Global Clinical Study Lead, Trials & Vendors

Regeneron Pharmaceuticals; Warren (MI); Ibrido; USD 110.000 - 179.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals seeks a Clinical Study Associate Manager to join our Clinical Trial management team. You will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, coordinating with internal teams and CROs.

The role involves overseeing study setup, vendor management, budgeting, data quality, and study close-out across assigned regions; travel up to 25%. Located in Armonk, NY, Warren, NJ, Cambridge, MA with on-site emphasis and hybrid flexibility.

Competenze

• Bachelor’s degree required; 4+ years of industry experience.
• Data-driven approach with attention to detail for trial activities.
• Proficiency with trial management systems and MS Office (Project, PowerPoint, Word, Excel).
• Budget awareness and vendor management experience.
• Knowledge of ICH/GCP and regulatory guidelines.

Mansioni

• May lead/oversee planning and management of a clinical study.
• Contributes to risk assessment and mitigation strategies.
• Oversees development of study documents and consent forms.
• Oversees setup and maintenance of CTMS and TMF systems.
• Engages vendors and forecasts drug supply; monitors contracts.
• Provides regular status reports and recruitment/retention strategies.
• Monitors data quality, protocol deviations, and site performance.
• Supports budget management and CAPA processes.

Conoscenze

Clinical trial management

Data-driven approach

Budget management

Vendor management

ICH/GCP knowledge

MS Office (Project, PowerPoint, Word,;

Formazione

Bachelor’s degree

Strumenti

Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Descrizione del lavoro

Regeneron Pharmaceuticals seeks a Clinical Study Associate Manager to join our Clinical Trial management team. You will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, coordinating with internal teams and CROs.

The role involves overseeing study setup, vendor management, budgeting, data quality, and study close-out across assigned regions; travel up to 25%. Located in Armonk, NY, Warren, NJ, Cambridge, MA with on-site emphasis and hybrid flexibility.