Profession of Clinical Data Manager

Thursday, April 07, 2005

Clinical research data management profession

Kriger CDM Training: Data Management Program , ,

This article has been published by the International Biopharmaceutical Association

The project is sponsored by KRC CRO and training services ( ) and ClinQua CRO ( )

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Clinical research data management, medical coding and analysis positions deal with data collected from clinical trials (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product including new drug substances and currently marketed drugs. Data processing and analysis is a very important part of every clinical trial.
Typical Work Activities
Typical work activities include:
maintaining the accuracy, integrity and security of a complex, large computerized records system.
applying knowledge of regulations, policies, protocols and/or procedures to control and maintain accurate records;
dealing with a large volume of information which may require the need to be screened, grouped , summarized, transcribed, coded etc.;
solving operational/data problems in consultation with other employees and/or supervisors;
maintaining confidentiality of data as required;
preparing a variety of standard status and statistical reports.
General clerical/secretarial duties include data entry, collating library searches, and other related tasks.
The job of Data Management Assistant, Data Coordinator, Clinical Data Analyst and Medical Coding Specialist can vary tremendously from company to company. In some companies you would be involved in the whole process of data management and analysis. In other companies the tasks would be more specific.
Work Conditions
Typical starting salaries range from $ 30,000 to $ 45,000
Typical salaries with 3 and more years of experience range from $40,000 to $ 75,000
Salaries vary quite widely from company to company, also bonuses may be paid.
Working conditions vary between companies. You will need to work extra hours, although weekend or shift work is uncommon. Generally most of time is spent in the office.
Jobs are found in different locations.
As a clinical data associate you will have an opportunity to watch a new drug move through the research process. Clinical data associates provide high-quality deliverables to sponsors and other internal Strategic Business Units to ensure continued success and growth of the department and company. You will review and process clinical trial data to ensure the accuracy and consistency of the clinical databases. This will involve the following data-related activities: CRF tracking, reviewing, validation, updating and safety coding.
Entry Requirements
The relevant requirements include a Bachelor's degree in computer science, statistics, or data base specialist, or life and medical science. Sometimes a minimum of High School Graduation is sufficient. Previous data entry experience and intermediate level skills in using the following computer programs, Powerpoint, M S Word, MS Access required.In particular, the following subjects may increase your chances:
BSc in computer Sciences
Database Administrators
IT specialists
SAS Programmers
Other Programmers
Oracle Specialists
Data Base Specialist
biomedical science;
molecular biology;
A statistics or database specialist degree , degrees in computer science or other IT degrees or life science degrees (especially pharmacology, pharmacy, biochemistry, immunology, physiology or toxicology) or a nursing degree is one of the requirements for entry into clinical research data management work. Other science degrees may be accepted. Some companies will employ recent graduates with necessary personal skills. As a graduate with no previous relevant experience you would be more likely to enter the field at a lower level, e.g. as a clinical data coordinator. These are generally jobs which deal with the data handling/co-ordination without the involvement of initiating and designing the trials. Experience in this type of work would generally qualify you to move on to other research positions.
In addition to a scientific or nursing background companies will look for excellent communication skills (both written and verbal), an ability to get along with people and an eye for detail. Numeracy, good organizational and administrative skills are also important. The job requires self-motivation and an ability to assimilate information quickly. A mature attitude is essential and mature students with relevant past experience may have an advantage. The people aspects of this job mean you need to have an outgoing, confident and friendly personality. You must be able to understand the importance of good clinical practice (GCP). Having relevant pre-entry experience is desirable and could include: statistical work or data management, a medical practice, a nursing background, medical sales, clinical laboratory work, clinical data work or pharmaceutical research.
Career Development
Career structures will obviously vary from company to company and are not always very clear cut. However, most companies have clinical trial data management/executive positions which would be the next step for an experienced employee. Some companies ask for PhD's in bio. statistics for senior posts.
Typical Employers
You would either be employed directly by a pharmaceutical company or by a contract research organisation (CRO - agencies which employ clinical research staff to contract out to pharmaceutical companies). Hospital academic departments occasionally have the same positions.
Sources of Vacancies
Kriger Research Center will provide you with current positions that could be suitable for your future employment by sending you KRC Inc. Newsletter.
You will have to make additional efforts in order to succeed. See specialist press for recruitment agencies or contact your careers service. It may be worth registering with a specialist recruitment agency. Alternatively (or in addition,) try approaching pharmaceutical or CRO companies directly.
The Clinical Research Data Management and Analysis Course is a summary of duties and responsibilities of Clinical Data Analysts, Biostatisticians, SAS Programmers, and Coding Specialists. This course is designed for statisticians, science teachers, data base specialists, physicians, pharmacists, biologists, biochemists, microbiologists, nurses, and SAS Programmers who want to enter the Clinical Research field.
