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Description
Centralized monitoring is an integral part of risk-based monitoring strategy, defined as the timely, remote review of accumulating subject and operational data to help distinguish between reliable and unreliable data, trends, outliers and unusual variability using analytics and statistical methods.
The Principal Central Monitor is responsible for leading the development of new tools, instruction guidelines and analyses essential for centralized statistical review of study data from study start through to study database lock. The Principal Central Monitor enables proactive identification, communication, escalation and management of risks at the study/country/site level.
More specifically, the Principal Central Monitor must:
Lead effort on the development of new tools, instruction guidelines and analyses within the area of specialty, including complex and collaborative approaches with other functions.
Lead the development and setup of study-specific tools, analyses, and centralized monitoring plans, ensuring that the monitoring approach is aligned with study risks, critical data, and critical processes.
Act as the strategic and technical lead for centralized monitoring across multiple studies and for function-wide initiatives, providing direction on complex analyses, resolving escalated issues, and establishing consistent approaches and standards.
Assist in creating tools, techniques and processes for automating risk-based monitoring tasks (data integration automation, data retrieval automation, data mapping automation, and automated report generation).
Act as mentor as well as train new team members and junior staff.
Identify data quality trends indicative of systematic errors and potential performance issues at study/country/site level and track evidence of issues and potential risks with support from senior team members.
Represent centralized monitoring in cross-functional study risk assessment meetings and provide expert guidance on identification, evaluation, prioritization, mitigation, and ongoing review of study risks.
Provide input to leadership as needed to support development of risk characterization and reporting.
Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
Bachelor’s degree in a field relevant to clinical research.
Experience
Minimum of 5 years of experience in central statistical monitoring with an 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 the 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) and the ability to learn and use interactive computer systems and tools.
Advanced level of understanding of descriptive analysis e.g. means, medians, significance, confidence intervals.
Demonstrated expertise in analyzing and reviewing clinical data, ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems with the ability to learn to identify trending of site/study data.
Must be able to work in non-traditional work environments.
Fluent in English (excellent oral and written).
Must be able to communicate clearly and effectively at all levels within the organization and with external customers.
Must be a fast learner and able to understand new concepts quickly.
Prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands.
Good understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.
Broad working knowledge of the roles, functions and process of conducting clinical trials.
Must be able to manage time effectively, working with multiple functions and requirements.
Must have been involved in the use of trial management or data management systems
Our company
The work environment
At Indero , you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in India.