DATA MANAGER Job in Charlestown Navy Yard 02114, Massachusetts US


Job Description

Receiving general direction from the Director of Data Management of the NCTU and Dr. Cudkowicz, the candidate will be responsible for data management of assigned clinical trials led by the investigators at Department of Neurology. The candidate will be responsible for all data management activities necessary to start, conduct and closing out assigned clinical trials. The candidate will use a clinical trial data management system for data collection, verification and reporting for clinical trials coordinated through the MGH Neurology Clinical Trials Unit. The candidate will also act as a liaison between the study monitors, clinical sites collecting data and the Clinical Trials Unit.

Data manager for multi-center clinical trials coordinated through the Neurology Clinical Trials Unit. Specific responsibilities include:

"€¢ Development/design of Electronic Case Report Forms (eCRFs)
"€¢ Designing, testing and validating the study-specific electronic data capture system.
"€¢ Developing programs to check the integrity of the data, including range, error, and logic checks.
"€¢ Creating data safety report on regular basis.
"€¢ Maintaining help desk to assist study sites with any EDC system related questions or problems.
"€¢ Preparing reports on the quantity of data and quality in the data management system.
"€¢ Retrieving data and generating reports from the database as requested by senior staff.

Drawing on previous data management experience, participate in the design and implementation of any new EDC/CTMS functionality:
"€¢ Develop workflow schema"€™s for any new functionality
"€¢ Provide direction and guidance to program developer for all segments of the new functionality
"€¢ Elicit, compile and present feedback from other members of NCTU regarding proposed functionality for EDC/CTMS.

Computer knowledge is a must. Understanding of clinical research methodology is essential.
Leadership skills, good presentation skills as well as, ability to lead, interact well with others, take initiative and think independently are also required.

A bachelor"€™s degree and at least two years prior experience in clinical data management are required. Prior experience with web based EDC or CTMS considered very helpful. Masters in Public Health preferred.

Training and some supervision of junior data manager, as indicated.

Office work. May travel for meetings, site visits.

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