Sr.Director, Clinical Data Management, Oncology
Core
Senior leadership role providing strategic and operational leadership of the Clinical Data Management (CDM) function for the oncology portfolio, ensuring complete, high-quality, and reliable clinical trial data for regulatory approval and market acceptance.
Role type
Senior Director, Clinical Data Management (Oncology)
Builds
Submission-quality clinical trial data for oncology programs
Domain
Biopharmaceuticals / Oncology / Clinical Data Management
Deliverable
production ML models
Required skills
Strategic planning, global team leadership, risk-based data management, AI/ML strategy, regulatory compliance (GCP, ICH E6), vendor management, budget forecasting
Preferred skills
Advanced degree (MS, PharmD, PhD, MBA), professional certification (CCDM, PMP), data science/AI training
Technologies
EDC, eCOA/ePRO, imaging systems, central lab systems, biomarker data systems, generative AI, large language models
Responsibilities
Define strategic vision and multi-year roadmap for the oncology CDM organization; Lead modernization of CDM into a technology-enabled, risk-based function using automation and AI; Ensure oversight and governance of CDM deliverables across the study lifecycle; Manage CRO, FSP, and technology vendor performance; Lead a global team of CDM professionals and drive culture of accountability.
Seniority
Senior Director, strategic leadership with hands-on oversight