Senior Manager, Clinical Outcomes Assessment
Company: Regeneron Pharmaceuticals, Inc.
Location: Warren
Posted on: February 12, 2026
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Job Description:
As a Senior Manager, Digital Health Technologies (DHT) you will
be accountable for implementation of digital tools and technologies
(e.g. electronic COA (eCOA), eConsent, wearables, sensors,
spirometry, ECG) in individual clinical research studies from study
design to close out. We support digital tool and technology project
timelines, translation, specifications, implementing UAT, and
ensuring collection of such data in accordance with our SOPs and
ICH/GCP. This role applies to internally sourced studies and
studies outsourced to Clinical Research Organizations (CROs). This
position is on-site either in Sleepy Hollow, NY or Warren, NJ
locations. If eligible, we can offer relocation assistance. We
cannot offer a remote work option. A typical day may include the
following: Responsible for reviewing and approving various project
related digital tool and technology study documentation during the
course of the project lifecycle. Applies patient technology
expertise on day-to-day activities when issues are brought up.
Communicates with internal and external partners and raises risks.
Provides input into protocol development as it relates to digital
tools and technologies. Support the integration of all supported
digital tools and technologies into existing systems and workflows
to minimize disruption and improve efficiency. Oversee or supports
license acquisitions and purchasing of digital tools and
technologies. Responsible for the selection of the digital tool and
technology vendor selection, in collaboration with study team.
Oversee vendor performance at the clinical trial level, performing
root cause analysis and identifying corrective actions, and serving
as point of escalation for issues. Project plan development,
execution, and change control. Coordinates resolution & risk
mitigation of all supported technology systems related issues and
end of study vendor deliverables Provides support for problem
resolution between vendors and Regeneron study team. Monitor
financial components related to digital tools and technologies for
each study. Collaborate with study team members on medical
monitoring plan. Collaborate with data management on all digital
tool data specifications, standards, and transfers. Provides
training and mentor new staff. Apply problem solving strategies to
issues and maintain issue tracking documentation to monitor
progress and ensure timely resolution to escalations. Develop
strategy & processes for expansion of eSource modalities to enable
data availability in a virtual clinical trial environment.
Communicates clinical innovations in eSource modalities to
stakeholders and broader organization. Develop trial strategy for
implementation of innovative clinical trial technologies and
radical innovations. Provide consultation on all digital tool
modality benefits, risks, costs and process. Facilitates and
contributes to study level lessons learned. Recommends and
participates in cross-functional and departmental process
improvement initiatives. May require up to 25% travel. This may be
for you if you: Want to have an impact on patient lives. Have a
data driven approach to planning, executing, and problem solving
Can demonstrate effective project management skills,
cross-functional team leadership and organizational skills. To be
considered you are to have a bachelors degree and minimum of 8
years relevant industry experience. Demonstrate knowledge of
digital tools and technologies within the eCOA systems development
processes. Ability to understand and implement our strategic
direction and guidance for respective clinical studies. Technical
proficiency in trial management systems and Microsoft Project
Server. Knowledge of ICH/GCP and regulatory guidelines/directives
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 Regenerons roles are required to be performed
on-site. Please speak with your recruiter and hiring manager for
more information about Regenerons 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) $134,400.00
- $219,200.00
Keywords: Regeneron Pharmaceuticals, Inc., New Haven , Senior Manager, Clinical Outcomes Assessment, Science, Research & Development , Warren, Connecticut