Clinical Data Manager

- (3238099)

GENERAL SUMMARY/ OVERVIEW STATEMENT:

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 checks
• Running queries to verify data quality on regular basis
• 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
• Assisting in 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 contact point for site users.

QUALIFICATIONS:

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.

WORKING CONDITIONS:

The position will be primarily remote, with the expectation of 5-20% hybrid flex time in office as needed, some travel may be required.

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.

Primary Location MA-Boston-MGH 165 Cambridge

Work Locations MGH 165 Cambridge 165 Cambridge Street Boston 02114

Job Data/Analytics

Organization Massachusetts General Hospital(MGH)

Schedule Full-time

Standard Hours 40

Shift Day Job

Employee Status Regular

Recruiting Department MGH Neurology Research

Job Posting Mar 27, 2023