Precision Medicine Group is hiring a
Patient Data Specialist, Remote - Hungary

Summary

The job description is for a Patient Data Specialist role in precision medicine, focusing on reviewing subject data for clinical trials, collaborating with various departments, and using EDC systems. The position is remote and can be based in Hungary, Serbia, UK, Spain, Romania, Slovakia or Poland.

Responsibilities

• Serves on assigned project team(s) reviewing subject data for accuracy per protocol, associated references and oncology standards of care and principles to support overall data quality and consistency (clinical sense of the data)
• Develops and maintains a good working relationship with internal and external project team members
• Collaborates with and is supported by management as well as the Medical Monitors to support cross functional departmental communication
• Provides input into project related documentation such as EDC specifications and related completion guidelines, Data Review Guidelines, etc
• Supports the development and User Acceptance Testing (UAT) of data outputs with Programming
• Requires the use of various EDC systems and data visualization tools
• Assists Management by serving as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
• Provides routine status updates on findings and escalates issues as appropriate with project team and Management
• Assists with identification of quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project
• Conducts UAT of programming output and participates in EDC UAT supporting the functionality as applicable
• Assists Management to provide review of the protocol from a scientific-operational perspective
• May provide indication input into data capture and other clinical trial document development
• Assists in the development and implementation of strategy for an integrated data cleaning process between all applicable departments
• Reviews and analyses clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on project specific review guidelines with an emphasis on scientific and clinical sense
• Issues and resolves queries in various EDC systems
• Communicates effectively with the internal and external project team as applicable and management to relay data quality issues/findings and implements necessary actions in response to those issues
• Provides study-specific training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
• Develops applicable study-specific monitoring/CRA and data review tools as applicable
• Participates as applicable in internal and external study-specific team meetings and presents data issues and/or trends as applicable
• Serves as a resource to the project team for scientific questions regarding data capture
• May review dictionary coding
• Establishes task tracking metrics to monitor trial and team progress towards project goals
• Provides routine Project Management updates at macro and micro level
• Ensures applicable eTMF documentation related is provided and managed including version control of owned documents
• Performs other duties as assigned by management