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 the study level; Leads the feasibility assessment to select relevant regions and countries for the study
Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan; Monitors data entry and query resolution and acts on any deviations from agreed metrics
Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
This role requires:
Aminimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience
We are seeking experience with line management as well as exceptional interpersonal and leadership skills
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization; Ability to influence and negotiate across a wide range of stakeholders
Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
We are seeking extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
Salary Range (annually)
$150,500.00 - $245,500.00
