Job Title: Manager Clinical Study Lead (CSL)
The Manager Clinical Study Lead (CSL) oversees the execution of clinical trials from design to close-out, ensuring timely completion, budget adherence, and compliance with Regeneron SOPs and ICH/GCP.
Key Responsibilities:
* Leads cross-functional study teams responsible for clinical study delivery
* Provides operational input into protocol development and oversees study specific documentation
* Ensures compliance with clinical trial registry requirements and identifies outsourcing needs of the study
* Leads risk assessment and develops mitigation strategies at the study level
* Monitors progress, acts on deviations, and escalates issues to stakeholders as needed
* Oversees data quality, vendor management, and study close-out activities
Requirements:
* Demonstrated leadership and interpersonal skills
* Data-driven approach to planning and problem-solving
* Effective communication and project management skills
* Budget management experience and awareness of industry trends
* Technical proficiency in trial management systems and MS applications
Qualifications:
* Bachelor's degree required; 6+ years of direct clinical trial experience preferred
* Direct experience managing global clinical trial operations and developing protocols a must