Senior Lead Clinical Data Manager (H/F)
Core
Senior Lead Clinical Data Manager responsible for producing data management documents, overseeing EDC system design, and ensuring data integrity for clinical trials supporting drug development and regulatory submissions.
Role type
Senior Lead Clinical Data Manager
Builds
Clinical trial data management deliverables (DMPs, CRFs, validation specs) and EDC systems
Domain
Clinical Trials / Life Sciences
Required skills
Clinical Data Management, EDC systems, Data Validation, CDISC-SDTM, Data Reconciliation, Regulatory Compliance, Data Integrity, Project Coordination, Vendor Management, Quality Management
Preferred skills
SAS programming, eCRF design, Computer Science degree, English proficiency
Technologies
Medidata Rave, Ennov, Veeva Vault, Oracle Clinical, Oracle InForm, SAS, EDC, eTMF
Responsibilities
Develop data management plans and validation specifications, oversee EDC system design and development, coordinate vendor and project team interactions, review and approve EDC specifications and UATs, ensure database lock activities and data integrity, maintain eTMF, support regulatory compliance and quality goals.
Seniority
Senior, hands-on IC with leadership responsibilities