Clinical Imaging Specialist

Job Summary

• Contribute to, review and approve imaging core lab documents:

• Data Transfer Specifications

• Communication Plans

• Imaging Core Lab RFPs and proposals

• Imaging Core Lab forms and study-related documents

• Review and design tumor assessment Case Report Forms in eCRF

• Review data derived from imaging aspects of protocols, collaborating with Clinical Operations, Biostatistics and Data Management

• Review tumor assessment sections of Patient Profiles from site CRF data and provide feedback to Data Management for site queries

• Act as the Imaging representative on teleconferences with CROs and imaging core labs

• Assess, analyze and proactively develop corrective action plans when needed

• Manage ongoing tumor assessment scan reconciliation between eCRF and Imaging Core Lab to ensure that all scans are received in a timely manner

Description of Required Skill Set:

Scientific background with understanding of clinical development and drug development process together with a broad understanding and experience of clinical operations or data management with clinical trials using medical imaging.

Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus

Experience with managing the imaging aspects of clinical trials or studies and programs from protocol development to final analysis and submission.

Experience in oversight and management of imaging CROs, to ensure successful conduct of the imaging aspects of clinical trials ensuring data integrity and quality.

Familiarity with oncology image-based tumor response criteria (e.g. RECIST 1.1, mRECIST for HCC, irRECIST)

Ability to work semi-autonomously with strong organizational, prioritization and analytical skills