The Role of a Clinical Data Manager (CDM) is to ensure that all data from clinical trials is collected and recorded correctly, protecting the integrity of this data, and allowing accurate conclusions to be extracted from it. CDMs also develop and execute data testing and analysis plans, ensuring robust data quality and identifying new ways to improve existing processes.
What are the Main Responsibilities of a Clinical Data Manager?
The main responsibilities will vary from role to role, but may include:
- Managing clinical data queries.
- Reviewing and maintaining data management documentation and record management systems.
- Reviewing case report forms (CRFs) to ensure information recorded is complete, accurate, and compliant with study protocols.
- Preparing reports and presentations with updates on clinical trial progress.
- Organising and analysing clinical trial data to identify important trends/issues.
- Identifying new tools, systems, and processes to manage and process data more accurately, and coordinating with IT staff to ensure compatibility with existing systems.
- Overseeing the development and maintenance of the clinical trial master file (TMF).
- Reviewing study protocols to ensure compliance with regulatory standards.
- Checking study results for accuracy and completeness.
- Providing training and guidance to staff on study procedures/processes.
- Building and maintaining relationships with external bodies, including regulatory agencies.
- Analysing data to identify anomalies and potential issues to protect the integrity of the clinical study.
How is the Role of a Clinical Data Manager Evolving?
The Clinical Research industry is experiencing a huge digital transformation, with a big contributor to this being the increasing use of AI and Machine Learning (ML) in Clinical Research. AI and ML are providing new ways to analyse and manage study data, ultimately improving the quality of data and allowing necessary actions to be taken swiftly when issues and anomalies arise.
This, combined with the increasing decentralisation of clinical trials, has forced Clinical Research Organisations (CROs) to embrace new technologies in order to improve efficiency and quality whilst also expanding their capabilities.
For those looking to further their career in Clinical Data Management, being able to showcase strong digital literacy, as well as knowledge of new and emerging technologies in the industry, will be incredibly important.
What Experience, Skills and Qualifications are Needed to Become a Clinical Data Manager?
The requirements to become a CDM will vary depending on the role and working environment, but may include:
- Excellent communication skills.
- Demonstrated project management, time management, organisation, and leadership skills.
- Strong problem-solving and data analysis skills.
- Bachelor’s degree in a relevant subject (e.g., Data Management or Computer Science).
- Master’s degree in the Life Sciences.
- Knowledge of GCP guidelines and CDISC standards.
- Relevant professional qualifications such as the Certified Clinical Data Management (CCDM) program offered by the Society for Clinical Data Management.
- Experience handling data within the clinical study process.
- Competent in using complex databases/systems to accurately log and manage clinical data.
- Strong understanding of the clinical study lifecycle.
- Proficient in Microsoft Excel, SAS Programming, and other statistical software.
- Able to identify ways of configuring and validating systems to collect data that fit the study’s protocol endpoints.
- Project management experience, and experience leading a team of Data Managers.
Search the Latest Clinical Data Manager Jobs
You can find the latest CDM roles on PharmiWeb.Jobs here. Don’t forget to create an account and upload your CV to help recruiters find YOU, and to create job alerts to hear about the latest CDM roles as soon as they’re posted.