Nancy Bomberger
Research & Development Collaborator who Inspires, Innovates & Optimizes for Successful Outcomes! My Why: To Connect Others to Solutions that Matter & Empower! I’d love to hear about your Why….
- Role
- Senior Principal Associate - Medical Quality at Eli Lilly and Company
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Nancy Bomberger
As a Clinical Operations, Quality Compliance Expert, offering over 15 years of successful clinical development experience, I have the privilege of preparing & executing clinical trials that make an impact on patients globally. Poised to integrate technology with quality by design clinical operations, I streamline clinical processes, implement innovative research procedures, & provide consulting, productivity optimization, & project management expertise. Well versed in protocols & regulatory compliance, I effectively secure alignment with internal & external statutes. Additionally, I champion customer service relationships & client retention. With years of practical clinical experience as a registered nurse in diverse settings, I understand the real impact research & product development can have in a patient’s life. Currently a Global Consultant with one of the leading companies of clinical research, I ensure that every trial operates in the most effective and efficient manner as possible.Areas of my expertise include: Clinical research operations, trial implementation, & execution. Clinical site selection, initiation, & trial management. Regulatory compliance & quality by design,\"fit for use\" process optimization. Data analytics, protocol development, & portfolio/clinical program improvements. Pharmaceutical research & product development. Clinical nursing, critical care, supervision & training. Project management of multiple, simultaneous & complex initiatives. Proactive change management & client relations management. Global consulting, advisement & presentations.Recent highlights of my career:Six Sigma Green Belt that surpassed corporate goal by 33% reduction in cycle times through project- managing 20 employees optimizing enrollment of clinical trials. The learnings from this are now applied across the portfolio.Integrated online technology & transformation of standard operating procedures; Increased staff productivity & decreased operational cost by 44%.
Experience
Senior Principal Associate - Medical Quality
Mar 2022 — Present
Ensure quality compliance across all aspects of global clinical development providing expertise in GCP compliance interpretation, inspection oversight, consultation, training, and recommendations across the organization, including groups such as Legal, Compliance, Finance, Medicines Development via the development and implementation of a risk-based quality strategy for the portfolio and cross functional partners.
Education
Widener University
BSN, Nursing
1988 — 1992
Archbishop Prendergast High School
Academic, General
1984 — 1988
Skills
- Leadership
- Edc
- Therapeutic Areas
- Clinical Research
- Oncology
- Cross-Functional Team Leadership
- Ich-Gcp
- Medical Writing
- Good Clinical Practice (Gcp)
- Psychiatry
- Standard Operating Procedure (Sop)
- Sop
- Cardiology
- Hematology
- Critical Care
- Training
- Strategy
- CRO
- Drug Development
- Clinical Trials
- Infectious Diseases
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