Planning, Workforce Planning, Coaching, Organizational..., Employee Engagement, Team Building, Employee Training, Leadership Development, Systems Thinking, Strategic Thinking, Creative Strategy, Leadership, Change Management, Management, Strategy
Education
Walden University 2008 — 2009
MBA
Colorado State University 2014 — 2015
Certificate - Performance Management
Harvard University 2013 — 2013
Cornell University 2007 — 2007
Certificate
Columbia University - Columbia Business School 2005 — 2005
Certificate
Salem State College 1996 — 1999
BFA
PAREXEL November 2014 - Present
PAREXEL June 2012 - November 2014
PAREXEL October 2010 - June 2012
PAREXEL September 2003 - October 2010
UnumProvident March 2001 - August 2003
Datex-Ohmeda October 1999 - February 2001
University of Nebraska at Omaha August 1997 - June 1999
Minnesota State University Moorhead August 1994 - August 1997
Skills
Instructional Design, Training Facilitation, Training, Career Development, Leadership Development, Performance Management, Coaching, Organizational..., Project Management, Consulting, Management Development, Training Delivery, Team Building, Culture Change, Leadership, Program Management, E-Learning, Staff Development, Management
Education
North Dakota State University 1992 — 1995
MA, Speech Communication
Concordia College 1988 — 1992
BA, Communication, Art
Valley City High School 1986 — 1988
Novella Clinical, Inc. March 2013 - Present
Theorem Clinical Research June 2012 - February 2013
Covance November 2011 - June 2012
PRA International September 2010 - March 2011
Hoffmann-La Roche May 2009 - March 2011
Boehringer Ingelheim 2010 - 2010
Purdue Pharma October 2007 - February 2009
PAREXEL May 2007 - October 2007
Paragon September 2006 - May 2007
PPD November 2005 - September 2006
Skills
Clinical Monitoring, EDC, CRO, Clinical Trials, GCP, Medidata, CTMS, Cardiovascular, Respiratory Disease, Phase Forward InForm, Documentum, JReview, Drug Accountability, Drug Distribution, Mentoring, Oncology, Remote Monitoring
Education
John Jay College of Criminal Justice
None, Criminalistics and Criminal Science
PAREXEL November 2014 - Present
Kronos July 2013 - November 2014
Public Consulting Group July 2011 - June 2013
U.S. Department of State May 2010 - July 2010
Skills
Spanish, Financial Analysis, Microsoft Excel, PowerPoint, Research, Business Process..., Microsoft Word, Positive Personality, Team Leadership, Portuguese, SharePoint, Cost Accounting, Healthcare Management, Financial Modeling, Financial Reporting, Access, OneNote, Oracle E-Business Suite, MS Project, Visio, Project Management, Vendor Management, Business Analysis, Cloud Computing, Cognos, Data Center, Microsoft Office
Education
University of Massachusetts Lowell 2014 — 2017
Master of Business Administration (MBA)
College of the Holy Cross 2007 — 2011
Bachelor of Arts (B.A.), Economics, Latin American & Latino Studies
Pontificia Universidad Católica del Perú 2009 — 2009
Spanish and Inca Culture
Lowell High School 2003 — 2007
PAREXEL April 1997 - September 2004
Zeneca Pharmaceuticals April 1996 - April 1998
Medical Center of Delaware September 1990 - March 1995
Skills
Strategic Planning, Negotiation, Clinical Trials, Clinical Research
Education
Clemson University
BSN, pre-med, Nursing
PAREXEL January 2015 - Present
PAREXEL July 2013 - January 2015
PAREXEL July 2010 - June 2013
Kendle International January 2009 - July 2010
Kendle International September 2007 - January 2009
Kendle International September 2004 - August 2007
Kendle International May 2003 - September 2004
SCIREX Corporation May 2002 - May 2003
SCIREX Corporation May 2001 - May 2002
Hartford Research Group September 1998 - April 2001
Skills
CRO, Clinical Development, Management, Pharmaceutical Industry, Clinical Trials, Biotechnology, Leadership, Drug Development, Clinical Research, Cross-functional Team..., Business Development, New Business Development
Education
University of Cincinnati College of Business 2002 — 2005
MBA, Management/ International Business
Columbia University in the City of New York 1993 — 1997
BA, Pre-Medicine and Religion
Champion Clinical Research Consultants, LLC January 2012 - Present
PAREXEL March 2011 - January 2012
INC Research (Formerly Kendle International) October 2005 - March 2011
Skills
Clinical Monitoring, EDC, CTMS, ICH-GCP, CRO, GCP, Clinical Trials, Therapeutic Areas, Clinical Development, Oncology, Oracle Clinical, Ophthalmology, Rheumatology, Cardiology, Neurology, Diabetic Retinopathy, Macular Degeneration, Orthopedic, Medical Devices, Hematology, Uveitis, Macular Edema, Retinal Vein Occlusion, Retinal Ophthalmology, Pulmonology, Lung Transplantation, Protocol, Regulatory Submissions, Infectious Diseases, Clinical Research, Pharmaceutical Industry, SOP, Drug Development
Education
Lorain County Community College 1997 — 1999
Registered Nursing Program
Southwest General Medical Center 1996 — 1997
NREMT-B, Emergency Medical Technology/Technician (EMT)
Cleveland State University 1995 — 1997
Pre-Medical Studies/Psychology
PRA Health Sciences September 2014 - Present
PRA International December 2012 - September 2014
INC Research December 2011 - December 2012
Chiltern International November 2010 - January 2011
Parexel May 2007 - November 2010
PAREXEL International 2006 - November 2010
Skills
Clinical Monitoring, ICH-GCP, EDC, Clinical Trial..., CRO, Clinical Research, Clinical Trials, Inform, Oncology, Phase I, Asthma, Infectious Diseases, CTMS, Line Management, Neurology, Cardiology, COPD, Rheumatology, Vaccines, Immunology, Clinical Development, Therapeutic Areas, GCP
Education
University of California, Los Angeles 1999 — 2003
Bachelors of Science, Biology
Colorado State University
M.Sc., Management
PAREXEL November 2012 - Present
PAREXEL May 2011 - November 2012
Boston Scientific April 2010 - May 2011
Boston Scientific October 2005 - April 2010
PTC 2001 - 2005
NTT DATA Americas 1998 - 2001
American Red Cross 1996 - 1998
Various Counseling Positions 1994 - 1996
Skills
Organizational..., Career Development, Performance Consulting, Organizational Diagnosis, Change Management, Organizational..., Leadership Development, Succession Planning, Competency Framework..., Executive Coaching, Employee Engagement, Organizational Structure, Talent Management, Strategy, Executive Team Coaching, Employee Training, Trusted Business Partner, Leadership, Performance Management, Organizational Design, Team Building, Program Management
Education
The University of Chicago Booth School of Business
Columbia University - Columbia Business School
Graduate Certificate
Suffolk University
Certificate of Advanced Graduate Studies (CAGS)
Northeastern University
Master’s Degree
Northeastern University
Bachelor’s Degree
PAREXEL June 2012 - Present
Group DCA January 2012 - June 2012
Complete Medical Communications Inc June 2008 - September 2011
Current Medical Directions 2007 - 2008
The Scienomics Group 2003 - 2006
Health Science Communications 1996 - 2003
Skills
Strategic Planning, Oncology, Publication Planning, Infectious Diseases, Marketing Strategy, New Business Development, Therapeutic areas, Market Conditioning, Medical Communications, Account Leadership, Cross-functional Team..., Therapeutic Areas, Medical Writing, Medical Education, Strategy, Pharmaceutical Industry, CRM, Integrated Marketing, Business Development, Biotechnology
Education
Kean University 2013 — 2016
Bachelor of Science (BS), Registered Nursing/Registered Nurse
City University of New York-Herbert H. Lehman College 1990 — 1993
Health Administrative Services
Sanofi 2013 - Present
Sanofi 2010 - 2012
sanofi-aventis 2007 - 2010
sanofi-aventis 2005 - 2007
sanofi-aventis 2002 - 2004
PAREXEL 2000 - 2002
PEDIATRIC NEPHROLOGY 1996 - 2000
JOURNAL OF MODERN LITERATURE 1992 - 1994
HOSPITALS, BIRTHING CENTERS AND OUTPATIENT PRACTICE 1982 - 1992
Skills
Healthcare, Operations Management, Healthcare Management, Strategic Innovation, Project Management, Strategic Communications, Clinical Trials, Operational Strategy, Operational Planning, Healthcare Information..., Strategic Sourcing, Performance Management, Clinical Trial..., Data Sharing
Education
Columbia Business School 2011 — 2013
MBA
Villanova University
MA, American Literature (United States)
Nazareth College of Rochester
BS, Registered Nursing/Registered Nurse
Continuum Clinical June 2014 - Present
PAREXEL May 2012 - May 2014
PPD August 2010 - May 2012
Merge LLC 2007 - 2009
Skills
Advertising, Marketing Communications, Patient Recruitment, Account Management, Clinical Trials, CTMS
Education
College of Charleston 1997 — 2001
BS, Business Administration
College of Charleston
Business Administration and Management, General
PAREXEL January 2015 - Present
