A clinical data manager (CDM) processes and reviews clinical data that relates to a particular client's deadlines and budgets. He or she makes sure that the data is accurate, complete, and consistent before it is dispatched to regulatory authorities. The data manager's main objective is to set up, run, and compile a report for all clinical trials. Before all that is done, the CDM has to analyze and edit test plans electronically. The clinical data manager can also assist or train junior data managers working under him or her, reviews their performances, and takes disciplinary action when necessary. The clinical data manager makes sure that guidelines and data flow procedures are compliant with the client's specifications and satisfaction.
Clinical research jobs involve reviewing and processing data by using clinical database software. Clinical data managers resolve data queries by generating and tracking them with data clarification forms. They maintain and review case report forms (CRFs). They make sure that Good Clinical Practice requirements for reporting and data entry are met. Data management, as well as data quality plans, should be edited and checked. Any clinical study data entry database should be developed through assisting code lists and testing data entry screens. The annotated CRFs are also designed by the clinical data managers. The personnel expedite resolutions and upgrade the quality of the data being collected by acting as the interface at the study site.
The vendors get the data transfer specifications from the clinical data managers, who also oversee immunology data and lab data transfers from the vendors. The clinical data manager also works in conjunction with the lab staff, as well as any other vendors when required.
The data manager has to have experience using different research data techniques. The data manager should be able to prove that he or she has the necessary skills for interpreting and analyzing qualitative and quantitative data. The manager should meet all deadlines in a fast-paced environment through multi-tasking. The manager should also possess problem and analytical solving abilities and be able to work with very diverse teams effectively and confidently. Apart from being an effective manager, he or she should also be able to have the skills to prototype at a very fast pace with Dreamweaver, Photoshop, Visio, or PowerPoint.
Educational Requirements
Any applicant wishing to work as a clinical data manager should have at minimum a bachelor’s degree in biological sciences and should also have worked a clinical research job in either a pharmaceutical firm, clinical research organization, or biotech company for at least a year. The applicant should have the experience and the ability to compile data for regulatory authorities. He or she should also have knowledge of Oracle Clinical.
Clinical data managers in the United States earn a median salary of about $92,000 per year.
