Clinical data managers are responsible for managing and collecting data from clinical trials, research studies that evaluate the effectiveness and safety of certain medications using a large group of human participants. As clinical trials can be performed by a variety of organizations, clinical data managers have a wide range of prospective employers; they could be hired to manage studies for governmental agencies, pharmaceutical companies, universities, or independent researchers, among others.
Clinical data managers play an active role in these trials. They participate in discussions about data collection options prior to the trial. From there, they follow the clinical trial protocol and oversee the development of data collection tools. While they may not be involved in enrolling subjects, they oversee subjects during the trial and the way in which data is collected from them. Throughout the study, clinical data managers must make sure data is complete and consistent.
Most clinical data manager positions require at least a bachelor's degree in a life science-related field, and some companies may prefer relevant certifications. Previous experience in a similar role is generally required as well. Clinical data managers must be proficient with relevant computer programs, pay close attention to detail, and have strong communication and organizational skills as well.
Clinical Data Manager Tasks
Build and maintain data standards for clinical trials.
Assist with study start up including protocol review, case report form design, database design, dataset specifications, data transfer specifications, and review of data management and handling plans.
Develop and implement the data correction process, discrepancy resolution, data control activities, and data validation plans.
Support clinical trial studies from preparation through closeout including regulatory submissions by standardizing data management.
Ensure documentation and management of clinical study data is in accordance with regulations.