Senior Central Monitoring Specialist (Remote)

ProPharma Group; United States, Northern America, Americas; Híbrido; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

ProPharma Group is seeking a Senior Central Monitor (Remote) to support clinical monitoring teams through centralized data and reporting tools in line with SOPs, regulatory requirements, ICH and GCP guidelines.

You will perform remote site monitoring, support study strategies, and help track recruitment, enrollment, drug supply, and site payments, while communicating with site institutions and contributing to risk assessments and data reviews.

Formación

• Bachelor’s degree preferred; comparable training/experience considered.
• Minimum 3 years of experience in study coordination and/or in-house monitoring.
• Experience in biotechnology or pharmaceutical regulated environments is desirable.
• Familiarity with RBQM systems (e.g., Cluepoints) is a plus.
• Understanding FDA/ICH GCP guidelines and SOPs.

Responsabilidades

• Perform remote site monitoring and management activities per FDA/local regulations and ICH GCPs.
• Support study monitoring teams to implement strategies, processes, and standards to ensure quality and on-time delivery.
• Assist data collection and generate reports on recruitment, enrollment, drug supply status, site payments, and tracking.
• Support data risk assessments and monitoring activities across the study.
• Coordinate with clinical site institutions and assist with document collection, visit prep, and data review as needed.

Conocimientos

Effective communication

Prioritization

Cross-functional collaboration

Attention to detail

Educación

Bachelor’s degree preferred

Herramientas

Electronic Document Management Systems

Electronic Data Capture Systems

Clinical Trial Management Systems

Descripción del empleo

ProPharma Group is seeking a Senior Central Monitor (Remote) to support clinical monitoring teams through centralized data and reporting tools in line with SOPs, regulatory requirements, ICH and GCP guidelines.

You will perform remote site monitoring, support study strategies, and help track recruitment, enrollment, drug supply, and site payments, while communicating with site institutions and contributing to risk assessments and data reviews.