Clinical Data Manager

Mass General BrighamSomerville, MA
3dHybrid

About The Position

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary 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. Qualifications This is not a Management/Leadership position. This person will be focused on managing Clinical Research Data. This is an entry to mid-level position. Clinical Research Data Management experience strongly preferred.

Requirements

  • A minimum of a bachelor's degree is required.
  • Basic computer knowledge and knowledge of MS Office applications are a must.

Nice To Haves

  • Previous clinical data management experience preferred.
  • Clinical Research Data Management experience strongly 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.
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