LYNNE BECKER, MSPHCharleston, South Carolina | 843-817-2530 | lynne.e.becker@gmail.com

SENIOR DIRECTOR-LEVEL MANAGEMENT IN CORPORATE RESEARCHProject Management | Clinical Trial Research | Epidemiology | Telemedicine/TelehealthBiostatistician with an emphasis in epidemiology. Highly flexible skill set encompassing 20+ years of experience in drug metabolism, orthopedics, diabetes, obesity, devices, oncology, ophthalmology, dermatology, animal research, gastrointestinal disorders, biologics, and behavioral research. Corporate, academic, and government experience. Proficient in telehealth applications and methodologies. In-depth understanding of clinical trial management from both sponsor and site perspectives. Keen ability to manage multiple projects in dynamic environments. Consensus-oriented. Open and productive communicator. Impressive portfolio of accomplishments as an individual and in successful collaboration with others. A “Can Do” philosophy complemented by a “What If” mind. Clinical Trial Project

Management Multidisciplinary Staff

Training Vendor Selection,

Negotiations, and Management

Site Monitoring/Management

Electronic Medical Records and Data Warehousing

International/Global Experience

Telehealth Budget Development and

Negotiations Clinical Research Protocol

Designs Adjunct Professor

Data Safety and Monitoring Board

Presentations Complex Database

Technologies Federal

Reporting/Compliance Highly Proficient with SPSS,

SAS, All Microsoft Tools, Redcap

PR O F E S S I O N A L EX P E R I E N C E

MEDICAL UNIVERSITY OF SOUTH CAROLINA, Charleston, SC 2011 - 2016International National Project Manager for a PCORI, 03/2016 – 06/2016Managed a four-year, $14.4M, 26-site multi-national longitudinal pragmatic project for the Medical University of South Carolina, funded by the PCORI Foundation in Washington, DC. Developed a management tracking system to maintain aggressive tracking timeline for milestone progress for fiscal sponsor and sites. Recruited and assisted with team selection of 26 medical facilities across the United States, Canada, and Europe. Hired and trained eight direct study support staff in longitudinal research methods, and presented the training programs for remote sites and staff members at the Investigator’s meeting. Developed Standard Operating Procedures (SOPs) for this clinical trial, with specific emphasis in site management, patient recruitment, and retention, vendor selection and SOW assignments. Negotiated/monitored budgets with study sponsor, research sites, and data vendors. Created all study materials for training local and remote coordinators. Selected Accomplishments:

Expeditiously developed scope of work contracts and negotiated budgets with vendors. Immediately slashed costs, saving the project $300K within two weeks of starting.

Implemented highly effective patient centric strategies for aggressive recruitment schedules and novel patient retention programs specific for the patient engagement portion of the clinical trial.

Partnered in the design, training, and deployment of a new eIRB system specific to this clinical trial.

Intensified protocols for the monitoring of risk-based variables for the Data Safety and Monitoring Committee.

Transformed a short-tenured contribution into tangible, sustainable project improvements.

National Project Manager for a Type 2 Diabetes Clinical Trial, 2011 – 2016Managed with support staff of six all aspects of all clinical research projects for Weight Watchers International, encompassing three clinical trials varying from $250K to $5M. Designed study definitions, objectives, methodologies, milestones and reporting (protocol). Recruited/selected 16 medical facilities across U.S. to conduct study with patients. Developed SOPs for clinical trial

LYNNE BECKER, MSPHCharleston, South Carolina | 843-817-2530 | lynne.e.becker@gmail.com

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monitoring and audits. Monitored external clinical trial sites and developed process improvement protocols on a site-by-site basis. Trained 16 national sites (approximately 45 staff) in study objectives, methods, and reporting. Developed patient profile, assisted in patient recruiting, developed patient collateral material. Designed master database tracking/electronic medical data reporting systems and reports. Monitored 16 sites for regulatory compliance of sponsor claims with Federal Trade Commission. Negotiated/monitored budgets with study sponsor, research sites, medical labs and data collection services.Selected Accomplishments:

Interjected success into a lagging project (six months behind, and a higher than expected screen fail rate), bringing it current and completed by original deadline, with a net profit of $1.2M from a $5M budget.

Energized the study from a failing patient enrollment timeline to finishing and retaining patients according to the original scheduled project timeline.

Voluntarily managed two additional research projects for Weight Watchers, a pilot study for a new health app assessment, and a large scale 10K-patient Phase I clinical trial, while continuing to manage original Type 2 Diabetes project.

