Central Risk Manager (Risk based Central Monitoring)

Job Summary:

The Central Risk Manager will oversee risk-based central monitoring activities for clinical trials. This role ensures that clinical trial risks are identified, assessed, mitigated, and monitored according to regulatory requirements, SOPs, and study plans. The individual will collaborate with cross-functional teams to support high-quality trial conduct and patient safety.

Key Responsibilities:

• Lead risk-based central monitoring activities for clinical trials, including identification, assessment, and mitigation of risks.
• Develop and implement risk management plans in alignment with study protocols and regulatory requirements.
• Monitor study data centrally to detect trends, deviations, and potential issues impacting trial quality or patient safety.
• Collaborate with clinical operations, data management, and safety teams to ensure timely resolution of identified risks.
• Maintain and update risk and monitoring documentation, including risk logs, reports, and dashboards.
• Review and analyze trial performance metrics to inform proactive decision-making and risk mitigation strategies.
• Ensure compliance with GCP, SOPs, ICH guidelines, and applicable regulatory requirements.
• Provide guidance and training to study teams on risk-based monitoring processes.
• Participate in audits and inspections, providing risk monitoring insights and documentation as required.

Qualifications:

• Bachelor's or Master's degree in life sciences, pharmacy, or related field.
• Minimum 510 years of experience in clinical operations, risk management, or central monitoring in a CRO or pharmaceutical environment.
• Strong knowledge of risk-based monitoring principles, clinical trial processes, and regulatory requirements.
• Proficient in data analysis, clinical trial metrics, and reporting tools.
• Excellent written and verbal communication skills.
• Strong organizational, problem-solving, and project management abilities.