Clinical data management (CDM) deals with collection, processing and analysis the data collected from clinical trials. It is the responsibility of the data management team to maintain the integrity and security of data collected from clinical trials. This field provides a wide range of career options. It promises rapid career growth and a high profile career opportunity. Following are some of the common positions available within the clinical data management and biostatistics department.

• Clinical Data Manager
• Bio-statistician
• Clinical Data Coordinator
• Clinical Data Reviewer
• Software Programmers e.g. SAS, SPSS, Oracle Clinical etc

Clinical Data Manager

The role of clinical data manager is to process clinical data using a group of computer applications and database system. A clinical data manager ensures completion and accuracy of the data for reporting to the regulatory bodies. Data processing and analysis are very important for clinical trial management. As a clinical data coordinator you can watch a new drug move through the research process. Clinical data associates are responsible to provide high-quality deliverables to sponsors and other Internal Strategic Business Units to ensure continued success and growth of the department and the company. The following are the data-related activities conducted by the data management department: CRF tracking, reviewing, validation, updating and safety coding. The job profiles of a data entry operator, data analyst, data reviewer and data coordinator vary from company to company. There is a broad spectrum of responsibilities for the clinical data managers which includes:

• Develop and manage documents for database tables, data deviations, data entry screens and edit checks programming
• Interface with the clients, sites and monitors to ensure collection and cleaning of clinical trial data
• Manage projects and ensure completion within establish timelines
• Prepare a variety of standard statistical reports and solve operational and data problems

Education:

- Master's or Bachelor's degree in computer science, mathematics, statistics, pharmacy or life sciences
- Intermediate level skills in using computer programs e.g. Oracle, SAS, MS Power Point, MS Word, and MS Access required

Skills:

- Strong understanding of ICH-GCP and clinical research process
- Goal oriented and meticulous
- Dedicated with strong sense of responsibility
- Good team player
- Good computer skills and sound awareness to all regulations
- Good interpersonal, verbal and written communication skills