The posting
Centralized monitoring is an integral part of a 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 central monitor is responsible for conducting a holistic and centralized statistical review of study data from study start through to study database lock according to the centralized monitoring plan, using analytical tools to identify emerging and existing risks to critical study data and process. The central monitor enables proactive identification, communication, escalation and management of risks at the study/country/site level.
RESPONSIBILITIES
- Follow established procedures for the review of clinical trial data (Operational and Subject data) using a variety of tools and systems in alignment with the centralized monitoring plan and with support from the senior team members.
- Identify data quality trends indicative of systematic errors and potential performance issues at study/country/site and track the evidence of issues and potential risks with support from senior team members.
- Ensure results of reviews are appropriately documented per procedures.
- Support Central Monitoring teams with performance of assigned reviews with high quality, on-time results.
- Provide input to senior team member as needed to support development of risk characterization and reporting.
- Support review set-up as directed by assigned lead including updating department database, pulling reports, etc. as assigned.
- Share the responsibility for data quality at the study, country and site levels.
Requirements
Education
- Bachelor’s degree in a field relevant to clinical research.
Experience
- Minimum of 1 year of experience in central statistical monitoring with overall 6 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
- Basic 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.).
- Good computer skills, with knowledge of advanced MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems and tools.
- Ideally a basic level of understanding of descriptive analysis e.g. means, medians, significance, confidence intervals.
- Must have been involved in the analysis and review of 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.
Attributes
- Fluent in English (excellent oral and written).
- Must be able to communicate clearly and effectively at all levels in an 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.
- Satisfactory 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.
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
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 and Rheumatology!
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.
