Clinical Data Management Future

What is the future scope of Clinical Data Management course? Will you provide me the information about it?

[Kiran Chandar]

As per your need here I am giving you the information about the Clinical Data Management course:

Clinical Data Management is a Collection, integration and validation of clinical trial data. In this course you have to manage a kind of data which is trial data including safety and efficacy data of drugs/agents under study

Here I am giving you some information about this course in the form of questions and answers:

What kind of data does CDM have?
All data coming from CRF from sites (hospitals/clinics) and non-CRF data coming from clinical laboratories.

What will be my daily routine in this Job?
You will be working on computer applications like Oracle - Clinical, Clin-Trial etc, creating database, CRF designing, validations, reviews, interacting with Investigators, etc.

Some one asked that My Dad says this CDM industry is new field is it true? If so what is the future in it for me? Is it not risky to take on as a career?
It certainly is a new field and one gets more advantage if you opt for CDM course as it adds value to one's career and is in much demand in the market. Drug Research can never stop. No risk as this is a growing industry.

All I can do with computers is only check mails, browse the Internet,chat, and type some letters- do I have to do any special computer courses?
No, not required

I have worked as a Medial transcriptionist and Proofreader, is CDM related to this kind of Job?
CDM is not related. It will be easier since you are familiar with medical terminology.

What exactly will I be doing in CDM?
Collect and validate the trial data, review and querying the investigators, and quality assurance of the trial data, etc.

A lady asked a question that My husband is a software engineer, he travels abroad very often can I work abroad as a CDM professional?
Yes

I am not comfortable with computers is it ok/ can I pick up the computer skills needed for CDM?
Basic knowledge of computers is essential because it is IT enabled service. No specialized computer skills are required

Does this job require lot of time to pick up skills?
No, because we are providing training for one year and the course is well structured.

Should I have to carry my job to home like most of the software professionals?
Since this job involves confidentiality, it cannot be carried home.

Does working in shifts are necessary?
This cannot be ruled out, it may happen depending on the company.

I have heard there is lot of stress in this Job, is it true?
It is not stressful; as a matter of fact stress is there in every modern day profession.

I have heard people in this industry need Hands-on-experience, could you please explain this?
We will provide hands - on experience. The 2nd semester would have practical sessions. Regualr assessment would be done to monitor the students.

As a Master degree holder I am always interested in research, does CDM give me exposure to research field?
Yes

Where will I be employed after doing CDM course?
You will be absorbed as Clinical Data Associate or Clinical Data Coordinator in Pharma / Biotech companies or Contract Research Organizations or IT companies providing CDM services.

How much will be the initial or start up salary for CDM professional?
Somewhere around Rs.2 lakh per annum

Is CDM an Out-sourced Job?
Clinical Research Organisation (CRO) itself is an outsourced job, especially the service industry. This is currently happening industry in our country.

I have heard many software companies are into CDM, is it true? Does this mean I will have a larger scope for employment?
Yes. The IT companies have already entered into CDM arena and therefore would be a huge opportunity for career growth.

How many trained CDM professionals are there in India today?
Few hundreds, which is just not enough for the current scenario

I am a Veterinary professional having done my Masters in Chemistry. What are the chances of getting involved into Clinical Trials?
You will be involved in Clinical Research related activity. The focus is on Clinical Data Management. From the career point of view, you can be considered.

I have worked in Insurance claims processing-BPO industry, is CDM in any way related to this process?
Insurance is totally different and not related to CDM.

I have heard CDM requires Eye-for-detail, could you please explain this terminology?
Accuracy and quality is essential in any business.

I have learnt some foreign language French / German / Spanish / Mandarin. Will this be helpful?
From the course point of view, it may not be essential but it value adds if you have a global exposure.

Is this course beneficial for Nurses?
Yes

How am I qualified for CDM as a pharmacy graduate/Postgraduate?
You should be familiar with Pharmacology related subjects.

I have 5 years of experience as a medical representative, will this experience help me in CDM job?
It would be a value-add to your career prospects, though CDM is not for you unless you want to shift your career as you have an adequate knowledge with regard to pharma.

I have assisted many Senior Doctors in Clinical trials, is CDM related to this?
Yes. It's a continuation of Clinical Research activity.

Why Life Science graduates/Postgraduates are preferred for CDM industry?
Because of the domain experience and the terminologies associated with it.

I am aware of fresh graduates who are employed in CDM industry without this course. Why should I do this course? What will be the salary difference of the person who has not done this course?
There's definitely a difference. You will have an edge over them and your chances of getting jobs are easier and, growth is faster. Salary difference could be significant.

Are all graduates eligible?
All graduates related to life sciences, maths, statistics, and computer science are eligible.

How best am I suited for a job in CDM as a Statistician?
That's one of the good background to have.

I am a fresh Masters in Bio-Statistics; What will be my role in CDM industry?
You can be part of the CDM team and specialize in statistical analysis and reporting

Hello sir, what is the future in Clinical data management? Is three any job are in Clinical data management then provide me information about the Clinical data management future?

[Raman Vij]

Clinical Data Management (CDM) is a vital phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

This is the provider of collection, integration and availability of data at appropriate quality and cost.

Job profile acceptable in CDM:
Clinical researcher
Clinical research associate
Clinical research coordinator

Clinical data management (CDM) careers opportunities are to work with cutting-edge technology and tools.

A career at PPD provides many advantages for data management professionals, including:

This is provides Structured training programs to candidates.
Various Opportunities to work with a variety of tools and technologies

Outstanding career progression and development as well as advancement potential for those who demonstrate proficiency and commitment to quality

Work environment that supports meaningful and challenging work

For positions in the United States, apprenticeship programs that help employees develop the skills and experience to advance to project lead positions


Various positions at PPD in Clinical data management includes:

Clinical data manager I
Clinical data manager II
Principal clinical data manager
Manager, clinical data management
Group manager, clinical data management
Associate director, clinical data management

I would like to know the basic concept of the Clinical Data Management as well as the future scope in Clinical Data management?

[Shaleen]

Clinical Data Management (CDM) is in a self-motivated state, with multiple factors dynamic change. As a result, there is a noteworthy need to drive flawless interoperability across applications, so as to diminish the duplication of effort and follow the critical path as driven by the Clinical Trial Transformation Initiative. The function of the data manager is also evolving to a more strategic one in the new era of risk-based monitoring.

Insights on the shifting dynamics of the CDM industry and discuss how CDM copes with this alteration:

Risk-based monitoring and its shock on the way clinical trials are being conducted: Clinical data managers require being cognizant of the changes in which clinical trials will be conducted in the future. As monitoring is gradually becoming centralized and data managers are becoming the 1st to view key trends at sites, these changes are directly affecting the activities that they are performing, and they need to comprehend the significance of their new enhanced roles.

Electronic Data Capture (EDC): An developing perspective, EDC has been adopted by a considerable portion of the industry, and the time savings have been notable. However, the challenges connected to technology issues, as well as prohibitive costs, have affected the drive to shift toward EDC. In addition, with the coming of esource, EDC itself may no longer be the major focus of the CDM industry.

The developing role of the data manager: Data managers need to advance from being hands-on processors to tech-, regulation- and cross-cultural-savvy project managers.

In current years the FDA and other government organizations working with clinical data have seen the critical need for more robust data standards which, in the long run, will lead to better and more efficient science.

REFERENCES
1) Cooper, Chuck, M.D., Office of Translational Sciences, CDER, FDA. ”Computational Science and Data Standards in CDER”, 8th Annual DIA eCTD Conference, 2009.

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