Principal Central Monitor

Job not on LinkedIn

🔥 14 hours ago

🇷🇴 Romania – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 12%

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Lead development of new tools, instruction guidelines, and analyses for centralized statistical review of study data from study start through database lock • Enable proactive identification, communication, escalation, and management of risks at study, country, and site levels • 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 for automating 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 indicative of systematic errors and potential performance issues at study, country, and site levels • 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) • Ability to learn and use interactive computer systems and tools • Advanced understanding of descriptive analysis, e.g. means, medians, significance, confidence intervals • Expertise in analyzing and reviewing clinical data • Ability to extract pertinent information from standard 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 fluidly in response to changing project demands • Good understanding of project protocol and project documentation, including centralized monitoring and risk-based monitoring • Broad working knowledge of roles, functions and processes of conducting clinical trials • Ability to manage time effectively while working with multiple functions and requirements • Involvement in the use of trial management or data management systems • Must be legally able to work in Romania

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Recruitment and selection accommodations for applicants with disabilities, upon request

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