Clinical Data Management Training Programs and Requirements
Clinical data managers categorize, arrange and track the information that researchers collect during clinical trials of pharmaceuticals and other medical treatments. They must have comprehensive knowledge of regulatory agency guidelines regarding pharmaceutical research.
Training Requirements and Recommendations
Clinical data managers usually have a minimum of a bachelor's degree in a health-related field, work experience and sometimes professional certification. Specific educational requirements vary by employer, although most prefer graduate-level education in the biological or life sciences. Such positions require extensive knowledge of clinical trials and associated regulations.
Formal Education
Clinical data management training heavily emphasizes ethics in research as well as the regulatory aspects of clinical data collection and drug development. Post-baccalaureate certificates in clinical trials are the most frequently offered programs to prepare graduates for direct work in the field.
Clinical Trials Management Certificate
Programs in clinical trials management usually last from 1-2 semesters and include courses on the clinical trial lifecycle, clinical study design, clinical research methodologies, regulatory issues, biostatistics, ethics and database management. Distance-learning and traditional classroom options are both available. Those currently working in a biomedical field or as clinical trials staff are generally eligible to enroll.
Job Experience
Prospective employers generally require job candidates to have 2-5 years of experience in assisting with clinical trials in order to obtain the appropriate experience necessary for the clinical data manager role. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. The ability to work on a team and to provide leadership to support personnel is also important.
Licenses and Certifications
The Society for Clinical Data Management (SCDM) offers a Certified Clinical Data Manager certificate. The criteria for certification include a combination of work experience and education totaling a minimum of four years. Following verification of experience, applicants must then pass an examination to earn the certification credentials.
Workshops and Seminars
Webinars and workshops are available through SCDM that provide professional advancement opportunities or preparation for the certifying exam. Sample topics include project management, advanced data management plans, query processing and database updates. Other programs focus upon the management of lab data and identification of data trends.
Additional Professional Development
Depending upon the size of the research study, staffing may include one or more clinical data management positions. Therefore, entry-level professionals may acquire additional experience under the supervision of others. Additional, clinical data managers may join the SCDM in order to obtain access to certification processes, educational opportunities and career assistance.
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