PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.
PATH’s Essential Medicines conducts vaccine and drug development, including associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization. The EM Clinical Functional Team provides leadership and support to the clinical activities conducted by various programs developing vaccines and drugs for implementation in low-resource settings, including the design of clinical development plans, protocols and related documents, implementation of clinical trials, monitoring and oversight of all trial activities, and support for regulatory submissions leading to local registration and WHO prequalification of new vaccines.
The Trial Master File Manager leads the oversight and management of EM’s in-house Trial Master File (TMF) and oversees internal processes for TMFs outsourced to contractors under the CVIA Clinical Functional Area. This position is responsible for building process, overseeing TMF staff, ensuring TMF audit readiness, and working with subject matter experts to ensure complete and accurate content and efficient management and filing processes.