Job Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Receiving direction from the Director of Data Managementof the Neurological Clinical Research Institute (NCRI), the incumbent will usea clinical trial data management system for data collection, analysis andreporting for large multi-center clinical trials coordinated through the MGH NCRI. The incumbent will act as a liaisonbetween 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 specificdatabase.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Data manager for multi-centerclinical trials coordinated through the Neurological Clinical ResearchInstitute.

Specific responsibilities include:

* Development/designof Electronic Case Report Forms (eCRFs)

* Testingand validating study specific Electronic Data Capture System (EDC)

* Developingprograms to check the integrity of the data, including range, error, and logicchecks

* Runningqueries to verify data quality on regular basis

* Preparingreports on the quantity of data and quality in the data management system

* Retrieving data and generating reports from the database as requested bysenior staff

* Assisting in preparation of regulatory documents for submission to the InstitutionalReview Board (IRB)/FDA

* Attending/conducting meetings, teleconferences and webinars relevant tocurrent or upcoming trials

* Develop user training course materials and serve as contact point forsite users.

WORKING CONDITIONS:

Office work.

QUALIFICATIONS:

A minimum of a bachelors degree is required. Previousclinical data management experience preferred.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

Basic computer knowledge andknowledge of MS Office applications is a must. Experience with MS Access orother databases is desirable but not required.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged