Lead Clinical Data Manager
Core
Lead clinical data management for pre-market and post-market trials in diagnostics, biopharma, and translational research.
Role type
Lead Clinical Data Manager
Builds
Study databases and clinical study reports for diagnostic and biotechnology trials
Domain
Life sciences, diagnostics, biotechnology
Required skills
Clinical trial data management, CRF design, database and edit check development, query generation/processing, user acceptability testing, data reconciliation, database cleaning, clinical research project planning, trend analysis, FDA regulations knowledge, Microsoft Access, Microsoft Excel
Preferred skills
In-vitro diagnostics (IVD) clinical research, Pathology clinical research, Companion Diagnostics clinical research, Medical terminology, Human physiology, Laboratory testing
Responsibilities
Design CRFs and develop databases/edit checks; Plan and implement data management for clinical research projects; Collaborate with clinical leads and statistical teams on data acquisition; Identify trial issues, protocol deviations, and suggest solutions; Provide data management portions of clinical study reports.
Seniority
Senior, hands-on IC