Google Cloud PlatformAnalyticsGCPGoogle CloudLeadershipMentoringCommunicationPresentation Skills
About this role
Role Overview
Partner with cross-functional Study Teams (Medical, Biostatistics, Data Management) to develop and execute data review plans, ensuring accurate collection and reporting of protocol-defined endpoints.
Perform ongoing review and interpretation of clinical data (efficacy and safety) across listings and visual analytics, identifying trends and generating actionable insights.
Monitor and analyze safety events across studies and programs, supporting risk identification, escalation, and informed decision-making.
Communicate and present clinical findings, trends, and recommendations to Study Teams, Medical leadership , and clients; contribute to strategic discussions and study modifications.
Support development of key deliverables, including clinical study reports (CSRs), regulatory documents (e.g., INDs, NDAs/BLAs, IBs), and data summaries for SRCs, DSMBs, and internal review meetings.
Collaborate on CRF design, data quality processes, and EDC query management; identify protocol deviations and ensure data integrity in partnership with internal teams and vendors.
Contribute to study execution and continuous improvement efforts, including dashboard/UAT support, study documentation, scientific writing (e.g., narratives, abstracts), and mentoring of junior staff.