Excerpts of commendations from project : “Vastly exceeded expectations…Adroitly handled a number of large responsibilities that were not originally expected…Was able to achieve for us a significantly higher margin than we originally expected…Rapid subject enrollment has kept overhead expenses at or below anticipated levels, while the greater than expected subject retention has increased revenue beyond expectations…”

NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA), Charleston, SC 2008 – 2011UNITED STATES DEPARTMENT OF COMMERCEIACUC Project Manager, 2005 – 2010Developed/implemented first Institutional Animal Care and Use Committee (IACUC) program for NOAA. Program was 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 and trained local IACUC members in protocol and animal research policies.Assisted in safety training, procedural inspections and program efficacy review.Selected Accomplishments:

Designed, implemented, and deployed the first animal research oversight committee for NOAA.

Launched the first world-wide virtual database management system for animal research projects.

SELECT HEALTH OF SOUTH CAROLINA, Charleston, SC 2007 – 2008(Insurance company owned by AmeriHealth Mercy, focus on Medicare, Medicaid, poverty, with outreach programs for community health improvement)Senior Business AnalystCreated wellness database system to identify and track patient improved health status. Analyzed electronic medical record data and reported results to non-profit evaluation agency, the National Committee for Quality Assurance (NCQA)/Healthcare Effectiveness Data and Information Set (HEDIS). Created cost reporting system for specific case and disease management teams. Member of Healthy Hoops Wellness Committee fundraiser and outreach program activities.Selected Accomplishments:

Developed an outreach program to assist low income members to utilize health and wellness programs.

Conceptualized and created member self-help portal to assist in treatment options and preventative measures.

LYNNE BECKER, MSPHCharleston, South Carolina | 843-817-2530 | lynne.e.becker@gmail.com

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COLLEGE OF CHARLESTON, Charleston, SC 2005 – 2008Office of Research and Grants AdministrationCompliance Program Manager – IRB and IACUCManaged human (IRB)/animal (IACUC) protocol (research project) approval process. Monitored annual protocol status reviews, modifications, new submissions, and adverse events. Co-Chaired IRB/IACUC review committees. Developed SOPs for clinical trial monitoring and audits. Monitored external clinical trial sites and developed process improvement protocols. Developed electronic signature input method.Selected Accomplishments:

Actualized an electronic database reporting system for protocol submission, tracking, and management.

Jump started 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.

Taught “Ethics in Research” course to graduate students and routinely lectured within many departments on the development of research principles and best practices.

Prior to 2005 - Medical University of South Carolina, Charleston, SC ~ 10 Years:Director of Information/Telecommunication Technology, SC Area Health Education Consortium, three yearsDirector of Clinical Trials, Hollings Cancer Center, two yearsBiostatistician/Data Analyst, Hollings Cancer Center, two yearsStatistician/Data Manager, Institute of Psychiatry, three years

E D U C A T I O N

Masters of Science Public Health (Biostatistics & Epidemiology) Loma Linda University, School of Public Health, Loma Linda, CA, 1992

Bachelor of Arts (Mathematics and Computer Science) Russell Sage College, Troy, NY, 1984

P R O F E S S I O N A L A S S O C I A T I O N S

Ambassador for PCORI (Patient Centered Outcomes Research Institute)Featured Presenter at Cambridge Institute June 2015: Tablet Technology in Clinical Trials

ManagementRegulatory Affairs Professional Society (RAPS)

Association of Clinical Research Professionals (ACRP)Society of Clinical Research Associates (SOCRA)

Public Responsibility in Medicine and Research (PRIMR)

PU B L I C A T I O N S

o Impact on Psychosocial Outcomes of a Nationally Available Weight Management Program Tailored for Individuals with Type 2 Diabetes, Journal of Diabetes and its Complications, Nov 2016

o Randomized Controlled Trial of a Nationally Available Weight Control Program Tailored for Adults with type 2 Diabetes, Obesity, 2016

o Impact on psychosocial outcomes of a nationally available weight management program tailored for individuals with Type 2 Diabetes, The Obesity Society’s Annual Meeting, 2016

LYNNE BECKER, MSPHCharleston, South Carolina | 843-817-2530 | lynne.e.becker@gmail.com

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o (Note: Invited Featured poster accepted for interim results – embargoed until presentation.)o Effects on glucose control and weight of a modified commercial weight control program for

people with Type 2 Diabetes, ICE/ENDO International Conference, 2014o Body Image and Eating Restraining in Men, Nutrition, 1993o Endophthalmitis Caused by the Coagulase-Negative Staphylococci; Disease Spectrum and

Outcome, Ophthalmology, 1992o Endophthalmitis Caused by the Coagulase-Negative Staphylococci; Factors Influencing

Presentation after Cataract Surgery, Ophthalmology, 1992