SeniorManager,ClinicalStudyLead

**Build our future together:** At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, supporting our Inflammation & Immunology therapeutic area. The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. You will be accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. **When & where:** * Work Location: Armonk, NY, Warren, NJ, Uxbridge, UK * Hybrid; 4 days per week on site * 25% Travel may be required **Discover your role:** * Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study * Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. * Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. * 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; Provides input into baseline timeline development and management * Leads risk assessment and identifies risk mitigation strategies at th