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

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

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

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)