Tufts Medical Center, Division of Nephrology June 2014 - January 2015
Boston Public Health Commission January 2012 - June 2014
Boston University School of Public Health January 2012 - May 2014
Boston University School of Public Health June 2011 - March 2012
Cornell University June 2008 - December 2010
Skills
Data Analysis, Research, Public Health, Program Management, Literature Reviews, Program Evaluation, Program Coordination, Epidemiology, Program Design, Women's and Perinatal..., Survey Design, Focus Groups, Prevention, Policy Analysis, SPSS, Program Development, Health Disparities, Infant Mortality, Global Health, Health Equity, Community Outreach, Grant Writing, Qualitative Research, Clinical Trials, Clinical Research, ICH-GCP
Education
Boston University School of Public Health 2011 — 2012
Master of Public Health (M.P.H.), Maternal and Child Health
Cornell University 2006 — 2010
Bachelor of Science (B.S.), Animal Sciences
Quintiles April 2014 - Present
Stiefel, a GSK Company November 2010 - April 2014
PPD 2007 - November 2010
University of North Carolina 2005 - 2007
Parexel 2000 - 2001
Skills
Drug Development, Clinical Development, Clinical Trials, Pharmaceutical Industry, Clinical Research, Oncology, CRO, Infectious Diseases, Regulatory Submissions, Regulatory Affairs, GCP, EDC, FDA, Pharmacovigilance, CTMS, Business Development, Due Diligence
Education
The University of Connecticut
PharmD, Pharmacy
College of the Holy Cross
BA, Biology
St. Joe's
SynteractHCR July 2014 - Present
SynteractHCR October 2013 - July 2014
Ansun Biopharmaceuticals, Inc. (formerly NexBio) October 2012 - October 2013
PAREXEL May 2012 - September 2012
PPD April 2011 - April 2012
D.I.S.C. sports and Spine Center September 2007 - February 2011
Blue Hill Medical Group October 2006 - September 2007
Childrens Hospital Los Angeles November 2004 - October 2006
Wallace Rheumatic Study Center June 2003 - November 2004
Skills
Clinical Trials, Clinical Monitoring, CTMS, Protocol, Clinical Research, CRO, EDC, Therapeutic Areas, GCP, IRB, ICH-GCP, Clinical Study Design, Clinical Development, CRF design, Medical Devices, Clinical Research..., Hematology, Clinical Data Management, Clinical Research..., Contract Negotiation, Regulatory Submissions, Spine, Cardiology, Regulatory Affairs, Patient Recruitment, Study Coordination, Rheumatology, Diabetes, Pharmaceutical Industry, CNS disorders, CRFs, Rheumatoid Arthritis, Multiple Sclerosis, Exercise Physiology, Nutrition Education, Lupus, ALS, Livelink, Budgets, Women's Health, Influenza, Virology, Meeting Planning, Source Documents, CDC Surveillance, Trip Report Review, Newsletters, Survey Monkey, TMF, Work Instructions/SOPs
Education
Colorado State University
BS, Health and Exercise Science
Springfield High School
Canon Business Process Services January 2015 - Present
OfficeMax May 2014 - January 2015
Sam's Club November 2013 - February 2014
Laurie Sarah Designs November 2011 - October 2013
PAREXEL April 2011 - November 2011
Angeles Valley College June 2009 - August 2009
PAREXEL October 2006 - December 2008
Skills
Facebook, Photography, Newsletters, Social Media, Photoshop, Lightroom 5, InDesign, Email Marketing, Editing, Marketing, Digital Photography, Sales
Education
College of the Canyons 2014 — 2016
Photography & Marketing
John Marshall High School 2004 — 2008
Diploma
MedSource March 2015 - May 2015
UNC, Lineberger Cancer Center Protocol Office October 2014 - November 2014
PAREXEL January 2014 - July 2014
PAREXEL September 2013 - December 2013
CALGB/ Duke University Medical Center July 2010 - September 2013
Skills
Clinical Trials, Oncology, Clinical Research, Clinical Data Management, ICH-GCP, Drug Development, CTMS, Clinical Monitoring, IRB, GCP, Hospitals, Protocol, Pediatrics, Public Health, Healthcare, Epidemiology, Clinical Development, Medical Writing, Pharmacovigilance, Patient Recruitment, Therapeutic Areas, Sop, FDA, EDC, Data Management, CRO, Pharmaceutical Industry, Regulatory Affairs
Education
The George Washington University School of Medicine and Health Sciences 2011 — 2014
M.S. Graduated Summer 2014., Clinical Research Administration
Concordia College 1998 — 1999
B.A, Behavioral Sciences Bronxville, N.Y.
PAREXEL March 2012 - Present
Avita Medical 2011 - March 2012
MMG April 2009 - September 2011
MMG 2005 - 2011
URO March 2002 - September 2004
Aurora Denver Cardiology November 2000 - March 2002
Skills
Project Coordination, Team Management, Clinical Research, HIPAA, Research, FDA, Compliance, Budgeting, IRB, Public Relations, Staff Development, Clinical Trials, GCP, Pharmaceuticals, Tactical Planning, Oncology, Diabetes, Data Management, SOP, Clinical Trial..., Data Entry, Clinical, Healthcare, Strategic Planning, Microsoft Office, Team Building, Cardiology, Documentation, Customer Relations, Regulatory Affairs, Negotiation, Writing, Public Speaking, Endocrinology, Dermatology, Neurology, Contract Negotiation, Public Health, Data Analysis, Life Sciences, ICH-GCP, CTMS, Cross-functional Team..., Clinical Development, Customer Service, Pharmaceutical Industry, Medical Writing, Patient Recruitment, Advertising, CRO
Education
University of Phoenix 2003 — 2005
MBA, Health Care Management
Colorado State University 1995 — 1999
BS, Exercise Sports Science/Wellness
Digital Mustard Seed January 2015 - Present
The Jesus Geeks Inc December 2009 - Present
PAREXEL December 2013 - May 2015
The Salvation Army May 2012 - December 2013
San Diego SEO Guy November 2010 - January 2013
Legal Shield, Inc. April 2010 - January 2013
Created Clothing Company January 2008 - January 2013
UC San Diego August 2008 - December 2009
Skills
SEO, Microsoft Office, Social Media, Web Design, Social Networking, Customer Service, Public Speaking, Small Business, Access, Non-profits, Legal Assistance, Nonprofits, Email Marketing, Technical Support, Cisco Technologies, Web Development, Computer Repair, Online Marketing, Social Media Marketing, Time Management, Leadership, Networking, Team Building
Education
Southwestern College 1999 — 2001
Associate of Science (AS), Computer Systems Networking and Telecommunications
Coleman College
Fantasia Consulting Associates LLC January 1999 - Present
Complya Consulting Group, LLC December 2012 - Present
SDG, LLC 2006 - Present
Tesaro Pharmaceuticals, Inc March 2014 - August 2014
Atreus Pharmaceuticals January 2011 - July 2014
Covidien January 2014 - March 2014
PAREXEL May 2012 - October 2012
Marina Biotech, Inc. June 2011 - December 2011
Anson Group 2010 - December 2011
Pfizer March 2008 - March 2010
Skills
PMA, IND, NDA, Maintenance, Validation, CAPA, Design Control, ISO 14971, Quality Control, Biotechnology, Regulatory Affairs, Regulatory Submissions, FDA, Pharmaceutical Industry, Technology Transfer, Quality Auditing, V&V, Oncology, Commercialization, Clinical Development, Quality Assurance, Quality System, GLP, ISO 13485, Maintenance & Repair, Clinical Trials, GMP, Change Control, Medical Devices, Clinical Research, R&D, 21 CFR Part 11, Pharmaceutics, Lifesciences, Biopharmaceuticals, GxP, Hardware Diagnostics, Aseptic Processing, Sop, Regulatory Requirements, Infectious Diseases, Protocol, Drug Development, SOP, Regulatory Compliance, Medical Imaging, Life Sciences
Education
Roosevelt University 1980 — 1984
MBA
Columbia University in the City of New York 1970 — 1974
BA, Biology
PAREXEL August 2012 - Present
AECOM July 2010 - August 2012
JP Morgan Chase January 2010 - June 2010
PricewaterhouseCoopers November 1998 - July 2009
Alex.Brown & Sons(now part of Deutsche Banc) 1991 - 1998
Skills
College Recruiting, Program Development, Diversity Strategy, Talent Acquisition, Talent Management, Recruiting, Strategic Planning, Leadership Development, Time Management, Coaching, Employer Branding, Executive Search, Leadership, Human Resources, Internet Recruiting, Interviews, Management, Program Management, Marketing, Strategic Partnerships, Hiring, Applicant Tracking..., Budgets, Analysis, Organizational..., Employee Relations, Onboarding
Education
Clarkson University 1986 — 1990
Bachelor of Science, Management
PAREXEL January 2013 - November 2013
Aerotek July 2010 - April 2011
University of Kansas Medical Center March 2009 - June 2010
Lysander Skating Rink, Baldwinsville, NY, Overland Park KS October 1990 - April 2009
University of Kansas Medical Center October 1993 - March 2003
St. Joseph’s Hospital, Syracuse NY and Kansas City, KS June 1984 - May 1992
Skills
Healthcare, Clinical Research, Healthcare Management, Medicine, Clinical Trials, Cancer, Respiratory Therapy, PSA Rated Figure..., EDC, Clinical Data Management, Oncology, ICH-GCP, GCP, Medical Research, CTMS, Clinical Monitoring, Clinical Development, CRO, Medical Writing, Infectious Diseases, Clinical Study Design, Clinical Operations, Therapeutic Areas, Regulatory Affairs, Hematology, Epidemiology, Protocol, Regulatory Submissions, Immunology, Sop, Diabetes, Lifesciences, Pharmaceutical Industry, Data Management, FDA, Inform, Biotechnology, Regulatory Requirements, Oracle Clinical, Hospitals, Medical Devices, Pediatrics, SOP
