Principal Central Monitor

Job not on LinkedIn

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 • Lead development and setup of 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 • Assist in creating tools, techniques, and processes to automate risk-based monitoring tasks, including data integration, data retrieval, data mapping, and automated 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, 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 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 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, including Word, Excel, and PowerPoint • Ability to learn and use interactive computer systems and tools • 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 plan, monitor, and manage workload in response to changing project demands • Good understanding of project protocols, project documentation, centralized monitoring, and risk-based monitoring • 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 India

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Home-based work location in India • Attendance at some meetings outside regular business hours, primarily in the evening