Director, Clinical Data Management
Core
Oversees and manages all aspects of data management operations, including staffing, project resource planning, and quality execution for clinical trials.
Role type
Director, Clinical Data Management (Management)
Builds
Clinical data management operations and strategies for ophthalmic drug and device development
Domain
Clinical Research / Ophthalmology / Data Management
Required skills
Clinical data management leadership, Project management, Budgeting and forecasting, ICH GCP knowledge, Title 21 CFR Part 11 compliance, CDISC CDASH/SDTM, Cross-functional collaboration, SOP development, Performance metrics analysis, Team training and development
Preferred skills
Advanced degree, Ophthalmology experience, Medical coding, EDC systems (Oracle Clinical, iMedNet), Clinical programming
Technologies
Oracle Clinical Life Sciences Suite, iMedNet, CDISC CDASH, SDTM
Responsibilities
Oversee day-to-day data management operations, Provide leadership to allocated team, Serve as CDM subject matter expert, Support business development, Manage department and clinical study budgets, Liaise with internal and external teams, Review/write/update standard operating procedures, Strive to continuously improve data management operations, Manage resourcing and workload of CDM team, Develop and conduct in-house training and development, Adhere to quality management system and regulatory requirements
Seniority
Director, Strategic Leadership & Operations