Clinical Data Monitoring Specialist

Ergomed; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group is seeking a professional to contribute to centralized monitoring of clinical studies. You will review centralized monitoring outputs, identify signals and trends, and support risk-based quality management across trials.

You will work with cross-functional teams, attend study meetings, maintain documentation, and ensure compliance with ICH-GCP and regulations. This role emphasizes analytical skills, attention to detail, and effective communication to protect patients and data

Qualifications

• Education: BA/BS in Life Science or equivalent.
• Minimum 1 year of experience in clinical research or related field.
• Understanding of Risk Based Quality Management and centralized monitoring principles.
• Working knowledge of clinical research regulations, ICH-GCP principles.
• Ability to review and interpret clinical study data, trends and risk indicators.
• Good written and verbal communication skills.
• Ability to work effectively within cross-functional study teams.
• Good organizational skills and ability to manage activities across assigned studies.

Responsibilities

• Review centralized data to identify signals and trends in predefined risk indicators.
• Support initial review of the Risk Assessment and Categorization Tool (RACT).
• Review outputs from RBQM system and escalates findings as appropriate.
• Conduct periodic review of site-level KRIs.
• Monitor site performance and identify issues requiring further review or corrective action.
• Review effectiveness of implemented actions and escalate concerns when additional action may be required.
• Evaluate quality and integrity of study site practices related to protocol compliance and applicable regulations based on centralized monitoring outputs.
• Maintain effective project-level communication with stakeholders regarding centralized monitoring findings and follow-up activities.
• Maintain relevant project documentation and contribute to centralized monitoring documentation.
• Attend study kick-off meetings, recurring project meetings and other relevant meetings.
• Maintain knowledge of applicable company SOPs, processes and centralized monitoring requirements.

Skills

Analytical skills

Data interpretation

Risk assessment

Communication

Cross-functional teamwork

Problem-solving

Attention to detail

Education

BA/BS in Life Science

Job description

Ergomed Group is seeking a professional to contribute to centralized monitoring of clinical studies. You will review centralized monitoring outputs, identify signals and trends, and support risk-based quality management across trials.

You will work with cross-functional teams, attend study meetings, maintain documentation, and ensure compliance with ICH-GCP and regulations. This role emphasizes analytical skills, attention to detail, and effective communication to protect patients and data