Manager, Central Monitoring

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

📋 Description

• Engage in the development and enhancement of the Study Quality Risk Assessment and Control Tracker (QRACT) to effectively identify and manage study risks.

• Take the lead in creating the Central Monitoring Plan tailored to study-specific requirements and Risk-Based Quality Management (RBQM) methodologies.

• Collaborate with data analysts to set up, implement, and operate the Central Monitoring RBQM system across designated studies.

• Conduct comprehensive Central Monitoring Reviews at the study level utilizing data analysis tools.

• Analyze Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to recognize trends that necessitate intervention.

• Share insights with clinical study teams, facilitate root cause analyses, and provide recommendations for subsequent actions.

• Document outputs from Central Monitoring Reviews, monitor decisions, and ensure prompt resolution of actions.

• Serve as the subject matter expert for Central Monitoring during audits, inspections, and within study teams.

• Collaborate with outsourcing management to synchronize monitoring strategies and oversee the execution of Central Monitoring activities by CROs.

• Assess processes and propose enhancements to tools, metrics, and methodologies.

• Act as a representative for Central Monitoring in cross-functional initiatives aimed at process improvement and evaluate new technologies.

⛳️ Requirements

• A Bachelor’s Degree or equivalent experience is mandatory.

• A minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry is required.

• At least 1 year of direct experience in Central Monitoring is necessary.

• Strong analytical, problem-solving, and critical thinking skills are essential.

• Proven experience in troubleshooting data refreshes and resolving execution errors in analytical systems.

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

• Excellent communication and interpersonal abilities; capable of building strong relationships both internally and externally.

• Ability to recognize and interpret current and future business trends and integrate them into centralized monitoring practices.

• Outstanding written communication skills with a capacity to convey complex technical and analytical insights in a clear and concise manner.

• Strong aptitude for mathematical concepts, statistical methodologies, and data analytics, particularly in interpreting KRIs and KPIs.

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

• Proficient in Microsoft Office applications, especially with advanced Excel skills for data manipulation and reporting.

• Experience with CluePoints or a similar centralized monitoring system is preferred.

• Site monitoring or data management experience is an added advantage.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Collaborative and inclusive work environment.