Careers in Clinical Trials

DID YOU KNOW?

A Clinical Data Manager usually progresses in his/her career to senior management positions such as Head of Data Management, Director etc.

MANAGING THE STUDY DATA

A Clinical Data Manager plays a vital role in the proper management of the data generated by clinical trials. A data manager ensures that data is collected as per the requirements of the study protocol and that it is free from any errors before it is analyzed.

Next Commencement Date

01 JUL

2021

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Careers in Clinical Data Management (CDM)

Clinical Data Management (CDM) is an important department in pharmaceutical and contract research organizations that usually employs more people than any other department. This department is involved in overall collection and handling of clinical trial data. Data Management teams develop tools for collection of data at clinical trial sites, quality check the collected data for errors and raise flags in case any discrepancy is identified. They develop tools for verification, validation and quality control of the data gathered during the clinical trial. Clinical data managers ensure the integrity and confidentiality of collected data is maintained at all times. Various security controls are incorporated into the system to ensure that the data extracted from the clinical trials is secure and not prone to any open threats. Careers in Clinical Data Management are very promising. This field offers a wide scope of career options. Common positions available in Data Management departments are:

– Clinical Data Manager
Bio-statistician
– Clinical Data Coordinator
– Clinical Data Entry Operator
– Clinical Data Reviewer
– Software Developers and Programmers with expertise in SAS, SPSS, Oracle Clinical etc

CLINICAL DATA MANAGER

A Clinical Data Manager plays a vital role in the setup of a clinical trial. A Clinical Data Manager is active in the inception phase of the study and participates in early discussions so as to provide expert opinion on how data should be collected, managed and analyzed. A data manager helps with the development of data collection tools, development of data management plans, setting up of the study in the applicable data management softwares and provides ongoing oversight of the study from a data management point of view. A data manager with the use of advanced computer softwares and database systems validates, verifies and processes clinical study data. Consistency and accuracy of data is guaranteed by the clinical data manager. Once all data is collected and declared as final, a ‘Database Lock’ or ‘Database Freeze’ is applied by the data manager. The verified and validated data is then sent for the statistical analysis by the Biostatistics team. Common data related activities that are observed by the clinical data manager are, reviewing, CRF tracking, safety coding and updating. Several other responsibilities rest with the clinical data manager. Some of them are:

– Management of database entries, databases, tables
– Interfacing with sponsors
– Checking database constraints
– Ensure completion of project within allotted deadlines
– Preparation of different types of statistical reports
– Resolving any ongoing data and operational problems

Competencies & Skills:

Various competencies and skills are required to become a Clinical Data Manager. Some of them are:

– Thorough understanding of the drug development process with extensive knowledge of ICH-GCP
– Extensive knowledge of clinical trial regulations such as those of US FDA, EMEA, DCGI etc
– Good computer skills
– Excellent leadership skills
– Good record keeping skills
– Ability to motivate
– Self confidence
– Ability to think Out-of-the-box
– Problem solving skills
– Time management skills

Education:

– Bachelors or Masters degree in Computer Science, Pharmacy, Life Science or Mathematics is highly recommended
– Knowledge of computer programs such as Oracle, SAS, MS Power Point, MS Word, and MS Access is required

RECOMMENDED PROGRAM

To work as a Clinical Data Manager (CDM) we suggest you consider the following online program(s):

Advanced PG Diploma in Clinical Research & Data Management
Professional Diploma in Clinical Data Management

Participant Feedback

"Thank you for the hands-on training on Oracle Clinical. It was amazing that we had remote access to the Oracle software during the training sessions. It significantly helped to understand how to use this software."
Reena Matthew
India


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