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A day in the life of a Clinical Data Lead

A Clinical Data Lead plays a pivotal role in clinical trials, supporting research teams to record information to be studied and validated. It’s a multi-faceted role that involves strict attention to detail and the ability to juggle multiple tasks – but what is it actually like to work as a Clinical Data Lead?

ICON’s own Katerina Kriger talks to us about her seven-year experience. She offers valuable insight into a typical day in her current role as a Clinical Data Lead as part of the Data Management team:

 Katerina begins her day by prioritising and assessing her workload — her mornings tend to be quieter than the afternoons, so she finds this to be the best time to catch up on paperwork. Typical admin tasks include updating the Data Management Plan, CRF Guidelines and Study Specific Procedures. This also involves programming tasks such as writing and finalising specifications and validating listing outputs. Moreover, an important aspect of her job includes liaising with her Sponsor and internal team. 

“Mornings are spent training the Clinical Data Coordination team in India, providing them with tasks for the next day in addition to discussing any issues/queries on the study during the internal DM team calls.”

In the afternoons, Katerina collaborates with her other Sponsor who is based in the US. She says effective communication and organisation are key to her role as one call can be more productive than several e-mails. In addition, collaboration, partnership and communication are integral, both for a CDL and as cultural values working for ICON.

Katerina works closely with the Clinical Operations team including the CTM and CRAs on her studies. They act as an initial point of contact to discuss any data entered in EDC by sites and are a valuable resource when writing CRF Completion Guidelines. The role of a CDL involves both managerial and financial aspects, working with a range of different functions:

“As a CDL, I like to get involved in the financial side of the studies that I am working on. This means I also work with the Cross Functional Project Manager to provide monthly figures based on the EDC reports.”

Katerina also aids and supports the Data Management team consisting of CDCs, DMPMs and programmers. Together, they write specifications for any review listings, resolve issues in the database and provide metrics reports.




 
The role of a CDL is not without its challenges, such as the need to be prepared for any and all questions a Sponsor may pose. This usually involves being calm, polite and knowledgeable and following up via email with any additional information that she wasn’t able to answer during the call. In addition, she mentions the key skill of prioritisation:

“There can be days where you can be overwhelmed with the number of different tasks from numerous studies and this can be challenging, especially if you are new in the role. Eventually, we all learn how to overcome these stressful days and prioritise the tasks, while always keeping your team updated on the progress.”

The support of the rest of the team and a little prioritisation can go a long way when handling a hefty workload. Katerina manages this as the team’s lead by delegating some tasks to the CDCs — who she makes sure are trained and supported to handle the work. This leaves Katerina with time to perform more complex tasks.

Though challenging at times, Katerina relishes her role as CDL and particularly enjoys the variety of tasks she gets to work on, along with the value she gains from working with a variety of stakeholders with diverse backgrounds.

“I always have a sense of pride when I deliver good results to the Sponsor. I find that you are never bored with one task in this position and there is always the possibility to learn new tasks if you are keen. You are always welcome to propose new ideas for processes in this job and discuss them with your colleagues.”

The role of a Clinical Data Lead provides many benefits such as flexible working on a variety of tasks and building strong relationships with stakeholders and team members. Are you considering a role as a Clinical Data Lead? ICON is a Clinical Research Organisation which hosts a variety of Clinical Data Lead jobs in over 40 countries worldwide. Take your next career step with us and apply for one of our roles today.

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