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Clinical Data Specialist Responsibilities and Duties

Develop ad hoc and standard reports for third parties on regulatory, research, quality improvement and administrative purposes.

Offer clinical initiatives such as National Quality Forum and Joint Commission on Accreditation of Healthcare Organizations Core Measures.

Manage, review and maintain Data Management Plans and other study related documentation.

Review accuracy of clinical data and remove data discrepancies thereof.

Ensure completeness and archive of necessary documentation.

Monitor vendors providing clinical trial data such as imaging.

Involve in clinical study teams and interface for Clinical Data Management associated issues and present them.

Offer status updates to clinical teams and interface between Biometrics CRO partner and Shire HGT clinical study team.

Offer clinical data management associated training to site personnel, clinical research analysts and investigators.

Develop, implement and evaluate clinical data management processes and standards.

Contribute to metric and performance measure tracking internally and externally.

Identify inclusion or exclusion criteria to read medical charts and enter new subject data.

Present confidential records and research materials to clinical study teams of other institutions.

Prepare statistical subject centered information reflecting in research study.

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