Senior Manager, Digital Health Technologies

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. Remote work is not available.

• Review and approve various project‑related digital tool and technology study documentation throughout the project lifecycle.
• Apply patient technology expertise to day‑to‑day activities when issues arise.
• Communicate with internal and external partners, raising risks.
• Provide 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 support license acquisitions and purchasing of digital tools and technologies.
• Lead vendor selection, collaborating with the study team.
• Oversee vendor performance at the clinical trial level, performing root cause analysis, identifying corrective actions, and acting as escalation point for issues.
• Develop and execute project plans, including change control. Coordinate resolution and risk mitigation for all supported technology system issues and end‑of‑study vendor deliverables.
• Provide support for problem resolution between vendors and the Re­genera­on study team.
• Monitor financial components related to digital tools and technologies for each study.
• Collaborate with study team members on the medical monitoring plan.
• Collaborate with data management on all digital tool data specifications, standards, and transfers.
• Provide training and mentor new staff.
• Apply problem‑solving strategies to issues, maintaining issue‑tracking documentation to monitor progress and ensure timely resolution of escalations.
• Develop strategy and processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment.
• Communicate clinical innovations in eSource modalities to stakeholders and the 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 processes.
• Facilitate and contribute to study‑level lessons learned.
• Recommend and participate in cross‑functional and departmental process improvement initiatives.
• Travel up to 25% of the time.

• Have a data‑driven approach to planning, executing, and problem solving.
• Can demonstrate effective project management skills, cross‑functional team leadership, and organizational skills.
• Bachelor’s degree and a minimum of 8+ years of relevant industry experience.
• Demonstrated knowledge of digital tools and technologies within the eCOA systems development process.
• 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.

Salary Range (annually)
$ - $

We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (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.

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.