Risk and Central Monitoring Associate Manager

This is a fully remote position, open to applicants in United States, +9 more locations.

📋 Description

• Lead and manage Risk-Based Quality Management (RBQM) initiatives for designated clinical studies.

• Create and uphold Central Monitoring Plans, ensuring necessary approvals and alignment with study objectives.

• Assist in the development and continuous evaluation of study risk assessments alongside cross-functional teams.

• Facilitate the identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).

• Conduct centralized monitoring reviews to detect trends, outliers, signals, and potential risks, providing recommendations to study teams.

• Maintain central monitoring dashboards and support ongoing supervision throughout the entirety of the study lifecycle.

• Provide training and guidance to study teams on RBQM strategies, monitoring techniques, and risk management processes.

• Contribute to readiness for inspections, budget awareness, sponsor interactions, audits, and project-related meetings.

• Collaborate with global teams, internal stakeholders, and sponsors to enhance inspection-ready processes and clinical trial quality.

⛳️ Requirements

• Bachelor's degree, RN, or an equivalent combination of education, skills, and experience.

• A minimum of 4 years of clinical research experience.

• At least 3 years of experience with Risk-Based Monitoring (RBM) and relevant ICH/regulatory guidelines.

• Previous experience working as a Central Monitor or in a Central Monitoring role.

• Comprehensive understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs.

• Capability to analyze complex data, recognize trends and risks, and utilize critical thinking for problem-solving and issue resolution.

• Experience working collaboratively across functions and effectively within global project teams.

• Excellent communication, presentation, planning, and organizational abilities.

• Proficient in English.

• Strong proficiency in Microsoft Office and clinical technology systems.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Transparent compensation and pay equity.