Data Management TA Lead, Early Development
Core
Lead data management strategy and a team of 6-8 Data Managers for early-phase clinical development programs, ensuring high-quality, analysis-ready data for decision-making under scientific uncertainty.
Role type
Senior Therapeutic Area Lead, Data Management
Builds
Data strategies, standards, and analysis-ready datasets for early clinical trials
Domain
Pharmaceutical R&D, Early Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
data strategy, CDISC standards, clinical data systems (EDC, eCOA, lab systems), team leadership, performance management, cross-study resource planning, regulatory requirements knowledge
Preferred skills
early development data strategies, biomarker data handling, adaptive trial designs, early-phase regulatory submissions, modular CRFs, decentralized data sources, automation, FAIR data, AI-assisted QC
Technologies
EDC, eCOA, lab systems
Responsibilities
Design and drive implementation of fit-for-purpose data practices for flexible study designs; anticipate and solve complex challenges involving non-standard data and external sources; lead alignment across biometrics contributors for consistency and efficiency; represent data management in internal forums for functional excellence; set quality expectations and mentor study-level data managers; manage team workload, capacity planning, and study allocation; foster collaboration across study teams and cross-functional partners
Seniority
Senior, hands-on IC with strategic leadership