and experience). Minimum of 4 years of on-site clinical monitoring experience. Strong knowledge of GCP, ICH guidelines, FDA...
. - Core Knowledge: Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations...
- Extensive knowledge of FDA regulations and their practical implementation - Ability to travel, including by air or by car...
Canada and Food and Drug Administration (FDA) regulations/guidelines.**Preferred Certifications:*** Microsoft Certified...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
(preferably with a medical device manufacturer or large manufacturing-based organization) - Complete knowledge with ANMAT, FDA...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...
Qualifications - Experience supporting global or multisite MES deployments - Knowledge of regulatory environments (e.g., FDA 21...
the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...