Doreen Waldron Lechner, Ph.D.
Assistant Professor
Department of Health Informatics
Program: Clinical Research Management; Clinical Trial Sciences
Phone: (973) 972-5984
Email: lechnedw@rutgers.edu
Office location:
Stanley S. Bergen Building
65 Bergen Street, Rm 171
Newark, NJ 07107
About
Dr. Doreen Lechner is an Assistant Professor of the M.S. Clinical Research Management Program at Rutgers SHP. She had held the Program Director role of the program from 2014 – 2022. She is a pharmacovigilance professional with over 30 years of industry experience in all areas of clinical trial and post-marketing drug safety. With her in-depth knowledge of FDA and EMA pharmacovigilance regulations she has built focused pharmacovigilance teams while maintaining regulatory compliance.
She has extensive experience in reducing the complexity of the drug safety business to bring innovative and cost-effective solutions to address global operational pharmacovigilance challenges. Dr. Lechner was a faculty member of the Drug Information Association’s Clinical Safety and Pharmacovigilance Certificate Program where she taught a course on “Pragmatic Approaches to Drug Safety across the Pre-Marketing and Post-Marketing Continuum.” In May 2013 she was recognized by PharmaVoice as “One of the 100 Most Inspiring People in the Life-Sciences Industry.” She is an active member of the Consortium of Academic Programs in Clinical Research and the Workforce Innovation Steering Committee of Association of Clinical Research Professionals. Dr Lechner was named co-lead on the Workforce Development Core of NJACTS (a CTSA hub), a representative of the Partners in Workforce Advancement as part of the Association of Clinical Research Professionals and the By Law Chair of the Consortium of Academic Programs in Clinical Research.
Prior to forming DWL Consulting, she served as the Vice President – Pharmacovigilance at Telerx (formerly Sentrx) for 15 years as well as held management positions at Bristol-Myers Squibb, Schering–Plough and Ayerst Pharmaceuticals in the areas of Regulatory Affairs, Drug Safety and Pre-Clinical Drug Metabolism earlier in her career. Dr. Lechner received her undergraduate degree from Seton Hall University and her doctoral degree in Pharmacology from Rutgers University – Graduate School of Biomedical Sciences
Education
Ph.D., Rutgers Graduate School of Biomedical Sciences (formerly UMDNJ – GSBS)
Professional Achievements
PharmaVoice 100 Honoree: One of the Most Inspiring People in the Life Sciences Industry, July 2013
Research
Title |
Sponsor |
Effective Dates |
Role |
|||
TRAIT- Clinical Trial Science Workforce Development Assessment |
Rutgers/National Science Foundation Regional I-Corps, |
Summer 2020 |
Entrepreneurial Lead |
|||
NJACTS (a CTSA hub) |
NIH |
March 2019 – current |
Workforce Development Core Co-Lead |
Publications
Title | Authors | Where and When | ||
Navigating Through an Academic Capstone Project in the time of COVID-19; |
Jose N, Waldron Lechner D, Tafuto B Palladino Kim , L |
Clinical Researcher, Volume 36, Issue 3, June 2022 |
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COVID-19 Pandemic Response Varies by Clinical Trial Sponsor Type. |
Cooper, L., Lee, I., & Waldron Lechner, D. |
Journal of Clinical and Translational Science, 1-20. doi:10.1017/cts.2021.25, 2021 |
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Competency-Based Self-Assessment Tools: A Mixed-Methods Retrospective Analysis of Need |
Trinh P, Tafuto B, Ebanks Y, Zunaed Z, Lechner DW |
Princ Pract Clin Res. 2021;7(4):23-26. doi:10.21801/ppcrj.2021.74.3 |
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Ensuring Compliance With Global Pharmacovigilance Regulatory And Safety Reporting Updates |
Peters, B; Ferrence, H; Lechner, D |
Pharmaceutical Compliance Monitor, April 2, 2014 |
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Translational Science Competencies in a Virtual CTSA Internship Program. |
Aleksunes, L., Ebanks, Y., Tafuto, B., Lechner, D., & Gladson, B |
Journal of Clinical and Translational Science, 6(S1) 97-99. Doi:10.1017/cts.2022.285, 2022 |
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. What are the Risk Factors Affecting PrEP Utilization Among Black Cisgender Women Who Are At Higher Risk Of HIV Acquisition? |
Mathurin, Alene; Kim, Palladino Lisa; Lechner, Doreen Waldron; Swaminathan, Shoba; and Tafuto, Barbara |
Journal of Clinical and Translational Science, 6(S1) 11-11. Doi:10.1017/cts.2022.51, 2022 |
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Training the Workforce During a Pandemic: Virtual Internships for Trainees. |
Aleksunes, L; Ebanks Y; Tafuto, B; Gladson, B; Lechner, D; |
J Clin Transl Sci 2021;:1–2. doi:10.1017/cts.2021.558 |
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Sponsor types of US interventional COVID-19 studies listed in ClinicalTrials.gov; |
Lee, Irene, Cooper, Lisa & Waldron Lechner, Doreen |
J Clin Transl Sci 2021:5. Doi:10.1017/cts.2021.499 |
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Novel use of REDCap to develop a Crisis Management Decision-Support Portal at an Academic Medical Center. |
Tafuto B, Master M, Lechner DW |
J Clin Transl Sci 2021;13:1–2. doi:10.1017/cts.2021.492 |
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A Review of Novel Uses of REDCap in Clinical and Translational Science. |
Toles A, Tafuto B, Lechner D. |
J Clin Transl Sci 2021;:1–2. doi:10.1017/cts.2021.529 |
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Assessing the Need for Competency-Based Self-Assessment Tools for CTSA Professionals. |
Trinh P, Tafuto B, Ebanks Y, Zunaed Z; Lechner, DW |
J Clin Transl Sci 2021;:1–2. doi:10.1017/cts.2021.555 |
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A Case Study of Needs Assessment Practices Using I-Corp Customer Discovery Protocols Alongside REDCap Surveys for CTSA Activities. |
Zunaed Z, Tafuto B, Ebanks Y, Y; Trinh, P; Lechner, DW |
J Clin Transl Sci 2021;:1–2. doi:10.1017/cts.2021.511 |