Associate Manager Digital Health Technologies

Regeneron Pharmaceuticals, Inc.

United States

On-site

USD 100,000 - 140,000

Full time

2 days ago
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Job summary

Regeneron Pharmaceuticals, Inc. seeks an experienced Digital Health Technology Associate Manager to implement digital tools (eCOA, eConsent, wearables) across clinical studies, from design to close-out.

You will oversee timelines, translations, specifications, and UAT activities in collaboration with study teams, ensuring ICH/GCP compliance. The role combines vendor management, project leadership, and cross-functional coordination, with frequent interaction with sponsors and study stakeholders.

Qualifications

  • Bachelor's degree required; 6+ years of relevant industry experience.

Responsibilities

  • Implement digital tools (eCOA, eConsent, wearables) in clinical studies.
  • Manage project timelines, translations, specifications, and UAT.
  • Oversee vendor performance and sponsor-level testing activities.
  • Coordinate risk management, communications, and documentation across studies.

Skills

Project management
Vendor management
UAT leadership
Stakeholder communication
Cross-functional collaboration

Education

Bachelor's degree

Tools

Microsoft Project Server
COA tools

Job description

Build our future together:

The Digital Health Technology Associate Manager (DHT AM) is responsible for implementing digital tools and technologies - electronic COA (eCOA), eConsent, wearables, sensors, spirometry, ECG, and similar - in individual clinical research studies, from study design through close-out, in collaboration with the study team. A typical day includes managing project timelines, translation, specifications, and UAT activities (either direct execution or oversight), ensuring data collection complies with Regeneron SOPs and ICH/GCP. This role applies to both internally sourced studies and studies outsourced to CROs, and includes responsibility for managing vendor activities and training/educating stakeholders.

Discover your role:
Study Delivery & Compliance
  • Responsible for the successful implementation of digital tools and technologies for one or more clinical research trials with quality and compliance
  • Responsible for reviewing and approving project-related DHT study documentation throughout the project lifecycle
  • Applies patient technology expertise to day-to-day activities and escalations
  • Provides input into protocol development as it relates to digital tools and technologies
  • Collaborates with study team members on the medical monitoring plan
  • Facilitates and contributes to study-level lessons learned
Vendor & Licensing Management
  • Acquires COA licenses, purchases digital tools and technologies, and manages associated translations
  • Oversees vendor performance at the clinical trial level, performing root cause analysis and identifying corrective actions
  • Provides support for problem resolution between DHT vendors and the Regeneron study team
  • Demonstrates vendor management experience across study-level engagements
Project Management
  • Uses interpersonal, negotiating, and project management skills to: Develop, execute, and manage change control for project plans
  • Coordinate resolution and risk mitigation for technology system issues and end-of-study vendor deliverables
  • Manage project documentation
  • Plan for risk management
  • Plan communications, distribute information, report performance, and close out projects
  • Monitors financial components related to DHT for each study
UAT Leadership
  • Drives UAT strategy, planning, execution, issue management, and oversight
  • Reviews test plans and drafts UAT plans, scripts, and relevant documentation
  • Directly participates in sponsor-level testing activities when applicable
Stakeholder Communication & Process Improvement
  • Communicates with internal and external stakeholders and escalates risks as needed
  • Participates in cross-functional and departmental process improvements
  • Applies problem-solving strategies and maintains issue-tracking documentation to monitor progress and ensure timely resolution of escalations
Travel
  • May require up to 25% travel
This role requires:
Knowledge & Technical Skills
  • Knowledge of digital tools and technologies, specifically eCOA systems development processes
  • Technical knowledge of trial management systems and Microsoft Project Server
  • Knowledge of ICH/GCP and relevant regulatory guidelines/directives
  • Awareness of relevant industry trends
Leadership & Interpersonal Skills
  • Demonstrated interpersonal and leadership skills
  • Ability to understand strategic direction and guidance for respective clinical studies
  • Ability to influence and negotiate
  • Demonstrated vendor management experience
Operational & Analytical Skills
  • Data-driven approach to planning, executing, and problem-solving
  • Effective project management skills, cross-functional team leadership, and organizational skills
  • Ability to independently manage multiple tasks simultaneously and meet deadlines in a complex environment spanning internal teams and external vendors
  • Effective communication skills - verbal, written, and presentation
Work Style

Proactive and self-disciplined; able to meet deadlines, manage time effectively, and prioritize.

Minimum Qualifications

Education: Bachelor's degree required (equivalent experience in lieu of degree may be acceptable, though number of years was not specified in the source document)

Experience: Minimum of 6+ years of relevant industry experience

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with

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