Principal Central Monitor

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

📋 Description

• Oversee the creation of new tools, instructional guidelines, and analyses for a centralized statistical review of study data from initiation to database lock.

• Spearhead the development and establishment of study-specific tools, analyses, and centralized monitoring plans that align with study risks, critical data, and essential processes.

• Serve as the strategic and technical lead for centralized monitoring across various studies and organization-wide initiatives.

• Offer guidance on complex analyses, address escalated issues, and set consistent approaches and standards.

• Aid in developing tools, techniques, and processes for automating risk-based monitoring tasks, including data integration, retrieval, mapping, and report generation.

• Mentor and train new team members as well as junior staff.

• Detect data quality trends that indicate systematic errors and potential performance issues at the study, country, or site level.

• Monitor evidence of issues and potential risks with the assistance of senior team members.

• Represent centralized monitoring in cross-functional study risk assessment meetings.

• Provide expert advice on the identification, evaluation, prioritization, mitigation, and ongoing review of study risks.

• Contribute insights to leadership for the development of risk characterization and reporting.

• Execute other assigned responsibilities when qualified and/or adequately trained.

⛳️ Requirements

• Bachelor’s degree in a field pertinent to clinical research.

• A minimum of 5 years of experience in central statistical monitoring.

• A total of 10 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.

• Strong understanding of statistical monitoring and Risk Based Quality Management (RBQM) and their effects on data integrity.

• Comprehensive knowledge of processes related to clinical study management, data management, and regulatory operations.

• Familiarity with clinical trial database systems (EDC, IRT, CTMS, etc.).

• Exceptional computer skills, particularly advanced proficiency in MS Office (Word, Excel, PowerPoint).

• Advanced knowledge of descriptive analysis, including means, medians, significance, and confidence intervals.

• Proficient in analyzing and reviewing clinical data and extracting relevant information from study documentation and electronic study data systems.

• Capability to identify trends in site/study data.

• Ability to thrive in non-traditional work settings.

• Fluent in English with excellent oral and written communication skills.

• Competence to communicate clearly and effectively at all levels within the organization and with external clients.

• Quick learner with the ability to grasp new concepts swiftly.

• Strong prioritization skills and the ability to plan, monitor, and manage workload in response to shifting project demands.

• Solid understanding of project protocols, project documentation, centralized monitoring, and risk-based monitoring.

• Extensive working knowledge of roles, functions, and processes involved in conducting clinical trials.

• Effective time management skills while collaborating with multiple functions and requirements.

• Experience with trial management or data management systems.

• Must be legally authorized to work in Argentina.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Ongoing learning and development opportunities.

• Attractive advancement prospects.

• Equal opportunity and accommodations throughout the recruitment and selection process for applicants with disabilities, upon request.