Clinical Data Managers
What is a Clinical Data Manager?
Clinical Data Managers (CDMs) play a crucial role in the field of clinical research, primarily responsible for collecting, validating, and managing data generated during clinical trials or studies. Their main objective is to ensure the integrity, accuracy, and consistency of data throughout the research process. CDMs work closely with clinical research teams, including clinical researchers, biostatisticians, and regulatory affairs personnel, to establish data management plans and standard operating procedures (SOPs) tailored to specific studies.
In their daily tasks, CDMs oversee the creation and implementation of clinical databases, which are essential for compiling data from various sources, including participant records, treatment protocols, and results of tests. They utilize specialized software and tools to design case report forms (CRFs), which are utilized to collect data during trials. Once the data is collected, CDMs engage in rigorous processes of data cleaning and validation, identifying discrepancies or anomalies that could compromise the study's findings.
CDMs also ensure compliance with regulatory standards set by organizations such as the Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH). Their role often involves collaborating with clinical monitoring teams to ensure that data collection adheres to predefined protocols and quality standards. As the clinical trial progresses, CDMs are responsible for generating reports and summaries that provide insights into the data, assisting research teams in making informed decisions based on the outcomes.
In addition to project-specific duties, CDMs are often involved in developing and training fellow team members on data management processes and best practices. As the landscape of clinical research continues to evolve, the role of Clinical Data Managers is increasingly focused on adopting new technologies, such as electronic data capture (EDC) systems and data analytics tools, making them integral to the successful execution of clinical trials and the push towards evidence-based medicine.
Tasks
- Design and validate clinical databases, including designing or testing logic checks.
- Process clinical data, including receipt, entry, verification, or filing of information.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and work flow processes.
- Monitor work productivity or quality to ensure compliance with standard operating procedures.
Technology Skills
- Data base user interface and query software
- Presentation software
- Analytical or scientific software
- Medical software
- Data base reporting software
Tools Used
- Mobile phones
- Notebook computers
- Portable data input terminals
Knowledge
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English Language
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
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Computers and Electronics
Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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Customer and Personal Service
Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
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Mathematics
Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
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Medicine and Dentistry
Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Skills
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Critical Thinking
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
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Active Listening
Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
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Reading Comprehension
Understanding written sentences and paragraphs in work-related documents.
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Speaking
Talking to others to convey information effectively.
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Writing
Communicating effectively in writing as appropriate for the needs of the audience.
Abilities
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Deductive Reasoning
The ability to apply general rules to specific problems to produce answers that make sense.
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Information Ordering
The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
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Oral Comprehension
The ability to listen to and understand information and ideas presented through spoken words and sentences.
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Oral Expression
The ability to communicate information and ideas in speaking so others will understand.
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Written Comprehension
The ability to read and understand information and ideas presented in writing.
Education
How much education does a new hire need to perform a job in this occupation?
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Bachelor's degree
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Associate's degree
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Post-baccalaureate certificate
Awarded for completion of an organized program of study; designed for people who have completed a Baccalaureate degree, but do not meet the requirements of academic degrees carrying the title of Master
Work Activities
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Working with Computers
Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
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Getting Information
Observing, receiving, and otherwise obtaining information from all relevant sources.
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Processing Information
Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
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Documenting/Recording Information
Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
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Communicating with Supervisors, Peers, or Subordinates
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
Detailed Work Activities
- Evaluate data quality.
- Create databases to store electronic data.
- Prepare data for analysis.
- Analyze data to identify or resolve operational problems.
- Develop procedures for data management.
Work Interests
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Conventional
Work involves following procedures and regulations to organize information or data, typically in a business setting. Conventional occupations are often associated with office work, accounting, mathematics/statistics, information technology, finance, or human resources.
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Investigative
Work involves studying and researching non-living objects, living organisms, disease or other forms of impairment, or human behavior. Investigative occupations are often associated with physical, life, medical, or social sciences, and can be found in the fields of humanities, mathematics/statistics, information technology, or health care service.
Job Outlook
Projected salary and job growth
$61070.0 - $184090.0
This career will grow rapidly in the next few years.
Assessment
Related assessments and tests
No assessment available.