BioBridges, LLC

Industry: Company

Description

Founded: 2005 Parent organization: The Adecco Group

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BioBridges, LLC Employees

Employee
Years
Job
Industry
Kenneth R Milstead Kenneth R Milstead Greater New Orleans Area Details
Kenneth R Milstead's BioBridges, LLC Experience August 2007 - February 2012
Job Senior Life Sciences Consultant at dWise Inc.
Industry Pharmaceuticals
Experience
d-Wise Inc.  July 2014 - Present
Multiple Clients/Organizations   February 2012 - July 2014
BioBridges, LLC   August 2007 - February 2012
Outcome Sciences, Inc.   July 2006 - August 2007
Multiple Clients/Organizations   June 1998 - July 2006
Columbia Laboratories  September 1996 - May 1998
Genetics Institute  February 1996 - August 1996
Serono Laboratories  September 1995 - February 1996
Multiple Clients/Organizations   April 1995 - August 1995
Fujisawa USA  July 1993 - March 1995

Skills
Data Management, CDISC, Clinical Research, SAS, Sop, MedDRA, Clinical Data Management, Clinical Trials, EDC, GCP, CRO, Biotechnology, Validation, Oncology, Pharmaceutical Industry, Project Management, 21 CFR Part 11, Medidata, Inform, Drug Development, Data Analysis, Epidemiology, Public Health, Consultant, Clinical Monitoring, Technical Writing, SQL, Contract Negotiation, Auditing, Electronic Data Capture, Medidata Rave, Technology Evaluation, Proposal Writing, Budget Process, System Testing, Test Case Generation, Requirements Analysis, Business Process..., Requirements Gathering, SDLC, Business Development, Software Documentation, User Acceptance Testing, CRF design, Health Care Information..., Training, Patient Registries, Medical Devices

Education
The University of Texas Health Science Center at Houston   1988 — 1993
Master of Science (M.S.), Public Health (Epidemiology)

Tulane University   1984 — 1988
Bachelor of Arts (B.A.), Psychology/Political Science

University of Toronto   2000 — 2000
Participated in DEEDS Project Oracle Training Program

David Bergamesca David Bergamesca Greater Boston Area Details
David Bergamesca's BioBridges, LLC Experience May 2013 - January 2015
Job Business Development
Industry Biotechnology
Experience
BioBridges, LLC   May 2013 - January 2015
Ralston Health Group   March 2011 - April 2012
eCast Corporation  February 2007 - July 2010
GE Capital Receivables Management   May 1997 - June 2002

Education
The University of Connecticut   1983 — 1988
BS, Marketing

Amy Mucci Amy Mucci South Easton, Massachusetts Details
Amy Mucci's BioBridges, LLC Experience November 2014 - July 2015
Job Training and Process Development Specialist at BioBridges, LLC
Industry Biotechnology
Experience
Vertex Pharmaceuticals  July 2015 - Present
BioBridges, LLC   November 2014 - July 2015
Biogen Idec  2006 - September 2014

Skills
QUMAS, Technical Writing, Document Management, Document Review, Deviation Management, Inspection, Training & Development, SOP, CRO, Pharmaceutical Industry, Biotechnology, FDA, Life Sciences, Clinical Development, Clinical Trials, GMP, Validation, Drug Development, GLP, Regulatory Submissions, Biopharmaceuticals, Regulatory Affairs, 21 CFR Part 11, GCP, Quality System

Education
Sacred Heart University   2003 — 2006
Bachelor of Science (B.S.), Biology, General

Jeff Souza Jeff Souza Greater Boston Area Details
Jeff Souza's BioBridges, LLC Experience July 2014 - Present
Job Biobridges, LLC.,Chief Executive Officer and Partner
Industry Pharmaceuticals
Experience
BioBridges, LLC   July 2014 - Present
BioBridges, LLC   September 2012 - Present
Leaders For Today, LLC   June 2009 - July 2014
Leaders For Today, LLC   March 2008 - June 2009
i3 Pharma Resourcing, Ingenix, United Health Group   February 2003 - March 2008
ClinForce/Cross Country Trav Corps   February 2000 - February 2003
Favorite Staffing  1996 - 1999

Skills
Healthcare, Recruiting, Leadership, Healthcare Consulting, Strategic Planning, Healthcare Management, HIPAA, EMR, Interim Management, Onboarding, Marketing, Business Development, Medicare, Revenue Cycle, Hospitals, Critical Care, Physicians, Management, Informatics, Inpatient, Temporary Placement, Time Management, Team Building, Quality Improvement, Clinical Research, Meditech, Patient Safety, Healthcare Information..., Medicaid, Networking, Practice Management, Managed Care, Medical Devices, Surgery, Acute Care, Nursing, Physician Relations, Utilization Management, Finance, Executive Search, JCAHO, Clinical Trials, EHR, Performance Improvement, Home Care, Oncology, Human Resource..., Budgets, Healthcare Industry, Project Management

