Associate Manager, Clinical Imaging Operations

Regeneron Pharmaceuticals•Warren, MI

3d•Hybrid

About The Position

As an Associate Manager, Clinical Imaging Operations, you will have a central role in the execution of key operational aspects of complex early and late phase clinical trials that will be focused on supporting our diverse general medicine portfolio. General medicine includes a wide variety of Imaging modalities such as US, MRI, DXA, CT and photography. 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.

Requirements

Basic knowledge of clinical imaging alongside familiarity with imaging vendor processes.
BA/BS degree and 3+ years of clinical trial experience.
A focus on imaging is preferred.
Preference for experience in implementation of complex site start-up logistics like site training and camera qualification.

Nice To Haves

Regulatory inspection experience is not required but would be preferred.

Responsibilities

Collaborate with clinical study leads and cross-functional teams to manage imaging start-up activities, including vendor selection, requests for proposals, and timeline management.
Oversee external imaging vendors at the study level to support successful delivery of study data and milestones.
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).
Provide technical support and training to clinical site personnel, including site initiation visits or teleconferences when needed.
Review and approve training materials for imaging facilities and clinical site personnel.
Track imaging progress during clinical studies and resolve issues in collaboration with clinical study teams, sites, and imaging CROs.
Provide day-to-day functional oversight by monitoring key imaging performance indicators, supporting query resolution, and troubleshooting timeliness and quality concerns.