Senior Manager Clinical Imaging Operations

Regeneron Pharmaceuticals • Warren, MI

20d • Onsite

About The Position

As 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. A day in the life may look like: Portfolio Oversight: Responsible for the execution, functional reporting, and imaging operational oversight of specific portfolios/assets through direct study management or indirect guidance of other team members working on the portfolio. Expected to develop an in-depth knowledge aligned to the portfolio and close relationships with cross-functional colleagues in similar supporting roles. Imaging Startup and Project Management Support: Collaborate with clinical operations study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials. Assist with imaging vendor selection, request for proposals, management, and performance tracking. Study Documentation and Compliance: Author, review, and/or 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. Process & Technology Improvement: Participate in process and technology improvement initiatives and ensure strict compliance with all procedures and regulations. This may be the right role for you if you have: A well-developed knowledge of clinical imaging across multiple indications alongside an in-depth knowledge of multiple imaging vendors. Excellent communication and organizational skills alongside strong capabilities to provide succinct and impactful updates that demonstrate a developed understanding of the impact of imaging. People management experience is highly preferred as the role will be expected to mentor other team members effectively and may have direct reports.

Requirements

• BA/BS with 8+ 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
• At least 3 years of imaging operational clinical trial experience in a pharmaceutical (sponsor) setting

Nice To Haves

• A well-developed knowledge of clinical imaging across multiple indications alongside an in-depth knowledge of multiple imaging vendors.
• Excellent communication and organizational skills alongside strong capabilities to provide succinct and impactful updates that demonstrate a developed understanding of the impact of imaging.
• People management experience is highly preferred as the role will be expected to mentor other team members effectively and may have direct reports.

Responsibilities

• Responsible for the execution, functional reporting, and imaging operational oversight of specific portfolios/assets through direct study management or indirect guidance of other team members working on the portfolio.
• Collaborate with clinical operations study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials.
• Assist with imaging vendor selection, request for proposals, management, and performance tracking.
• Author, review, and/or 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, which may include conducting site initiation visits or Teleconferences.
• Review and approve training materials for imaging facilities and/or clinical site personnel.
• Participate in process and technology improvement initiatives and ensure strict compliance with all procedures and regulations.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level