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 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 Operations representative on teleconferences with CROs and Imaging Core Labs \" Assess, analyze and proactively develop action plans when needed in support of study team objectives \" 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 \" Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus \" Experience in oversight and management of imaging CROs preferred \" Familiarity with oncology image-based tumor response criteria \" Ability to work semi-autonomously with strong organizational, prioritization and analytical skills \" Proficiency with MS office and ability to utilize Excel to produce and interpret meaningful metrics \" Detail oriented mindset with experience reviewing data for clinical trials Familiarity with some sort of Imaging (even if it is hands off) is required.
Qualifications \" Bachelor s degree required in associated scientific discipline \" 3+ years of pharmaceutical experience, with 3 years of experience with clinical trials with imaging aspects desired ONCOLOGY REQUIRED
MUST HAVES: - Clinical Trial Operational experience - Oncology Required - Familiar with data review of patient profiles Familiarity with some sort of Imaging (even if it is hands off) is required. Associated topics: aseptic, biomedical, immunology, medical, medicine, microbiology, patient, physiologist, trauma, vaccine