Senior Central Monitor-India

The Senior Central Monitor is responsible for setting up study-specific tools/analysis and a centralized monitoring plan for conducting a centralized statistical review of study data from study start through to study database lock, using analytical tools to identify emerging and existing risks to critical study data and process. The Senior Central Monitor enables proactive identification, communication, escalation, and management of risks at the study/country/site level.

Responsibilities

More specifically, the Senior Central Monitor must:

• Lead setup of study-specific tools/analysis and centralized monitoring plan for data review with support from the manager.
• Demonstrate expertise across the majority of analyses and identifies complex data quality trends per guidelines in alignment with the centralized monitoring plan.
• Provide training support to new and junior staff members within areas of expertise.
• Track and review timelines, develop analysis assignments for team and be able to organize, communicate with internal team, and delegate as appropriate to ensure reviews are completed on time, on budget, and with high quality.
• Develop and deliver centralized monitoring reports as well as lead centralized monitoring meetings with support from the manager, as needed.
• Represent centralized monitoring team in the cross-functional project specific risk assessment meetings (initial and periodic) with support from the manager.
• Support review set-up as directed by assigned including updating department database, pulling reports, etc. as assigned.
• 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.

Education

• Bachelor s degree in a field relevant to clinical research.

Experience:

• Minimum of 3 years of experience in central statistical monitoring with overall 8 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
• Good 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 advanced knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems and tools.
• Ideally a good 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 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.
• 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.