Clinical Data Manager - (Job Number: 3304444)

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.PRINCIPAL DUTIES AND RESPONSIBILITIES:Data manager for multi-center clinical trials coordinated through the Neurological Clinical Research Institute.Specific responsibilities include:Development/design of Electronic Case Report Forms (eCRFs)Testing and validating study specific Electronic Data Capture System (EDC)Developing programs to check the integrity of the data, including range, error, and logic checksRunning queries to verify data quality on a regular basisPreparing reports on the quantity of data and quality in the data management systemRetrieving data and generating reports from the database as requested by senior staffAssisting in preparation of regulatory documents for submission to the Institutional Review Board (IRB)/FDAAttending/conducting meetings, teleconferences, and webinars relevant to current or upcoming trialsDevelop user training course materials and serve as point of contact for site users.A minimum of a bachelor’s degree is required. Previous clinical data management experience preferred.SKILLS/ABILITIES/COMPETENCIES REQUIRED:Basic computer knowledge and knowledge of MS Office applications is a must. Experience with MS Access or other databases is desirable but not required.

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