Principal Central Monitor

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

📋 Description

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

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

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

• Provide guidance on complex analyses, resolve escalated issues, and establish uniform approaches and standards.

• Assist in the development of tools, techniques, and processes for automating risk-based monitoring tasks, including data integration, retrieval, mapping, and automated report generation.

• Mentor and train new team members and junior staff.

• Identify trends in data quality that indicate systematic errors and potential performance issues at the study, country, and site levels.

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

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

• Offer expert advice on identifying, evaluating, prioritizing, mitigating, and continuously reviewing study risks.

• Contribute insights to leadership to aid in risk characterization and reporting.

• Carry out additional assigned responsibilities when qualified and/or adequately trained.

⛳️ Requirements

• Bachelor's degree in a field related to clinical research.

• At least 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.

• Comprehensive understanding of statistical monitoring and Risk-Based Quality Management (RBQM) and how they affect data integrity.

• In-depth knowledge of clinical study management, data management, and regulatory operations processes.

• Familiarity with clinical trial database systems, including EDC, IRT, and CTMS.

• Advanced proficiency in MS Office applications, including Word, Excel, and PowerPoint.

• Capability to learn and utilize interactive computer systems and tools.

• Advanced understanding of descriptive statistics, including means, medians, significance, and confidence intervals.

• Expertise in the analysis and review of clinical data.

• Ability to extract relevant information from protocols and electronic study data systems.

• Skill in identifying trends within site/study data.

• Capacity to work effectively in non-traditional work environments.

• Proficient in English with excellent verbal and written communication skills.

• Ability to communicate clearly and effectively across all organizational levels and with external clients.

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

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

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

• Broad knowledge of clinical trial roles, functions, and processes.

• Effective time management skills while handling multiple functions and requirements.

• Experience with trial management or data management systems.

• Legally authorized to work in India.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Opportunities for ongoing learning and development.

• Home-based work location in India.

• Attendance at some meetings outside regular business hours, primarily in the evening.