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INTRODUCTION
CAREERS IN CLINICAL RESEARCH
Clinical Data Manager Job Description
Career Description
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 whether it is new drug substances or 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 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.;
- assisting in standardizing data management procedures;
solving operational/data problems in consultation with other employees and/or supervisors;
maintaining confidentiality of data as required;
preparing a variety of standard statistical reports.
general clerical/secretarial duties include data entry, collating library searches, and other related tasks.
The job of a Data Management Assistant/Associate, 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 $ 35,000 to $ 60,000 USD
- Typical salaries with 3 and more years of experience range from $45,000 to $ 80,000 USD
The median salary for a typical data manager in the US is about $90,000.
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 support the research process that may lead to the development of a new drug. 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 clinical databases. This will involve the following data-related activities: CRF tracking, reviewing, validation, updating and safety coding.
Entry Requirements
The relevant minimum requirements to begin a career in clinical data management include the following:
A statistics or database specialist degree, a Bachelor's degree in computer science or other information technology (IT) field; and/or a life sciences, (especially pharmacology, pharmacy, biochemistry, immunology, physiology or toxicology) medical science or a nursing degree.
A minimum of High School graduation may be considered, depending on the company and the specific duties of the position.
Previous data entry experience and intermediate level
skills using a range of software applications (such as Powerpoint, MS
Word, and MS Access) is required.
In particular, study in the following subject areas may increase your chances:
BSc in computer Sciences
Database Administrators
IT specialists
SAS Programmers
Other Programmers
Oracle Specialists
Data Base Specialist
biochemistry;
anatomy;
biology;
biomedical science;
dentistry;
microbiology;
medicine;
nursing;
molecular biology;
physiology;
pharmacology;
pharmacy.
A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility, such as a clinical data coordinator. These are generally jobs that deal with the data handling/co-ordination without the involvement of initiating and designing the trials. Experience in this type of work will generally qualify you to move on to other research positions.
In addition to an IT, scientific or nursing background, companies 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 professional 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 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 paths and organization structures obviously vary from company to company and are not always clear. However, most companies have clinical trial data management/executive positions that are the next step for an experienced employee. Some companies look for individuals with PhD's in bio. statistics for senior posts.
Typical Employers
A Clinical Data Manager is employed directly by a pharmaceutical company or by a contract research organization (CRO - agencies which employ clinical research staff to contract out to pharmaceutical companies). Hospital academic departments occasionally offer the same positions.