Senior Manager, Clinical Imaging
DUTIES – RESPONSIBILITIES:
The Senior Manager, Clinical Imaging will contribute to the design, data collection, data review and management of medical imaging aspects of clinical studies, research collaborations and the development of digital products. He or she will be responsible for working with Imaging Core Labs, Clinical Research Organizations (CROs), External Investigators and Government Agencies to train, initiate, and manage timelines and deliverables.
The primary responsibilities for this position include:
• Assisting in the development and adherence to imaging trial documents (i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.).
• Providing subject matter expertise to internal and external stakeholders.
• Maintaining an archive of imaging related data.
• Overseeing management of imaging related aspects of clinical studies and ensuring CRO and clinical sites execute activities in accordance with the clinical protocol, study manuals and plans, contract/budgets and timelines.
• Preparing and participating in study start up, conduct and close-out activities, and collaborate with internal and external team and collaborators to ensure high-quality and timely deliverables.
• Communicating issue identification, resolution and project updates to management and stakeholders.
• Design, management and quality assurance in investigational studies conducted in collaboration with partners.
• Guidance and oversight in imaging data activities in relation to the development of automated tools for imaging diagnostics and imaging biomarkers.
• Supporting multi-disciplinary department and company initiatives.
Education: Masters’ degree with Life Science focus and Nuclear Medicine Technologist (NMTCB) certification or equivalent.
Experience: Candidates should have a minimum of 5 years of medical imaging experience in a clinical research environment and/or Imaging Core Laboratory (ICL).
• Specialty scientific expertise and applied experience in PET imaging is strongly preferred.
• Training in Good Clinical Practices (GCP), Quality Assurance/Compliance (QA/QC) in a clinical trial setting is required.
• Ability to clearly articulate and present the role and impact of molecular imaging on decision making within drug discovery and development.
• Self-motivation and exceptional verbal and written communication skills.
• Ability to multi-task and work effectively in a team or independently on assigned tasks.
• Adaptable in a fast-paced oncology company.
• Proficiency in business computer skills and MS Office Suite.