Lynne E. Becker is seeking a senior level position in corporate project research. She has over 10 years of experience managing multi-site clinical research projects, including experience in protocol development, site selection and training, patient recruitment and retention, and ensuring regulatory compliance. She is skilled in data analysis, database management, and using technology like telemedicine to efficiently achieve project goals. Her background includes managing both domestic and international clinical trials with budgets in the millions of dollars.

1. Lynne E. Becker, MSPH
lynne.e.becker@gmail.com
670 North Stiles Drive
Charleston, SC 29412 843 817-2530
Objective
A Senior Level Position in Corporate Project Research
Summary
 Experienced in protocol development, execution and management in all phases of clinical research
 Site Selection, Training and Patient Recruitment and Retention (local, national, and international)
 Knowledgeable in multiple phases of telemedicine applications and systems
 10 years of project management experience for multi-site projects and across platforms
 IRB and IACUC project management experience
 Ability to train administrative, study staff and scientific professionals in complex procedures
 Experienced in all phases of federal regulatory requirements and reporting mandates
 Employs telemedicine and telehealth technology to achieve goals efficiently
 Efficient in data warehousing principles to maintain project lifecycle timelines
I am a Data Scientist with significant experience in project management. I blend my experiences in
epidemiology with computer analysis and statistical skills, to efficiently manage large-scale national and
international projects. I am skilled in interpreting data in a scientific manner for dissemination to clinicians as
well as for publications and business decisions for market expansion. I manage large data warehouses with
emphasis in data cleaning, visualization, and analysis. I am able to use my epidemiological and research
methodology experiences in all phases (I-IV) of protocol development to design experimental trials,
forecasting, modeling, employing statistical inference and other procedures for successful clinical studies.
Experience
Medical University of South Carolina, Charleston, SC 2011 - Present
International National Project Manager for a PECOURRI (Mar 2016-Present)
I am managing an International research trial for the orthopedics unit at the Medical University of South Carolina.
 I am managing a 4 year, 14.4 million dollar, 26 site multi-national longitudinal pragmatic project for the
Medical University of South Carolina, funded through the PCORI Foundation in Washington, DC
 Coordinate all correspondence for the fiscal sponsor and sites.
 Recruited & assisted with the team selection of 26 medical facilities across U.S. to conduct study
 Trained 66 national site staff in study objectives, methods, and reporting - 100+ persons
 Developed patient profile; assisted in patient recruiting; developed patient collateral material
 Designed master database tracking / reporting system; designed all forms and reports
 Developed a patient engagement program as this is a primary focus of the project, patient centric outcome
assessments
 Assisted the development of the central IRB development and eIRB process
 Negotiated / monitor budgets with study sponsor, research sites, and data vendors
 Created all study materials for training local and remote coordinators, via WebEx support and SOP manuals
 Assure necessary ancillary vendors provide reliability, security and confidentiality

2. Lynne E. Becker, MSPH Page 2
National Project Manager for a Type 2 Diabetes Clinical Trial (Nov 2011-Mar 2016)
 Manage with staff of 6 all aspects of all clinical research projects within the Weight Management Center.
Studies vary from $5M to $250k, Pilot Projects to Phase III clinical trials
 Designed study definitions, objectives, methodologies, milestones and reporting (protocol)
 Recruited / selected 16 medical facilities across U.S. to conduct study with patients
 Trained 16 national site staff in study objectives, methods, and reporting - 40+ persons
 Developed patient profile; assisted in patient recruiting; developed patient collateral material
 Designed master database tracking / reporting system; designed all forms and reports
 Monitor 16 sites for regulatory compliance of sponsor claims with Federal Trade Commission
 Negotiated / monitor budgets with study sponsor, research sites, medical labs and data collection services
 Assure necessary ancillary vendors provide reliability, security and confidentiality
United States Department of Commerce 2008 - 2011
National Oceanic and Atmospheric Administration (NOAA), Charleston, SC
IACUC Project Manager
Institutional Animal Care and Use Committee, as mandated by U.S. National Institute of Health Office of
Laboratory Animal Welfare (OLAW)
 Developed / implemented first IACUC program for NOAA: program adopted globally
 Edited protocols in accord with NOAA scientists and IACUC guidelines for statistical soundness and
research design methodologies
 Designed database and reporting systems for tracking and submitting data to OLAW
 Recruited / trained local IACUC members in protocol and animal research policies
 Assisted in safety training, procedural inspections and program efficacy review
Select Health of South Carolina, Charleston, SC 2007 - 2009
Insurance company owned by AmeriHealth Mercy; focus is on those on Medicare, Medicaid and in poverty;
offers outreach programs intended to improve community health.
Senior Business Analyst / Program Manager
 Created wellness database system; identifies / tracks patient improved health status based on reduction in
medications taken; presumed a result of community outreach programs
 Analyzed accrued data; reported results to non-profit evaluation agency National Committee for Quality
Assurance (NCQA) / Healthcare Effectiveness Data and Information Set (HEDIS)
 Created cost reporting system for specific case and disease management teams; objective to identify cost
cutting / expense containment areas against actual budget expenditures
 Created member self- help portal to assist in treatment options and preventative measures
 Member of Healthy Hoops Wellness Committee; fund raiser and outreach program activities
College of Charleston, Charleston, SC 2005 - 2008
Office of Research and Grants Administration
Compliance Program Manager - IRB and IACUC
(Institutional Review Board)
 Managed human (IRB) / animal (IACUC) protocol (research project) approval and funding
 Monitored annual protocol status reviews, modifications, new submissions, adverse events
 Co-Chaired IRB / IACUC review committees and scientific community
 Began an initiative to train 500+ scientists / students / committee members in workshops on compliance
with OLAW, USDA, Public Health Service, college provost and other agency regulations
 Developed electronic signature input method greatly speeding data capture process

