Senior Manager Clinical Study Lead (CSL)
The Senior Mgr Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
Key Responsibilities
* Leads the cross-functional study team responsible for clinical study delivery
* Provides operational input into protocol development
* Oversees and provides input to the development of study specific documentation
* Ensures compliance with the clinical trial registry requirements
* Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
* Provides input into baseline budget development and management
* Leads risk assessment and identifies risk mitigation strategies at the study level
* Monitors data entry and query resolution and acts on any deviations from agreed metrics
Requirements
* Bachelor's degree with a minimum of 8 years of relevant industry experience
* Advanced degrees may be considered in lieu of relevant experience
* Direct experience managing global clinical trial operations
* Technical proficiency in trial management software and MS applications
About Regeneron
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.