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Associate Manager Digital Health Technologies

Role overview

Qualifications

  • Bachelor’s degree required
  • Minimum of 6+ years of relevant industry experience
  • Knowledge of digital tools and technologies, specifically eCOA systems development processes
  • Demonstrated interpersonal and leadership skills

Responsibilities

  • Implement digital tools and technologies in clinical research studies
  • Manage project timelines, specifications, and UAT activities
  • Acquire COA licenses and manage vendor performance
  • Communicate with stakeholders and participate in process improvements

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • English

Hard skills

Other skills

  • Social Skills
  • Negotiation
  • Problem Solving
  • Time Management
  • Organizational Skills

About the company

Regeneron logo

Regeneron

Biotechnology

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.

Company details

Company typeLarge
IndustryBiotechnology
Company size10001

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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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 


Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.


As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.


For jobs in Canada: this posting is for an existing position.


Salary Range (annually)

$98,100.00 - $160,100.00

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Marcus Rivera

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