Clinical Research Roles: How to Become a Clinical Data Manager

What is a clinical data manager or clinical data analyst?

Clinical trials generate enormous amounts of data. Appropriate collection, organization, and analysis of clinical data is vital for interpreting and validating study results, as well as for acting as proof of compliance with ethical and regulatory standards. Clinical data refers to the information collected in a clinical trial, both at the micro (patient-level) and macro scales (having broader relevance for the health system). Good data is the foundation of a successful clinical trial, and the data manager’s role is to ensure that the entire data management process is well-controlled.

Clinical data manager job description

A clinical data manager may work alone in data management tasks, or may work with a team of data scientists or even an entire IT department in a clinical data management team. A clinical data manager (or a position with similar functions) could also be referred to as a clinical data analyst, data deliverables manager, clinical data specialist, or clinical informatics manager.[¹]

Before the study even starts, the clinical data manager (or data management team) is responsible for designing the case report form (CRF), defining data fields to stipulate what and how data is to be collected throughout the trial, as well as creating the data management plan (DMP) which guides the data management methods to be used in the trial.[²]

A clinical data manager would typically be tasked with (performing or overseeing) the setup and maintenance of data collection and input systems, collection and organization of the incoming and existing data, validation of data quality and consistency, and analysis of the data to identify trends that form the scientific and statistical basis for the study results. A clinical data manager is also responsible for reporting findings to the relevant parties.

Clinical data managers have responsibilities relating to regulatory compliance (audit trails, transparency), security (secure storage of confidential or sensitive personal data), technology and IT systems (data and clinical trial management tools, backups), and statistics (data analysis, identification of errors in data and potential safety issues). Examples of more specific tasks that could fall on a clinical data manager role include:

• Collaborating with IT staff to create, implement, and maintain data collection models and databases for storing incoming data
• Validating data and databases to ensure consistency and identify potential errors
• Analyzing clinical data to resolve operational issues, identifying potential safety concerns such as adverse events, and validating the research outcomes
• Developing strategies for data management, which could be related to workflow, coding, reporting, and/or data transfer
• Ensuring that trial staff, investigators, sites, and automated workflows adhere to the implemented data strategy
• Monitoring activities to ensure operations comply with ethical research standards and regulations set forth by organizations like the Food and Drug Administration (FDA)
• Preparing analytical reports
• Preparing instruction manuals and resolving IT issues
• Training personnel in the usage of data collection and management software

The exact role of a clinical data manager also depends on the type and size of the trial or company they work for. For instance, a clinical data manager could be tasked with only overseeing and maintaining data collection systems at large organizations running multiple trials, or could be responsible for data collection, analysis, and reporting in a smaller organization or for an individual trial (hypothetical example).

Qualifications and skills: What makes a good clinical data manager?

Clinical data managers should have knowledge and experience in the fields of life sciences, IT, bioinformatics, data science, and/or statistics. The role also requires good communication and management skills, as it could be a managerial role and involves interacting with other departments and reporting to various stakeholders. As their main responsibility, clinical data managers need to be well-versed in data collection and analysis specific to health and clinical research.

Most job postings for clinical data managers require a minimum of a bachelor’s degree in life sciences, IT, statistics, or data science. Education in related fields such as artificial intelligence, computer science, data analysis, or bioinformatics could also be acceptable. Beyond educational prerequisites, many companies are looking for candidates with prior experience in clinical data management. Familiarity with computers and software is a must. If you are just getting started and are looking for an entry-level position, it could be a good idea to take a course in clinical data management to demonstrate deeper job-specific knowledge and interest in the profession (see next section).

The following are some other skills that would be relevant and important for a clinical data manager:

• Communication - A clinical data manager will communicate frequently with various stakeholders and other departments/teams involved in the trial, and should be able to communicate results or important findings in a way that is appropriate (understandable and relevant) for the given audience
• Attention to detail and problem-solving - Any issues identified in the data could indicate manual or technical errors in data input/transfer, operational process or equipment failures, or even adverse events or safety concerns. The data manager should be able to accurately interpret what the data is saying in order for appropriate corrective action to be taken
• Critical thinking - Critical thinking skills are necessary for interpreting data and informing decision-making processes, some of which could be urgent and/or have financial, safety, or legal implications
• Proficiency with modern technologies - As technological solutions are being increasingly adopted across clinical trial operations, a clinical data manager should be comfortable with technologies such as remote data collection systems (eCOA, eConsent, etc.) and data management tools, as they could also be tasked with the setup, operation, and even maintenance of such systems

Clinical data manager certification

There are many places you can go for clinical data management training or to obtain a clinical data management certification. Such courses could be taken by current clinical data managers looking to brush up on their knowledge and develop professionally, or by those looking to gather further knowledge and qualifications in order to pursue a career in clinical data management.

