Risk and Central Monitoring Associate Manager (Fully Remote)

Partner Company; United States; À distance; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Fully remote work arrangement

International collaboration

Résumé du poste

Partner Company seeks an experienced RBQM specialist to drive risk-based quality management for multicenter trials. You will lead centralized monitoring efforts, develop monitoring plans, and analyze data to mitigate risks, collaborating with international teams.

The role emphasizes regulatory compliance, training, and sponsor collaboration in a fully remote, global environment.

Qualifications

• Bachelor’s degree or RN with 4+ years of clinical research experience including RBM.
• Strong knowledge of RBQM, KRIs, QTLs, and centralized monitoring processes.
• Excellent analytical, communication, and project coordination skills; proficient in MS Office.

Responsabilités

• 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.

Connaissances

RBQM

Centralized monitoring

KRIs

QTLs

Data analysis

Communication

Project coordination

Formation

Bachelor’s degree or RN qualification

Outils

Microsoft Office

Description du poste

• 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.
• 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.

Partner Company

A global clinical research organization focused on advancing medical innovation and improving patient outcomes through high-quality clinical trials. The company fosters a collaborative, multidisciplinary remote environment with international teams and a strong emphasis on regulatory compliance and data-driven decision-making.