Principal Central Monitor

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

📋 Description

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

• Facilitate proactive detection, communication, escalation, and management of risks at the study, country, and site levels.

• Direct the development and implementation 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 intricate analyses, address escalated issues, and establish consistent methodologies and standards.

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

• Mentor and train new team members and junior staff.

• Detect data quality trends that indicate systematic errors and possible performance issues at 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.

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

• Contribute 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 discipline relevant 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.

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

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

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

• Proficient computer skills, with advanced knowledge of MS Office (Word, Excel, PowerPoint).

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

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

• Expertise in analyzing and reviewing clinical data.

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

• Proficiency in identifying trends in site/study data.

• Ability to thrive in non-traditional work environments.

• Fluent in English (excellent oral and written communication skills).

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

• Quick learner capable of grasping new concepts swiftly.

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

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

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

• Ability to manage time effectively while collaborating with multiple functions and requirements.

• Experience with trial management or data management systems.

• Must possess legal eligibility to work in Romania.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Ongoing learning and development opportunities.

• Attractive prospects for advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.