Education
Jamesville DeWitt HS
Regents Degree
The New School
Master's degree, Health/Health Care Administration/Management
Colby College
Bachelor's degree, Human Resources Development
Onondaga Community College
Associate's degree, Respiratory Care Therapy/Therapist
Elite Educational Institute June 2015 - Present
PAREXEL July 2015 - Present
Prom Project, a program of the YWCA of North Orange County September 2009 - Present
Daniel Chang Neurology 2010 - July 2015
Cornell Daily Sun January 2013 - December 2014
Multi-Organ Transplant Center at St. Vincent Medical Center June 2014 - August 2014
Skills
Copy Editing, Journalism, Research, Blogging, Editing, Press Releases, Microsoft Word, CPR Certified, Leadership
Education
Cornell University 2011 — 2015
English Language and Literature/Letters
Troy High School 2007 — 2011
CTP Inc May 2008 - Present
PAREXEL January 2012 - December 2013
PPD 2004 - 2007
Aventis 2004 - 2004
Megapharm 2000 - 2001
Skills
GCP, EDC, Start-ups, Clinical Monitoring, CTMS, ICH-GCP, Clinical Trials, Clinical Research, CRO, Clinical Development, Pharmaceutical Industry, Medical Devices, Regulatory Submissions, Oncology, Biotechnology, Healthcare, Regulatory Affairs, Medicine, Lifesciences, Clinical Operations, Hematology, Biopharmaceuticals, Therapeutic Areas
Education
Clark University
MPA, Health Management
Pace University
AAS, Nursing
University of New England
BSN, Nursing
MacroGenics, Inc. February 2015 - Present
PAREXEL December 2012 - Present
Emergent BioSolutions January 2011 - November 2012
OriGene Technologies, Inc April 2010 - December 2010
Skills
Biotechnology, GMP, Lifesciences, FDA, Validation, CAPA, Process Improvement, Biopharmaceuticals, Change Control, GLP, Quality Assurance, Data Analysis, ELISA, Vaccines, Regulatory Affairs
Education
Coastal Carolina University 2001 — 2005
Bachelor's degree, Marine Science
PAREXEL July 2014 - Present
PAREXEL May 2011 - June 2014
PAREXEL February 2009 - May 2011
PAREXEL August 2006 - February 2009
PAREXEL March 2003 - July 2006
PAREXEL June 2002 - March 2003
PAREXEL July 2000 - June 2002
PAREXEL November 1998 - July 2000
Skills
Biotechnology, Clinical Development, New Business Development, Cross-functional Team..., Clinical Trials, CRO, Business Development, Medical Devices, Leadership, Clinical Research, Pharmaceutical Industry, Project Management, Lifesciences, Management, CRM, Life Sciences
Education
Rensselaer Polytechnic Institute - The Lally School of Management and Technology 2000 — 2002
MBA, Entrepreneurship
Cornell University 1996 — 1997
MS, Biological Engineering
Cornell University 1993 — 1996
BS, Biological Engineering
Clinical Science, GIPB, Pfizer January 2015 - Present
Pfizer August 2010 - December 2014
Wyeth July 2006 - August 2010
AstraZeneca 2004 - 2006
PAREXEL 2001 - 2004
Skills
Clinical Development, Clinical Trials, Drug Development, Clinical Research, Pharmaceutical Industry, Neuroscience, Vaccines, Clinical Monitoring, GCP, Therapeutic Areas, ICH-GCP, CRO, Medical Writing, Infectious Diseases, Protocol, Biopharmaceuticals, Psychiatry
Education
Columbia University in the City of New York
BSN, Nursing with Concentration in Psychology
Yale University
MSN, Psychiatric Nurse Practitioner
Boehringer Ingelheim October 2012 - Present
PAREXEL March 2011 - October 2012
COMSYS November 2009 - December 2010
Pfizer July 1992 - June 2007
Bristol-Myers Squibb April 1990 - March 1992
Clemson University January 1987 - January 1989
Skills
Regulatory Affairs, Medical Writing, Clinical Development, Pharmaceutical Industry, FDA, Immunology, Genetics, Cell, Clinical Trials, Regulatory Submissions
Education
Clemson University 1987 — 1990
MASTERS OF SCIENCE, Biochemistry
Lehigh University 1983 — 1987
BACHELOR OF SCIENCE, Molecular Biology
PAREXEL July 2015 - Present
Dana-Farber Cancer Institute May 2014 - August 2014
The Cadmus Group, Inc. May 2008 - July 2008
Skills
Research, Biotechnology, Molecular Biology
Education
Colby College 2011 — 2015
Biology w/ Neuroscience concentration, Managerial Economics minor
Nashoba Regional High School 2007 — 2011
Rue La La October 2013 - Present
Rue La La September 2012 - October 2013
PAREXEL August 2011 - August 2012
Myrtle Beach Area Chamber of Commerce January 2011 - May 2011
LHWH Advertising August 2010 - December 2010
Education
Coastal Carolina University 2007 — 2011
BA, Communication
Shrewsbury High School
Shrewsbury High School
Shrewsbury High School
PAREXEL January 2014 - March 2015
Perceptive Informatics, Inc February 2013 - January 2014
PAREXEL September 2010 - February 2013
Forest Laboratories November 2009 - September 2010
Abt Bio-Pharma Solutions, Inc. June 2008 - October 2009
Perceptive Informatics, Inc. April 2008 - May 2008
Perceptive Informatics, Inc. April 2007 - March 2008
UMass Medical School January 2006 - March 2008
Perceptive Informatics, Inc. August 2006 - April 2007
College of the Holy Cross January 2005 - July 2006
Skills
Clinical Trials, Clinical Research, Cross-functional Team..., Biotechnology, Pharmaceutical Industry, CTMS, Medical Imaging, FDA, Healthcare, Protocol, Validation, Strategy, Sop, Software Documentation, CRO, GCP, Oncology, SOP
Education
College of the Holy Cross 2002 — 2006
BA, Psychology
College of the Holy Cross 2002 — 2006
Bachelor of Arts (B.A.), Psychology
Greenville Health System August 2013 - Present
Beth Israel Deaconess Medical Center November 2012 - August 2013
PAREXEL August 2011 - November 2012
Education
Clemson University 2006 — 2010
Bachelor’s Degree, Biology/Biological Sciences, General
Urorad Healthcare July 2007 - Present
Centra Health Virginia June 2005 - July 2007
Permanent and Locum Travel for Medical Agencies September 1994 - July 2005
PAREXEL January 1998 - August 1998
Midwest Weather Inc. November 1990 - August 1994
U.S. Air Force April 1982 - October 1990
Skills
Hospitals, Clinical Trials, Clinical Research, Healthcare Management, Healthcare, Oncology, Healthcare Information..., EMR, Cancer, Treatment, Healthcare Consulting, Revenue Cycle, EHR, Patient Safety, Informatics, Quality Improvement, Physician Relations, Policy, Medical Coding, Management, HIPAA, BLS, Patient Education, Medical Terminology, Medical Imaging, Strategic Planning, Strategy, JCAHO, Quality Management, Health Policy, Healthcare Industry, Ultrasound, Medicare, Radiology, Medical Devices, Medicine, Managed Care, Physicians
Education
Geneva College 2004 — 2007
Master's degree, Higher Education/Higher Education Administration, 3.75
Evangel University 1994 — 1998
Bachelor of Applied Science (B.A.Sc.), Biblical Studies, Human Sciences, Business Administration, 3.65
Community College of Allegheny County 1991 — 1994
Associate of Arts and Sciences (A.A.S.), Radiation Therapy Technology, 3.6
Validation Plus, Inc September 1995 - Present
L Perrigo Co 2015 - 2015
Bend Research July 2014 - September 2014
UCB March 2014 - May 2014
confidential pharma company January 2013 - March 2014
PAREXEL 2012 - 2014
Validation Plus, Inc 1995 - 2014
Novartis December 2011 - December 2012
American Red Cross 2011 - 2011
APVS 2009 - 2009
Skills
Computer System..., Validation, GxP, GAMP, 21 CFR Part 11, V&V, FDA, GLP, Testing, Process Simulation, Sop, Pharmaceutical Industry, Document Management, Quality Management, Quality Auditing, Biotechnology, GMP, Quality System, Aseptic Processing, Change Control, Technology Transfer, Software Documentation, Vaccines, Lifesciences, Biopharmaceuticals, ISO 13485, Quality Assurance, CAPA, Medical Devices, Pharmaceutics, Contract Manufacturing, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements
Education
Columbia Engineering 1984 — 1986
MSChE, Chemical Engineering
Clarkson University 1977 — 1981
BSChE, Chemical Engineering
PAREXEL September 2015 - Present
PAREXEL January 2013 - September 2015
Clutter to Clean, LLC January 2011 - March 2013
Independent Consultant August 2011 - January 2013
Next Generation Clinical Research January 2005 - July 2011
Next Generation Clinical Research November 1999 - January 2005
Madison Area Technical College June 2004 - December 2004
Wisconsin Children's Trust Fund June 2001 - June 2004
Wisconsin Department of Workforce Development July 2000 - June 2001
Skills
Clinical Research, Clinical Trials, GCP, CRO, ICH-GCP, FDA, Quickbooks, Administrative Support, Customer Service, Bookkeeping, Data Entry, MS Office Suite, Office Management, Protocol, CTMS, Pharmaceutical Industry, QuickBooks, Administrative...
