In this role, the selected candidate serves as a liaison for collaborating institutions, human subjects review boards, and commercial partners; provides guidance or assistance on participant screening, consent, data collection and storage.
The Clinical Safety Scientist will support Clinical Safety Physicians in the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches.
In this role, the selected candidate will support the goals of the Gen Med organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met.
The candidate must have on-site clinical monitoring experience including source data verification using medical charts, review of regulatory study binders, adverse events and data clarification process.
In this role, you will be responsible for
provides assurance of accurate documentation in compliance with all governing regulations.Develop databases or modify existing databases to create datasets for analysis.