Senior Manager, Clinical Study Lead

About the role

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) will operate with a 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 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 outsourced to Clinical Research Organizations (CROs), with the balance of direct leadership versus oversight varying accordingly.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and serves as the primary point of contact for 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 the 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 are 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.

Requirements

• A minimum of a Bachelor's degree is required.
• A minimum of 8 years of relevant clinical trial experience.
• Experience with line management as well as exceptional interpersonal and leadership skills.
• Proactive and self-disciplined, with the ability to meet deadlines, effective use of time, and strong prioritization skills.
• 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.
• 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.

Work location and model

Work location: Armonk, NY, Warren, NJ. Primarily on-site with hybrid flexibility.

Travel

25% travel may be required.

Pay

Salary range (annually): $150,500.00 - $245,500.00