Education
National Association of Professional Organizers 2011 — 2011
Professional Organizer Curriculum
Concordia University-Wisconsin 1996 — 1997
Management & Communications
Madison Area Technical College 1992 — 1995
Associates of Arts, Administrative Assistant-Information Processing
CIBC 2011 - 2012
Independant Contractor 2005 - 2011
PAREXEL 2001 - 2005
Reuters Financial Services (Thomson Reuters Group) 2000 - 2001
Skills
Strategy, Negotiation, Business Development, CRM, French, Leadership, Management, International Business, Marketing Communications, Business Strategy, New Business Development, Risk Management, Competitive Analysis, Portfolio Management, Account Management, Finance, Outsourcing, Sales, Business Intelligence, Solution Selling, B2B, Translation, CRO, Pharmaceutical Industry, Pharmacovigilance, Salesforce.com, Sales Management, Market Research, Business Planning, Analytics, Training, Analysis, Project Management, Consulting, Team Leadership, Business Analysis, Marketing, Marketing Strategy, Team Building, Sales Operations, Customer Service, Vendor Management, Talent Acquisition, Program Management
Education
ENPC MBA Paris - ENPC School of International Management 1996 — 1998
Master of Business Administration (MBA), International Marketing
Concordia University 1990 — 1993
Bachelor of Arts (B.A.), Psychology (Honours Thesis)
Concordia University 1986 — 1989
Bachelor of Science (B.Sc.), Biology
PAREXEL June 2015 - Present
Hewlitt Packard (sub contractor) NGEN January 2013 - April 2015
United States Air Force January 2010 - January 2012
United States Air Force January 2008 - January 2010
Skills
Security, Troubleshooting, Microsoft Exchange, Network Administration, Software Documentation, Databases, Microsoft Word, Networking, Help Desk Support, Program Management, Routers, Computer Security, Microsoft Office, Microsoft Excel
Education
Community College of the Air Force
A.S, Information Systems Technology; Computer Systems Operations
PAREXEL December 2014 - Present
PPD May 2014 - November 2014
PPD January 2013 - May 2014
Hagemeyer North America December 2011 - September 2012
Hagemeyer North America January 2010 - December 2011
Hagemeyer North America March 2009 - January 2010
Hagemeyer North America January 2008 - March 2009
Harbor Island Surf School June 2005 - August 2007
Skills
Lean Trained, Action Selling Trained, Spanish, Contract Negotiation, Procurement, Negotiation, Marketing Strategy, Social Media Marketing, Business Analysis, Catalogue Production, Photography, Lean Operations, Sales, Customer Service, Logistics, Instructional Design, Training, Business Development, Selling, Leadership, Microsoft Office, Microsoft Excel, Marketing, Pricing, Process Improvement, Sales Management, Purchasing, Management
Education
College of Charleston 2003 — 2007
B.S, International Business
College of Charleston 2003 — 2007
B.A, Spanish
University of Newcastle 2007 — 2007
International Business
Universidad Internacional de Menendez-Pelayo 2005 — 2005
Spanish
PAREXEL March 2013 - Present
Allergan January 2008 - March 2013
Allergan May 2000 - January 2008
ARCADIS JSA 1999 - 2000
ARCADIS JSA 1998 - 1999
Skills
eCTD, Regulatory Submissions, Information Management, SharePoint, Document Management, Publishing, Regulatory Operations, Computer System..., FDA, Regulatory Affairs, 21 CFR Part 11, Change Control, Pharmaceutical Industry, GCP, Lifesciences, Life Sciences
Education
Concordia University-St. Paul 1995 — 1998
B.A. Natural Science, Biology, Chemistry
BIND Therapeutics December 2014 - Present
C after D Inc. January 2004 - Present
Cubist Pharmaceuticals May 2005 - April 2011
Sention 2002 - 2005
Biochem Pharma/Shire Biologics 1999 - 2003
PAREXEL 1998 - 1999
Procter and Gamble 1993 - 1997
University of Washington 1991 - 1992
Cornell University 1985 - 1990
Skills
Regulatory Affairs, Pharmaceutical Industry, Biotechnology, FDA, Clinical Trials, Lifesciences, Regulatory Submissions, Clinical Development, Pharmacology, Oncology, Clinical Research, Pharmacovigilance, Sop, GMP, Medical Devices, GLP, GCP, Chemistry, Medical Affairs, Biopharmaceuticals
Education
University of Washington 1990 — 1991
Post-doc, Biomedical Engineering
Cornell University 1985 — 1990
MS, PhD, Analytical Chemistry
William & Mary 1981 — 1985
BS, Chemistry
PAREXEL April 2015 - Present
PAREXEL March 2013 - Present
PAREXEL April 2010 - Present
PAREXEL April 2010 - October 2010
AllOne Health Resources August 2005 - April 2010
Skills
GCP, Clinical Monitoring, EDC, Clinical Trials, Clinical Development, Clinical Data Management, Oncology, CRF design, Pharmaceutical Industry, Sop, Data Management, FDA, Medical Writing, Biotechnology, CRO, Clinical Research, Medical Imaging, SOP
Education
Clark University 2007 — 2009
Masters Certificate, Graphic and Web Design
Elgin Community College 2001 — 2002
Associate of Arts and Sciences (A.A.S.), General Studies
PAREXEL 2012 - Present
Pfizer 2008 - 2012
Pfizer 2006 - 2008
Pfizer 2004 - 2005
ICON Clinical Research 2002 - 2004
Barton and Polansky Associates 2001 - 2002
Barton and Polansky Associates 1999 - 2001
Barton and Polansky Associates 1999 - 1999
Barton and Polansky Associates 1996 - 1998
Skills
Clinical Trials, Pharmaceutical Industry, CRO, Data Management, Clinical Data Management, Cross-functional Team..., EDC, SAS programming, Project Management, Change Management, Cross Cultural..., Adaptability, Integrity, Superior Work Ethic, Teamwork, Virtual Teams, Communication Skills, Inclusive Leadership, Close Attention to..., Negotiation, Patience, Problem Solving, High Pressure Situations, Risk Management, Operations Management, Collaborative Problem..., GCP, Clinical Study Design, Clinical Development, Oncology, ICH-GCP, Outsourcing, Clinical Research, Therapeutic Areas, Vaccines, Drug Development, Program Management, FDA, Neurology, Clinical Monitoring, Regulatory Submissions
Education
University of Phoenix 2005 — 2007
MBA, Global Management
Cornell University 1985 — 1990
Bachelor of Arts, Mathematics
Middlesex School
PAREXEL December 2014 - Present
Education
Rutgers University School of Law - Camden 2002 — 2005
J.D
Columbia University in the City of New York 1993 — 1997
B.A.
Horace Mann School 1989 — 1993
Merck January 2015 - Present
Covance July 2012 - January 2015
Lung LLC (Division of United Therapeutics) January 2012 - June 2012
PRA International August 2011 - January 2012
ICON Clinical Research April 2005 - July 2011
PPD June 2004 - April 2005
PAREXEL June 2001 - June 2004
Park Nicolet Hospital January 2000 - June 2001
International Paper April 1999 - January 2000
Morton Chemical January 1998 - February 1999
Skills
Clinical Trials, Oncology
Education
Elmhurst College 1992 — 1995
Bachelor, Clinical Research; Science Chemistry
College of DuPage
Associate, Science Biology
PAREXEL June 2015 - Present
Verizon Information Technology January 2004 - September 2014
GTE/Verizon September 1999 - January 2004
Skills
Telecommunications, Troubleshooting, Technical Support, Business Analysis, Windows, Process Improvement, Integration, Microsoft Office, Networking, Project Management, Disaster Recovery
Education
Connecticut College
BA, Psychology and Pre-Med
University of Grenoble (FR)
French Language and Literature
PAREXEL September 2015 - Present
Freelance Medical Editor May 2015 - Present
Custom Learning Designs (CLD) March 2014 - September 2015
Custom Learning Designs July 2013 - March 2014
Holy Cross Ballroom Dance Team August 2009 - May 2013
College of the Holy Cross 2009 - 2013
Hanscom Air Force Base June 2012 - August 2012
Hanscom Air Force Base June 2011 - August 2011
Skills
Event Planning, Team Leadership, Medical Writing, Microsoft Word, Microsoft Powerpoint, Microsoft Excel, Public Speaking, American Sign Language, Social Media, Type 77 WPM, Government-Designed..., Standard Laboratory..., Fundraising, PowerPoint, Spanish, Leadership, Community Outreach, Nonprofits, Research, Editing, Writing, Microsoft Office
Education
College of the Holy Cross 2009 — 2013
Bachelor of Arts (B.A.), English Language and Literature/ Premedical Science
PAREXEL April 2015 - Present
ICON plc June 2013 - April 2015
Duke Clinical Research Institute January 2006 - May 2013
AT Work Interiors, Inc May 2005 - May 2006
UNC School of Dentistry August 2000 - August 2004
Skills
Microsoft Office, Project Management, Access, Customer Service, PowerPoint, Microsoft Word, Microsoft Excel, Research, Furniture, Data Analysis, Cross-functional Team..., Outlook, Fundraising, Time Management, Leadership, Budgets, Sales, Clinical Trials, Management
Education
IFMA (International Facility Management Association) 2009 — 2010
