pfm medical, inc. is hiring a
Patient Data Specialist in United States

Summary

The job is for a remote-based Scientist in Clinical Science Analytics and Insights at Precision for Medicine. The role involves reviewing clinical data, collaborating with internal and external teams, developing and maintaining relationships, and ensuring data quality and consistency. The required qualifications include a Bachelor's degree or equivalent experience, at least two years of experience in clinical operations or related fields, oncology therapeutic experience, and proficiency with electronic data capture systems.

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, serving as an ambassador to promote Precision’s high quality and ethical image in accordance with the company Core Values
• Collaborates with and is supported by CSAI-OS 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
• Provides input into project related documentation such as EDC specifications and related completion guidelines, CSAI-Data Review Guidelines, etc. and requires patient review to be coordinated and tracked with other departments as applicable (data management, medical, safety etc.)
• Supports the development and User Acceptance Testing (UAT) of data outputs with CSAI-OS Programming (e.g., Smart Patient Profiles, CSAI-OS metrics/trackers, CSAI-OS listings)
• Requires the use of various EDC systems and data visualization tools
• Assists CSAI-OS 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 CSAI-OS 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 CSAI-OS programming output and participates in EDC UAT supporting the CSAI-OS functionality as applicable
• Assists CSAI-OS 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 (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
• 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.)
• Reviews and analyses clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on CSAI-OS 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
• Communicates effectively with the internal and external project team as applicable and CSAI-OS management to relay data quality issues/findings and implements necessary actions in response to those issues (e.g., CRA and/or site re-training)
• Provides study-specific CSAI-OS training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
• Demonstrates, an understanding of the service culture
• Exhibits high self-motivation, and is able to work and plan independently as well as be highly effective in a remote team environment
• Ability to assimilate clinical and technical information quickly
• Demonstrates a high level of emotional intelligence
• Possesses practical knowledge of IT tools and systems including proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, EDCs, EMRs and data visualization tools