Education
Curry College   1977 — 1980
Bachelor Science Nursing, Nursing

Alice Susan Horne Alice Susan Horne Charlotte, North Carolina Area Details
Alice Susan Horne's BioBridges, LLC Experience July 2013 - August 2013
Job Medical Writer/Drug Safety Associate/Documentation Specialist/Physician Assistant
Industry Biotechnology
Experience
Available for Employment  June 2014 - Present
Self employed  October 2013 - May 2014
Orbis Clinical  May 2011 - September 2013
BioBridges, LLC   July 2013 - August 2013
Sunovian Pharmaceuticals; RPS Inc, Smart Biotech Inc   October 2006 - October 2010
Audio Digest  May 2006 - October 2006
Biogen Idec  July 2001 - May 2006

Skills
Medical Writing, Clinical Trials, Clinical Development, Pharmaceutical Industry, Drug Safety, GCP, Biotechnology, Clinical Research, Protocol, FDA, IND, Medicine, Medical Devices, CRO, Oncology, Pharmacovigilance

Education
Medical University of South Carolina
Physician Assistant Certificate

Lenior Rhyne University
Bachelor of Science (BS) Biology

Jeff Randles Jeff Randles Washington D.C. Metro Area Details
Jeff Randles's BioBridges, LLC Experience June 2014 - Present
Job Senior Career Manager at BioBridges, LLC
Industry Pharmaceuticals
Experience
BioBridges, LLC   June 2014 - Present
Precept Life Sciences  March 2000 - June 2014
IMI Systems  July 1998 - March 2000
IMI Systems  July 1998 - March 2000

Skills
Benefits Negotiation, Interviews, Clinical Trials, Pharmaceutical Industry, Applicant Tracking..., Contract Recruitment, Internet Recruiting, Clinical Research, Technical Recruiting, Regulatory Affairs, Medical Writing, Medical Devices, Recruiting, Clinical Development, Clinical Data Management, CTMS, CRO, Staffing Services, EDC, GCP, Talent Acquisition, Therapeutic Areas, Sourcing, Human Resources, Executive Search, Protocol

Education
Capital University   1986 — 1990
BA, Marketing and Communications

Karen Shaver Karen Shaver Greater Boston Area Details
Karen Shaver's BioBridges, LLC Experience March 2012 - March 2013
Job Independent Contracting and Consulting
Industry Biotechnology
Experience
Pharmaceuticals and Medical Devices   July 2013 - Present
Anika Therapeutics  March 2013 - Present
BioBridges, LLC   March 2012 - March 2013
Interleukin Genetics  December 2007 - February 2012

Skills
Clinical Trials, Clinical Research, Regulatory Affairs, Clinical Development, Clinical Trial..., Regulatory Submissions, FDA, Genetics, Clinical Project..., Life Sciences, Nuclear Medicine, Cardiology, Inflammation, CRO Management, Infectious Diseases, GMP, Oncology, IND, Lifesciences, Biotechnology, CTMS, Neurology

Education
The University of Texas at Austin

Karen M McCormack, PhD Karen M McCormack, PhD Greater New York City Area Details
Karen M McCormack, PhD's BioBridges, LLC Experience July 2015 - Present
Job Consulting Senior Medical Writer at Sanofi
Industry Pharmaceuticals
Experience
BioBridges, LLC   July 2015 - Present
Regulatory Medical Writing, Pharmaceutical Research   June 2002 - Present
PPD  January 2015 - June 2015
Kinapse  December 2013 - December 2014
GSK  October 2012 - November 2013
Johnson & Johnson  December 2010 - June 2011
Merck  July 2010 - October 2010
ReSearch Pharmaceutical Services  October 2007 - July 2009
Wyeth Pharmaceuticals  January 2007 - July 2007
Adolor  August 2006 - December 2006

Skills
Medical Writing, Therapeutic areas, Pharmacovigilance, Clinical Trials, Pharmaceuticals, Clinical, Protocol Development, Neuroscience, Oncology, Clinical Research, Clinical Development, Gastroenterology, Cardiology, Regulatory Affairs, Neurology, GCP, SOP, Dermatology, Immunology, CRO, Research, Pain, Writing, Pharmacology, Word, Cancer, PowerPoint, Editing, Documentation, Regulatory Submissions, Infectious Diseases, CNS disorders, Clinical Study Reports, Clinical Study Design, Clinical Pharmacology, Cardiovascular Disease, Investigator Brochures, Safety and Efficacy..., Protocol, Pharmaceutical Industry, Pharmaceutics, Sop, ICH-GCP, CTMS, Scientific Writing, Software Documentation, Pain Management, Therapeutic Areas, Drug Development, FDA

Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences   1996 — 2002
PhD, Neuropharmacology/Toxicology

Binghamton University   1991 — 1995
BS, Psychobiology

Jesse Nandhavan Jesse Nandhavan Greater Boston Area Details
Jesse Nandhavan's BioBridges, LLC Experience October 2010 - Present
Job Career Management at BioBridges, LLC
Industry Biotechnology
Experience
BioBridges, LLC   October 2010 - Present
NAAAP Boston  June 2013 - Present
UK Trade and Investment  October 2008 - October 2010
Independent  July 2008 - October 2009
BG Medicine  October 2007 - October 2008
Perceptive Informatics, Inc  June 2006 - September 2007
Hebrew SeniorLife  2005 - 2006