FMP, SFP, Facility Management/Sustainability
Meredith College 2002 — 2004
Bachelor of Science, Interior Design
College of Charleston 1997 — 1999
Bachelor of Arts, Arts Management
St. Mary's College 1995 — 1997
Associate of Arts
CHHS 1991 — 1995
PAREXEL January 2015 - Present
TSYS May 2014 - August 2014
First Citizens Bank and Trust Company, Inc. October 2011 - August 2013
Yoj Events, llc May 2009 - April 2010
J.Crew May 2007 - December 2009
Skills
Interpersonal..., Human Resources, Human Capital, Leadership, Event Planning, Social Media, Sales, Facebook, Social Networking, Customer Service, Time Management, PowerPoint, Microsoft Office, Microsoft Excel, Microsoft Word, HR Consulting
Education
University of South Carolina-Columbia 2013 — 2014
Master of Human Resources, 3.9
College of Charleston 2006 — 2010
BA, Communications and Media Studies
The Downers Grove First United Methodist Church June 2014 - Present
Platinum Restoration January 2013 - June 2014
Chick-fil-A September 2012 - January 2013
Westminster Presbyterian Church July 2010 - May 2012
Grace United Methodist Church August 2008 - March 2010
Milan Free Methodist Church April 2006 - June 2008
Hillsdale Free Methodist Church September 2000 - April 2006
i3 Statprobe July 1998 - September 2000
Clintrials Research September 1997 - June 1998
PAREXEL January 1997 - August 1997
Skills
Program Management, Youth Ministry, Discipleship, Preaching, Theology, Pastoral Care, Biblical Studies, Pastoral Counseling, Religion, Community Outreach, Volunteer Management, Missions, Spiritual Direction, Student Ministry, Church Events, Public Speaking, Teaching, Pastoral, Pastoring, Leadership, Religious Studies, Conflict Resolution, Program Development, Church Administration, Church Growth, Youth Mentoring, Apologetics, Evangelism, Psychotherapy, Bible, Discipleship Training, Ministry Development, Non-profit..., Bible Study, Youth Development, Community Organizing, Chaplaincy, Expository Preaching, Ministry Leadership, Practical Theology, Project Management, Restoration, Water Damage Restoration, Volunteer Training, Youth Leadership, Networking, Adults, Staff Development, Fundraising, Leadership Development
Education
Concordia University-River Forest 2012 — 2014
Master of Arts (M.A.), Counselor Education/School Counseling and Guidance Services
Asbury Theological Seminary 1997 — 2009
MA, Youth Ministry
Greenville College 1987 — 1991
Bachelor of Science (B.S.), Social Studies Teacher Education
Lane Tech 1982 — 1987
High School Diploma, Math/Science
PAREXEL March 2012 - March 2014
Montreal Heart Institute- Coordinating Center/Trialynx August 2010 - February 2012
GE Healthcare January 2007 - July 2010
Education
Mercer County Community College 2007 — 2007
Class, Medical Terminology, A
McGill University 2006 — 2006
Certificate HR Management, Human Resources Management/Personnel Administration, General, With Honors
Concordia University
Bachelors, Human Relations
Medtronic January 2015 - Present
Covidien May 2014 - January 2015
PAREXEL July 2011 - May 2014
Cactus Communications November 2012 - March 2014
The Lydian Center May 2007 - July 2011
Depew Chiropractic Clinic January 2006 - November 2006
VA Medical Center, Buffalo June 2006 - September 2006
Clarkson University May 2001 - May 2003
Masonic Medical Research Laboratory May 2002 - August 2002
Skills
Medical Writing, Medical Devices, Clinical Study Reports, Abstracts, Manuscript Development, Protocol Writing, Medical Editing, Clinical Research, Pharmacovigilance, Clinical Trials, Medicine, CRO, Pharmaceutical Industry, ICH-GCP, eCRF, SAE Narrative Writing, Argus Safety Database, Clinical, Datalabs EDC, InForm, SAE Reconciliation, MedDRA, Chiropractic, Orthopedic
Education
New York Chiropractic College 2003 — 2006
D.C., Chiropractic
Clarkson University 1999 — 2003
B.S., Biomolecular Science
PAREXEL May 2015 - Present
PAREXEL March 2014 - May 2015
CR Bard September 2013 - December 2013
VertiFlex, Inc. September 2011 - August 2013
MCRA March 2008 - September 2011
US Oncology April 2007 - March 2008
Silimed, Inc January 2007 - April 2007
Texas Workforce Commission October 2005 - December 2006
Pitman Creek Physical Therapy October 1999 - January 2004
Skills
Budgets, Process Scheduler, Research, Data Collection, Workshop Facilitation, Clinical Monitoring, Medical Devices, Public Speaking, Health Insurance, Spine, Surgeons, Patient Recruitment, Site Selections, Travel, Travel Planning, Continuing Education, Clinical Research, Clinical Trials, Clinical Data Management, Spinal Stenosis, Orthopedic, Social Services, Sociology, Adult Education, Oral & Written..., Written & Oral..., Report Writing, Leisure Travel, Regulatory Affairs, Regulatory Submissions, Healthcare, Surgery, Physician Relations, FDA, EMR, EHR, GCP, CTMS, IRB, Protocol, Medical Research, Regulatory Documentation, CRO, Clinical Study Design, Sop, Cardiology, ISO 13485, Neurosurgery, CAPA, Vascular
Education
The University of Texas at Dallas 2002 — 2005
Bachelor of Arts, Sociology
Collin County Community College 1999 — 2002
Associate's degree, Sociology
PAREXEL February 2015 - Present
PAREXEL September 2014 - February 2015
Southeast Retina Center, PC March 2013 - September 2014
Experian Data Quality November 2010 - March 2011
Northeast Consulting, Inc. September 2009 - September 2010
Skills
Clinical Trials, Clinical Research, EDC, iMedidata, ICH-GCP, Ophthamology, Endocrinology, Cardiology, Oncology, Data Analysis, Microsoft Office, InForm, DataLabs, IVRS/IVRWS, Protocol Editing, Contract Writing, SOPs
Education
Clemson University
Bachelor's Degree, Health Services/Allied Health/Health Sciences, General
Horizon Healthcare Services LLC December 2014 - April 2015
RNR Consulting December 2013 - June 2014
Cuyahoga County Treasurer June 2008 - November 2013
Xpress Loan Servicing May 2006 - June 2008
PAREXEL September 1998 - November 1999
Skills
Government, Policy, Microsoft Excel, Microsoft Office, Research, Customer Service, Outlook, Microsoft Word, Data Entry, PowerPoint, Public Speaking, Accounting, Analysis, Access, Tax Law, Sales&Marketing, Proactive self-starter, Leadership, Budgets, Team Building, Strategic Planning, Project Management, Program Management, Coaching, Process Improvement, Internal Audit, Nonprofits, Fundraising, Business Process..., Management, Sales, Event Planning, Software Documentation, Mentoring, Business Strategy, Organizational..., Finance, Community Outreach
Education
Colorado State University-Global Campus 2013 — 2015
Master of Management, Business Administration and Management, General
Colorado State University 2013 — 2013
Bachelor of Science (BS), Business Management
Cuyahoga Community College 2011 — 2013
Associate of Arts (A.A.), Art/Art Studies, General
Shaker Hts. 1991 — 1995
Covance August 2015 - Present
Terumo BCT February 2013 - August 2015
PAREXEL May 2012 - August 2012
Allegiance Clinical, Inc. January 2012 - May 2012
Terumo BCT January 2009 - January 2012
Terumo BCT April 2007 - January 2009
University of Colorado Health March 2006 - December 2007
National Jewish Health July 2004 - March 2006
National Jewish Health October 2001 - July 2004
National Jewish Health October 2000 - October 2001
Skills
Research, Problem Solving, Budgeting, Customer Relations, Administration, GCP, Auditing, Phlebotomy, Clinical Research, Clinical Trials, Supervisory Skills, Quality Assurance, Medical Devices, Process Improvement, Mentoring, FDA, Microsoft Office, Clinical Trial..., Personnel Supervision, Budget Development, EKG, Clinical, Pharmaceuticals, Compliance, Regulatory Affairs, SOP
Education
Community College of Aurora
Associate's degree
Metropolitan State College
Science & Human Services -
Pharmaceutical Training Institute
South
Sample6 January 2014 - Present
PAREXEL December 2010 - August 2013
Inotek Pharmaceuticals October 2008 - December 2010
IC Sciences Corp. (NorthPoint Domain, Inc.) October 2006 - October 2008
Merck & Co., Inc. July 2000 - September 2006
Ernst & Young September 1993 - July 1998
Skills
Risk Management, Essbase, Cash Management, Salesforce.com, Cognos, Business Development, Financial Modeling, Forecasting, Financial Analysis, Managerial Finance, Financial Reporting, Strategic Financial..., Strategic Planning, Revenue Recognition, Budgets, Sarbanes-Oxley Act, Finance, Accounting, Hyperion Enterprise, Acquisition Integration, QuickBooks, Equity Edge, Management, Auditing, Analysis, Executive Management, Internal Audit, Business Planning, Valuation, Leadership
Education
Duke University - The Fuqua School of Business 1998 — 2000
MBA
College of the Holy Cross 1989 — 1993
B.A.
