Principal Central Monitor
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Job Description
Principal Central Monitor leading risk-based statistical monitoring and data-quality analysis for Indero, a global dermatology and rheumatology clinical research CRO.
Responsibilities:
- Lead development of new tools, instruction guidelines, and analyses for centralized statistical review of study data from study start through database lock
- Lead development and setup of study-specific tools, analyses, and centralized monitoring plans aligned with study risks, critical data, and critical processes
- Act as strategic and technical lead for centralized monitoring across multiple studies and function-wide initiatives
- Provide direction on complex analyses, resolve escalated issues, and establish consistent approaches and standards
- Assist in creating tools, techniques, and processes to automate risk-based monitoring tasks, including data integration, retrieval, mapping, and report generation
- Mentor and train new team members and junior staff
- Identify data quality trends indicating systematic errors and potential performance issues at study, country, or site level
- Track evidence of issues and potential risks with support from senior team members
- Represent centralized monitoring in cross-functional study risk assessment meetings
- Provide expert guidance on identification, evaluation, prioritization, mitigation, and ongoing review of study risks
- Provide input to leadership to support development of risk characterization and reporting
- Perform other assigned responsibilities when qualified and/or adequately trained
Requirements:
- Bachelor’s degree in a field relevant to clinical research
- Minimum of 5 years of experience in central statistical monitoring
- Overall 10 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management
- Excellent understanding of statistical monitoring and Risk Based Quality Management (RBQM) and their impact on data integrity
- Thorough understanding of processes associated with clinical study management, data management, and regulatory operations
- Knowledge of clinical trial database systems (EDC, IRT, CTMS etc.)
- Excellent computer skills, with advanced knowledge of MS Office (Word, Excel, PowerPoint)
- Advanced understanding of descriptive analysis, including means, medians, significance, and confidence intervals
- Expertise in analyzing and reviewing clinical data and extracting pertinent information from study documentation and electronic study data systems
- Ability to identify trending of site/study data
- Ability to work in non-traditional work environments
- Fluent in English (excellent oral and written)
- Ability to communicate clearly and effectively at all levels within the organization and with external customers
- Fast learner able to understand new concepts quickly
- Prioritization skills and ability to plan, monitor, and manage workload in response to changing project demands
- Good understanding of project protocol, project documentation, centralized monitoring, and risk-based monitoring
- Broad working knowledge of roles, functions, and processes involved in conducting clinical trials
- Ability to manage time effectively while working with multiple functions and requirements
- Experience using trial management or data management systems
- Must be legally able to work in Argentina
Benefits:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Equal opportunity and accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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