Associate Manager – Digital Health Technologies

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $98.1k - $160.1k / year

⏰ Full Time

🟡 Mid-level

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Implement digital tools and technologies—including eCOA, eConsent, wearables, sensors, spirometry, and ECG—in clinical research studies from study design through close-out • Manage project timelines, translation, specifications, and UAT activities through direct execution or oversight • Ensure data collection complies with Regeneron SOPs and ICH/GCP • Review and approve DHT study documentation throughout the project lifecycle • Provide input into protocol development related to digital tools and technologies • Collaborate with study team members on medical monitoring plans • Facilitate and contribute to study-level lessons learned • Acquire COA licenses, purchase digital tools and technologies, and manage translations • Oversee vendor performance, perform root cause analysis, and identify corrective actions • Support resolution of issues between DHT vendors and the Regeneron study team • 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, risk management, communications, performance reporting, and project close-out • Monitor financial components related to DHT for each study • Drive UAT strategy, planning, execution, issue management, and oversight • Review test plans and draft UAT plans, scripts, and related documentation • Participate in sponsor-level testing activities when applicable • Communicate with internal and external stakeholders and escalate risks as needed • Participate in cross-functional and departmental process improvements • Maintain issue-tracking documentation to monitor progress and ensure timely resolution of escalations • May require up to 25% travel

🎯 Requirements

• Bachelor’s degree required; equivalent experience in lieu of degree may be acceptable • Minimum of 6+ years of relevant industry experience • 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 • 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 • Data-driven approach to planning, executing, and problem-solving • Effective project management, 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 verbal, written, and presentation communication skills • Proactive and self-disciplined; able to meet deadlines, manage time effectively, and prioritize

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required