Clinical Data Associate - Cambridge, MA

The Clinical Data Associate Principal position requires a highly skilled individual, who seeks a technical rather than a managerial career path.

Will often be responsible and play a key role in the development, implementation and maintenance of web-based data collection and reporting tools for observational rare disease registries in support of scientific, clinical, regulatory and commercial goals.

Job Responsibilities:

Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management.
Work with the Global Medical Director and project team in designing and developing Case Report Forms (CRFs).
Create the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
Good working knowledge of CDISC-SDTM, ODM, CDASH guidelines.Develop and maintains X-Registry eCRF library and validation checks.
Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing. Lead and assign user accepting testing to data management peers and oversee the completion of the... View Full Description

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