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. We cannot offer a remote work option.

• 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.

• 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 bachelor’s 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…