Luisa Monica

Luisa Monica is a TMF Project Manager at LMK Clinical Research Consulting,   a certified women-owned TMF consulting and services company. She is a Six Sigma White Belt certified clinical research professional with over a decade of experience in clinical trial master files within the pharmaceutical, healthcare, and biotech industries. For the past five years, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, quality control, coordination of migration projects, facilitated training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA and MHRA inspections.

Courses Taught