Senior Director, Clinical Data Management
Core
Define and execute global clinical data management strategy, build a high-performing team, and safeguard data integrity across all phases of clinical development for antibody-based medicines.
Role type
Senior Director, Clinical Data Management (Strategic & Hands-on Operational Leader)
Builds
Global clinical data management teams and data integrity for early and late-stage programs in women's health, oncology, and endocrinology.
Domain
Biotechnology / Clinical Development / Data Management
Required skills
Global clinical data management strategy, team building and scaling, end-to-end data management lifecycle, EDC and connected systems integration, CDISC standards (CDASH, SDTM, Define-XML), regulatory compliance (ICH-GCP, 21 CFR Part 11), vendor management, risk-based quality management (RBQM)
Preferred skills
Experience with registrational studies, advanced proficiency in metadata management and controlled terminologies (LOINC)
Technologies
EDC, IRT, eCOA, Imaging systems, CDISC platforms
Responsibilities
Build and scale a high-performing Clinical Data Management team; plan and manage full-lifecycle clinical data quality and integrity; drive strict compliance with global regulatory standards; cultivate cross-functional partnerships; lead selection and oversight of CROs and specialty vendors; manage vendor budgets; serve as primary escalation point for clinical data management issues.
Seniority
Senior Director, Strategic & Operational Leadership
