Principal Central Monitor

Job not on LinkedIn

🔥 14 hours ago

🇵🇭 Philippines – 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 • Develop and set up study-specific tools, analyses, and centralized monitoring plans aligned with study risks, critical data, and critical processes • Serve 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 • Create tools, techniques, and processes to automate 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 indicating systematic errors and potential performance issues at study, country, or site level • 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 • Work with colleagues and attend some meetings outside regular business hours, primarily in the evening • May be assigned other responsibilities when appropriately experienced, qualified, and/or 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 clinical study management, data management, and regulatory operations processes • Knowledge of clinical trial database systems, including EDC, IRT, and CTMS • Advanced knowledge of MS Office (Word, Excel, PowerPoint) • Advanced understanding of descriptive analysis, including means, medians, significance, and confidence intervals • Expertise in analyzing and reviewing clinical data • Ability to extract pertinent information from protocols and electronic study data systems • Ability to identify trending of site/study data • Ability to work in non-traditional work environments • Fluent in English, with excellent oral and written skills • Ability to communicate clearly and effectively at all organizational levels and with external customers • Fast learner able to understand new concepts quickly • Prioritization skills and ability to manage changing project demands • Good understanding of project protocols and centralized/risk-based monitoring documentation • Broad working knowledge of clinical trial roles, functions, and processes • Ability to manage time effectively while working with multiple functions and requirements • Experience using trial management or data management systems • Legally authorized to work in the Philippines

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Home-based work location