Ridgewood High School 1986 — 1989
LumiThera, Inc. September 2015 - Present
LumiThera, Inc. April 2013 - September 2015
Vital Therapies, Inc. January 2013 - September 2015
Aeolus Pharmaceuticals, Inc. July 2012 - March 2014
PhotoThera January 2006 - September 2012
PAREXEL December 2002 - January 2006
PAREXEL August 2000 - December 2002
Atrix Laboratories December 1993 - August 2000
Atrix Laboratories June 1991 - December 1993
Skills
FDA, Oncology, Clinical Operations, Medical Devices, Lifesciences, Data Management, Biotechnology, Regulatory Affairs, Protocol, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, EDC, CRO, GCP, Life Sciences, ICH-GCP, Clinical Trials, CTMS
Education
Regis University 1998 — 2000
MBA, International Business
Colorado State University 1986 — 1991
BS, Business Administration
Colorado State University 1986 — 1991
BS, Psychology
Self-employed May 2007 - Present
Kronos April 2006 - May 2007
PAREXEL January 2000 - June 2005
Altron January 1996 - June 1999
GenRad, Inc. August 1987 - December 1996
Sanders Associates Inc. April 1982 - August 1987
Education
Suffolk University Law School 1971 — 1975
JD, Corporate Law
College of the Holy Cross 1967 — 1971
BA, Political Science
Cardiovascular Clinical Studies June 2012 - Present
Mass Ave Music September 2010 - Present
Ariad Pharmaceuticals February 2009 - June 2010
PAREXEL April 2008 - February 2009
MGI Pharma October 2007 - April 2008
Alkermes May 2007 - August 2007
Genomics Collaborative January 2005 - January 2007
Eastern Cooperative Oncology Group 2004 - 2004
Skills
Clinical Trials, Pharmaceutical Industry, Oncology, Biotechnology, Clinical Data Management, GCP, Data Management, Clinical Research, CRO, Lifesciences, FDA, Regulatory Affairs, Clinical Data, EDC
Education
College of the Holy Cross 1991 — 1995
Bachelor of Arts (B.A.), Music
Xavier High School 1987 — 1991
PAREXEL January 2015 - Present
Quintiles Medical Education August 2011 - December 2014
Fast4wD Ogilvy January 2010 - July 2011
The Scienomics Group June 2007 - January 2009
Skills
Account Management, Healthcare, Advertising, Vendor Management, Budget, Marketing Communications, Digital Marketing, Marketing Strategy, Event Management, Market Research, Cross-functional Team..., Social Media, Business Development, Marketing, Strategic Planning, Contract Negotiation, Event Planning, Team Leadership, Online Advertising, Integrated Marketing, Leadership, Pharmaceutical Industry, Strategy, Program Management, New Business Development, Microsoft Office, Budgets, Management, Customer Service, Project Management, Microsoft Excel, PowerPoint, Oncology
Education
City University of New York
PAREXEL March 2014 - Present
Huron Consulting Group September 2008 - February 2014
Winston & Strawn LLP January 2008 - September 2008
Kennedy Covington July 2006 - January 2008
Cadwalader 2003 - 2006
Skills
Legal Research, Legal Writing, Corporate Law, Litigation, Intellectual Property
Education
Columbia University School of Law 2000 — 2003
JD
University of North Carolina at Chapel Hill 1996 — 2000
BA, Economics
PAREXEL May 2012 - Present
Schering-Plough Research Institute 2009 - 2012
Lantheus Medical Imaging 2008 - 2009
Execupharm June 2007 - July 2008
Pfizer January 2005 - June 2007
Pfizer 2003 - 2005
US Navy 1996 - 2001
Skills
Clinical Development, Management, Biotechnology, Pharmaceutical Industry, Oncology, CRO, FDA, Leadership, Vendor Management, Outsourcing, Clinical Trials, Sop, Cross-functional Team..., Regulatory Affairs, CTMS, GCP, SOP
Education
The George Washington University School of Medicine and Health Sciences 2011 — 2012
Master's Certificate in Clinical Research Administration
Rensselaer Polytechnic Institute - The Lally School of Management and Technology 2005 — 2008
MBA, Business Administration
Southern Illinois University, Carbondale 1999 — 2002
B.S Workforce Education and Training
Naval Hospital Corps School 1997 — 1998
Naval School of Health Sciences 1996 — 1997
City University of New York
PAREXEL 2003 - Present
PHT Corporation 2000 - 2002
CareTools 1997 - 2000
Skills
Clinical Trials, Oncology, Clinical Research, Clinical Development, Cardiology, Medicine, Healthcare, Orthopedic, Pharmaceutical Industry, Diabetes, Project Management
Education
Columbia University in the City of New York 1979 — 1983
BSN
University of Texas Medical Branch
MSN
American Radiology Services July 2009 - Present
The Johns Hopkins Hospital July 2008 - June 2009
Maine Medical Center July 2003 - June 2008
PAREXEL 1998 - 1999
Parexel 1998 - 1999
New England Medical Center 1993 - 1994
New England Medical Center 1993 - 1994
Education
Geisel School of Medicine at Dartmouth 1999 — 2003
MD, Medicine
Colby College 1993 — 1997
Falmouth High School 1989 — 1993
C3 Research Associates January 2015 - Present
Health Decisions November 2012 - December 2014
PAREXEL June 2011 - November 2012
Aspen BioPharma March 2011 - June 2011
PAREXEL May 2010 - September 2010
Epigenomics AG January 2009 - April 2010
PPD May 2008 - October 2008
Cell Therapeutics, Inc (CTI) May 2004 - May 2008
Behavioral Tech 1999 - 2003
Skills
Sop, Clinical Trials, Protocol, Clinical Monitoring, GCP, Clinical Research, CTMS, Site Management, ICH guidelines, Study Monitoring, Biotechnology Industry, Pharmaceutical Industry, Quality Control, Remote Monitoring, Building Relationships, Communication, Team-oriented, Highly detail oriented, Problem Solving, Regulatory Requirements, Regulatory Submissions, Non-profit Volunteer, Volunteering, EDC, IRB, ICH-GCP, Biotechnology, CRO, eCRF, Clinical Operations, Oncology
Education
PPD Headquarters 2008 — 2008
North Seattle Community College 2005 — 2005
University of Washington 1989 — 1991
BFA
Clark College 1985 — 1988
AA
PAREXEL November 2010 - Present
PAREXEL March 2009 - November 2010
PAREXEL April 2007 - March 2009
AHC, The Receivables Management Company, Inc. January 2005 - February 2007
AHC, The Receivables Management Company, Inc. February 2004 - January 2005
Skills
Negotiation, Contract Negotiation, Strategic Planning, Pharmaceutical Industry, Litigation, Clinical Trials, Trials, Management, Medicaid, Mergers, Legal Writing, FDA, CTMS, EDC, Contract Management, Mergers & Acquisitions, Cross-functional Team..., GCP, CRO, Biotechnology, Oncology, Diabetes, Leadership, Microsoft Office, Public Speaking
Education
Cleveland State University - Cleveland-Marshall College of Law 1999 — 2002
2002, Law
North Carolina Central University 1994 — 1998
B.A., Political Science
IlluminOss Medical Inc. February 2015 - Present
Cordis, Johnson & Johnson Medical 2010 - Present
Cordis 2008 - 2010
Cordis, Johnson & Johnson 2005 - 2008
Mitsubishi Tanabe Pharma America 2003 - 2005
sanofi-aventis 2000 - 2003
PAREXEL 1997 - 2000
Skills
Medical Devices, Clinical Trials, Cardiology, FDA, Clinical Development, CTMS, Clinical Monitoring, Clinical Research, EDC, GCP, CRO, ICH-GCP, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs
Education
Columbia University in the City of New York 2004 — 2007
MPH, Public Health
University of Rochester 1993 — 1997
Bachelor of Arts, Health and Society
ARIAD Pharmaceuticals, Inc. September 2014 - Present
Millenium Pharmaceuticals August 2008 - September 2014
Acambis Inc September 2004 - July 2008
Antigenics June 2003 - September 2004
Genzyme November 1998 - June 2003
PAREXEL 1997 - 1998
Skills
IND, Regulatory Affairs, Drug Development, Biologics, Regulations, Pharmaceutical Industry, Clinical Research, eCTD, Management, Clinical Trials, Regulatory Submissions, Life Sciences, Biotechnology, Clinical Development, Drug Discovery, GMP, Biopharmaceuticals, FDA, CMC, Strategy, Oncology, GCP, Lifesciences, Pharmaceutics, Vaccines
Education
Connecticut College 1988 — 1992
BA, Biology
Massachusetts College of Pharmacy and Health Sciences
MS, Regulatory Affairs
Wesleyan University
PAREXEL October 2008 - Present
West Coast Clinical Trials July 2007 - October 2008
PharmaNet January 2004 - July 2007
Anapharm 2004 - 2007
PharmaNet Development Group, Inc. 2004 - 2007
MDS Pharma Services 1999 - 2004
MDS 1999 - 2004
MDS Pharma Services 1994 - 2004
Skills
Clinical Development, Biotechnology, Pharmaceutical Industry, GCP, CRO, Clinical Research, Drug Development, Clinical Trials, GMP, Regulatory Affairs, GLP, Sop, Regulatory Submissions, EDC, Direct Sales, FDA, Lifesciences, Drug Discovery, CTMS, Biopharmaceuticals, Bioanalysis, ICH-GCP, 21 CFR Part 11, Oncology, Medical Devices, Pharmacokinetics, Sales Management, International Sales, Business Development, Technology Transfer, Strategy, Validation, Vaccines, Pharmacovigilance, Therapeutic Areas, Medical Writing, Infectious Diseases, IND, Pharmacology, Clinical Data Management, Life Sciences
Education
Concordia University 1984 — 1994
PRA Health Sciences 2009 - Present
Laureate Online Education 2010 - 2010
PRA International 2008 - 2009
Roche Canada 2006 - 2007
GlaxoSmithKline 2004 - 2005
PAREXEL 2001 - 2004
GlaxoSmithKline 1998 - 2000
Skills
Clinical Research, GCP, ICH-GCP, Regulatory Guidelines, Mentoring, Coaching, Project Management, Clinical Site Management, Oncology, CTMS, Microsoft Excel, Microsoft Word, EDC, Adobe Acrobat, Multi-skilled, CRO, Pharmacokinetics, Training, Toastmasters, Pro-active Leader, Teaching, Dermatology, Clinical Monitoring, Clinical Operations, Clinical Data Management, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, Clinical Trials
Education
Concordia University
Graduate Diploma, Ecotoxicology
Concordia University
B.Sc., Biochemistry, Specialization Medicinal Chemistry
PAREXEL July 2012 - Present
Axcelis Technologies March 2001 - February 2012
