The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH) is one of the preeminent global centers running and coordinating multi-center clinical research trials in Neurology, focused on developing cures and improving treatment of Amyotrophic lateral sclerosis (ALS), Parkinson's Disease, Huntington's Disease, Multiple Sclerosis and other neurological diseases. To capture and manage information from clinical trials, NCRI utilizes an Electronic Data Capture, Data Management and Clinical Trials Management system (the "System"). Working independently under minimal supervision of the Director of Systems, NCRI, the Analyst will: Acquire detailed knowledge of the System so as to serve as an in-house expert and to triage issues and enhancement requests from the professional and support staff Provide second tier support in using the System to the end user Develop specification requirements for new System modules and/or functionalities Support internal or sponsor-initiated audits Create training programs for the various modules of the System Install, support, troubleshoot and maintain the System The NCRI is looking for a motivated team player with the ability to provide a high level of services while working on multiple projects simultaneously. Excellent project management and communication skills, as well as being able to work independently, take initiative and prioritize tasks is required.
PRINCIPAL DUTIES AND RESPONSIBILITIES: General Duties: Report and track System enhancement requests and issues into a database Release new versions of the system for testing, training and deployment Be responsible for the System releases, installations and upgrades Develop end user training programs for the System Support internal or sponsor-initiated audits Serve as a liaison between software development team and end users Update electronic Case Report Forms (eCRFs) using PharmaARCHITECT™ development system Create test scenarios and scripts Execute test scripts in an integrated environment while incorporating quality management concepts Coordinate testing and validation procedures Develop user and functional specifications requirements for the System and specific clinical trials Participate in system support and track user-reported issues Accepts responsibilities for special projects as requested
Bachelor's degree is required; a concentration in Computer Science, Information Technology, Biology or related field is a plus. Minimum of three to five years of relevant experience is required. Experience with computer systems or customer support is required. Familiarity with clinical trials or clinical trial systems is required. Working knowledge of database programming is required. Knowledge of SAS® is highly desirable. Understanding of clinical trial design, data management, and compliance with federal regulations (including but not limited to GXP and CFR 21 Part 11) is highly desirable Experience with business analyses and user training is preferred. Social media and web design skills are also a plus
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Fluency with computers and working knowledge of database design and programming is a must. Excellent organizational and time management skills Outstanding attention to detail Able to handle multiple projects simultaneously Able to meticulously produce and maintain large volumes of documentation Problem solving skills are a must with an understanding of analytical and quantitative methods Excellent verbal and written communication skills with the ability to create and deliver presentations is required Working knowledge of SQL, SAS®, R or Python is desirable Data analysis experience is also a plus
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