Associate Manager Digital Health Technologies

Overview

Implement digital health technologies (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.

What you'll do

• Manage project timelines, translation, specifications and UAT activities, either by direct execution or oversight.
• Ensure data collection complies with Regeneron SOPs and ICH/GCP.
• Review and approve project-related DHT study documentation throughout the project lifecycle.
• Apply patient technology expertise to day-to-day activities and escalations.
• Provide input into protocol development as it relates to digital tools and technologies.
• Collaborate with study team members on the medical monitoring plan.
• Facilitate and contribute to study-level lessons learned.
• Acquire COA licenses, purchase digital tools and technologies, and manage associated translations.
• Oversee vendor performance at the clinical trial level, performing root cause analysis and identifying corrective actions.
• Provide support for problem resolution 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, plan for risk management, plan communications, report performance and close out projects.
• 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 relevant documentation.
• Directly 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.
• Apply problem-solving strategies and maintain issue-tracking documentation to ensure timely resolution of escalations.

What you'll need

• 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 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 verbal, written and presentation communication skills.
• Proactive and self-disciplined; able to meet deadlines, manage time effectively and prioritize.

Details

• Remote, United States.
• May require up to 25% travel.
• Many roles are required to be performed on-site; confirm on-site expectations with the recruiter and hiring manager.
• Salary range (annually): $98,100.00 - $160,100.00.