Clinical Data Manager

About the Role

This role involves receiving direction from the Director of Data Management of the Neurological Clinical Research Institute (NCRI) to use a clinical trial data management system for data collection, analysis, and reporting for large multi-center clinical trials. The incumbent will act as a liaison between study monitors, clinical sites, and the NCRI.

Key Responsibilities

• Writes and runs basic queries as needed.
• Assists in maintaining existing reporting systems.
• Contributes to presentations to key stakeholders.
• Works with senior analysts to design, maintain, and distribute reports.
• Learns leading practice analysis methodologies.
• Conducts continuous analysis of current performance and accurately forecasts data trends.
• Develops/designs Electronic Case Report Forms (eCRFs).
• Tests and validates study-specific Electronic Data Capture System (EDC).
• Develops programs to check data integrity, including range, error, and logic checks.
• Runs queries to verify data quality on a regular basis.
• Prepares reports on data quantity and quality within the data management system.
• Retrieves data and generates reports from the database as requested by senior staff.
• Assists in the preparation of regulatory documents for submission to the Institutional Review Board (IRB)/FDA.
• Attends/conducts meetings, teleconferences, and webinars relevant to current or upcoming trials.
• Develops user training course materials and serves as a contact point for site users.
• Manages the trial-specific database.

Requirements & Tech Stack

• Clinical trial data management system
• Electronic Case Report Forms (eCRFs)
• Electronic Data Capture System (EDC)
• MS Office applications (basic computer knowledge required)
• MS Access or other databases (desirable, not required)
• Word processing, spreadsheet, and database PC applications

Qualifications

• A minimum of a bachelor's degree in Analytics or a Related Field of Study is required.
• Experience can be accepted in lieu of a degree.
• 0-1 year of Data Analysis Experience preferred.
• Building proficiency in statistics, data analysis, and data sets.
• Proficient in time management and project management skills.
• Ability to exercise sound judgment to make decisions within the scope of job responsibilities.
• Solid quantitative, analytical, and technical aptitude skills.
• Ability to participate in dealing with all levels of employees/management and build proficient relationships with teams and all organizational customers.
• Ability to find and define problems, understand business impact, identify solutions, and provide recommendations for corrective action.
• Previous clinical data management experience preferred.