Manager, Central Monitoring

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Engage in the development and enhancement of the Study Quality Risk Assessment and Control Tracker to recognize and manage study-related risks.

• Lead the formulation of the Central Monitoring Plan tailored to study-specific requirements and RBQM methodologies.

• Set up, implement, and execute the Central Monitoring RBQM system across assigned studies, collaborating with data analysts.

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

• Analyze KRIs/KPIs and evaluate trends to pinpoint areas needing intervention.

• Present insights to clinical study teams and assist in root cause analysis.

• Offer recommendations for follow-up actions to address identified risks.

• Document outputs from Central Monitoring Reviews and monitor decisions and action closures.

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

• Collaborate with outsourcing management to oversee CRO Central Monitoring operations.

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

• Represent Central Monitoring in cross-functional initiatives aimed at process improvement.

• Evaluate emerging technologies to bolster Central Monitoring capabilities.

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

• Work in partnership with Central Monitors and Centralized Data Risk Analysts.

⛳️ Requirements

• High School Diploma, Associate's Degree, Bachelor's Degree, Master's Degree, Ph.D., PharmD, MD, or Board-Certified MD.

• A minimum of 7 years of pertinent experience in the biotechnology/pharmaceutical industry.

• At least 1 year of direct Central Monitoring experience.

• Strong analytical problem-solving and critical thinking skills.

• 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 standards.

• Effective communication and interpersonal abilities.

• Capacity to cultivate relationships both internally and externally.

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

• Exceptional written communication skills.

• Proficiency in mathematical concepts, statistical methodologies, and data analytics.

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

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

• Experience with CluePoints is preferred.

🏝️ Benefits

• Premium salary.

• Attractive benefits.

• Medical care plan: Health, Dental & Vision.

• Life Assurance.

• Excellent work environment.

• Culture of teamwork and collaboration.

• People who inspire and face challenges together.

• Innovative technology.

• Excellent training.

• Annual performance-based bonus plan for eligible roles.

• Annual salary review for eligible roles.

• Total rewards incentives for eligible roles.

• Flexible work arrangements.

• Professional development opportunities.

• Up to 25% travel requirement.