Skills
Clinical Trials

Education
Boston University   2010 — 2012
Masters of Science, Computer Information Systems

Babson College   2009 — 2010

Boston University   2001 — 2005
B.S., Biomedical Engineering, minor in Business Administration

Malden Catholic High School

Judy Maggs Judy Maggs Natick, Massachusetts Details
Judy Maggs's BioBridges, LLC Experience January 2009 - April 2014
Job Administrative Assistant at Natick Public Schools
Industry Education Management
Experience
BioBridges, LLC   January 2009 - April 2014
Synovate  September 1999 - December 2008
Regus  November 1996 - September 1999
Woodard & Curran  1990 - 1996

Skills
Microsoft Office, QuickBooks, Receptionist Duties, Office Administration, Microsoft Excel, Microsoft Word, PowerPoint, Training, Time Management

Education
University of Massachusetts, Amherst   1981 — 1985
Bachelor of Arts (B.A.), Early Childhood Education and Teaching

Jennifer Thayer Jennifer Thayer Greater Boston Area Details
Jennifer Thayer's BioBridges, LLC Experience 2013 - Present
Job Head, Medical Writing and Scientific Communications at BioBridges
Industry Biotechnology
Experience
BioBridges  September 2015 - Present
Boston University - Metropolitan College  June 2015 - Present
BioBridges, LLC   2013 - Present
Vertex Pharmaceuticals  2012 - 2013
Dyax Corp.  2010 - 2012
Dyax Corp.  2009 - 2010
Dyax Corp.  2007 - 2009
Biogen  2001 - 2007
Biogen Idec  1996 - 2001

Skills
Clinical Trials, Clinical Development, Clinical Research, Cross-functional Team..., Medical Writing, Regulatory Submissions, Drug Development, Medical Education, Patient Advocacy, Corporate Social..., Strategic Planning, Issue Resolution..., Life Sciences, Leadership, FDA, Drug Discovery, GCP, Molecular Biology, Regulatory Affairs, Biotechnology, Change Control

Education
Simmons School of Management   2009 — 2012
MBA

Harvard University   1998 — 2000
EdM, Education

Boston University   1995 — 1996
MA, English

University of California, Los Angeles   1992 — 1994
BA, English

Stephan Ogenstad Stephan Ogenstad Raleigh-Durham, North Carolina Area Details
Stephan Ogenstad's BioBridges, LLC Experience 2008 - 2012
Job President, Statogen & President & Secretary North Carolina Chapter of American Statistical Association ASA
Industry Biotechnology
Experience
Georgia Southern University  February 2009 - Present
Georgia Southern University  January 2009 - Present
American Statistical Association - ASA  January 2007 - Present
Statogen Consulting (sogenstad@Statogen-Consulting.com)   August 2006 - Present
Innovalyst   May 2008 - December 2012
BioBridges, LLC   2008 - 2012
American Statistical Association - ASA  January 2009 - December 2009
Vertex Pharmaceuticals, Inc.   August 1997 - June 2006
Amgen  August 1995 - July 1997
Parexel International  August 1993 - July 1995

Skills
Clinical Trials, Pharmaceutical Industry, SAS, Clinical Development, Biotechnology, Biostatistics, Statistics, Data Management, Drug Development, Oncology, Clinical Study Design, FDA, Strategy, Statistical Programming, Data Analysis, Clinical Research, Medical Devices, Lifesciences, Management, GCP, Business Strategy, Analysis, Life Sciences, Consulting, Start-ups, Data Mining, Management Consulting, Leadership, Business Planning, Analytics, Cross-functional Team..., Healthcare, Predictive Modeling, Training, CRO, Biopharmaceuticals, Program Management, Change Management, Leadership Development, Validation, Product Development, Statistical Modeling, Pharmaceuticals, Six Sigma, Thought Leadership, Sop, CDISC, EDC, Protocol, Biostatistical expert...

Education
Stockholm University
PhD, Statistics

Laura Loewy Laura Loewy Greater Boston Area Details
Laura Loewy's BioBridges, LLC Experience November 2013 - March 2015
Job Yoga Instructor at Some.Yoga.Studio
Industry Health, Wellness and Fitness
Experience
Centre Yoga   August 2015 - Present
Some.Yoga.Studio   August 2015 - Present
Backcountry Yoga   March 2015 - Present
Karma Yoga Studios  May 2014 - Present
BioBridges, LLC   November 2013 - March 2015
Granite Telecommunications  May 2013 - November 2013
Starwood Hotels & Resorts Worldwide, Inc.   December 2012 - May 2013
Lewis & Clark River Expeditions   May 2012 - September 2012
Hampden County District Attorney  December 2011 - May 2012

Skills
Customer Service, Project Management, Strategic Sourcing, Contract Recruitment, Career Management, Recruiting, Event Planning, Event Management, Social Media Marketing, Management, Leadership, Sales, Social Networking, Microsoft Office, PowerPoint, Microsoft Excel, Data Analysis, Research, Microsoft Word

Education
University of Massachusetts, Amherst   2008 — 2012
Bachelor of Arts (BA), Communications

