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 identify and mitigate study risks.

• Spearhead the formulation of Central Monitoring Plans tailored to the specific needs of studies and aligned with Risk Based Quality Management methodologies.

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

• Perform study-level Central Monitoring Reviews utilizing data analysis tools.

• Analyze Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to evaluate data trends and pinpoint areas needing intervention.

• Share findings with clinical study teams, assist in root cause analysis, and provide suggestions for subsequent actions.

• Record the outputs of Central Monitoring Review meetings, monitor decisions, and ensure timely resolution of actions.

• Serve as a subject matter expert in 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 Central Monitoring processes and propose enhancements to tools, metrics, and methodologies.

• Represent Central Monitoring in cross-functional initiatives aimed at process improvement and evaluate emerging technologies.

⛳️ Requirements

• Strong analytical problem-solving and critical thinking skills, with experience in troubleshooting data refreshes and addressing execution errors in analytical systems.

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

• Effective communication and interpersonal abilities; capacity to cultivate relationships both internally and externally.

• Proven capability to recognize and interpret current and future business trends, applying them to centralized monitoring practices.

• Exceptional written communication skills, with the ability to articulate complex technical and analytical insights clearly and succinctly.

• Proficiency in 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.

• Expertise in Microsoft Office applications, with advanced proficiency in Excel for data manipulation and reporting.

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

• A minimum educational requirement of a High School Diploma, Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, or Board Certified MD.

• At least 7 years of relevant experience in the biotechnology/pharmaceutical industry.

• A minimum of 1 year of direct experience in Central Monitoring.

• Site monitoring or data management experience is advantageous.

🏝️ Benefits

• No benefits, perks, or compensation extras are specified in the posting.