Senior Manager Clinical Study Lead (Cell Therapy)

Role Summary

The Senior Clinical Study Lead (CSL) operates 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. The Senior CSL is accountable for study timelines and budgets, and ensures study conduct aligns with Regeneron SOPs and ICH/GCP. This role applies to internally sourced studies and studies outsourced to CROs, with leadership vs. oversight varying accordingly. This role is onsite only (not fully remote) at one of the following locations: Armonk, NY; Warren, NJ; Cambridge, MA; Dublin, Ireland; or Uxbridge, London.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and serves 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 documentation such as CRFs, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, and statistical analysis plan
• Oversees setup and maintenance of study systems including CTMS and TMF
• Ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs and leads engagement, contracting, and management of required vendors
• Provides input into baseline budget and timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level
• Leads feasibility assessments to select relevant regions and countries
• Oversees site evaluation and selection; leads investigator meeting preparation and execution
• Monitors site activation and monitoring visits, addressing deviations from plan
• Leads the development and implementation of patient recruitment and retention strategies
• Monitors data entry and query resolution, addressing deviations from 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 and develops actions to address them
• Oversees the execution of the clinical study against planned timelines, deliverables, and budget
• Monitors data quality, including data metrics, protocol deviations, eligibility violations, dosing deviations, and potential non-compliance by sites
• Ensures CROs and third-party vendors deliver per the scope of work
• Ensures audit and inspection readiness throughout the study lifecycle; supports internal and external audits and contributes to CAPAs
• Manages study close-out activities including database lock, vendor contract reconciliation, budget closure, TMF, and drug accountability
• Contributes to clinical study report writing and review; facilitates study-level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvements
• Identifies innovative approaches to clinical study execution with global considerations and continuous CTM SOP improvement
• May perform unmasked tasks (e.g., handling unmasked trial materials, IVRS issues) as assigned
• Holds direct supervision of CTM staff with line management responsibilities (assignments, performance, recruitment, development, coaching, training, compliance)
• May require up to 25% travel

Qualifications

• Exceptional interpersonal and leadership skills
• Expertise in operational strategic direction and guidance for clinical studies
• Data-driven planning, execution, and problem solving
• Advanced communication skills (verbal, written, presentation)
• Proactive, self-disciplined, able to meet deadlines and prioritize effectively
• Ability to influence and negotiate with diverse stakeholders
• Strong budget management experience
• Awareness of relevant industry trends
• Ability to build, lead, and develop productive study teams and collaborations
• Advanced negotiation and interpersonal skills for vendor management
• Technical proficiency in trial management systems and MS Office applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC)
• Extensive experience in global clinical trial operations with ability to contribute to protocol development and key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Advanced project management and cross-functional leadership skills
• Line management experience
• Bachelor’s degree required; minimum of 8 years of relevant clinical trial experience
• Background in cell therapy clinical trials is highly preferred

Education

• Bachelor’s degree required

Additional Requirements

• Travel: May require up to 25% travel