Description

As a Clinical Imaging Operations Lead, you will have a leading role in the execution of key operational aspects of complex early and late phase clinical trials with special emphasis in oncology. Imaging includes all modalities, with a focus on CT, MRI, and PET. 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.

A day in the life may look like:

Leading the imaging operational component of assigned clinical trials.
Collaboration and oversight of the external imaging vendor at the study level to ensure successful delivery of study data and milestones.
Coordinate and contribute to cross functional review of imaging-related study documents such as Imaging Manuals, Independent Review Charters, Standard Operating Procedures, Work Instructions, etc. Ensuring study documentation is audit ready by ongoing filing in the Trail Master File (TMF).
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, management, and performance tracking. Collaborating with data management on BICR deliverable timelines, coordination of transfer specifications and review of imaging electronic case report forms.
Contribution to vendor scan reconciliation in coordination with data management.

This may be the right role for you if you have:

Knowledge of oncology clinical imaging alongside familiarity with imaging vendor processes.
Strong communication, organization, and writing skills alongside a willingness to learn and expand their expertise.
Tracking imaging progress during clinical studies and address imaging issues that may come up in close collaboration clinical study teams, sites, and imaging CROs, including functional oversight through day-to-day monitoring of key performance indicators related to imaging timeliness, quality, etc., query resolution and troubleshooting.

In Order to be considered qualified for this role you must have:

BA/BS degree and 3+ years of clinical trial experience. A focus on imaging is preferred.
Experience in implementation of standard response criteria in oncology (e.g. RECIST, Lugano, RANO, PCWG3, etc.).
Regulatory inspection experience is not required but would be preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$109,900.00 - $179,300.00

Associate Manager, Clinical Imaging Operations

Description

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