The role of a clinical data manager is to track and commit to a database the data gathered from clinical trials of new drugs. They must ensure the completeness, accuracy and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies.
As such, clinical data managers are key members of the multidisciplinary teams (often comprising clinicians, statisticians, clinical research associates and quality managers) involved in the setting up, running and reporting of clinical trials. A company's clinical trials database is considered to be one of its most valuable assets.
A clinical data manager processes clinical trial data using a range of computer applications and database systems to support collection, cleaning and management of subject or patient data.
Typically this includes: contributing to the design of protocols, which define what and when data are to be collected, designing and approving forms on which data are collected, designing databases and ensuring they meet requirements for the entry and reporting of clinical data.
Training clinical research associates to help improve the quality of the data being collected, producing summaries and listings of safety and efficacy data, testing new processes and systems for the management of clinical trials.
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