Senior Manager, Clinical Data Analytics
Core
Design, validate, and maintain clinical safety dashboards and reports for internal stakeholders and safety governance bodies (e.g., DSMB, Safety Review Committee) within the Transcatheter Mitral and Tricuspid Therapies business unit.
Role type
Senior Manager, Clinical Data Analytics (Safety)
Builds
Clinical safety dashboards, reports, and data reconciliation pipelines
Domain
Medical device / Clinical safety / Pharmacovigilance
Deliverable
dashboards & analysis
Required skills
People management, clinical safety/pharmacovigilance knowledge, regulatory reporting (DSURs, IND safety reports), signal detection methodology, process improvement, Python (pandas, NumPy), dashboarding/BI tools (Tableau, Power BI, Spotfire), MedDRA/WHO-DD coding, ICH-GCP safety reporting, cloud data architecture concepts (AWS, data lakes), MS Office Suite
Preferred skills
Project management, leadership, problem-solving, analytical skills, forecasting, stakeholder communication, web app frameworks (Flask, Streamlit, Dash), data engineering partnership
Technologies
Python, pandas, NumPy, Flask, Streamlit, Dash, Tableau, Power BI, Spotfire, AWS, SharePoint
Responsibilities
Own end-to-end design, validation, and maintenance of clinical safety dashboards and reports; Lead safety data reconciliation across clinical, safety, and central lab/vendor sources; Ensure regulatory-compliant and timely expedited/periodic safety reporting; Manage a team responsible for safety data QC, dashboard build/maintenance, and ad hoc safety analytics requests; Partner with Biostatistics, Clinical Data Management, and Medical Safety on signal detection methodology and dashboard logic; Partner with cloud/data engineering teams to translate clinical/safety reporting needs into technical requirements; Develop a robust talent development plan; Develop and deliver comprehensive presentations and written communications on clinical operations and study developments; Identify issues, determine root cause, and lead implementation of corrective actions and process improvements.
Seniority
Senior Manager, hands-on leadership