Senior Manager Clinical Study Lead; Cell Therapy

Overview

The Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design through study close out. The Senior CSL is responsible for study timelines, budget, and ensuring study conduct complies with Regeneron 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.

Contributes to and drives ongoing process improvement initiatives. This role is not eligible for fully remote work and must be onsite at one of the following locations:
Armonk, NY;
Warren, NJ;
Cambridge, MA;
Dublin, Ireland; or Uxbridge, London.

A typical day in this role looks like:

• Leads the cross-functional study team responsible for clinical study delivery and acts as the primary point of contact for leadership and oversight for the assigned study
• Provides operational input into protocol development
• Oversees and provides input to the development of study-specific documentation including but not limited to: CRF, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan
• Oversees set-up and maintenance of study systems including CTMS and TMF
• Ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs of the study and leads/oversees engagement, contracting and management of required vendors
• Provides input into baseline budget and timeline development and management
• Leads risk assessment and risk mitigation strategies at the study level
• Leads feasibility assessment to select relevant regions and countries for the study
• Oversees/conducts site evaluation and selection
• Leads investigator meeting preparation and execution
• Monitors progress for site activation and monitoring visits and acts on deviations from plan
• Leads the development and implementation of patient recruitment and retention strategies and acts on deviations from plan
• Monitors data entry and query resolution and acts on deviations from agreed metrics
• Ensures accurate budget management and scope changes for internal and external studies
• Oversees study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to the Program Operations Leader (POL) and other stakeholders and develops appropriate actions
• Oversees execution of the clinical study against planned timelines, deliverables and budget
• Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Oversees alignment with CROs and Third Party Vendors per the scope of work
• Ensures clinical project audit and inspection readiness through the study lifecycle and supports internal or external audits and CAPA development as required
• Manages and oversees study close-out activities including database lock, vendor contract reconciliation, budget, TMF, and study drug accountability
• Contributes to clinical study report writing and review
• Facilitates and contributes to study-level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Identifies innovative approaches to clinical study execution including global considerations and CTM SOP improvements
• May be assigned unmasked tasks for studies (e.g., assisting with unmasked investigational product, unmasked TMF setup, unmasked data review, IVRS issues) and oversee unmasked clinical monitoring
• Responsible for direct supervision of CTM staff, including work assignments, performance management, recruitment, development, coaching, training and compliance
• May require up to 25% travel

This role may be for you if you have:

• Exceptional interpersonal and leadership skills
• Ability to apply advanced expertise to operational direction for clinical studies
• Data-driven planning, execution and problem-solving capabilities
• Advanced…