3. Lynne E. Becker, MSPH Page 3
Medical University of South Carolina, Charleston, SC 1993 - 2003
Director - Information / Telecommunication Technology 2000 - 2003
South Carolina Area Health Education Consortium
 Managed data processing of 4 remote location $1M+ federally funded program; objective to bring quality
medical care closer to remote SC patients and continuing education to MDs
 Re-engineered web site for interactive video conferencing to accommodate above goals
 Developed / implemented customized physician / patient surveys utilizing optical character recognition
(OCR) / optical mark recognition (OMR); improved ease, accuracy and speed
 Trained headquarters and remote staff in effective operation of system capabilities
 Gathered / analyzed system data for reporting to appropriate federal / state agencies
Director of Clinical Trials - Hollings Cancer Center 1998 - 2001
 Managed staff of 18 providing clinical trial service center for center’s scientific community; included data
managers, nurses, IRB / quality assurance staff and programmers (internal CRO)
 Managed submissions, activities, logistics of 50 active / 150 long term follow-up protocols
 Created database systems for work loads, patient calendars, budget analysis and reporting
 Assisted Clinical Review Committee improving IRB / peer panel submission efficiency
 Assured physician procedural compliance as member of Data Safety and Monitoring Board
 Generated $500K+ net income annually from pharmaceutical companies in post marketing trials
Biostatistician / Data Analyst - Hollings Cancer Center 1996 - 1998
 Participated in telemedicine test case development for U.S. Department of Defense, Office of Naval
 Research and IBM; prove efficacy of transmitting shipboard medical data to onshore facility for processing,
thereby improve speed, expense and reduce onboard facility
 Designed / tested all survey tools; coordinated patient recruitment / management
 Created / authored video for community consumption to gain volunteer cooperation
 Supervised data entry methods / personnel at local and remote locations; conducted analysis
Statistician / Data Manager - Institute of Psychiatry 1993 - 1996
 Developed / implemented database system to verify / analyze protocol data on a multi-site research
project to establish baseline alcohol abuse for NIH
 Assisted in coordination of 7 national research institutions
 Assisted scientists in grant funding applications; wrote justifying statistical portions
 Taught research fellows, nurses, graduate students grant design methodologies
Previous positions:
Alliance Pharmaceutical Corporation, San Diego, CA 1990 - 1992
Biostatistician / Regulatory Writer
IOPTEX Research, Inc. Azusa, CA 1987 - 1990
Clinical Program Manager
University of Southern California, Pasadena, CA 1986 - 1987
National Institute of Health Research Fellow - Children’s Cancer Study Group
Gerber Scientific Products, Hartford, CT 1985 - 1987
Graphics Instructor
Dun & Bradstreet, New York, NY 1984 - 1986
Analyst

4. Lynne E. Becker, MSPH Page 4
Education
Loma Linda University, Loma Linda, CA 1992
School of Public Health
Masters of Science Public Health - Biostatistics & Epidemiology
Russell Sage College, Troy, NY 1984
Bachelor of Arts - Mathematics and Computer Science
Publications
 Effects on glucose control and weight of a modified commercial weight control program for people with Type 2
diabetes, ICE/ENDO International Conference, 2014.
(Note: Invited Featured poster accepted for interim results - embargoed until presentation.)
 Body Image and Eating Restraining in Men, Nutrition, 1993.
 Endophthalmitis Caused by the Coagulase-Negative Staphylococci; Disease Spectrum and Outcome,
Ophthalmology, 1992.
 Endophthalmitis Caused by the Coagulase-Negative Staphylococci; Factors Influencing Presentation after Cataract
Surgery, Ophthalmology, 1992
Professional Associations
Featured Presenter at Cambridge Institute June 2015: Tablet Technology in Clinical Trials Mgt
Regulatory Affairs Professional Society (RAPS))
Association of Clinical Research Professionals (ACRP)
Society of Clinical Research Associates (SOCRA)
Public Responsibility in Medicine and Research (PRIMR)