Manager Digital Health Technologies

Position Overview

The Digital Health Technologies (DHT) Manager is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team.

• Accountability for the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
• Apply to both internally sourced studies and studies outsourced to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight of eCOA will vary accordingly.
• Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training and education of stakeholders.
• May participate in process improvement initiatives in global development.
• Responsible and accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance.
• Review and approve project‑related eCOA study documentation throughout the project lifecycle.
• Apply eCOA systems expertise on day‑to‑day activities when issues are escalated.
• Communicate with internal and external stakeholders and elevate risks.
• Provide input into protocol development as it relates to clinical outcomes.

• Minimum 5 years of relevant experience within the eCOA field.
• Foundational knowledge of clinical studies.

We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Salary Range (annually) $ – $

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.

We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.