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Sobre este puesto de Associate Manager Digital Health Technologies en Regeneron

Regeneron · Remoto · Remote - United States

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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Sobre Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a

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