Principal Central Monitor

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

📋 Description

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

• Design and implement study-specific tools, analyses, and centralized monitoring plans that align with study risks, critical data, and essential processes.

• Act 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 develop consistent methodologies and standards.

• Develop tools, techniques, and procedures to automate risk-based monitoring tasks, including data integration, retrieval, mapping, and report generation.

• Mentor and provide training to new team members and junior staff.

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

• Monitor and document 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 the identification, evaluation, prioritization, mitigation, and ongoing review of study risks.

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

• Collaborate with colleagues and participate in some meetings outside regular business hours, primarily in the evening.

• May take on additional responsibilities when appropriately experienced, qualified, and/or trained.

⛳️ Requirements

• Bachelor’s degree in a field relevant 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.

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

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

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

• Proficient in MS Office applications (Word, Excel, PowerPoint).

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

• Expertise in analyzing and reviewing clinical data.

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

• Ability to identify trends in site/study data.

• Capacity to work in non-traditional work environments.

• Fluent in English, with exceptional oral and written communication skills.

• Ability to communicate clearly and effectively at all organizational levels and with external customers.

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

• Strong prioritization skills and the ability to manage shifting project demands.

• Good understanding of project protocols and centralized/risk-based monitoring documentation.

• Extensive working knowledge of clinical trial roles, functions, and processes.

• Proficient time management skills while working with multiple functions and requirements.

• Experience with trial management or data management systems.

• Legally authorized to work in the Philippines.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Home-based work location.