State Street Global Advisors 1996 - 2000
Skills
Project Management, SDLC, Business Analysis, Software Development, Project Planning, Troubleshooting, Cross-functional Team..., Business Process, Scrum, Quality Assurance
Education
Project Management Institute 2012 — 2012
Project Management Professional (PMP)
Scrum Alliance 2012 — 2012
Certified ScrumMaster (CSM)
Clark University
PAREXEL September 2012 - Present
PPD 2011 - September 2012
PPD 2008 - 2011
PPD 2007 - 2008
PPD 2006 - 2007
Skills
CRO, Clinical Monitoring, CTMS, EDC, ICH-GCP, Oncology, GCP
Education
The University of Texas at Arlington 2004 — 2005
Bachelor of Science (B.S.), Biology, Business
Collin County Community College 2000 — 2004
Associate, Biotechnology
PAREXEL August 2015 - Present
Merck February 2013 - July 2015
Merck January 2012 - February 2013
Merck September 2010 - January 2012
Merck September 2007 - September 2010
Drexel University 2001 - 2006
Atofina 1993 - 2001
Skills
Six Sigma, Process Improvement, Change Management, Project Management, Cross-functional Team..., Strategy, Pharmaceutical Industry, Regulatory Affairs, Chemistry, Strategic Planning
Education
Drexel University 2001 — 2006
PhD, Biomedical Science - Tissue Engineering Regenerative Medicine
Penn State University 1999 — 2001
MBA, Finance / New Ventures
Columbia University - Columbia Business School
PAREXEL January 2011 - Present
Skills
Cross-functional Team..., Program Management, Project Management, Change Management, Process Improvement, Pharmaceutical Industry, Management, Strategic Planning, Business Analysis, Vendor Management, Six Sigma, SDLC, Project Portfolio..., Quality Assurance, PMP, PMO, Leadership, Customer Service, Marketing, Social Media Marketing, Microsoft Office, Public Speaking, Social Media, Team Building
Education
Concord University
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
PAREXEL January 2006 - April 2008
Lee Hecht Harrison 2002 - 2005
Priceline.com 1999 - 2001
Simms Capital Management 1996 - 1998
Education
City University of New York-Hunter College 1972 — 1976
BA, Music & Communication
Novartis December 2013 - Present
PAREXEL September 2013 - November 2013
Morphotek, Inc. May 2012 - September 2013
Novartis October 2009 - May 2012
Medarex 2007 - October 2009
Celgene 2005 - 2007
Organon Pharmaceuticals 2003 - 2005
Kendle International 2002 - 2003
Kendle International 2000 - 2002
Kendle International 1999 - 2000
Skills
Pharmaceuticals, Clinical Monitoring, Oracle Clinical, Clinical Data Management, EDC, CDISC, GCP, Oncology, Clinical Trials, Data Management, CRO, Clinical Research, Validation, SOP, ICH-GCP, Therapeutic areas, 21 CFR Part 11, CRF design, Biotechnology, Infectious Diseases, FDA, Documentation, Mentoring, Access, Process Improvement, Document Management, Hematology, Immunology, MedDRA, Cardiology, Team Leadership, Mentoring Of Staff, Project Manager..., Cross-functional Team..., Cross Functional Team..., Cross Functional..., Computer System..., Drug Development, Pharmaceutical Industry, Pharmacovigilance, Sop
Education
College of Saint Elizabeth
Kutztown University of Pennsylvania
Cardinal Health November 2013 - Present
Cardinal Health November 2007 - November 2013
Cardinal Health October 1999 - November 2007
PAREXEL 1996 - 1999
Skills
Medical Devices, Pharmaceutical Industry, Department of..., Hazardous Materials, Regulatory Affairs, Regulatory Submissions, Good Clinical Practices, Supply Chain Management
Education
Franklin University 2004 — 2009
Columbus State 2002 — 2004
Associate of Science (AS), Legal Assistant/Paralegal
Columbia University August 2011 - Present
Columbia University October 2010 - July 2011
Columbia University December 2009 - May 2010
PAREXEL November 2007 - July 2009
Long Island University March 2002 - October 2007
St. Vidyasagar Inc. January 2000 - February 2002
Skills
Financial Reporting, SOX, Reconciliation, Variance Analysis, Financial Analysis, Quickbooks, Excel, Accounting, Budgeting, Accounts Payable, Microsoft Office, Accounts Receivable, Auditing, Budgets, Account Reconciliation, Microsoft Excel, Forecasting, Analysis, Financial Modeling, Finance, QuickBooks, Sarbanes-Oxley Act
Education
Columbia University in the City of New York 2011 — 2013
MS, Negotiation and Conflict Resolution (NECR)
LIU Post 2002 — 2005
MBA, Finance & MIS
Long Island University, C.W. Post Campus 1998 — 2002
BS, Finance
University of Calcutta 1988 — 1991
B.Com, Accounting
Baxter BioScience November 2006 - Present
Parus Interactive October 2005 - November 2006
PAREXEL September 1996 - June 2005
Skills
Clinical Trials, Clinical Research, FDA, Human Resources, Pharmaceutical Industry, GCP, Clinical Development, CTMS, CRO, EDC, Oncology, Sop
Education
College of Lake County
PAREXEL November 2010 - Present
PAREXEL February 2009 - October 2010
PAREXEL December 2006 - February 2009
PAREXEL February 2004 - December 2006
PAREXEL May 2003 - November 2003
PAREXEL June 2002 - May 2003
PAREXEL June 2001 - June 2002
Strategic Reports May 2000 - June 2001
DuPont March 1997 - November 1999
DuPont July 1993 - March 1997
Skills
CRO, Clinical Trials, GCP, CTMS, EDC, Clinical Research, Oncology, Sop, Biotechnology, Lifesciences, Clinical Monitoring, Clinical Development
Education
Clemson University
Masters of Science, Molecular Biology
University of Delaware
PAREXEL 2015 - Present
GlaxoSmithKline 2011 - 2015
Procter & Gamble 2008 - 2011
Procter & Gamble Pharmaceutical 2004 - 2008
Procter & Gamble Pharmaceutical 2001 - 2004
Columbia University Medical Center 1999 - 2001
Education
Columbia University College of Physicians and Surgeons
Postdoctoral Scientist, Human and Microbial Genomics/ Genetics/Pharmacogenomics
University of Cincinnati
Doctor of Philosophy (PhD), Biomedical Engineering/Bioinformatics
Columbia University in the City of New York
Master of Science (MS), Biomedical/Medical Engineering
Peking Union Medical College/Shandong Medical School
M.D. Internal Medicine, Internal Medicine Residency Program
Boehringer Ingelheim (Contractor providing support via Yoh, A Day & Zimmermann Company) April 2014 - Present
PAREXEL March 2011 - April 2014
Merck & Co., Inc. February 2003 - March 2011
Merck & Co., Inc. February 2003 - February 2007
Skills
Clinical Trials, EDC, Clinical Research, GCP, Data Management, Pharmaceutical Industry, CRO, Protocol, Therapeutic Areas, Oncology, Clinical Data Management, ICH-GCP, Clinical Monitoring, CTMS, Clinical Development, Infectious Diseases, Strategy, Drug Development, Feasibilities, Teamwork
Education
College of Charleston 1996 — 2000
MS
Franklin & Marshall College 1991 — 1995
BA, Biology
Alcon, a Novartis company (via Fidelis) March 2015 - Present
Salix Pharmaceuticals (via SRG Woolf) August 2014 - February 2015
Salix Pharmaceuticals (via SRG Woolf) October 2013 - August 2014
PAREXEL November 2012 - October 2013
Quintiles (through Valesta) July 2012 - October 2012
United BioSource Corporation January 2012 - July 2012
Duke Clinical Research Institute 2007 - January 2012
Cato Research July 2007 - August 2007
General Clinical Research Center at the Medical University of South Carolina January 2007 - July 2007
Roper St. Francis Healthcare 2005 - 2007
Skills
Clinical Monitoring, GCP, CRO, Research, Clinical Trials, CTMS, Clinical Research, EDC, ICH-GCP, Therapeutic Areas, Clinical Development, Clinical Data Management, Oncology, Protocol, Infectious Diseases, Pharmaceutical Industry
Education
Duke University 2006 — 2008
MSN, Clinical Research Management
Medical University of South Carolina 2003 — 2005
BSN, Nursing
Coastal Carolina University 2001 — 2003
Pre-Nursing
PAREXEL March 2015 - Present
GSK 1998 - Present
GlaxoSmithKline 1998 - 2009
GSK 1999 - 2001
GSK 1999 - 2001
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, Drug Development, Regulatory Submissions, CRO, GCP, Biotechnology, Oncology, Regulatory Affairs, CTMS, FDA, Life Sciences, SOP, Clinical Research, Infectious Diseases, Therapeutic Areas, Cross-functional Team..., Drug Discovery, GMP
Education
North Carolina State University 1980 — 1984
Master's degree, Animal Physiology
Clemson University 1976 — 1980
Bachelor's degree, Animal Sciences
PAREXEL August 2009 - Present
PAREXEL 2007 - 2015
PAREXEL May 2008 - August 2009
Perceptive Informatics July 2007 - May 2008
Skills
Clinical Trials, Pharmaceutical Industry, CRO, Biotechnology, SOP Authoring, Cross-functional Team..., Cross Functional Team..., Gap Analysis, Training & Development, Project Management, Learning Management..., Business Objects, Conference Coordination, Meeting Planning, Biopharmaceuticals, SOP, 21 CFR Part 11, Business Development, Executive..., Process Improvement, Software Documentation, Validation, Microsoft Office, Management
Education
Community College of the US Air Force
Ironwood Pharmaceuticals August 2014 - Present
Wolfe Advisors Inc. November 2006 - Present
Shire HGT July 2010 - July 2014
BioBridges, LLC March 2010 - July 2010
Outcome May 2009 - March 2010
Aeris Therapeutics April 2007 - October 2008
Ariad Pharmaceuticals September 2004 - March 2007
Alkermes September 1997 - September 2004
PAREXEL October 1993 - September 1997
Deaconess Waltham Hospital 1994 - 1997
Skills
Clinical Trials, CRO, Sop, Data Management, Oncology, Oracle Clinical, EDC, FDA, CDISC, Clinical Data Management, Clinical Research, CTMS, Clinical Development, SOP
Education
Clark University 2000 — 2000
Certificate, Client-server programming
Northeastern University 1989 — 1993
BS, Health Information Management
Internships 1990 — 1993
Health Information Management
