Clinical Data Management (CDM) is an emerging domain of clinical research and concerns itself with the use of computer applications for managing trial data or information by storing them in database systems to support collection of data. In simpler terms, it is associated with the integration, collection and validation of the clinical trial data. Allied with the scope of Bioinformatics, this field is replete with a multitude of career opportunities that one can explore. Clinical data managers collect the patients’ data and then analyze the assimilated data using statistical analysis. Let’s discover what CDM entails, courses offered, top universities as well as the prospects you can avail.
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What is Clinical Data Management?
Often provided as a postgraduate program as it is a specialised field, Clinical Data Management involves an intensive study of data generation and how data is sourced into clinical trial database. It is an amalgamation of clinical research and data management and constitutes of different concepts like electronic CRFs, clinical site medical records, reconciled data, significant data analysis, amongst others.
Subjects Covered in Clinical Data Management
Though the curriculum of a program in Clinical Data Management can vary as per the course as well as the institution, there are some key subjects under this discipline which are included in the study of Clinical Date Management. To help you understand what CDM comprises of, the following table lists down a few of the major sub-disciplines that are often incorporated under courses offered in this field:
|CRF Design||Creating Reports and Transfer Data||Identifying and Managing Discrepancies|
|Data Entry & Remote Data Entry||Collecting Adverse Event Data||Introduction to Data Management|
|Data Management Plan||Tracking CRF Data||Introduction to Clinical Research, Roles and Responsibilities|
|Recreating Reports and Transferring Data||Clinical Research and Regulatory Submissions||Clinical Submissions|
|Planning for Clinical
|Electronic Data Capture||Managing Lab Data|
Note: The above-mentioned list is only for indicative purposes. The course offerings might differ as per the program as well as the university.
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There are certain prerequisites that every candidate needs to fulfil in order to apply for an academic program. Similarly, in order to opt for a course in Clinical Data Management, every candidate needs to satisfy some specified eligibility criteria. Some of the general requirements include minimal formal schooling of 10+2 as well as an MBBS degree/BSc Biology/ a bachelor’s degree in the domain of Life Sciences, Computer Sciences, Pharmacy or some other related domain. Further, applicants also need to qualify English language proficiency tests like IELTS, TOEFL, etc.
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Courses for Clinical Data Management
- Advanced Post Graduate Diploma in Clinical Data Management
- Executive Diploma in Clinical Data Management (CDM)
- PG Diploma in Clinical Research and Data Management
- PGD Clinical Studies Data Management and Medical Writing
- Clinical Data Management Certification Programme
- Certificate Course for Clinical Data Management
- Online Clinical Data Management Courses
- Certificate in Clinical Research and Clinical Data Management
Top Universities in the World
As Clinical Data Management is more of a specialised and emerging discipline, there are an array of institutions across the globe that have started offering a multitude of programs in this field. To help you further in your research, we have compiled a list of major universities that you must consider while applying for a program in this field:
- Keiser University
- Northwestern University
- The University of Manchester
- University of Brighton
- City, University of London
- Indiana University
- University of Washington
- Stanford University
- University of Missouri
- Northcentral University
- Herzing University
- Xavier University (Ohio)
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Top Universities in India
- ICRI – Jagannath University, Delhi
- ISBM University
- ICRI Bangalore
- Apeejay Stya University
- ICRI- ZEE Himgiri University
- People’s University, Bhopal
For the young individuals wanting to pursue this new springing field of clinical data management, there are a plethora of career prospects available in different sectors. Moreover, the pharmaceutical industry is in dire demand of specialised experts with the knowledge of efficient data management for medical purposes. Further, aspirants can also choose to work in the arena of research and development to build exciting technological innovations for the medical industry. Some of the major job profiles that one can consider in this field are:
- Clinical Data Manager
- Clinical Data Coordinator
- Data Validation Associate
- Data Manager
- Medical Coder
- Database Programmer
- Quality Assurance Associate
Professionals with Clinical Data Management course can make anywhere between INR 3 Lakh to INR 11 lakhs in India. The highest salary of a Clinical Data Manager is ₹11,22,503 per annum and the lowest salary for a Clinical Data Manager in India is ₹3,16,980 per annum.
Roles and Responsibilities
- They collect data from a variety of medical research projects, such as clinical and pharmaceutical trials
- They screen data, summarize, transcribe and code the collected data
- Consult with other employees to solve operational or data problems
- Work on data entry, transcription, coding, and collating searches
- Make project management decisions and validate clinical trial data based on project-specific guidelines.
- Manage clinical trials through review, computerization, cleaning, and auditing of clinical data
- They manage databases in compliance with standard operating procedures, client guidelines, and regulatory agency guidelines.
- Work in drug development process and evaluation of the accurate drugs
- Implement strategy for data cleaning and the design and programming of clinical databases.
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Interview Questions for CDM Roles
- Have you had GCP training or formal CRA training through an employer or accredited course?
- Do you have experience with the following therapeutic areas: Cardiovascular, CNS, Oncology, Diabetes, HIV, etc.?
- What is a Placebo?
- What is a Patient File? What Information Does It Contain?
- Define the Different Phases of Clinical Trials
- What Causes the Different Phases of Trials to Fail?
- What Does the Declaration of Helsinki State?
- Describe the Process of Discrepancy Resolution
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Hence, we hope that this blog has helped you understand what Clinical Data Management as well as the varied prospects it is filled with. If you are planning to establish your career in this specialised domain and don’t know which course to opt for, sign up for a 30-minute free career counselling session with our experienced counsellors at Leverage Edu and we will help you find a suitable program and university as well as throughout the admission process to ensure that you get successfully shortlisted.