Remote Clinical Scientist, Clinical Science Analytics and Insights

Summary

Join Precision for Medicine as an experienced Clinical Scientist to work remotely from Poland, Hungary, Serbia, Romania or Slovakia. The Scientist, Clinical Science Analytics and Insights 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.

Requirements

• Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or healthcare discipline with proficiency in medical terminology
• Other Required: At least two (2) years in clinical operations and/or, data management or related discipline in either the CRO or pharmaceutical industry and/or experience conducting oncology clinical research as a Study Coordinator, Research Nurse or related discipline, or equivalent, relevant experience and/or demonstrated competencies
• Experience as a Clinical Research Associate (CRA) or Study Coordinator/Research Nurse preferred
• Oncology therapeutic experience required with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.)
• Experience in the review of data from oncology clinical trials with working knowledge of oncology standards
• Experience in phase I, II and III oncological trials preferred
• Experience with electronic data capture systems (EDC) and data visualization tools preferred
• Computer proficiency
• Working knowledge of FDA & ICH/GCP regulations and guidelines

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
• Develops applicable study-specific monitoring/CRA and data review tools as applicable
• Participates as applicable in internal and external study-specific team meetings
• Serves as a resource to the project team for scientific questions regarding data capture
• May review dictionary coding
• Establishes CSAI-OS 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 to CSAI-OS is provided and managed including version control of CSAI-OS owned documents
• Performs other duties as assigned by management