Key skills
Google Cloud PlatformGCPGoogle CloudProblem SolvingCollaboration
About this role
Role Overview
- responsible for reviewing and approving various project related digital tool and technology study documentation during the course of the project lifecycle
- applies patient technology expertise on day-to-day activities when issues are brought up
- communicates with internal and external partners and raises risks
- provides input into protocol development as it relates to digital tools and technologies
- support the integration of all supported digital tools and technologies into existing systems and workflows to minimize disruption and improve efficiency
- oversee or supports license acquisitions and purchasing of digital tools and technologies
- responsible for the selection of the digital tool and technology vendor selection, in collaboration with study team
- oversee vendor performance at the clinical trial level, performing root cause analysis and identifying corrective actions, and serving as point of escalation for issues
- project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables
- provides support for problem resolution between vendors and Regeneron study team
- monitor financial components related to digital tools and technologies for each study
- collaborate with study team members on medical monitoring plan
- collaborate with data management on all digital tool data specifications, standards, and transfers
- provides training and mentor new staff
- apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
- develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
- communicates clinical innovations in eSource modalities to stakeholders and broader organization
- develop trial strategy for implementation of innovative clinical trial technologies and radical innovations
- provide consultation on all digital tool modality benefits, risks, costs and process
- facilitates and contributes to study level lessons learned
- recommends and participates in cross-functional and departmental process improvement initiatives
- may require up to 25% travel
Requirements
- bachelor's degree
- minimum of 8+ years’ relevant industry experience
- knowledge of digital tools and technologies within the eCOA systems development processes
- technical proficiency in trial management systems and Microsoft Project Server
- knowledge of ICH/GCP and regulatory guidelines/directives
Tech Stack
- Google Cloud Platform
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)