Job Description
The Senior Clinical Study Lead (CSL) is responsible for the global execution of assigned large and/or complex clinical trials from study design through execution to study close out.
Key Responsibilities
* Led a cross-functional study team responsible for clinical study delivery and served as the primary point of contact for leadership and oversight.
* Provided operational input into protocol development, including but not limited to case report forms, data management plan, monitoring plan, and statistical analysis plan.
* Ensured compliance with clinical trial registry requirements and identified outsourcing needs of the study.
* Led risk assessment and identified risk mitigation strategies at the study level.
Requirements
* Exceptional interpersonal and leadership skills, with advanced expertise in implementing operational strategic direction and guidance.
* Demonstrated expert knowledge and a data-driven approach to planning, executing, and problem-solving.
* Advanced communication skills via verbal, written, and presentation abilities.
* Awareness of relevant industry trends and ability to build, lead, and develop productive study teams and collaborations.
Qualifications
* Bachelor's degree with a minimum of 8 years of relevant industry experience.
* Direct experience managing global clinical trial operations, including experience developing protocols and key study documents.
* 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.