Associate Manager – Digital Health Technologies

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute the implementation of digital tools and technologies—including eCOA, eConsent, wearables, sensors, spirometry, and ECG—in clinical research studies from study design through to close-out.

• Oversee project timelines, translations, specifications, and UAT activities through direct execution or supervision.

• Ensure compliance of data collection with Regeneron SOPs and ICH/GCP standards.

• Review and authorize DHT study documentation throughout the lifespan of the project.

• Contribute insights into protocol development concerning digital tools and technologies.

• Work collaboratively with study team members on medical monitoring strategies.

• Facilitate and contribute to the discussion of study-level lessons learned.

• Obtain COA licenses, procure digital tools and technologies, and manage translations.

• Supervise vendor performance, conduct root cause analyses, and determine corrective actions.

• Aid in resolving issues between DHT vendors and the Regeneron study team.

• Create, implement, and manage change control processes for project plans.

• Coordinate the resolution and risk mitigation concerning technology system issues and vendor deliverables at the end of studies.

• Oversee project documentation, risk management, communications, performance reporting, and project close-out procedures.

• Track financial elements related to DHT for each study.

• Lead UAT strategy, planning, execution, issue management, and oversight.

• Review testing plans and draft UAT plans, scripts, and related documentation.

• Engage in sponsor-level testing activities when necessary.

• Communicate with both internal and external stakeholders, escalating risks as required.

• Participate in cross-functional and departmental enhancements to processes.

• Maintain issue-tracking documentation to monitor progress and guarantee timely resolution of escalations.

• May require travel up to 25% of the time.

⛳️ Requirements

• A Bachelor’s degree is required; equivalent experience may be considered in lieu of a degree.

• At least 6+ years of pertinent industry experience is necessary.

• Familiarity with digital tools and technologies, particularly eCOA systems development processes.

• Technical proficiency in trial management systems and Microsoft Project Server.

• Understanding of ICH/GCP and relevant regulatory guidelines/directives.

• Awareness of current industry trends.

• Proven interpersonal and leadership capabilities.

• Ability to comprehend strategic direction and guidance for respective clinical studies.

• Capacity to influence and negotiate effectively.

• Demonstrated experience in vendor management.

• Data-driven mindset for planning, executing, and resolving issues.

• Strong project management, cross-functional team leadership, and organizational skills.

• Ability to independently manage multiple tasks concurrently and meet deadlines in a complex environment involving internal teams and external vendors.

• Proficient verbal, written, and presentation communication skills.

• Proactive and self-motivated; capable of meeting deadlines, managing time effectively, and prioritizing tasks.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company matching.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process when required.