Clinical Data Manager (Boston, MA)

New England Research Institutes, Inc. (NERI) is a dynamic, independent company specializing in clinical trials management, public health research, survey research and media development. (NERI) offers clients exceptional capabilities as a first rate Contract Research Organization together with the deep knowledge and broad experience of one of the nation's premier public health research institutes.

We are currently looking for full-time and part-time Clinical Data Manager(s).

Develops/designs/codes case report forms (CRFs) and database; and designs/produces data reports in a timely manner. Generates/resolves queries; CRF and database validations; and logic checks. Contributes to site management activities; performs site training in electronic data capture; assures site compliance with protocol, ICH guidelines, and FDA regulations. Provides regular data reports using SAS programming at regular intervals. Ability to write reports, business correspondence, and documentation. Communicates concisely, both verbally and in writing, in multidisciplinary environment with sponsor, management, project team, statisticians, IS programming, clinical sites, and subcontractors (core lab, etc.).

Qualifications:
Proven skills in SAS, MS Query and Excel. Working knowledge of CDM in CRF design/development, query generation/resolution, validations and logic checks. Database design/testing. Working knowledge of electronic data systems (EDC) preferred. BS in biological/computer sciences or similar plus 3 years experience in clinical data management. Must possess understanding of ICH/GCP, SOPs, FDA regulations.

NERI is an Equal Opportunity/Affirmative Action Employer M/F/D/V.

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