Manager, Clinical Imaging OperationsSummaryAs a Clinical Imaging Operations Lead, you will have a leading role in the design and execution of key strategic and operational aspects of complex early and late phase clinical trials across multiple therapeutic areas, where imaging is a primary or key endpoint. You will collaborate with Clinical Imaging Science Leads and be fully integrated within clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with all study specific procedures. You should expect to work closely with our imaging vendor partners, the clinical operations function, the data management function, external clinical research organizations (CROs), and clinical sites to ensure the successful completion of startup activities, ongoing execution, and close-out of clinical studies.
Imaging Startup and Project Management Support: Collaborate with clinical study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials. Assist with vendor selection, request for proposals, and timeline management.
Study Documentation and Compliance: Author, review, and manage essential study documents such as Imaging Manuals, Independent Review Charters, Communication plans, data transmittal forms, Standard Operating Procedures, and Work Instructions. Ensure all documentation is audit-ready and filed appropriately in the Trial Master File (TMF).
Site Management and Training: Provide technical support and training to clinical site personnel, which may include conducting site initiation visits or Teleconferences. Review and approve training materials for imaging facilities and/or clinical site personnel.
Study maintenance: Track imaging progress during clinical studies and address imaging issues that may come up in close collaboration with clinical study teams, sites, and imaging CROs, including functional oversight through day to day monitoring of key performance indicators related to imaging timeliness, quality, etc., query resolution and troubleshooting
Process Improvement: Participate in process improvement initiatives and ensure strict compliance with all procedures and regulations.
This Role Requires:- BA/BS with 5+ years of clinical trial imaging experience
- Certification as a Registered Technologist (R.T.) with experience in modalities like CT, MRI, or Nuclear Medicine is highly preferred
- Experience in imaging CRO oversight and implementation of quality control procedures
- Well-developed knowledge of the use of clinical imaging across multiple indications alongside knowledge of imaging vendor operational process.
Salary Range (annually)$128,600.00 - $210,000.00
