Patient Data Specialist

The Patient Data Specialist will perform early and continuing scientific review of clinical data in various formats by applying the protocol and/or other applicable references along with oncology standards for the indication being studied to support overall data quality and consistency (clinical sense of the data) allowing for insights to support a continuous risk management approach.

Essential functions of the job include but are not limited to:

1. 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)
2. Develops and maintains a good working relationship with internal and external project team members, serving as an ambassador to promote Precision’s high quality and ethical image in accordance with the company Core Values
3. Collaborates with and is supported by management as well as the Medical Monitors to support cross functional departmental communication as applicable on data capture / review trends (e.g., Medical Monitoring, Safety, Clinical Operations, Project Management, Data Management, SAS Programming, Biostatistics, Translational Science, other vendors, etc.) to meet project deliverables in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs
4. Provides input into project related documentation such as EDC specifications and related completion guidelines, Data Review Guidelines, etc. and requires patient review to be coordinated and tracked with other departments as applicable (data management, medical, safety etc.).
5. Supports the development and User Acceptance Testing (UAT) of data outputs with Programming (e.g., Smart Patient Profiles, metrics/trackers, listings)
6. Requires the use of various EDC systems and data visualization tools
7. Assists Management by serving as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
8. Provides routine status updates on findings and escalates issues as appropriate with project team and Management
9. 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
10. Conducts UAT of programming output and participates in EDC UAT supporting the functionality as applicable
11. Assists Management to provide review of the protocol from a scientific-operational perspective
12. May provide indication input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
13. Assists in the development and implementation of strategy for an integrated data cleaning process between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
14. 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 (e.g., adherence to applicable disease assessment criteria).
    Issues and resolves queries in various EDC systems
15. 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 (e.g., CRA and/or site re-training)
16. Provides study-specific training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
17. Develops applicable study-specific monitoring/CRA and data review tools as applicable
18. Participates as applicable in internal and external study-specific team meetings
19. Serves as a resource to the project team for scientific questions regarding data capture
20. May review dictionary coding
21. Establishes task tracking metrics to monitor trial and team progress towards project goals
22. Provides routine Project Management updates at macro and micro level
23. Ensures applicable eTMF documentation related is provided and managed including version control of owned documents
24. Performs other duties as assigned by management