The course begins by exploring the fundamental and proven techniques of Clinical Trial Processes, Collection, Management and Reporting of Clinical Study Data. This comprehensive course provides the essentials of understanding roles and responsibilities of Clinical Data Analysts, Biostatisticians, SAS Programmers, and Coding Specialists. It is followed by a discussion of related Good Clinical Practices and FDA Regulations for overall compliance. Additional details will be given on the allocation of Clinical Trials staff members for projects. Attendees will develop communication and negotiation skills that will enhance the success of their employment. By the end of this course applicants will gain the knowledge they need to start a new career in the pharmaceutical industry.
Upon completion of this course, participants will be competent and possess the skills needed in order to manage clinical data in any clinical research study.
Taking this program could be a substantial asset for getting an employment position in Clinical Research. Check clinical positions on our web site - you will see that enrolling in KRC programs can be valuable towards getting a job. Upon completion of your study and exams you will receive a Diploma . This program is exempted from registration under The Private Career Colleges Act and Regulations, as it is considered a short professional development program. Thus, it is not scrutinized by the Ministry of Training, Colleges and Universities, Clinical Research Association or other institutions.
During this course you will receive frequent email issues of the KRC Inc. Newsletter which includes current position openings in the field . In addition, you can get help in your resume preparation. As a participant of this program you are encouraged to take part in Kriger Research Center Research projects as a volunteer. This would enable you to earn appropriate experience.
This on-line program will help you to gain the appropriate knowledge and practical skills to apply for the position of Data Manager . To complete the program you will need to pass an on-line final exam and will then receive by mail a diploma stating your new qualifications. You will then obtain approval as a clinical data coordinator to participate in the clinical research projects of our center. You will be appointed to join one of the on-line research groups working on a specific drug and will receive individual clinical research and data management tasks that will give you sufficient experience to get started in your job in this field. Modern clinical research activities are almost entirely based on networking and internet on-line communications. Your experience in this area will be most valuable towards your future employment . You will receive all tasks on-line and will conduct work as a home-based Clinical Data Management Position. You will actively participate in the development of some parts of the protocol, preparing CRF-s (Case Report Forms), reviewing inform consent forms, networking with potential investigators, creating databases, performing data entry and analysis, and many other tasks. You will use your knowledge of ICH GCP (Good Clinical Practice) in each phase of the clinical research. You will submit your work for approval by e-mail. At the end of your work you will receive a reference letter stating your experience and qualifications with our contract research center. At this stage you would work with our company as a volunteer. The most successful participants could be offered employment with our company upon completion of this program.
You can move through sessions at your own pace and submit your answers to the open questions to on-line teachers who are active researchers in our company involved in real clinical trial projects. Some of our teaching personnel hold PhD's in clinical trial-related areas and have extensive clinical research experience. Every answer that you submit to an open question receives comments from our on-line teachers. They send you additional related articles, and you submit your feedback to the articles and receive comments if needed. You will also receive comments to every practical task you submit. Expect 200-250 communications throughout the program. Students ask many questions and they always get a reply. We review everything that comes on-line: answers to training questions, practical tasks. We review resumes and give advise for future interviews. We prepare reference letters for successful participants of the research projects. Performance assessment works as follows: we save all your answers and your comments regarding the additional articles in a special folder under your name, and when you get to the end and finish your on-line final exam we get the message from the final page with your request to issue the Diploma. Then we check your participation in answering the open questions. If you have answered most of them - you get your diploma by mail. If not, we ask you to complete the questions, and then you get your Diploma by mail. Don't move on until your answer is accepted. You have to save a copy of all your answers in one to two text files in order to be able to re-submit them if necessary. Our responsibility is to make sure that the Diploma is issued only to those who qualify, in other words, have showed his/her knowledge by answering most of our questions. Multiple choice questions at the end of each session serve only as keys to proceed through sessions.After training you participate in real research projects. The most important thing is that you get a reference letter on your project participation that is adjusted to your needs and reflects appropriate details of your active participation in these full-scale research projects. Without proper reference letters it is completely useless to approach any serious Contract Research Organization or Sponsor (pharmaceutical company) in order to get a job in Clinical Research. You get perpetual support from our research center staff when you mention our institution in your resume as a place where your potential employer could obtain references. Almost always, a prospective employer makes a call to collect references through a personal phone conversation. When your prospective employer calls us for a reference we will be able to relate all the details of your research participation and appropriate qualifications. This could drastically increase your chances to get a job in Clinical Research . You get active help in your new resume preparation. Remember, your resume is the first step in being able to get a job. On average every two weeks you will get a letter from us that includes current, exclusive Clinical Research Data Management Positions that you can apply for. You are most welcome to ask any questions. If we are unable to answer them right away we will talk to people that work on study design, protocol development and regulatory affairs and then get back to you.

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