Clinical Data Manager

Mass General Brigham•Somerville, MA

1d•Hybrid

About The Position

Receiving direction from the Director of Data Management of the Neurological Clinical Research Institute (NCRI), the incumbent will use a clinical trial data management system for data collection, analysis, and reporting for large multi-center clinical trials coordinated through the MGH NCRI. The incumbent will act as a liaison between the study monitors, clinical sites collecting data, and the NCRI. The incumbent will develop case report forms, generate reports, perform data quality checks, and manage trial specific database.

Requirements

A minimum of a bachelor's degree is required.
2-3 yrs data management experience required.
Basic computer knowledge and knowledge of MS Office applications are a must.

Nice To Haves

Clinical Research Data Management experience strongly preferred.
Data management experience in a clinical setting is preferred.
Experience with MS Access or other databases is desirable but not required.

Responsibilities

Manages data for multi-center clinical trials coordinated through the Neurological Clinical Research Institute.
Development/design of Electronic Case Report Forms (eCRFs)
Testing and validating the study-specific Electronic Data Capture System (EDC)
Developing programs to check the integrity of the data, including range, error, and logic checks
Running queries to verify data quality regularly
Preparing reports on the quantity of data and the quality of the data management system
Retrieving data and generating reports from the database as requested by senior staff
Assisting in the preparation of regulatory documents for submission to the Institutional Review Board (IRB)/FDA
Attending/conducting meetings, teleconferences, and webinars relevant to current or upcoming trials
Develop user training course materials and serve as a contact point for site users.