Manager, Central Monitoring

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Oversee centralized monitoring efforts for intricate global clinical trials

• Assess key risk indicators and operational performance metrics

• Share insights as a vital member of clinical study teams

• Integrate KRI and KPI data from analytical tools with additional operational data and trends

• Assist in identifying and addressing issues that require intervention

• Support multiple studies within a therapeutic area and at the program level

• Collaborate with Central Monitors and Centralized Data Risk Analysts to execute and report on central monitoring activities

• Engage in the development and enhancement of the Study Quality Risk Assessment and Control Tracker (QRACT)

• Create and write Central Monitoring Plans that align with study requirements and RBQM methodologies

• Partner with data analysts to configure, implement, and operate Central Monitoring RBQM systems

• Conduct study-level Central Monitoring Reviews and analyze KRIs, KPIs, and trends

• Present findings, assist in root cause analysis, and suggest follow-up actions

• Document meeting outcomes, track decisions, and ensure timely resolution of actions

• Represent Central Monitoring during audits, inspections, and within study teams

• Supervise CRO Central Monitoring activities with outsourcing management

• Assess processes and recommend enhancements to tools, metrics, and methodologies

• Contribute to cross-functional initiatives and evaluate emerging technologies

• Travel up to 25% may be necessary

⛳️ Requirements

• Strong analytical problem-solving skills and critical thinking capabilities

• Experience in troubleshooting data refreshes and resolving execution errors in analytical systems

• Proficient communication and interpersonal skills

• Ability to foster relationships both internally and externally

• Capability to identify and interpret current and future business trends and apply them to centralized monitoring practices

• Excellent written communication proficiency

• Skill in conveying complex technical and analytical insights clearly and concisely

• Aptitude for mathematical concepts, statistical methodologies, and data analytics

• Proficient in Microsoft Office applications

• Advanced Excel capabilities for data manipulation and reporting

• Bachelor's degree

• Minimum of 7 years of relevant experience in the biotechnology/pharmaceutical sector

• At least 1 year of direct experience in Central Monitoring

• Familiarity with the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements

• Knowledge and experience with clinical databases, electronic data capture systems, quality control procedures, and auditing processes

• Experience with CluePoints or comparable centralized monitoring RBQM systems is preferred

• Background in site monitoring or data management

🏝️ Benefits

• Competitive salary

• Comprehensive benefits package

• Medical care plan

• Life Assurance

• Excellent work environment

• Culture of teamwork and collaboration

• Access to innovative technology

• Exceptional training opportunities

• Flexibility in work arrangements

• Opportunities for growth and advancement