Jennifer Kealy Email and Phone Number

External faculty for the DAS in Clinical Trial Practice and Management.

Regulation and Pre-qualification Department, Access to Medicines and Health Products Division.

Responsible for the management of FIND’s portfolio of diagnostics clinical studies across multiple disease programs including malaria/fever, hepatitis C, pandemic preparedness, anti-microbial resistance, neglected tropical diseases and tuberculosis. Created and led the Clinical Trial Unit, comprised of Clinical Operations, Biostatistics, Data Management and Biobanking. Developed a suitable and effective Quality Management System; set-up a regulatory intelligence process; provided functional… Show more Responsible for the management of FIND’s portfolio of diagnostics clinical studies across multiple disease programs including malaria/fever, hepatitis C, pandemic preparedness, anti-microbial resistance, neglected tropical diseases and tuberculosis. Created and led the Clinical Trial Unit, comprised of Clinical Operations, Biostatistics, Data Management and Biobanking. Developed a suitable and effective Quality Management System; set-up a regulatory intelligence process; provided functional expertise for IVD and non-IVD products to programs and projects, notably defining regulatory pathways. Accountable for establishing monitoring, analysis and reporting of KPIs into organizational M&E. Acted in the role of Quality Manager for ISO related activities and led the ISO 13485:2016 certification process. Show less

Led the Staff Unit QMS, including strategy, planning, personnel and finances. Managed all QMS projects in the Medicines Research Department and served as Senior Project Leader for complex clinical trials conducted in resource limited settings. Identified and acquired new projects (value +5 million CHF).

Provided clinical research consulting services globally to bio-pharmaceutical clients for a variety of therapeutic indications. Services included project management, operational logistics, quality improvement initiatives, training, capacity building, CRO selection and data collection methods (EDC). Conducted GCP compliance audits, prepared sites for regulatory inspections, monitored complex trials in challenging settings and wrote final reports. Extensive phase I PK/PD experience (first in… Show more Provided clinical research consulting services globally to bio-pharmaceutical clients for a variety of therapeutic indications. Services included project management, operational logistics, quality improvement initiatives, training, capacity building, CRO selection and data collection methods (EDC). Conducted GCP compliance audits, prepared sites for regulatory inspections, monitored complex trials in challenging settings and wrote final reports. Extensive phase I PK/PD experience (first in human, dose ranging, food interactions, gender/age, bioequivalence). Show less

Project management support within the WHO TDR/Neglected Diseases initiative. Supply chain coordination and monitoring of the phase 3 ivermectin vs moxidectin clinical trial for onchocerciasis. Research capacity building and training of local staff on GCP, GCLP, electronic data capture and good business practices. Completed 8 UN-WHO missions to Bolahun, Liberia.