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 (Strategy & Operations)
Builds
Submission-quality clinical trial data for oncology programs using a technology-enabled, risk-based, and AI/ML-augmented operating model.
Domain
Life Sciences / Oncology / Clinical Data Management
Required skills
Strategic planning, global team leadership, oncology clinical trial management, CDM modernization, AI/ML strategy, regulatory compliance (GCP/ICH), vendor management, budget forecasting, inspection readiness, change management
Preferred skills
Advanced degree (MS/PhD/MBA), GxP-validated AI/ML deployment, novel oncology modalities (cell therapy, ADCs), CRO/FSP governance at scale
Technologies
EDC, eCOA/ePRO, imaging systems, central lab systems, biomarker data systems, generative AI, large language models, CDISC standards
Responsibilities
Define strategic vision and multi-year roadmap for oncology CDM; lead modernization of CDM into a technology-enabled, risk-based function; oversee governance of CDM deliverables across the study lifecycle; manage CRO, FSP, and technology vendor performance; lead a global team of CDM professionals; ensure compliance with GCP, ICH E6(R3), and data privacy regulations; represent the company in health authority inspections and audits.
Seniority
Senior Director, strategic leadership with hands-on oversight