Andrew J. Young Andrew J. Young Greater Boston Area Details
Andrew J. Young's BioBridges, LLC Experience January 2005 - December 2013
Job CEO at NovusLife
Industry Biotechnology
Experience
BioBridges, LLC   January 2005 - December 2013
Bioforce Solutions   April 2000 - August 2004
Darwin Partners  1997 - 1999

Skills
Pharmaceutical Industry, Clinical Development, Business Development, Biotechnology, Medical Devices, Start-ups, Management, Life Sciences, Strategic Planning, Recruiting, Clinical Trials, Contract Negotiation, Oncology, CRM, Sales Management, Business Planning, New Business Development, Project Management, Lifesciences, Regulatory Submissions, Business Strategy, Biopharmaceuticals, Consulting, Operations Management, Process Improvement, Brand Development, Key Account Development, Drug Development, Rare Diseases, Clinical Evidence, Leadership, Cross-functional Team...

Education
Boston College   1990 — 1994
Bachelor's Degree, History, cum laude

Brigid Doherty Brigid Doherty Greater Boston Area Details
Brigid Doherty's BioBridges, LLC Experience August 2013 - December 2014
Job Clinical Data Manager at Merrimack Pharmaceuticals
Industry Research
Experience
Merrimack Pharmaceuticals  January 2015 - Present
BioBridges, LLC   August 2013 - December 2014
Frontier Science & Technology Research Foundation, Inc. (FSTRF)   October 2007 - August 2013
Weight Watchers  January 2008 - May 2013
Commonwealth Hematology Oncology  May 2004 - October 2007

Skills
Data Management, SAS, Clinical Trials, Clinical Data Management, EDC, Medidata, Oracle Clinical, GCP, Employee Training, CTMS, Phase I, Clinical Research, CRF design

Education
Bridgewater State College   2001 — 2005
BS, Business Administration and Management, General

Jovanna Baptista Jovanna Baptista Greater Boston Area Details
Jovanna Baptista's BioBridges, LLC Experience October 2009 - August 2010
Job Director, Biostatistics at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals  April 2014 - Present
Shire Pharmaceuticals  March 2012 - April 2014
Shire Pharmaceuticals  May 2010 - March 2012
BioBridges, LLC   October 2009 - August 2010
Infinity Pharmaceuticals  November 2009 - April 2010
Altus Pharmaceuticals  October 2008 - September 2009
Altus Pharmaceuticals  March 2008 - October 2008
AMAG Pharmaceuticals  August 2006 - March 2008
Averion International  October 2005 - August 2006

Skills
Biostatistics, Clinical Trials, Clinical Research, SAS, FDA, CRO, Data Analysis, Regulatory Submissions, Study Design, CDISC, Protocol Development, Statistical Programming, EDC, Clinical Study Design, 21 CFR Part 11, Clinical Data Management, Clinical Development, Protocol

Education
Harvard T.H. Chan School of Public Health   2000 — 2002
MS, Biostatistics

Worcester Polytechnic Institute   1996 — 2000
BS, Actuarial Mathematics

Jennifer Sugarman Jennifer Sugarman Framingham, Massachusetts Details
Jennifer Sugarman's BioBridges, LLC Experience January 2015 - June 2015
Job Contract Clinical Operations Study Lead at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals  August 2015 - September 2015
BioBridges, LLC   January 2015 - June 2015
pSivida   September 2011 - November 2014
BioBridges, LLC   March 2011 - September 2011
NormOxys, Inc   April 2010 - December 2010
Eyegate Pharmaceuticals, Inc   June 2008 - April 2010
Vertex Pharmaceuticals Inc  June 2006 - June 2008
Critical Therapeutics, Inc   November 2004 - June 2006
Perceptive Informatics, Inc  November 2003 - November 2004
Biogen, Inc  August 2003 - November 2003

Skills
Clinical Development, CTMS, Clinical Trials, GCP, CRO, Sop, Clinical Research, FDA, Clinical Study Design, EDC, Clinical Monitoring, Clinical Operations, Biotechnology, Pharmaceutical Industry, Infectious Diseases, Lifesciences, Clinical Data Management, Drug Development, Medical Devices, Regulatory Affairs, Medical Writing, Protocol, Therapeutic Areas, Phase I, Life Sciences, ICH-GCP, SOP

Education
Boston University   1998 — 1999
MPH, Public Health

Keene State College   1990 — 1994
BA, Psychology

Michelle Harrison Michelle Harrison Greater Boston Area Details
Michelle Harrison's BioBridges, LLC Experience May 2008 - April 2010
Job Associate Director, Clinical Data Management at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals  February 2014 - Present
Vertex Pharmaceuticals  February 2012 - February 2014
Vertex Pharmaceuticals  April 2010 - February 2012
BioBridges, LLC   May 2008 - April 2010
Coley Pharmaceutical Group  October 2001 - March 2008
PAREXEL  April 1998 - October 2001

Skills
Clinical Data Management, Clinical Data, CRO, GCP, EDC, Pharmaceutical Industry, Oncology, Drug Development, Biotechnology, Clinical Research, Data Management, Therapeutic Areas, Clinical Development, FDA, Life Sciences, SOP, 21 CFR Part 11, Regulatory Submissions, Clinical Trials

