Director, eCOA Management
Core
Leading the operationalization of electronic Clinical Outcome Assessment (eCOA) technology, processes, and vendor partnerships to support BMS clinical trials and the R&D pipeline.
Role type
Director, eCOA Management
Builds
eCOA instruments, devices, and data acquisition systems for studies across therapeutic areas, including complex Neuroscience rater studies.
Domain
Biopharmaceuticals / Clinical Trials / Digital Health
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
End-to-end eCOA operationalization, vendor management, GCP/ICH guidelines, SDLC and system validation, strategic project execution, cross-functional stakeholder influence, global team leadership, data quality assurance, regulatory compliance, complex Neuroscience study expertise.
Preferred skills
Advanced degree (Master's or PhD), experience with localization/translations, experience with blinded data analytics.
Technologies
eCOA platforms, SDLC tools, data analytics systems
Responsibilities
Provide comprehensive leadership of the eCOA Management function ensuring technology and processes are optimized; Ensure quality development and timely delivery of eCOA instruments and devices; Ensure data acquired through eCOA meets quality standards and is reliable for analysis; Define key quality and performance metrics and review results to identify improvements; Lead initiatives to establish industry-leading eCOA capabilities; Manage the eCOA book of work and forecast resource needs; Lead a global team of eCOA Management professionals; Collaborate with eCOA vendors to ensure quality and timely delivery; Represent the function for Health Authority inspections and internal audits.
Seniority
Director, strategic leadership & global team management
