Every day, the health care industry is reliant on data-driven insights obtained from clinical trials. The success of these studies hinges on effective clinical data management, and the person overseeing the collection and analysis of that data is the Clinical Data Manager. As technology and health care regulations evolve, more people are taking on the role.
In this article, we will examine the purpose of clinical data management, how managers impact the process, what they do, and how to position yourself for a career in this field.
What Is Clinical Data Management?
Clinical data management (CDM) is essential in clinical research, ensuring high-quality, reliable, and statistically sound data is used in clinical trials, according to the National Library of Medicine. The agency defines CDM as “the process of collection, cleaning, and management of subject data in compliance with regulatory standards.” The primary objective of CDM is “to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis.”
What Is a Clinical Data Manager?
According to O*Net, clinical data managers apply their expertise in health care and database management to analyzing clinical data and identifying and reporting their findings. The position can also fall under the category of clinical data management manager, clinical informatics manager, data deliverables manager, or data management manager, O*Net reports.
What Does a Clinical Data Manager Do?
Clinical data managers play a pivotal role in ensuring the efficiency of data, and the role involves multiple responsibilities. According to O*Net, eight of the most important include:
- Database design and validation: Clinical data managers oversee the creation and validation of clinical databases so they align with study protocols and industry standards.
- Data processing: Clinical data managers must oversee the entire data processing cycle, from the first receipt of clinical information to data entry, verification, and filing. Throughout this process, they must ensure accuracy in compliance with regulatory requirements.
- Query generation: Clinical data managers must single out discrepancies in data by generating queries and collaborate with colleagues and subordinates to fix errors.
- Data management plan creation: Clinical data managers must tailor data management plans to each project’s requirements, addressing areas such as coding methodologies, reporting structures, data transfer protocols, and the workflow processes.
- Quality monitoring: Clinical data managers must create systems to monitor and maintain high-quality work output.
- Data set preparation: Clinical data managers must prepare data sets that meet specific project needs.
- Form design: Clinical data managers must design user-friendly forms for receiving, processing, and tracking clinical data.
- Analysis and reporting: After thorough analysis, clinical data managers must prepare reports on activity, performance, and progress.
What Skills Are Required to Be a Clinical Data Manager?
Technology is essential to the role of a clinical data manager, so someone entering the field must have an expert understanding of several software programs. Among the most important are:
- Analytical or scientific software, including IBM SPSS Statistics, Oracle Remote Data Capture, and SAS
- Categorization or classification software, such as Autocoders and Drug coding software
- Database management system software, particularly relational database management and Teradata Database
- Database reporting software, including Oracle SQL Loader, SAP BusinessObjects Crystal Reports, and SAP Crystal Reports
- Database user interface and query software, including clinical trial management software, Microsoft Access, relational database software, and Structured Query Language (SQL)
- Development environment software, such as Go and Microsoft Visual Basic
- Enterprise application integration software, including Extensible Markup Language (XML)
- Successful clinical data managers also bring strong soft skills to their roles. Among them:
- Critical thinking: Clinical data managers must be able to apply logic and reasoning in order to make the best decision.
- Active learning: Clinical data managers must be able to adapt to new information and understand its implications.
- Monitoring: As clinical data managers may have oversight over other employees, they must be able to assess the performance of others.
- Complex problem solving: Clinical data managers must be able to identify problems, analyze information, and evaluate all options in order to find a solution.
- Mathematics: Clinical data managers must be able to apply mathematical principles to solve problems.
Why Is the Role of a Clinical Data Manager Important?
A clinical data manager is a leadership role and essential to the entire CDM process, ensuring integrity, accuracy, and compliance. From developing data management plans to overseeing all CDM procedures, the clinical data manager serves as the linchpin and supervisor, setting the tone for the rest of the team.
Clinical data managers may oversee a group that includes a database programmer/designer, medical coder, quality control associate, data entry associate, and clinical data coordinator. As the person responsible for the team’s success, the clinical data manager has great influence on clinical trials and breakthrough insights in medical research.
How Do I Become a Clinical Data Manager?
The first step to potentially becoming a clinical data manager, according to Indeed, is to pursue your undergraduate degree. Typically, clinical data managers hold bachelor’s degrees in fields such as biology, business, information technology, or statistics. These degrees include a number of relevant courses – accounting, calculus, chemistry, computer programming, and economics, among others – and will give you a foundation in data management.
Securing an entry-level position is the next step, according to Indeed. In order to gain experience necessary to become a manager, you may have to begin your career as an analyst or coordinator. Indeed has some suggestions for formatting your resume to apply for roles in the clinical data management field. You can find that information here.
You may also choose to pursue an advanced degree, or earn a certification. The Society for Clinical Data Management created a certification program in order to establish standards for clinical data managers. The 130-question exam was last revised in 2019 and focuses on knowledge and experience in the areas of medicinal, biological development, medical device therapies, and the clinical research community.
For more information on careers in this occupational field, please visit the Department of Labor site here.
O*NET Online is a helpful resource for providing up-to-date data on salary information, site here.
Summary: What Is a Clinical Data Manager?
Clinical data management is vital to clinical research studies in today’s rapidly growing health care industry, and it is the responsibility of the clinical data manager to ensure all data collected is accurate, of the highest quality, and in compliance with regulatory standards. Clinical data managers design and validate databases, oversee the data processing cycle, generate queries, and craft data management plans, among other responsibilities. As leaders and supervisors, they hold great influence over the outcome of clinical trials, and oversee teams that are responsible for everything from medical coding to database programming. The job outlook for clinical data managers is promising, though education and entry-level experience will play a key factor in your ability to become a clinical data manager. For more information about careers in the health care industry, visit the BLS website here.