Central Monitoring Specialist - Ukraine Home Based

📋 Description

• • The Central Monitoring Specialist is responsible for executing key Central Monitoring activities including site, subject, and study-level reviews as applicable to ensure compliance with study protocols and regulatory standards.
• • Collaborates directly with the study team to implement and adhere to the approved Central Monitoring plan across all phases of clinical trials.
• • Conducts systematic reviews of data and activities on applicable Informatics platforms to identify anomalies, trends, and risks at the country, study, site, and subject levels.
• • Timely reports findings from central monitoring activities, including recommendations for changes to risk profiles and appropriate escalations to project stakeholders.
• • Performs risk assessments by analyzing risk indicators and proposes actionable mitigations to project teams to enhance data quality and trial integrity.
• • Conducts deep-dive analyses to identify site- and subject-level risks in non-contributing sites that may collectively impact overall study-level risk.
• • Ensures all central monitoring activities are completed within established timelines and aligned with sponsor and regulatory expectations.
• • Maintains accurate documentation of monitoring activities, findings, and recommendations in accordance with internal procedures and regulatory requirements.
• • Supports continuous improvement of central monitoring processes by providing feedback and insights based on real-world trial data and outcomes.
• • Works independently with minimal supervision while maintaining strong communication with cross-functional teams including clinical operations, data management, and project management.
• • Applies clinical research knowledge to interpret complex data patterns and translate them into meaningful risk signals for trial oversight.
• • Adheres to all applicable GCP, FDA, EMA, and other regulatory guidelines governing clinical trial monitoring and data integrity.
• • Participates in training and knowledge-sharing sessions to stay current with evolving industry standards, technologies, and monitoring methodologies.
• • May assist in the development or refinement of central monitoring strategies, risk-based monitoring tools, and performance metrics for future studies.
• • Acts as a subject matter expert in central monitoring practices within assigned studies and provides guidance to junior team members as needed.