Data Managers were once associated with “Data Entry Clerk”, and the role usually required no formal training and had no defined role within clinical research. Thanks to regulatory guidelines such as GCP (Good Clinical Practice) implementation, regulatory authorities such as the European Union audits and inspections as well as FDA requirements for drug submissions, the role of the Data Manager has changed.
Due to increased requirements by regulatory authorities in the drug development process, the Clinical Data Manager has more of a stake in the requirements for data collection, data accuracy and quality. The relationship of the Data Manager has changed from 1:1 (Data Manager to Statistician or Clinical Research Leader) to 1:Many, and the Data Manager now plays a particular role in the study team.
The Clinical Data Manager is now involved in more of a Matrix environment:
The Matrix environment is a result of diverse functional teams working together to achieve a project goal. In this sense, the Data Manager must develop team building skills.
Clinical Data Managers are also increasingly working in global and/or virtual teams. While this can present many advantages like increased productivity, extended market opportunities and virtual knowledge transfer, it also presents some disadvantages which a Data Manager must be prepared for. For example, virtual teams can lead to communication breakdowns and poor leadership.
As a result, Clinical Data Managers are required to have a new skill set.
First, the Clinical Data Manager is shifting from a technical background to a more scientific background with degrees in biology, chemistry and life sciences in order to understand the nature of clinical data. Most Clinical Data Managers are also equipped with computer science skills to bridge the gap between science and informatics.
In addition to logical being a core characteristic of a Data Manager, they must now develop more “soft skills” such as:
- Building Relationships
- Customer Oriented
- Flexible Thinking
Clinical Data Manager in Functional Service Provision
This modern profile of the Clinical Data Manager puts them in a good position for success in the Functional Service Provision role. The FSP outsourcing model allocates a dedicated team of resources to a project for a determined period of time. Clinical Data Managers can be a key component of an FSP model and are often assigned to projects for months at a time at the Sponsor’s site. What are the benefits of outsourcing a skilled Clinical Data Manager in an FSP model?
- Scalable and customized solution: determine a work schedule that fits your needs
- Choose the Data Manager(s) that fits your needs based on therapeutic area expertise and technical competencies like EDC experience
- Minimum training required and CRO is responsible for most training requirements
- High quality clinical data management deliverables
- Data Managers trained in GCDMP and CDISC standards
- Consistent pricing contracts
- Flexibility: on-site or remote working
Are we moving towards the Hybrid Data Manager?
Clinical trial Sponsors are increasingly adopting a Risk-Based Monitoring approach. The role of the Data Manager is crucial in this strategy for maintaining a high level of data quality to ensure the validity and integrity of the final analysis results. Risk-Based Monitoring is not only the task that the monitor/CRA performs off-site, but a cross-functional approach to managing the quality of studies. The Data Manager is responsible for eCRF setup, data handling and cleaning, and a review of metrics for site quality.
Are we now looking at a hybrid data management role in which the Data Manager takes on more duties of the CRA who, in turn, spends less time at sites?