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:

q Development/design of Electronic Case Report Forms (eCRFs)

q Testing and validating study specific Electronic Data Capture System (EDC)

q Developing programs to check the integrity of the data, including range, error, and logic checks

q Running queries to verify data quality on regular basis

q Preparing reports on the quantity of data and quality in the data management system

q Retrieving data and generating reports from the database as requested by senior staff

q Assisting in preparation of regulatory documents for submission to the Institutional Review Board (IRB)/FDA

q Attending/conducting meetings, teleconferences, and webinars relevant to current or upcoming trials

q Develop 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.

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.