Risk and Central Monitoring Associate Manager

Role Overview:

• Support clinical trial quality by leading risk-based quality management (RBQM) activities and centralized monitoring strategies.
• Collaborate with multidisciplinary teams and sponsors to evaluate clinical data and develop proactive risk mitigation approaches.
• Ensure regulatory compliance and inspection readiness aligned with ICH GCP guidelines.

Key Accountabilities:

• Lead RBQM activities, develop Central Monitoring Plans, and maintain study risk assessments and dashboards.
• Conduct centralized monitoring reviews to identify trends, outliers, and risks, recommending follow-up actions.
• Provide training on RBQM principles and support sponsor interactions, audits, and project meetings.

Requirements:

• Bachelor's degree or RN qualification with at least 4 years of clinical research experience, including 3 years in RBM.
• Strong knowledge of RBQM, KRIs, QTLs, and centralized monitoring processes.
• Excellent analytical, communication, and project coordination skills with proficiency in Microsoft Office.

Benefits:

• Fully remote work arrangement with collaboration across international teams.
• Competitive compensation and opportunities to develop expertise in clinical trial oversight.
• Contribute to meaningful clinical research initiatives improving patient outcomes.