Senior Manager Clinical Imaging Operations

Role Summary

As a Clinical Imaging Operations Lead, you will design and execute the strategic and operational aspects of complex early- and late-phase clinical trials across multiple therapeutic areas in which imaging is a primary endpoint. You will collaborate with Clinical Imaging Science Leads and be integrated within clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with study 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 startup, execution, and close-out of clinical studies.

Responsibilities

• 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. Develop in-depth knowledge aligned to the portfolio and build 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, requests for proposals, vendor 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 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.

Qualifications

• Preferred: A well-developed knowledge of clinical imaging across multiple indications alongside an in-depth knowledge of multiple imaging vendors.
• Preferred: Excellent communication and organizational skills alongside strong capabilities to provide succinct and impactful updates that demonstrate a developed understanding of the impact of imaging.
• Preferred: People management experience is highly preferred as the role will be expected to mentor other team members effectively and may have direct reports.
• Required: BA/BS with 8+ years of clinical trial imaging experience
• Preferred: Certification as a Registered Technologist (R.T.) with experience in modalities like CT, MRI, or Nuclear Medicine is highly preferred
• Required: At least 3 years of imaging operational clinical trial experience in a pharmaceutical (sponsor) setting

Education

• BA/BS degree