Associate Director, Clinical Data Management
Core
Lead global clinical data management (CDM) activities for drug development programs, ensuring high-quality deliverables, regulatory compliance, and operational efficiency across Takeda and third-party vendors.
Role type
Senior IC clinical data management director with line management responsibilities
Builds
Production clinical trial data sets, regulatory submissions, and inspection-ready trial master files
Domain
Pharmaceutical clinical trials / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management expertise, line management, vendor/CRO oversight, project management, regulatory compliance (ICH-GCP, FDA), data quality assurance, budget management, process improvement
Preferred skills
Drug development process knowledge, therapeutic area experience, NDA/CTD experience, strategic supplier partnership management
Technologies
EDC, IRT, ePRO, eCOA, TMF, CRF, statistical analysis plans
Responsibilities
Direct line management and mentoring of CDM team members and functional service providers; oversee CDM activities for studies and programs conducted within Takeda or by strategic partners; ensure compliance with ICH-GCP and Takeda Scope of Work; manage external CDM budgets; oversee data collection tools, data cleaning, and database locks; ensure archival and inspection readiness of Trial Master File documents; lead continuous process improvement initiatives at the enterprise level.
Seniority
Senior, hands-on IC with management responsibilities
