Clinical Data Manager

Mass General Brigham•Somerville, MA

1d•$53,040 - $75,889•Hybrid

About The Position

The Clinical Data Manager supports data collection, analysis, interpretation, and reporting for large multicenter clinical trials coordinated through the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital. Receiving direction from the Director of Data Management, the role uses clinical trial data management systems to manage trial-specific databases and serves as a liaison among study monitors, clinical sites, and NCRI. The position develops electronic case report forms, validates electronic data capture systems, performs data quality checks, generates reports, and supports regulatory submissions and site-user training.

Requirements

Bachelor's degree in analytics or a related field; a minimum of a bachelor's degree is required.
The role may accept experience in lieu of a degree.
Basic computer knowledge of Microsoft Office applications.
Quantitative, analytical, and technical aptitude.
Knowledge of statistics, data analysis, and data sets.
Time management and project management skills.
Ability to exercise sound judgment within the scope of job responsibilities.
Knowledge of word processing, spreadsheet, and database PC applications.
Ability to work with employees and management at all levels and build effective relationships with teams and organizational customers.
Ability to identify and define problems, understand business impact, identify solutions, and recommend corrective action.

Nice To Haves

Zero to one year of data analysis experience preferred.
Previous clinical data management experience preferred.
Experience with MS Access or other databases is desirable but not required.

Responsibilities

Manage data for multicenter clinical trials coordinated through the Neurological Clinical Research Institute.
Design and develop electronic case report forms (eCRFs).
Test and validate study-specific electronic data capture (EDC) systems.
Develop programs to check data integrity, including range, error, and logic checks.
Run queries regularly to verify data quality.
Prepare reports on the quantity and quality of data in the data management system.
Retrieve database data and generate reports requested by senior staff.
Assist with preparing regulatory documents for submission to the Institutional Review Board (IRB) and FDA.
Attend and conduct meetings, teleconferences, and webinars relevant to current or upcoming trials.
Develop user training materials and serve as a contact point for site users.
Maintain existing reporting systems and work with senior analysts to design, maintain, and distribute reports.
Contribute to presentations for key stakeholders.
Analyze current performance and forecast data trends.
Act as a liaison among study monitors, clinical sites collecting data, and NCRI.