Senior Global Clinical Study Lead - Immunology

BioSpace; Armonk (NY); Presencial; USD 151 000 - 246 000; Tempo integral

Resumo da oferta

Regeneron is seeking a Senior Clinical Study Lead to join our Clinical Trial Management team in Armonk, NY. The role demands high independence and global execution of large/complex trials from design to close-out.

You will oversee study systems, risk management, patient recruitment strategies, and budget/timeline governance, ensuring adherence to SOPs and ICH/GCP. On-site with hybrid flexibility; 25% travel may be required.

Qualificações

• Bachelor's degree required; minimum 8 years clinical trial experience.
• Experience with line management and leadership skills.
• Ability to lead global CRO relationships and vendor management.
• Strong communication and stakeholder management.

Responsabilidades

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight for the assigned study.
• Oversees development of study documentation including CRF, data management plan, monitoring plan, monitoring oversight plan, training plan, data review plan, and statistical analysis plan.
• Oversees setup and maintenance of CTMS, TMF, and related study systems.
• Identifies outsourcing needs and leads engagement, contracting and management of vendors.
• Provides input into baseline budget development and management and baseline timeline development and management.
• Leads risk assessment and mitigation strategies and feasibility assessment for region/country selection.
• Monitors site activation and monitoring visits and addresses deviations from plan.
• Leads recruitment and retention strategies and monitors data entry and queries.
• Oversees study drug and clinical supplies forecasting, drug accountability and reconciliation.
• Escalates issues to Program Operations Leader and develops actions to address issues.
• Manages close-out activities including database lock, vendor contracts reconciliation, TMF, and drug accountability.
• May perform unmasked tasks related to trials as needed.
• Oversees CTM staff with performance management, recruitment, and professional development.

Conhecimentos

Cross-functional leadership

Trial management

Project management

Budget management

Communication skills

Leadership

Formação académica

Bachelor's degree

Ferramentas

CTMS

TMF

EDC

MS Office

IVRS/IWRS

Descrição da oferta de emprego

Regeneron is seeking a Senior Clinical Study Lead to join our Clinical Trial Management team in Armonk, NY. The role demands high independence and global execution of large/complex trials from design to close-out.

You will oversee study systems, risk management, patient recruitment strategies, and budget/timeline governance, ensuring adherence to SOPs and ICH/GCP. On-site with hybrid flexibility; 25% travel may be required.