Career and job prospects in clinical data management
What is clinical data management?
Clinical data management (CDM) is a crucial clinical research phase, ideally leading to high-quality, solid, reliable information or data supported by statistics from clinical trials. CDM plays a necessary role in the data collection stage of clinical studies. CDM procedures aim to offer top quality data by omitting errors and building up the most information feasible for evaluation.
CDM is an essential department in pharmaceutical and contract research organizations that typically employs more individuals than any other department.
Team members of CDM are actively associated with all phases of the clinical trial from clinical to end. The clinical data management’s process covers clinical research subjects such as case record form designing, medical coding, data entry, and database design.
As of now, there is a high need to boost CDM standards so they more appropriately address regulatory needs and remain ahead of the competition by faster commercialization of medical items.
Best practices are adopted to make sure complete, reliable, and processed data is readily available to accomplish this.
The findings provided by CDM research are critical in the medical field because they drastically reduce the time from drug development to the marketing process.
They need to have ample process understanding that assists maintain the high-quality standards of CDM processes.
The field of CDM has happened due to demands from both the pharma sector and the regulatory authorities.
The standards made by the CDISC (Clinical Data Interchange Standards Consortium) that are essential to CDM are:
- The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG).
- The Clinical Data Acquisition Standards Harmonization (CDASH).
How does clinical data management work?
The regulatory agencies believe that there is a persistence in offering clinical trial data for the authorization of new medicines by pharma firms. Thus, the firms have to ensure that clinical study personnel is trained and qualified to do the Clinical Data Management work.
The process of clinical data management is as follows:
- Case report form (CRF) Creation – Translating the protocol-specific activities into data being generated.
- Database Designing – Clinical software application as per regulatory compliance.
- Data Collection – Filling up CRF’s as per guidelines.
- Data Entry – Double data entry helps in getting a cleaner database compared to single data entry.
- Data Validation – Process of testing validity of data as per the protocol.
- Discrepancy management – Discrepancy may be due to irregular data, range checks, and deviation from the protocol.
- Medical Coding – It helps in identifying and classifying the medical terminologies associated with clinical trials.
- Database Lock – The database will be locked and send for analysis after a proper quality check and assurance with final data validation if there is no discrepancy.
CRF forms may be utilized to gather information by paper or digital means. Anyhow, as innovation has continued to evolve, the fad towards electronic data collection has actually done the same. Moreover, remote data entry or e-CRF has been adopted by several pharma firms as a time-saving approach.
Tools for CDM
Many software tools for data management are available, and these are known as Clinical Data Management Systems. Generally utilized clinical data management tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. Few open-source tools are OpenClinica, openCDMS, TrialDB, and PhOSCo.
What are the roles involved?
CDM requires several functions as well as the duties of team members, and they are:
- Data manager – Collecting data from several clinical research studies, monitor the CDM process, maintain all the clinical research and clinical trial data, and analyze the outcomes of clinical research and trials.
- Database programmer or designer – executes the CRF annotation, develops the research study database, facilitates data validation, develops data entry screens, and carry out edit checks utilizing dummy information.
- Medical coder – codes variants like adverse events as well as medical history.
- Clinical data coordinator – Designs the case report form, develops the filling instructions and develops disparity protocols.
- Quality control associate – Checks the accuracy of data entry as well as carry out data audits.
- Data entry associate – Tracks the receipt of CRF pages as well as enters data into the database.
Other Job profiles in CDM
- Clinical Data Reviewer
- Clinical Data Entry Operator
- Clinical Data Coordinator
- Clinical Data Manager
- Software Developers and Programmers with expertise in Oracle Clinical, SPSS, SAS, etc.
- Bachelor’s or Masters’s degree in pharmacy, paramedical science, biochemistry, biotechnology, medical, dental, physiotherapy, or nursing.
- Understanding computer programs such as Oracle, SAS, MS Word, MS Access, and MS PowerPoint is needed.
- Knowledge of the drug development process with a considerable understanding of ICH-GCP.
- Expertise in clinical trial regulations such as Food and Drug Administration, European Medicines Agency, Drugs Controller General of India, etc.
- Good computer skills.
- Good leadership skills.
- Good record-keeping skills.
- Problem-solving skills.
- Time management skills.
- Communication skills
One of the most important facets of clinical data management work requires:
- Ensuring accuracy of all clinical data
- Checking for complete data to facilitate accurate outcomes
- Making sure the collected data follows a logical path.
- Maximizing consistency to weed out discrepancies and errors
Associations & Resources for Clinical Data Management
The SCDM (Society for Clinical Data Management) generates the GCDMP (Good Clinical Data Management Practices) guidelines describing the field’s practice criterion.
Likewise, SCDM carries out the International Association for Continuing Education, Training (IACET) accredited certification program for clinical data managers, online and in-person educational opportunities, and career resources for both job-seekers and companies.
The ACDM (Association for Clinical Data Management) has actually been running for the last 3 decades. The organization uses training, resources, and professional development for those associated with CDM phases in pharma, biotechnology, and academics.
Job prospects in CDM
CDM is needed in all phases of processing the clinical data, collaborating with the ranges of computer applications and database systems to sustain clinical trial data collection and management. There is massive career development in clinical data management. Candidates have tremendous career development in CDM.
There is a great deal of job opportunity in this field, and it has even more economic advantages.
Top companies offering CDM jobs in India
- Syneos Health
- PRA Health Sciences
- Fisher Clinical Services
Certification Course For Clinical Data Management – Clinical Data Management Certification Program
Keyword – Career In Clinical Data Management