Role Description and purpose:
A key member of the Blue Earth Diagnostics Research & Development (R&D) team, the Imaging Project Manager will support the development of new diagnostic radiopharmaceuticals. This includes supporting the setup, execution and close-out of clinical studies and managing relationships with external parties such as Imaging Core Labs (ICLs). The Imaging Project Manager will be a highly motivated individual, willing to take on a broad ranging role in a fast-paced environment as part of a global project team.
Main Responsibilities, Activities, Duties and Tasks
•Assist Clinical Operations in the setup, execution, and close-out of clinical studies, including the provision of technical expertise for the development of study documents (e.g. imaging component of the Clinical Protocol, Imaging Manual, Independent Review Charter etc.) whilst remaining compliant with ICH-GCP. Participate in site selection with respect to scanner qualification, acquisition protocols and training. Manage the transfer of images collected within a study and of contracted central blinded imaging reads. Support the analysis & interpretation of imaging data. Support the archiving of medical imaging data from clinical trials.
•Supporting the management and delivery of outsourced imaging and medical physics work including vendor selection
•Lead the imaging interface with the Clinical CRO, site monitors and study team.
•Support study team in resolving imaging issues and/or risks including analysing, developing, and implementing action plans to address issues with investigator sites, ICLs, and vendors.
•Collaborate, through close and frequent interactions, with other key functions including Medical, Clinical Operations, Biometrics, Regulatory Affairs and Quality Assurance.
•In collaboration with the study team, ensure regulatory inspection readiness.
•Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data within the diagnostic radiopharmaceutical arena.
•Support the scientific development of global Health Care Professional training materials, particularly acquisition and image interpretation training.
•Support the EU Medical team in preparations for product launch.
- Support the EU Medical team in organising medical education activities at
conferences and external meetings.
• Support the design and implementation of image management strategies of medical imaging data from clinical studies, in compliance with national and international guidelines and legal
requirements (e.g. GCP, GDPR, HIPAA).
• Contribute to the assessment of emerging technologies and their impact on clinical trials, and
the broader clinical practice
• As a representative of Blue Earth, responsible for clear and confident communication with
external parties and effective internal and external stakeholder management.
• Maintain oversight of relevant imaging and medical physics literature, evaluating the
significance of emerging data.
• Ensure the highest compliance with ‘good practice’ quality standards and regulations (GxP) and
that Blue Earth’s Standard Operating Procedures are followed.
Education
•Graduate degree or equivalent in radiography, physics, nuclear medicine technology or other related subject.
Professional Experience, Knowledge & Technical Skills
• Experience working in nuclear medicine, including PET/CT
• Hands on experience of PET/CT scanner qualification (phantom imaging and analysis) and image
QC.
• Ability to review technical documents, such as imaging component of the Clinical Protocol,
Imaging Manual, Independent Review Charter.
• Vendor management skills including vendor oversight.
• Ideally experience with PACS systems or undertaking image management on equipment within PACS networks
• Basic knowledge or awareness of relevant UK/EU clinical trials guidance and legislation (ICH,
GCP, GDPR)
• A high degree of initiative and the ability to work systematically and independently.
• A background in research and development, in a pharma or biotech company or Imaging Core
Lab/CRO, is preferred, ideally in diagnostic radiopharmaceutical development
• Experience in global clinical trials is preferred, ideally with experience from early to
late-stage drug development.
Soft Skills – Company Values & Behaviours
• Strong coaching, facilitation, and organizational skills; team player. Experience
and skills with cross-functional and highly matrixed organizations.
Excellent oral & written communication skills.
• Excellent interpersonal skills, including communication verbally and in writing. Ability to
influence and build relationships in a global organisation
• Excellent organisational skills, including multitasking, efficiency, punctuality, and project
management
