Clinical Review Specialist

The objective of a Clinical Review Specialist is to review patient data in accordance with Good Clinical Practice, Standard Operating Procedures/Working Practice Documents and Data Validation Manuals (DVMs).
Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.
Reviews patient data in accordance with the Clinical Listings Review Plan in the DVM.
Identifies data issues and works with PPD team and study sites to resolve.
Ensures data accuracy according to departmental operating procedures.
Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time.
Provides support, guidance and direction on clinical data review to the CDM project team.