Education
Boston University   1997 — 2000
Master's degree, Social Work

University of Massachusetts Dartmouth   1990 — 1994
Bachelor of Arts (B.A.), Psychology

Bonnie A Brescia Bonnie A Brescia Greater Boston Area Details
Bonnie A Brescia's BioBridges, LLC Experience June 2013 - Present
Job Founding Principal, BBK Worldwide
Industry Pharmaceuticals
Experience
BBK Worldwide  July 1983 - Present
BioBridges, LLC   June 2013 - Present
Middlesex Savings Bank  April 2014 - Present
Charles River School  July 2011 - Present
Groundswell International   2010 - 2013

Skills
Strategic Planning, Training & Development, Speaking Engagements, Public Speaking, Management, Leadership, Market Research, Employee Training, Patient Recruitment, Healthcare, Training, New Business Development, Clinical Research, Clinical Development, CRO, Marketing, Pharmaceutical Industry

Education
Emerson College   1980 — 1982
bfa, poetry

University of Delaware   1976 — 1979
BioChemistry; Political Theory

Pat DePasquale Pat DePasquale Greater Boston Area Details
Pat DePasquale's BioBridges, LLC Experience April 2014 - Present
Job Senior Consultant at BioBridges, LLC
Industry Biotechnology
Experience
BioBridges, LLC   April 2014 - Present
Integrated Commissioning and Qualification   October 2011 - February 2014
Avecia/AstraZeneca/Cubist   September 2010 - October 2011
Hyaluron Contract Manufacturing  December 2009 - September 2010
GTC-Biotherapeutics  December 2006 - February 2010
Biogen Idec  December 2004 - November 2006
Shire Pharmaceuticals  August 2001 - November 2004
Astra Zeneca  December 1995 - August 2001

Skills
Validation, Biotechnology, Lifesciences, FDA, Pharmaceutical Industry, GMP, Quality System, Change Control, Quality Assurance, CAPA, GxP, Auditing, Biopharmaceuticals, Sop, 21 CFR Part 11, V&V, Software Documentation, Technology Transfer, LIMS, Medical Devices, Quality Auditing, Manufacturing, Computer System..., Regulatory Affairs, Clinical Development, Regulatory Requirements, Quality Control, Clinical Trials, R&D, GAMP, Process Simulation, Regulatory Submissions, Cross-functional Team..., GLP, Vaccines, Aseptic Processing, Drug Development, Oncology, Quality Management, GCP, Chemistry, HPLC, ISO 13485, Product Launch, Technical Writing, Pharmaceutics, Process Engineering, Analytical Chemistry, Document Management, SOP

Education
Massachusetts Institute of Technology   1966 — 1971
Bachelor of Science, Humanities and Science

OLHS

OLHS

OLHS

Elizabeth Merica Elizabeth Merica Greater Boston Area Details
Elizabeth Merica's BioBridges, LLC Experience January 2007 - May 2012
Job Director, Clinical Development at Agios Pharmaceuticals
Industry Biotechnology
Experience
Agios Pharmaceuticals  March 2014 - Present
Merica Clinical Consulting   May 2011 - March 2014
BioBridges, LLC   January 2007 - May 2012
Acambis (now Sanofi Pasteur)   June 2004 - December 2006
Vertex Pharmaceuticals  November 1997 - June 2004
Genzyme (a Sanofi Aventis company)   1996 - 1997
EMD Serono, Inc.   1995 - 1996
Dana-Farber Cancer Institute  1990 - 1994

Skills
Clinical Research, Clinical Trials, Regulatory Affairs, Project Management, Technical Writing, Medical Writing, Rare Diseases, Oncology Clinical..., CNS disorders, Vaccines, Infectious Diseases, Emerging Growth..., Biotechnology Industry, Drug Safety, Regenerative Medicine, End Stage Renal Disease, Drug Development, Pharmaceutical Industry, Vendor Management, Personnel Management, Sarcoma, Business Operations, Budget, Process Improvement, Lifesciences, Orphan Drugs, Business Partner..., Patient Outcomes, Dry Powder Inhalers, European Studies, FDA, Biotechnology, Protocol, Budgets, CRO

Education
Boston University
B.S., Communication Disorders

University of Massachusetts, Amherst
M.F.A., English

Ava Taylor Ava Taylor Greater Boston Area Details
Ava Taylor's BioBridges, LLC Experience August 2012 - Present
Job Medical Writer
Industry Pharmaceuticals
Experience
BioBridges, LLC   August 2012 - Present
BG Medicine  August 2011 - September 2012
Millennium: The Takeda Oncology Company  March 2010 - July 2011
Millennium: The Takeda Oncology Company  April 2009 - March 2010
Synta Pharmaceuticals  November 2008 - March 2009
Ophthalmic Research Associates, Inc.   August 2006 - October 2008
Genzyme  July 2004 - August 2006
University of Connecticut Health Center  August 2002 - April 2004

Skills
FDA, Medical Writing, Lifesciences, Clinical Development, Clinical Trials, Oncology, Biotechnology, Neuroscience, eCTD, Pharmaceutical Industry, Drug Development, CRO, Research, GCP, Therapeutic Areas, Clinical Study Design, IND, Life Sciences

