Clinical Study Manager: Trials Delivery & Vendor Oversight

Regeneron Pharmaceuticals, Inc.; New Jersey; Presencial; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Clinical Study Associate Manager to oversee delivery of clinical studies across regions. You will support the Clinical Study Lead, manage study documents, budgets, timelines, and vendor engagement to ensure compliant trial execution.

The role emphasizes data quality, risk management, and collaboration with CROs and internal teams to advance trials from start-up to close-out, in a fast-growing science-driven environment.

Qualificações

• Bachelor's Degree and 4+ years of relevant industry experience.
• Data driven approach to executing and problem solving, with attention to detail to deliver on study activities.
• Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF.
• Budget awareness with ability to participate in various aspects of budget management.
• Familiarity with medical terms and vendor management experience.
• Experience in clinical trial operations including experience developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Responsabilidades

• May lead/oversee planning and management of a clinical study in assigned regions.
• Contributes to risk assessment and mitigation strategies and assists feasibility assessments.
• Oversees development of study documents and reviews site-level informed consents and start-up materials.
• Oversees setup and maintenance of study systems (CTMS, TMF) and investigator meeting preparation.
• Oversees engagement, contracting and management of vendors and forecasting of drug supplies.
• Provides status reports and supports recruitment and retention strategies.
• Monitors recruitment, site activation progress and data quality issues.
• Supports audit readiness and CAPA processes during the study lifecycle.
• Manages study close-out activities including database lock and budget reconciliation.

Conhecimentos

Data-driven problem solving

Vendor management

Trial management systems

MS Office (PowerPoint, Word, Excel)

Budget management

ICH/GCP knowledge

Regulatory guidelines

Formação

Bachelor's Degree

Ferramentas

CTMS

TMF

IVRS/IWRS

EDC

Descrição da vaga

Regeneron Pharmaceuticals, Inc. in the United States is seeking a Clinical Study Associate Manager to oversee delivery of clinical studies across regions. You will support the Clinical Study Lead, manage study documents, budgets, timelines, and vendor engagement to ensure compliant trial execution.

The role emphasizes data quality, risk management, and collaboration with CROs and internal teams to advance trials from start-up to close-out, in a fast-growing science-driven environment.