What does a Clinical Data Manager do?
SummaryA clinical data manager ensures that statistical information and results from clinical trials are recorded accurately.
- Author Name: Editor
A clinical data manager ensures that statistical information and results from clinical trials are recorded accurately. A professional is usually involved in every aspect of a trial, from selecting qualified participants to publishing final scientific papers. Clinical data managers record information about the effects of medication on patients, daily experimental data, and ongoing issues with a study. Most clinical data manager jobs are found in government organizations, pharmaceutical companies, and biotechnology firms. Clinical data managers develop and execute data testing and analysis plans, ensuring robust data quality and identifying ways to improve processes.
- Maintaining the accuracy, integrity and security of complex, large computerised records system
- Applying knowledge of regulations, policies, protocols and/or procedures to control and maintain accurate records
- Dealing with a large volume of information which may require the need to be screened, grouped, summarized, transcribed, coded etc
- Assisting in standardizing data management procedures
- Solving operational/data problems in consultation with other employees and/or supervisors
- Maintaining confidentiality of data as required
- Preparing a variety of standard statistical reports
- General clerical/secretarial duties include data entry, collating library searches, and other related tasks
For candidates seeking positions in clinical data management, qualifications should generally include a BSc within a scientific or related field, as well as relevant experience in clinical research. A background in computer sciences can also be beneficial.
Knowledge of various of software packages is also crucial for securing a position in clinical data management. Candidates should be familiar with Oracle Clinical, Medidata Rave, Phase Forward, Clintrial, SQL and PL / SQL and they should have a basic understanding of SAS programming.
Experience in the development of clinical trial databases in both paper and electronic data capture (EDC) environments is also helpful. Additionally, IT skills - with the ability to use Microsoft Word, Excel and MS Access - are essential.