Education
The University of Connecticut Health Center   1999 — 2002
MS, Neuroscience

Wesleyan University   1995 — 1999
Bachelor of Arts (BA), Neuroscience and Behavior and Biochemistry

Steve Linhares Steve Linhares Greater Boston Area Details
Steve Linhares's BioBridges, LLC Experience June 2008 - August 2008
Job Vice President of Regulatory and Clinical Affairs at Neograft Technologies
Industry Medical Devices
Experience
Neograft Technologies   October 2010 - Present
Insulet Corporation  September 2008 - September 2010
BioBridges, LLC   June 2008 - August 2008
Boston Scientific  May 2005 - January 2008
Phase Forward  2000 - 2005
PLC Medical Systems  1981 - 1999
Raytheon  1979 - 1981

Skills
Medical Devices, FDA, ISO 13485, CAPA, Clinical Trials, 21 CFR Part 11, Quality System, Regulatory Affairs, Validation, Clinical Research, Design Control, R&D, Biomedical Engineering, Lifesciences, Hardware Diagnostics, Oncology, DMAIC, Computer System..., Biotechnology, Quality Assurance, Sop, ISO, Regulatory Submissions, Root Cause Analysis, Clinical Data Management, Quality Control, GCP, Quality Auditing, ISO 14971, CRO, Minitab, Pharmaceutical Industry, V&V, SPC, Product Launch, GMP, CTMS, Process Simulation, Commercialization, Regulatory Requirements, Design of Experiments, Technology Transfer, FMEA, Biopharmaceuticals, GxP, Clinical Development, GLP, Change Control

Education
Bridgewater State University   1976 — 1979
BS, Physics

Coyle and Cassidy Memorial High School   1971 — 1975
Diploma

coyle cassidy   1971 — 1975

Saint Anthony Taunton   1963 — 1971

Monica C. Sanford Monica C. Sanford Waterford, Connecticut Details
Monica C. Sanford's BioBridges, LLC Experience August 2013 - November 2013
Job Clinical Research Operations Manager
Industry Pharmaceuticals
Experience
Pfizer  July 2014 - Present
BioBridges, LLC   August 2013 - November 2013
Amarin Pharma Inc  2010 - August 2013
ExecuPharm, Inc  2005 - 2010

Skills
Clinical Operations, Clinical Trials, CRO, Project Management, Therapeutic Areas, Protocol, CTMS, Patient Recruitment, Trial Management, Clinical Research, ICH-GCP, Phase I, eCRF, Sop, Diabetes, Clinical Development, Clinical Research...

Education
Quinnipiac University

Aaron Croteau Aaron Croteau Hartford, Connecticut Area Details
Aaron Croteau's BioBridges, LLC Experience 2013 - 2013
Job Project Lead at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL  April 2013 - Present
ExecuPharm  June 2007 - Present
BioBridges, LLC   2013 - 2013
Pfizer  January 2006 - June 2007
Pfizer  January 2005 - January 2006
Pfizer  March 2002 - January 2005
Pfizer  January 2001 - March 2002

Education
University of Connecticut   1998 — 2000
MA, French

Eleanor Czarnowski Eleanor Czarnowski New London/Norwich, Connecticut Area Details
Eleanor Czarnowski's BioBridges, LLC Experience July 2014 - Present
Job Contracted to Sanofi U. S. | Clinical Trial Operations Manager at BioBridges
Industry Pharmaceuticals
Experience
BioBridges, LLC   July 2014 - Present
BioBridges, LLC   March 2013 - July 2014
Pfizer  2006 - 2013
Pfizer  1999 - 2006
Target Data Systems   1998 - 1999
CSC  1994 - 1998
Battelle  1992 - 1994
SAIC  1991 - 1991
Sonalysts  1987 - 1990

Skills
SDTM, Data Management, Project Management, OC RDC, Data Standards, Clinical Development, Clinical Data Management, Clinical Trials, GCP, Regulatory Submissions, CTMS, Clinical Study Design, CRO, EDC, Oracle Clinical, Pharmaceutical Industry, Sop, Validation, Clinical Research, Biotechnology, Pharmacovigilance, 21 CFR Part 11, CDISC, Protocol, Drug Development, MedDRA, ICH-GCP, Data Validation, Therapeutic Areas, CRF design, Clinical Operations, Vaccines, Oncology, Infectious Diseases, Computer System..., GxP, Regulatory Affairs, Medidata, Inform, SOP

Education
University of New Haven   2013 — 2014
Certification in Graphical Information System (GIS)

East Lyme High School

Hartford Graduate Center   1994 — 1996
Master of Science (MS), Computer Science with a concentration in databases

Eastern Connecticut State University
Bachelor of Science (B.S.), Mathematics and Computer Science

Laurie Ridener Laurie Ridener Greater Boston Area Details
Laurie Ridener's BioBridges, LLC Experience September 2009 - February 2010
Job Principal at Erskine Mar Consulting LLC
Industry Biotechnology
Experience
Erskine Mar Consulting LLC   February 2014 - Present
EMD Serono  February 2010 - January 2014
BioBridges, LLC   September 2009 - February 2010
Millennium Pharmaceuticals  September 2009 - February 2010
*   May 2009 - August 2009
Pervasis Therapeutics, Inc.   March 2006 - May 2009
Serono, Inc.   March 2001 - March 2006
Biolink, Inc.   July 1999 - March 2001
Continuum Biomedical   March 1997 - June 1999
Buckman Company   November 1992 - March 1997

