Job Title: Senior Manager Clinical Study Lead (CSL)
The Senior Manager Clinical Study Lead (CSL) is responsible for the global execution of assigned large and/or complex clinical trials. This role requires a high degree of independence and accountability for study timelines, budget, and conduct in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs). The balance of direct leadership versus oversight will vary accordingly.
Key Responsibilities:
* Led the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight for the assigned study
* Provides operational input into protocol development and oversees the development of study specific documentation
* Ensures compliance with clinical trial registry requirements and identifies outsourcing needs of the study
* Leads risk assessment and identifies risk mitigation strategies at the study level
* Monitors progress for site activation and monitoring visits and acts on any deviations from plan
* Ensures accurate budget management and scope changes for internal and external studies
This role has a 3-day onsite minimum requirement at one of Regeneron's locations worldwide. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.
Technical proficiency in trial management systems and MS applications is also required. Advanced degrees may be considered in lieu of relevant experience.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.