Manager, Clinical Imaging Operations
About the Role
As a Clinical Imaging Operations Lead, you will play 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 will work closely with 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.
Responsibilities
- 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 in close collaboration with clinical study teams, sites, and imaging CROs. Provide functional oversight through day-to-day monitoring of key performance indicators related to imaging timeliness, quality, query resolution, and troubleshooting.
- Process Improvement: Participate in process improvement initiatives and ensure strict compliance with all procedures and regulations.
Requirements
- 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 processes.
Benefits
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:
- Annual bonuses or other incentive plans.
- Equity awards.
- Pension or retirement benefits, 401(k) company match.
- Health and wellness programs, fitness centers.
- Insurance benefits (e.g., medical, dental, vision, life, and disability).
- Paid time off and family support benefits.
For additional information about Regeneron benefits in the U.S., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.
Pay
Salary Range (annually): $128,600.00 - $210,000.00 (for jobs in Canada). The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Schedule
Many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.