Lesley Alphonso Email & Phone Number

Cranbury, New Jersey, United States

Develop, oversee and lead the Clinical Safety Program (CSP) strategy across the Oncology Therapeutic Area with leaders/colleagues within Global Drug Development (GDD) and Research and Early Development (R&ED) and entire cross-functional matrix, to ensure that CSP strategy, insight generation and key research collaborations are executed in alignment with defined safety strategy. Set up structure/framework for all foundation setting activities across various TAs including Scope and Strategy determination, medical concept translation to CRF and database development, regulatory and compliance documentation and adverse event identification report design.

● Responsible for the operational delivery of Phase I-IV clinical trials for various Therapeutic Areas for high volume and complex studies.● Oversaw the collection, validation, and analysis of clinical trial data to ensure accuracy, completeness, and compliance with regulatory standards. ● Designed and implemented data management processes, developing case report forms (CRFs) for data capture, and oversaw database development and maintenance including UAT/QC of forms and processes.● Collaborated with cross-functional teams, including clinical trial leads, statisticians, and regulatory affairs professionals, to ensure data integrity and supported timely decision-making throughout the clinical trial process. ● Partnered with site facing roles such as Site Managers/Monitors to mentor/train sites & junior staff on protocol requirements, CRF completion guidelines and query resolution.● Developed and reviewed SOPs and other procedural documents to support data cleaning and reconciliation activities.

East Hanover, Nj

Provides timely and professional ongoing data management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines

Kenilworth, Nj

Responsible for processing clinical trial data to ensure the integrity of the data used for the inclusion in worldwide health registration in compliance with SPRI SOPs and process guidelines.

Rahway, Nj

Responsible for utilizing computer-based and clinical development knowledge combined with communication and organization skills to support development and test of protocol-specific tools required for the data collection and data management activities of drug development programs.