Clinical Documentation Specialist-41814 - (Boston, MA)

The Clinical Document Specialist is responsible for the management of clinical study records (e.g., clinical Trial Master File) from set-up through to final archival, ensuring compliance with company SOP's and processes. With a focus on inspection readiness, monitors Trial Master File (TMF) compliance and supports preparation of documentation required for regulatory agency inspection and internal audits. Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the Clinical Document Management team, performs periodic quality assessments of clinical TMF documents where required. Contributes to assigned Clinical Document Management initiatives.