Associate Manager, Clinical Imaging Operations

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Presencial; USD 110 000 - 179 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonuses

Equity awards

Pension plan

401(k) match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Resumo da oferta

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate Manager, Clinical Imaging Operations to lead imaging start-up activities and vendor oversight across early and late-phase trials in general medicine, including US, MRI, DXA, CT, and photography. You will ensure high-quality image acquisition, data integrity, and audit-ready TMF documentation.

You will collaborate with imaging science leads and cross-functional teams to manage vendor selection, timelines, and study materials, while

Qualificações

• Basic knowledge of clinical imaging and familiarity with imaging vendor processes.
• BA/BS degree and 3+ years of clinical trial experience are required.
• Imaging-focused experience is preferred.

Responsabilidades

• Collaborate with clinical study leads and cross-functional teams to manage imaging start-up activities, including vendor selection, RFPs, and timeline management.
• Oversee external imaging vendors at the study level to support data delivery and milestones.
• Author, review, and manage essential study documents such as Imaging Manuals, Independent Review Charters, Communication plans, data transmittal forms, SOPs, and Work Instructions.
• Ensure all documentation is audit-ready and filed in the Trial Master File (TMF).
• Provide training to clinical site personnel, including site initiation visits or teleconferences as needed.
• Review training materials for imaging facilities and clinical site personnel.
• Track imaging progress during studies and resolve issues with teams, sites, and imaging CROs.
• Monitor imaging performance indicators and assist with timely issue resolution.

Conhecimentos

Clinical imaging knowledge

Imaging vendor processes familiarity

Formação académica

BA/BS degree

Descrição da oferta de emprego

Build Our Future Together: 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.

When & Where:

This role can sit on-site in our Tarrytown, NY, Warren, NJ or Cambridge, MA office four days per week.

Discover Your Role:

• 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.

This Role Requires:

• Qualified candidates will possess a 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.
• Regulatory inspection experience is not required but would be preferred.

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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

For other locations, additional information will be provided during the recruitment process.

Salary Range (annually) $109,900.00 - $179,300.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

For jobs in Canada: this posting is for an existing position.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.