Penn State University 1987 — 1989
Health Policy Administration
PAREXEL April 2015 - Present
PAREXEL February 2013 - April 2015
PPD July 2011 - February 2013
PPD March 2011 - July 2011
PPD February 2009 - March 2011
PPD March 2006 - February 2009
Skills
Forecasting, Budgeting, Process Improvement, Contract Negotiations, Analysis, Management, Budgets, Negotiation, Cross-functional Team..., Strategic Planning, Contract Management, Financial Analysis, CRO, Clinical Trials, CTMS, Pharmaceutical Industry, Clinical Development, GCP, Contract Negotiation
Education
Concordia University-Ann Arbor 2001 — 2005
Concordia University Texas 2001 — 2004
Business/Accounting, Sales and Accounting
GlobalCare Clinical Trials, Ltd December 2014 - Present
Parexel December 2008 - December 2014
ClinPhone PLC 2002 - 2008
Independence Plus, Inc. 2000 - 2002
CTI Network, Inc 1999 - 2000
Rush University Medical Center 1998 - 1999
Children's Memorial Hospital 1992 - 1999
Johnson & Johnson 1997 - 1998
Skills
eClinical, CRO, IVR, Clinical Trials, Line Management, Account Management, Strategic Partnerships, Technical Writing, Project Management, IWR, Pharmaceutical Industry, Program Management, CTMS, EDC, Clinical Research, GCP, 21 CFR Part 11, Clinical Development, Data Management, Clinical Data Management, FDA, SOP, Oncology, Management, Biotechnology, Cross-functional Team..., Validation
Education
City University of Seattle 1997 — 2002
Master of Business Administration (MBA), Project Management
Rush University 1993 — 1995
Bachelor of Science (BS), Perfusion Technology/Perfusionist
National-Louis University 1991 — 1993
Bachelor of Arts (B.A.), Health/Health Care Administration/Management
PAREXEL January 1996 - Present
Ropes & Gray LLP 1992 - 1995
Cornerstone Research 1991 - 1992
Skills
Clinical Development, Pharmaceutical Industry, Clinical Trials, CRO, Regulatory Affairs, Biotechnology, Oncology, CTMS, FDA, Clinical Research, Regulatory Submissions, Drug Development, Lifesciences, Market Access, GCP, Pharmacovigilance
Education
College of the Holy Cross 1987 — 1991
Bachelor of Arts (B.A.), Economics
Tetraphase Pharmaceuticals January 2015 - Present
Tetraphase Pharmaceuticals November 2013 - December 2014
Curis January 2013 - November 2013
Curis May 2012 - December 2012
BioVex December 2009 - May 2012
PAREXEL July 2009 - December 2009
PAREXEL March 2008 - July 2009
PAREXEL June 2007 - March 2008
Harvard School of Public Health June 2005 - June 2007
Skills
Clinical Trials, Clinical Development, Oncology, FDA, CRO, Clinical Monitoring, Clinical Research, CTMS, Biotechnology, Drug Development, EDC, Regulatory Affairs
Education
College of the Holy Cross 2001 — 2005
BA, Chemistry
PAREXEL 1991 - September 2013
Biomedical Information Center, Ridgewood, New Jersey 1989 - 1991
Seton Hall University, South Orange, New Jersey 1985 - 1987
Department of Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Mass 1981 - 1984
Downstate Medical Center and Institute for Basic Research in Mental Retardation, New York 1973 - 1975
Skills
Medical Writing, Pharmaceutical Industry, Oncology, Medical Education, Publication Planning, Strategic Communications, Medical Communications, Publications, Neurology, Cardiology, Cell, Clinical Trials, Diabetes, Life Sciences, Therapeutic Areas
Education
State University of New York Downstate Medical Center College of Medicine 1975 — 1981
PhD, Biochemistry
City University of New York-Brooklyn College 1969 — 1973
BS, Biology
PAREXEL June 2014 - Present
Edwards Lifesciences January 2012 - May 2014
Genentech September 2010 - January 2012
Exelixis May 2010 - September 2010
Roche Molecular Systems December 2009 - May 2010
Cytokinetics November 2007 - November 2009
PDL BioPharma June 2006 - November 2007
Gilead Sciences June 2004 - May 2006
Chiron Corporation January 2003 - April 2004
La Jolla Pharmaceutical Company 2002 - 2002
Skills
SAS, Clinical Trials, Macro development, Staff Supervision, SOP development, Macro, CDISC, Statistical Programming, SAS programming, Regulatory Submissions, Data Analysis, Data Management, CRO, Unix, Clinical Data Management, SDTM, Oracle Clinical, EDC, Oncology, Validation, Biostatistics, Clinical Research, 21 CFR Part 11, Clinical Development, Protocol, GCP, Sop, FDA, Statistics, CTMS, ICH-GCP, Clinical Study Design, CRF design, Inform, Data Warehousing, Medidata, Infectious Diseases, Drug Development, Pharmaceutical Industry, Biotechnology, Computer System..., Databases, Software Documentation, Clinical Monitoring, Lifesciences, Survival Analysis, Medical Devices, Data Validation, Biopharmaceuticals, Programming
Education
Columbia University Mailman School of Public Health 1990 — 1992
MPH, Biostatistics
Princeton University 1986 — 1990
AB, History
PAREXEL 2014 - Present
PAREXEL 2014 - 2014
PAREXEL 2012 - 2013
Ockham Development Group (an ASG Company) 2008 - 2012
Skills
CRO, Clinical Trials, EDC, GCP, Oncology, Clinical Monitoring, CTMS, ICH-GCP, Clinical Development, Clinical Data Management, Pharmaceutical Industry, Clinical Research, Biotechnology, Regulatory Affairs, Regulatory Submissions
Education
Colorado State University
Bachelor's Degree, Microbiology
The University of Texas Medical School at Houston
Master's Degree, Molecular Biology - Oncology
University of Nebraska at Omaha
Bachelor's Degree, Biotechnology
AbbVie February 2014 - Present
Bridgeline Digital July 2013 - November 2013
PAREXEL September 2010 - July 2013
University of Colorado April 2005 - February 2008
Skills
21 CFR Part 11, Data Management, Pharmaceutical Industry, Protocol, Validation, Sop, SDLC, Software Documentation, Integration, EAI, Quality Assurance, SQL, FDA, Oracle, Lifesciences, Clinical Trials, Software Development, Life Sciences, SOP, Time Management
Education
Colorado College 2000 — 2004
Bachelor's degree, Biology, General
PAREXEL December 2009 - February 2011
Sports and Arts in Schools Foundation 2008 - 2009
Education
City University of New York-Hunter College 2002 — 2006
BA, Psychology
Sacred Heart University
MA, Education
Biogen Idec June 2014 - Present
Biogen Idec February 2013 - May 2014
Averion International September 2010 - February 2013
Veristat, Inc. March 2008 - September 2010
Averion International January 2006 - February 2008
Averion International January 2001 - January 2006
PAREXEL January 1996 - January 2001
Education
Clark University 2005 — 2006
CCA, Medical Coding
Massachusetts College of Pharmacy and Health Sciences 1983 — 1988
BS, Pharmacy
Parexel April 2014 - Present
PAREXEL May 2012 - May 2014
Creations Garden Natural Products August 2009 - September 2010
bouquet mobil Services August 2008 - August 2009
Skills
Microsoft Excel, HPLC, FTIR, cGMP practices, Matlab, Pro II, ICP, Labview, Gas Chromatography, Public Speaking, COMSOL, PFD, Quality Control, Chemical Engineering, Laboratory, PowerPoint, Research
Education
University of California, Los Angeles 2010 — 2013
Bachelor of Science (B.S.), Chemical Engineering
College of the Canyons 2007 — 2010
Chemical Engineering
PAREXEL December 2014 - Present
Hoffmann La Roche September 2011 - December 2014
Roche Pharmaceuticals June 1993 - September 2011
Hoffmann La Roche June 1993 - June 1999
Hoffmann La Roche July 1987 - June 1993
Skills
Oncology, Clinical Trials, Pharmaceuticals, Diabetes, Clinical Research, GCP, Pharmaceutical Industry, Clinical Development, CRO, Therapeutic Areas, CTMS, ICH-GCP, Biotechnology, Drug Development, EDC, Infectious Diseases
Education
Emilio Aguinaldo College of Medicine 1981 — 1984
MD, Medicine
John Jay College of Criminal Justice 1974 — 1977
BS, Forensic Chemistry
PAREXEL November 2010 - June 2012
PAREXEL April 1999 - December 2007
Education
Clark University 2007 — 2007
Medical Coding and Billing
University of Mumbai
BSc, Chemistry, Physics, Mathematics
PAREXEL July 2013 - Present
Michael S. Somero, MD, FACP June 2012 - June 2013
Quintiles, Inc. 2000 - 2011
Quintiles, Inc. 1995 - 2000
ADI Properties, Inc. 1988 - 1995
Childrens' Center 1980 - 1988
Education
American Commonwealth University
Bachelor's degree, Business Administration and Management, General
College of the Desert
Associate of Arts (AA), Early Childhood Education and Teaching
Kaplan College
Medical Assistant
PAREXEL September 2012 - Present
Self employed 2005 - Present
self employed 1991 - Present
Menander and Associates 2007 - September 2012
NORCAL Mutual Insurance Company 1988 - 1995
Skills
clinical research..., oncology studies..., regulatory medical..., Site qualifications and..., independent, pro-active..., extensive medical..., excellent oral and..., Clinical Monitoring, Medical Writing, Medicine, Pharmaceutical Industry
Education
Columbia University in the City of New York 1986 — 1988
Master's degree, Ethics
Pepperdine University 1980 — 1984
Bachelor of Arts (B.A.), English/Religion
Castilleja
PAREXEL 2000 - 2008
Education
Columbia University in the City of New York
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
PAREXEL May 2013 - Present
PAREXEL July 2011 - April 2013
INC Research October 2010 - July 2011
i3 Innovus April 2008 - May 2010
AAI Pharma April 2008 - August 2008
MedImmune July 2004 - December 2007
Omnicare October 2002 - April 2004
Skills
Clinical Data Management, Data Management, EDC, Therapeutic Areas, Oracle Clinical, Sop, Clinical Research, Biostatistics, GCP, CRO, Clinical Trials, CTMS, Oncology, ICH-GCP, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Lifesciences, Oncology Clinical..., Protocol, Clinical Study Design
Education
Concordia University 1990 — 1994
Bachelor of Science (BSc), Cell/Cellular and Molecular Biology