Central Radiologist – Clinical Trials

The Central Radiologist is responsible for the independent, standardized, and high-quality interpretation of medical imaging acquired as part of clinical trials, including MRI, CT, and PET scans. The role supports the assessment of disease status, treatment response, and disease progression in accordance with study protocols, imaging charters, and applicable response assessment criteria, including RANO, RANO 2.0, RANO-BM, RECIST 1.1, modified RECIST, and other study-specific criteria as applicable.

The Central Radiologist works collaboratively with clinical operations, medical monitors, imaging specialists, and other study stakeholders to ensure consistent, accurate, and reproducible imaging assessments throughout the clinical trial lifecycle. The role contributes to data quality, patient safety, and the integrity of clinical trial endpoints through timely image interpretation, standardized reporting, and compliance with applicable regulatory requirements, Good Clinical Practice (GCP), and study-specific procedures.

Key Responsibilities

Central Imaging Review and Interpretation

• Perform independent central review and interpretation of MRI, CT, and PET scans collected during clinical trials, in accordance with study protocols, imaging charters, and predefined assessment guidelines.
• Evaluate baseline and follow-up imaging to assess disease burden, treatment response, disease progression, and other relevant imaging endpoints.
• Review imaging across multiple time points to support longitudinal assessment of disease status and treatment outcomes.
• Assess image quality, completeness, and suitability for evaluation, identifying technical limitations, missing sequences, or other issues that may affect interpretation.
• Document imaging findings, measurements, and response assessments accurately and consistently using study-specific reporting tools and systems.

Application of Response Assessment Criteria

• Apply relevant standardized response assessment criteria, including RANO, RANO 2.0, RANO-BM, RECIST 1.1, modified RECIST, and other protocol-defined criteria, as appropriate to the disease indication and study design.
• Maintain and ensure the accuracy, completeness, and timely updating of the online imaging and tumor response repository, including radiology assessments, lesion measurements, response classifications, and supporting documentation. Ensure imaging review data are appropriately recorded, organized, and traceable in accordance with study protocols, imaging charters, and applicable procedures, and promptly address discrepancies or missing information to support data integrity and inspection readiness.
• Assess response categories, including complete response, partial response, stable disease, and progressive disease, where applicable.
• Evaluate disease progression and treatment response using relevant clinical and imaging criteria, including the assessment of target and non-target lesions and the identification of new lesions, as applicable.
• Apply neuro-oncology-specific assessment criteria, including evaluation of enhancing and non-enhancing disease, where required by the study protocol and applicable RANO criteria.
• Support assessment of equivocal or complex imaging findings through appropriate documentation and escalation in accordance with study procedures.

Clinical Trial Protocol and Imaging Charter Compliance

• Interpret imaging in accordance with the study protocol, imaging charter, central review guidelines, and predefined endpoint assessment requirements.
• Ensure imaging assessments are performed consistently across subjects, visits, and study sites.
• Adhere to study-specific requirements for image review, lesion selection, measurement methodology, response confirmation, and progression assessment.
• Maintain appropriate documentation of imaging findings, rationale for assessments, and deviations from predefined review procedures.
• Participate in protocol, imaging charter, and study-specific training as required.

Image Quality and Data Integrity

• Identify and document image quality concerns, protocol deviations, missing imaging sequences, and discrepancies that may affect the reliability of study assessments.
• Collaborate with imaging operations teams and clinical trial sites to resolve imaging-related queries and obtain clarifications or repeat imaging when appropriate and permitted by the protocol.
• Ensure accurate recording of measurements, response assessments, and other imaging data in the designated clinical trial systems.
• Support quality control activities, including review of discrepant assessments, assessment consistency, and documentation completeness.
• Contribute to maintaining traceable, reliable, and audit-ready imaging review records.

Collaboration and Clinical Trial Support

• Collaborate with other central radiologists, independent reviewers, adjudicators, medical monitors, and cross-functional study teams to support consistent imaging assessments.
• Participate in consensus review, adjudication, or discrepancy resolution processes when required by the study design.
• Provide medical and imaging-related input during study start-up, protocol review, imaging charter development, and discussions of imaging endpoints.
• Support the development and review of imaging guidance, training materials, and assessment instructions for internal teams and participating clinical trial sites, as appropriate.
• Communicate imaging-related concerns and assessment limitations to the appropriate study stakeholders in accordance with established procedures.

Quality, Compliance, and Continuous Improvement

• Maintain compliance with applicable professional standards, regulatory requirements, GCP principles, study protocols, and organizational SOPs.
• Participate in reader training, calibration exercises, qualification assessments, and ongoing performance monitoring as required.
• Support audits, inspections, and quality reviews related to central imaging activities.
• Maintain appropriate professional credentials, continuing education, and disease-specific imaging expertise.
• Contribute to the continuous improvement of central imaging review processes, reporting standards, and assessment consistency.

Education

• Medical degree (MD or equivalent) with specialist training and board certification or equivalent recognized specialist qualification in Radiology.
• Valid medical registration and appropriate professional credentials for the intended scope of practice and jurisdiction.
• Fellowship training or demonstrated expertise in oncologic imaging, neuro-radiology, or a relevant subspecialty preferred, depending on study indications.

Experience

• Demonstrated experience interpreting MRI, CT, and PET imaging, with expertise appropriate to the clinical trial indications supported.
• Experience with oncology imaging and standardized tumor response assessment criteria, including RECIST 1.1 and, where relevant, RANO, RANO 2.0, and modified RECIST.
• Experience evaluating serial imaging studies and performing reproducible lesion measurements and longitudinal response assessments.
• Familiarity with clinical trial imaging workflows, imaging charters, central review processes, and study-specific assessment requirements.
• Experience with blinded independent central review (BICR), consensus review, or adjudication processes preferred.