Lead Clinical Data Manager
Core
Lead end-to-end clinical data management activities for assigned clinical trials and standards initiatives, ensuring high-quality data processes and tools in compliance with ICH-GCP and regulatory requirements.
Role type
Senior IC Lead Clinical Data Manager
Builds
High-quality clinical data management processes, tools (eCRFs, edit checks, Data Validation components), and data integrity for global clinical trials.
Domain
Life Sciences / Clinical Research / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Data Management, Clinical Development, Clinical Information Systems, Clinical Operations, Clinical Research, Data Validation, Standards Implementation (CDISC/SDTM), Project Management, Team Leadership, Process Improvement
Preferred skills
Database structures knowledge, Medical terminology, Cross-functional collaboration, Independent work under pressure, Microsoft Excel proficiency
Technologies
eCRF, Data Validation components, CDISC, SDTM, Microsoft Office
Responsibilities
Lead protocol-level start-up, in-life, and database lock activities; Design, create, validate, and maintain data management tool specifications; Review data integrity and manage query resolution; Coordinate database lock preparation; Support investigator meetings; Mentor junior staff; Participate in global standards forums (SRC, GDO TAST, SLIC); Identify and implement process improvements.
Seniority
Senior, hands-on IC with leadership responsibilities
