Associate Manager Digital Health Technologies

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

• 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

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