My earlier blog on Clinical Data Management and Data Analytics, got most of my readers
thinking, will Data Analysis replace the Clinical Data Management forever? How can a
Clinical Data Manager acquire the skills of data analyst? Will there be only clinical data
analyst and no clinical data managers?
While I try to answer these questions in my this blog, I decide to stir up my memory and
think about the tasks I have performed as clinical data manager over a decade.
Evolution of Clinical Data Management
Clinical Data Management has gone through numerous changes over the years. From paper
trials to EDC trials, from double data entry (Figure 1) to single data entry (Figure 2), from
Data Clarification Forms (DCFs) to electronic query and from several databases to one
Comparison of both the figures can easily describe how the Clinical Data Management
process has changed. Do we have more changes on our way? We come back to our question
will the clinical data management become the thing of the past? Will only the data analyst be
working on clinical trial data?
We will try to figure out the answers of these questions by answering few more questions as yes or no.
As a Clinical Data Manager, the response to all these questions would be yes. These tasks
may be considered as “traditional” however they remain the same and still are being
performed by the clinical data managers. It is important to emphasise that without these
“traditional” tasks being performed, reaching the ultimate goal of having clean, complete
and consistent (3Cs) data is not possible. The 3C concept plays crucial role in reaching the
database lock milestone on time, the journey of submission and marketing approval of a
Data Analyst and Clinical Data Manager- together, yet apart
Clinical Data Manager and Data Analyst may work on same data however their approach
and task may not cross each other very often.
While having the clean data is the prime most important task for a Clinical Data Manager,
there are other enough and more assignments to keep them engaged before they call it a day
as listed in above table.
There are certain skills which differentiate Clinical Data Managers from Data Analyst as
well as there are several must have skills for both the professions. The common skills can be
but not limited to, understanding of clinical study protocol, project timelines and deep
knowledge of clinical data collection and structure.
Data Analyst needs a defined objective to reach to the end of the analysis and provide a
deep business insight. The process of analysis involves extensive efforts to bring data to the
stage of interpretation of the results.
Clinical Data Managers work on the data provided to them in a structured way (Case Report
Form) by the sites or vendors whereas Data Analyst can get data from several places and in
different shapes. Data Analyst must know to scrutinise the raw data and give it a structured
format to help the business make important decision and identify the trends. Data Analyst
may also help in generating the useful reports for data interpretation. They may also work in developing the systems or programs for data analysis based on their expertise.
Can Clinical Data Managers become Data Analyst?
The response to this question is independent of the job role and can be explored by skills
and interests of an individual. There are few common “must” have skills for a Clinical Data
Manager and Data Analyst apart from a good clinical research knowledge and data
management skills, few are listed below
✓ Analytical Skills
✓ Decision Making Skills
✓ Problem-Solving Skills
✓ Communication Skill
✓ Time Management Skills
✓ Interpersonal Skills
✓ Project Management Skills
✓ Team Player
As mentions in above section, Data Analyst can be part of a team of system or program
development therefore they are required have some basic or advanced technical skills as
well, list can be extensive however few skills are
✓ Structured Query Language (SQL)
✓ Microsoft Excel
✓ R or Python-Statistical Programming
✓ Data Visualization
I would put Data Analyst in bucket closer to the Statistician than Clinical Data Manager.
This could be another blog series.
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The blog was written with best of my knowledge.
I take no responsibility if any portion of this article/blog is copied without checking the facts