DOCS - A day in the life of a Data Manager

Ciara Barron, Director of Program Management at DOCS, talks about her experience working in Data Management

My role
I’m the Director of Global Program Management at DOCS, overseeing DATA Management and other functional FSPs. Before joining the DOCS team, I worked at ICON for 15 years as Director of Data Management.

What Data Managers do
Data Management processes are vital to ensure the data integrity required for effective analysis, ultimately determining if the drug assessed will help make a difference to people’s lives if it goes to market.

For any analysis to occur, all subjects or patients involved in the clinical trial must complete the same details in a Case Report Form (CRF). This data is then databased by the investigator or doctor at the site, typically in an electronic CRF. It’s at this point the data is ready for Data Management to review. In some cases, other data is captured by a third party outside of the CRF data (for example Central Lab data). This data also gets sent to Data Management to be cleaned and reconciled with the CRF data.

The team carries out a series of checks on the data, ranging from the very standard to more complex. They pick up if anything is missing, doesn’t match up or looks unusual, cross checking all the data and raising queries with the trial site as needed. Once all data is collected and all anomalies addressed, it’s passed to Biostatistics to be analysed.

Different Data Manager roles
Data Management is made up of many different roles, including Data Management Project Manager (DMPM), Clinical Data Lead (CDL) and Clinical Data Coordinator (CDC).

Clinical Data Coordinators are hands-on with the data, combing through it for discrepancies and queries and passing these on to the site. Meanwhile, the Clinical Data Lead coordinates the CDC activities, producing status reports and managing day-to-day Data Management activities and tasks. The Project Manager oversees all these activities and does metrics, risk reporting and escalation. While these roles are separate, our teams work together closely to ensure we do the best work possible.

There are also support roles that provide essential assistance in carrying out Data Management activities. An example of this is the team that builds and supports the electronic CRF or the team that programmes cleaning outputs for CDCs to review.

A day in the life
It’s hard to describe a typical day in the life of a Data Manager, as there’s always something different at every turn. That’s what I like most about this industry - you’re never sure what’s coming next. You can’t predict what questions are going to come in or how a site will respond to a query.

Also, as Data Management cleaning is placed at such a critical step in the clinical trial process, there is lots of interaction required with other functional areas. This always challenges how you look at data and gives you the chance to interact with other people. As Data Management is a service, we need to take the time to understand the sponsors’ needs and preferences. This diversity and exposure to other methods of data cleaning helps Data Management become experts in identifying upfront the challenges that go along with the different client methods of data cleaning.

Finally, there are also great opportunities to work on new systems and develop new processes. You never stop learning in Data Management.

Succeeding in Data Management
Analytical people do well in this role. On paper it’s very transactional but we do better with analytical people who ask “why?” and dig a little deeper to get the bigger picture.
Patient people are a good fit, too. Every site is likely working on a number of different trials and so have a different set of rules to abide by on each trial, so Data Management needs to take their time and work through every step carefully. There are always a lot of questions sites ask us when we’re managing the data, so Data Managers must be patient and understand that ensuring data integrity is key. They also need to understand the full clinical trial process.

Getting started
When it comes to hiring people as Data Managers, we predominately look for people with scientific degrees. A graduate’s degree or diploma can indicate their relevancy for a role, but experience is also really important, particularly when problem solving and dealing with customers.

In terms of which companies offer the best experiences for Data Managers, I strongly recommend both ICON and DOCS. This is largely down to the sheer diversity of trials and clients that come through the door every day – as I say, you never know what’s coming next.

Moving up
There’s a clear progression ladder for Data Managers and plenty of scope for moving around. The Clinical Data Coordinator role has plenty of levels within it, for example. Performance and experience are key when it comes to advancing and there’s also scope to move across departments.

If you’re interested in learning more about Data Management or want to see the full scope of roles available at DOCS, click here.