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Clinical Imaging Specialist
Ref No.: 17-00274
Location: Woodcliff lake, New Jersey
Description of Duties:
• 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 Client 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

• Bachelor's degree required in associated scientific discipline, Imaging Technologist experience preferred; Master's degree strongly preferred
• 3+ years of pharmaceutical experience, with 3 years of experience with clinical trials with imaging aspects desired