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.
In this role, the selected candidate will
comply with all laboratory safety protocols, including, but not limited to, use of personal protective equipment (PPE), proper laboratory techniques, disposal of bio-hazard, etc.
In this role, the selected candidate will prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc.).