Skills
Regulatory Submissions, Clinical Trials, Regulatory Affairs, FDA, Clinical Development, Biotechnology, CRO, Pharmaceutical Industry, GCP, Medical Devices, GMP, Medical Writing, Regulatory Requirements, IND, Clinical Research, Drug Development, Biopharmaceuticals, Quality Assurance, eCTD, R&D, 21 CFR Part 11, Quality System, Pharmaceutics, Neurology, Therapeutic Areas, Dressage, Iyengar Yoga

Education
University of Colorado Boulder
BA

Amy Steinberg Amy Steinberg Greater Boston Area Details
Amy Steinberg's BioBridges, LLC Experience November 2013 - Present
Job Event Planning and Marketing Specialist
Industry Events Services
Experience
BioBridges, LLC   November 2013 - Present
Fairway Independent Mortgage Corporation  February 2013 - October 2013
Leventhal-Sidman J.C.C.   December 2009 - February 2013
Destination Partners Inc  March 2009 - June 2009
Destination Partners Inc  January 2009 - March 2009

Skills
Microsoft Office, Budgets, Customer Service, Databases, Management, Marketing, Microsoft Excel, Negotiation, PowerPoint, Process Scheduler, Project Planning, Event Management, Event Planning, Leadership, Pharmaceutical Industry, Research, Sales, Social Media, Social Media Marketing, Trade Shows

Education
University of New Hampshire   2005 — 2009

University of New Hampshire   2005 — 2009
Bachelor of Science (BS), Recreation Management, Marketing and Event Planning

Rachel Tobiasz Weiss Rachel Tobiasz Weiss Montreal, Canada Area Details
Rachel Tobiasz Weiss's BioBridges, LLC Experience July 2008 - December 2010
Job Consulting Medical Writer at Rachel Weiss Science and Clinical Writing, Inc.
Industry Biotechnology
Experience
Rachel Weiss Science and Clinical Writing, Inc.   January 2011 - Present
BioBridges, LLC   July 2008 - December 2010
Shire HGT  2006 - 2008
Genzyme  2004 - 2006
Inex Pharmaceuticals  2003 - 2004
PRA International  1999 - 2001

Skills
Oncology, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Biostatistics, Clinical Research, Lifesciences, Medical Writing, Continuing Education, Evidence-based Medicine, Gerontology, Clinical Trials

Education
The University of Toronto   1990 — 1996
PhD, Epidemiology

The University of British Columbia   1984 — 1986
MSc, Epidemiology

McGill University

Amy (Wolfe) Strileckis Amy (Wolfe) Strileckis Greater Boston Area Details
Amy (Wolfe) Strileckis's BioBridges, LLC Experience March 2010 - July 2010
Job Associate Director, Data Management at Ironwood Pharmaceuticals
Industry Pharmaceuticals
Experience
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

Carolyn Winker Carolyn Winker Greater San Diego Area Details
Carolyn Winker's BioBridges, LLC Experience November 2014 - Present
Job Clinical Trial Manager at BioBridges
Industry Biotechnology
Experience
BioBridges, LLC   November 2014 - Present
ReSearch Pharmaceutical Services  February 2014 - October 2014
ReSearch Pharmaceutical Services  March 2012 - February 2014
Polaris Pharmaceuticals  January 2011 - May 2012
Biogen Idec  August 2009 - January 2011
Biogen Idec  August 2007 - August 2009
Cadence Pharmaceuticals  2006 - 2007
Biogen Idec  2004 - 2006
PAREXEL  June 2002 - May 2004

Education
San Diego State University-California State University   1996 — 2000
BS, Kinesiology

Krista Mullen Krista Mullen Greater Boston Area Details
Krista Mullen's BioBridges, LLC Experience January 2011 - September 2013
Job Senior Clinical Data Manager at eClinical Solutions
Industry Biotechnology
Experience
eClinical Solutions  April 2014 - Present
Atlantic Research Group  January 2014 - August 2014
Optimer Pharmaceuticals  April 2013 - August 2014
BioBridges, LLC   January 2011 - September 2013
eClinical Solutions, a division of Eliassen Group  January 2010 - February 2011
Genexion, Inc.   March 2009 - December 2009
Eliassen Group  January 2008 - 2009
BioBridges, LLC   September 2005 - 2008
EMD Serono  May 1999 - September 2003
PAREXEL  January 1997 - May 1999

Skills
Clinical Data Management, Oncology, MedDRA, CRO, EDC, Clinical Data, CTMS, Medical Coding, Inform, GCP, ICH-GCP, Clinical Development, Data Management, Clinical Research, Oracle Clinical, Clinical Trials, CDISC, 21 CFR Part 11, CRF design, Therapeutic Areas, Medidata, Biostatistics, Pharmacovigilance, Regulatory Submissions

Education
MGH Institute of Health Professions   1994 — 1995
Graduate courses, Dietetic Internship

