Centralized Monitor

About the role

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications, partnering with small to midsize biotech companies on early-phase trials. As a Centralized Monitor, you will review and analyse aggregated data to spot signals and trends in predefined risk indicators, supporting risk-based quality management and site oversight.

Key responsibilities

• Review and analyse centralized, aggregated data to identify potential signals and trends in predefined risk indicators.
• Support the initial review of the Risk Assessment and Categorization Tool (RACT).
• Review outputs from the RBQM system and escalate findings as appropriate.
• Periodically review site-level Key Risk Indicators (KRIs) and monitor site performance, identifying issues needing review or corrective action.
• Review the effectiveness of implemented actions and escalate concerns when more action is needed.
• Evaluate the quality and integrity of study site practices related to protocol compliance and applicable regulations.
• Maintain project-level communication with stakeholders on findings and follow-up, and contribute to centralized monitoring documentation.
• Attend study kick-off meetings, recurring project meetings and other relevant meetings.

Required profile

• BA/BS degree in a Life Science field, or equivalent education and experience in line with country-specific requirements.
• At least 1 year of experience in clinical research or a related field.
• Knowledge of Risk-Based Quality Management and centralized monitoring principles.
• Working knowledge of clinical research regulations and ICH-GCP principles.
• Ability to review and interpret clinical study data, trends and risk indicators.
• Good analytical, problem-solving, written and verbal communication skills, and ability to work in cross-functional study teams.