Manager Digital Health Technologies

Regeneron Pharmaceuticals; Montgomery (AL); On-site; USD 108,200 - 176,600; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Job summary

Regeneron Pharmaceuticals is seeking a Digital Health Technologies (DHT) Manager to own eCOA from study design through closeout in collaboration with the study team.

You will ensure project timelines, SOP/ICH-GCP alignment, and quality across internal and CRO studies, while leading vendor performance and training stakeholders. The role emphasizes process improvement and compliant eCOA delivery across trials.

Qualifications

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

Responsibilities

• Ensure eCOA project timelines, SOP/ICH-GCP alignment and UAT execution.
• Lead eCOA activities in internal studies and CROs with appropriate oversight.
• Create and enforce eCOA system standards and manage vendors.
• Support training and education of stakeholders on eCOA processes.
• Participate in global development process improvement initiatives.
• Deliver successful and compliant eCOA across one or more trials; review study documentation.
• Escalate risks and communicate with internal and external stakeholders.

Skills

eCOA experience

Clinical study knowledge

Job description

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.

Typical Day

• 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.

Qualifications

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

Benefits

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.

Compensation

Salary Range (annually) $108,200.00 – $176,600.00

Equal Employment Opportunity

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.