University of Vermont   1991 — 1994
BS, Dietetics

Patti Doherty Patti Doherty Greater Boston Area Details
Patti Doherty's BioBridges, LLC Experience April 2007 - March 2013
Job Sr. Clinical Data Manager at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals  March 2013 - Present
BioBridges, LLC   April 2007 - March 2013
EMD Serono  2000 - 2002
Synarc, Inc.   1996 - 2000

Skills
Clinical Data Management, CDISC, EDC, GCP, Clinical Data, Clinical Trials, CRO, Oracle Clinical, CRF design, Data Management, CTMS, MedDRA, Medidata, 21 CFR Part 11, ICH-GCP, Clinical Development, Sop, Therapeutic Areas

Education
Northeastern University   2004 — 2010
Bachelor of Science (B.S.), Health Science

Massachusetts College of Pharmacy and Health Sciences   1992 — 1994
Associate of Science (A.S.), Nuclear Medical Technology/Technologist

East Bridgewater High School

Melissa Silvia Melissa Silvia Greater Boston Area Details
Melissa Silvia's BioBridges, LLC Experience August 2008 - June 2012
Job Senior Clinical Data Manager at Pro Unlimited, assigned to Genzyme, a Sanofi company
Industry Pharmaceuticals
Experience
Genzyme, contract with ProUnlimited   March 2014 - Present
Talking Writing Magazine   July 2013 - June 2014
Biobridges, LLC   August 2008 - June 2012
Genzyme  April 2000 - August 2008
Muro Pharmaceuticals  October 1999 - April 2000
Quintiles  1997 - 1999

Skills
Data Management, EDC, Inform, Clinical Data Management, Clinical Trials, SAS, Validation, Data Entry, SOP, Data Validation, User Acceptance Testing, CRF design, Pharmaceuticals, QC, Pharmaceutical Industry, Oncology, CRO, Sop, GCP, Drug Development

Education
Massachusetts College of Art   1993 — 1994

Sandra Hankins Sandra Hankins Greater New York City Area Details
Sandra Hankins's BioBridges, LLC Experience February 2014 - January 2015
Job Senior Clinical Trials Operations Manager at Sanofi
Industry Pharmaceuticals
Experience
Sanofi  January 2015 - Present
BioBridges, LLC   February 2014 - January 2015
Celgene  November 2012 - February 2014
Otsuka  July 2011 - November 2012
Millennium Pharmaceuticals  January 2010 - July 2011
Novartis  April 2009 - January 2010
Pfizer  November 2007 - April 2009
Eisai  August 2007 - November 2007
Bristol-Myers Squibb  April 2007 - August 2007
Mitsubishi Tanabe Pharma America  July 2006 - April 2007

Skills
Clinical Development, Oncology, GCP, Pharmaceutical Industry, CTMS, CRO, Clinical Trials

Education
North Carolina State University   1990 — 1994
B. A., Communications with concentration in Public Relations

Alyssa Larkin Alyssa Larkin Greater Boston Area Details
Alyssa Larkin's BioBridges, LLC Experience March 2013 - December 2013
Job Associate Director, QAGCP at Merrimack Pharmaceuticals
Industry Pharmaceuticals
Experience
Merrimack Pharmaceuticals  December 2013 - Present
BioBridges, LLC   March 2013 - December 2013
Seaside Therapeutics  October 2012 - March 2013
Sunovion Pharmaceuticals Inc.  December 2010 - June 2012
Millennium Pharmaceuticals  July 2009 - June 2010
Genzyme  May 2008 - June 2009
Altus Pharmaceuticals  January 2006 - April 2008
Cubist Pharmaceuticals  September 2004 - January 2006
Millennium Pharmaceuticals  July 2002 - September 2004
Cytomatrix   March 2001 - June 2002

Skills
Quality Auditing, Quality Assurance, GCPs, GLPs, Medical Technology, Medtech, Immunohistochemistry, Hematology, Coagulation, SOP development, GCLP, CAPA, Vendor Assessments, Pharmacovigilance..., CROs, Systems audits, GxP, CRO

Education
University of Massachusetts at Lowell   1991 — 1995
Bachelor of Science (B.S.), Clinical Laboratory Science/Medical Technology/Technologist, 3.0

Nicole Hevehan Nicole Hevehan Greater Boston Area Details
Nicole Hevehan's BioBridges, LLC Experience March 2013 - Present
Job Sr. Clinical Project Manager
Industry Pharmaceuticals
Experience
BioBridges, LLC   March 2013 - Present
Execupharm  July 2010 - December 2012
Pfizer (formerly Wyeth)   November 2007 - July 2010
Wyeth  April 2007 - November 2007
Massachusetts General Hospital  September 2004 - April 2007

Skills
CTMS, GCP, EDC, Therapeutic Areas, Clinical Development, CRO, Clinical Trials, ICH-GCP, Clinical Operations, Patient Recruitment, Oncology, Trial Management, Clinical Data Management, Regulatory Submissions, Clinical Study Design, Clinical Research, Pharmaceutical Industry

Education
UMass Lowell   1995 — 2000
Bachelor of Science (B.S.), Health Education

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