Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Core team member with expert level knowledge, responsible for performing quality and timely review consistent with requirements defined by procedural and project specific Data Validation Manuals (DVM).

Essential Functions:

• Applies relevant components of the project protocols and the Data Validation Manuals (DVMs) to daily tasks.
• Reviews patient data and generates and manages manual queries in accordance with the Manual Data Review Plan (MDRP) in the DVM and Client expectations.
• Identifies data issues and works with the PPD team to resolve, using creative thinking while maximizing efficiency to ensure data accuracy and quality expectations within budget and timelines.
• Provides support, guidance and direction on clinical data review to the Clinical Data Management (CDM) project team related to listing review, applicable sections of the DVM, study metrics, utilization, and resourcing.
• Performs assigned activities that contribute to the finalization of project-specific DVM and MDRP, Case Report Form (CRF) Completion Guidelines, listing specifications, database specifications, and edit check specifications,
• Liaises effectively with colleagues in other functional groups, and provides support to the clinical data team leads by attending project and client team meetings when required.
• Provides mentoring to serve as role model, subject matter expert, and resource to the clinical listing review team. May develop and deliver training for the clinical review team
• Collaborates with functional teams and partners to ensure seamless functionality across multiple studies, while managing the individual studies from a metrics perspective and supporting their study leads.
• Assists with forecasting and adjustment of resource allocation
• Performs assigned clinical review and data management activities independently and efficiently, with attention to quality.