Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter...
the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...
of guidelines (FDA, ICH, EMA and GCP) Working knowledge of biostatistics, data management, and clinical operations procedures...
in clinical research, such as SAS, Python, and/or SQL. Strong understanding of CDISC standards, FDA/EMA regulations, and ICH-GCP...
organizations and achieve ramp ups Experience conducting self-inspections in a GMP context based in FDA requirements, COFEPRIS, EMA...
, biotech, or CRO environments. Strong knowledge of global clinical development regulations (e.g., FDA, EMA, ICH) and regional...
· Excellent interpersonal, influencing and team building skills · Understanding guidelines (FDA, ICH, EMA and GCP) · Working...