• Certified Clinical Data Manager (CCDM) by the Society for Clinical Data Management (SCDM) - The Society for Clinical Data Management (SCDM) designed a certification program for clinical data managers, aiming to establish a formalized and widely-recognized standard of the skills, knowledge, and expertise required to be a successful clinical data manager. The “Certified Clinical Data Manager” (CCDM) certification exam is designed for current clinical data professionals, and is open to those with 2+ years of full-time experience in clinical data management (depending on the level of education), and aims to facilitate recognition of clinical data management capabilities throughout the clinical research industry.
• There are various bachelor’s degrees in clinical administration and closely related subjects available, which represent an option for studies that are directly oriented toward a career in clinical research, including as a clinical data manager. For those with prior studies looking for more specialized education, there are also master’s degrees - see the programs offered by Arizona State University and The George Washington University School of Medicine & Health Sciences (top 2 results here).
• Data Management for Clinical Research by Vanderbilt University - Coursera offers a 6-week online course in data management for clinical research taught through Vanderbilt University. The entry-level course is designed for beginners, so it could be perfect as a first step to gaining job-specific knowledge. There is an enrollment fee if you wish to obtain a certificate, but otherwise the course can be taken (audited) for free.
• The Clinical Data Interchange Standards Consortium (CDISC) offers various education and training programs in aspects of clinical data, both in-person and online.

Where to find clinical data manager jobs

Clinical data managers might be employed by various organizations, such as:

• Contract research organizations (CROs)
• Pharmaceutical/drug development organizations conducting clinical research
• Research hospitals or universities
• Medical device manufacturers
• Biotechnology companies

Job seekers can search for clinical data manager positions on job boards like glassdoor or Indeed, or could reach out directly to specific companies or research centers.

What is the average clinical data manager salary?

The average salary of a clinical data manager depends on the data manager’s qualifications and experience, and the location and details of the company or organization. Generally, annual salaries for clinical data managers in the United States range from USD $59,000 to $160,000+, with a median of $100,000.[¹]

Clinical data management job outlook

The current outlook for clinical data management jobs looks positive. Since 2019, clinical data manager job opportunities have increased by 93% across the US, with increases in both training and hiring.[³] The demand for clinical data managers is expected to continue to grow by ~15% through 2030, driven by increasing IT usage in the clinical research industry.[⁴] In order to stay relevant and competitive in an industry that is growing but also changing rapidly, it would be ideal to become familiarized with new technologies that are being employed more often in clinical research, as we discuss below.

Clinical data management is evolving quickly

Over the past decade or so, the role of clinical data managers has been evolving rapidly due to the increasing integration of advanced technological systems and adoption of hybridized and decentralized clinical trial models. For instance, some clinical trials now leverage artificial intelligence and machine learning to help collect, track, and analyze trial data.[⁵] In such cases, the trial’s data manager would work closely with these systems and integrate the results and processes into the broader data management operations/framework. In a more general sense, the adoption of technological solutions that facilitate various trial operations has accelerated, particularly since the onset of the COVID-19 pandemic. Thus, beyond having a general understanding of clinical trial data management, a clinical data manager is increasingly likely to need to interact with these types of tools, such as data functions of clinical trial management systems (CTMS) or remote data collection platforms such as eCOA. At the same time, the automated workflows that these solutions offer are changing the function and tasks required of the clinical data manager. For example, increased automated analyses may shift the data manager’s role away from actual data analysis toward data validation and maintenance of technological systems.

Conclusion

Clinical data managers are responsible for data quality in clinical trials, which can include designing, implementing, and maintaining data management systems and the data management plan, training personnel in the use of these systems, and analyzing and reporting data to the sponsor. The data manager position is central to ensuring trial quality as well as regulatory compliance and patient safety. There are various pathways to becoming a clinical data manager or similar role, but most involve a combination of knowledge and experience in both health/life sciences and data management/IT systems.