Global Study Lead (Fsp Role)
Current- Lead site management, as the primary point of contact for 2+ clinical trials, ensuring adherence to GCP, FDA regulations, and SOPs. Successfully manage site initiation, monitoring, and close-out activities, resolving.
- Develop and implement comprehensive study-specific monitoring plans, informed consent forms (ICFs), study procedure manuals, and other essential site materials. Streamline processes resulting in a 23% reduction in.
- Partner with data management teams to develop eCRFs, ensuring data integrity and compliance with study protocols. Guide CRAs on study procedures and regulatory requirements, including co-monitoring and observatory visits