Who is a Clinical Data Manager?
A clinical data manager is a person who would use his/her database management skills in collecting and analyzing the results obtained from clinical research studies. As a clinical data manager, you will be responsible for leading the data management process of the clinical trials. Generally, a clinical data manager would provide clinical data management support for clinical operations team, study project teams and biostatisticians. Clinical Data Manager will have the opportunity to work in different settings like:
- Research laboratories
- Federal government (1), (3), (5)
The clinical data manager needs to do the following tasks:
- Provide the clinical data management support needed for clinical operations team and/or study project, and biostatistics team.
- Participate in the review of clinical research documents (examples: protocols, case report forms, reports and statistical analysis).
- Need to develop Data Management Plan (DMP), maintain the DMP throughout the lifecycle of each study project and ensure that DMP is followed according to study design and requirements.
- Need to develop Case Report Form (CRF), electronic and/or paper.
- Need to develop database (DB) for the clinical trial data specifications, eCRF designs, the user requirements, editing of rules and checks, with query logic and data validations.
- Lead EDC database (DB) specification process.
- Need to develop Data Transfer Agreements (DTAs) between the external data vendors and core labs.
- Need to reconcile the electronic data transfers from vendor to sponsor.
- Need to coordinate the archiving of study databases and their related documents.
- Must keep open communication with members of the research team and abide by any federal, state or local regulations concerning clinical research.
- They should be committed to maintaining the confidentiality of all study participants, and the proprietary information that belongs to the pharmaceutical company or research organization involved.
- To participate in the conference calls and meetings with vendors. (1), (2), (5)
How to become a Clinical Data Manager?
The candidate requires a bachelor's degree in a science related field with few of the positions requiring a graduate degree. In addition, you might need approximately five years of experience in this field for acquiring your position as clinical data manager. Also, he/she should have knowledge of:
-Good clinical practices
-Clinical trial processes
-Regulatory requirements and terminology
-Clinical database applications like EDC and CTMS
Furthermore, you should have excellent verbal and written skills along with good organizational, interpersonal, and team skills. (1), (2), (5)
In the United States:
The BLS (Bureau of Labor Statistics) has stated that a bachelor's degree in statistics may be enough to qualify for an entry-level position. Other related degrees may include:
- Computer science
You may need to pursue a master's degree in any related field in order to enhance your options.
As per the BLS, the opportunities for advancement may require the need to have a Ph.D. Other options for advancements might include research-oriented and academic positions. A Ph.D. may also be needed if one would like to become a consultant.
The Society for Clinical Data Management (SCDM) is offering a program for Certified Clinical Data Manager (www.scdm.org). In order to qualify and apply for this certification, a combination of education and/or experience is needed.
Once you have obtained the certification, you will need to renew it every 3 years, according to the SCDM. Part of the renewal process will include completion of at least 1.8 continuing education units, sixty percent of which should consist of CDM training. Other CEUs can be earned by taking courses that would address core competencies. (2)
In India, generally a college graduate with life sciences, computing or nursing qualifications are preferred, with 3 to 4 years of experience in relevant field. (4)
There are some certificate programs in clinical data management which are post-baccalaureate programs. The candidates who are interested need to have a bachelor's or master's degree in the field of biology, health sciences or natural sciences.
As the clinical data managers will have to coordinate and supervise the clinical trials that are done to test new pharmaceutical drugs and/or medical devices, the courses included in a clinical data management certificate program would cover clinical, regulatory, scientific, and project management topics related to the field of clinical research.
Students are taught on the ways of monitoring trials, executing right safety protocols, achieving industry regulations and documenting accurate data. Most typically, they are also required to complete basic training in management and communication. Some specific courses are as follows:
- Clinical trials design
- Human subjects protection
- Drug safety
- Monitoring clinical trials
- Writing medical reports
- Clinical study management
- Clinical trial data management systems
- Patient recruitment for trials (6)
The candidate should have applicable knowledge working with other clinical databases such as Oracle Clinical, SAS and others. In addition, the candidate should have experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry, and AE Coding, if applicable.
- Clinical database design
- Remote data entry technology
- Standard coding dictionaries
- Database methodology
- Microsoft Windows and Office
Some positions, such as senior clinical data manager, may only require a bachelor's degree plus 2-3 years of experience. (1), (2)
In the United States, according to the BLS May 2011 wage report, statisticians was found to be paid with a median salary of $35.52 per hour which equals $73,880 per year. Per www.salary.com, clinical data managers are earning a median salary of $97,029 annually.
Payscale.com reported in December 2014 that clinical data managers earned between $37,675 and $99,701 annually, with the median salary being $66,590.
In India, a Clinical Data Manager earns on an average of Rs 373,805 per year. The range is between Rs 175, 143 and Rs 786, 598. (2), (4), (7)