Associate Manager, Clinical Imaging Operations

Clinical Imaging Operations Lead

As a Clinical Imaging Operations Lead, you will have a leading role in the execution of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modalities, with a focus on CT, MRI, and PET. 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 imaging 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.

A day in the life may look like:

• Leading the imaging operational component of assigned clinical trials.
• Collaboration and oversight of the external imaging vendor at the study level to ensure successful delivery of study data and milestones.
• Coordinate and contribute to cross functional review of imaging-related study documents such as Imaging Manuals, Independent Review Charters, Standard Operating Procedures, Work Instructions, etc. Ensuring study documentation is audit ready by ongoing filing in the Trail Master File (TMF).
• 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, management, and performance tracking. Collaborating with data management on BICR deliverable timelines, coordination of transfer specifications and review of imaging electronic case report forms.
• Contribution to vendor scan reconciliation in coordination with data management.

This may be the right role for you if you have:

• Knowledge of oncology clinical imaging alongside familiarity with imaging vendor processes.
• Strong communication, organization, and writing skills alongside a willingness to learn and expand their expertise.
• Tracking imaging progress during clinical studies and address imaging issues that may come up in close collaboration 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.

In order to be considered qualified for this role you must have:

• BA/BS degree and 3+ years of clinical trial experience. A focus on imaging is preferred.
• Experience in implementation of standard response criteria in oncology (e.g. RECIST, Lugano, RANO, PCWG3, etc.).
• Regulatory inspection experience is not required but would be preferred.