Anyone who works in clinical data management participates in the process of developing drugs by ensuring there is adequate data collection to demonstrate the effectiveness and safety of a therapeutic molecule. To learn more about this branch of clinical research, we met Valérie LaSalle, senior clinical data manager at Quintiles.
What does your work consist of?
I am the centre point between the pharmaceutical companies that oversee the clinical studies, the sites where the studies are conducted and the statisticians who analyze the data collected. Specifically, I supervise the team that designs the electronic records of clinical study participants. If, for example, the protocol provides for 15 visits, I make sure that the procedures carried out by the doctors and nurses (e.g., taking blood pressure) are detailed and that the data to be collected in the participant’s file are those that are necessary for statisticians to prove the efficacy and safety of their medication. I also make sure that the data is clean, that is, free of unrealistic measurements, such as a body temperature of 82°C!
Why did you choose the pharmaceutical field?
I wanted to contribute to innovation in the health sector. More and more diseases are being identified today which are difficult to treat. I wanted to participate in developing new drugs to treat these pathologies, to make a difference in the life of those suffering with them. A career in clinical research therefore seemed to me to be the ideal field to combine my interests and my professional aspirations.
I got a Bachelor’s degree in pharmacology and a Master’s in drug development, clinical research option. After my studies I naturally turned to clinical data management, since this branch of drug development allowed me to remain in contact with all the research specialities.
What skills are required for a position in clinical data management?
For a position in clinical data management, having a university degree in science is recommended, along with a basic knowledge of the medical field and the stages of drug development. Without being a doctor, you have to be able to understand the study protocols and the parameters to be analyzed. Statistical concepts are also required in order to understand what statisticians need to carry out analysis of the data.
Regarding personnel, you need to have good interpersonal and leadership skills, be organized and be flexible both for tasks and work schedules. Indeed, a study can launch or close very quickly and we are called on to work with people from other countries in different time zones. Finally, bilingualism is essential.
What are the opportunities in clinical data management?
People making a career in clinical data management can work in a pharmaceutical company or for a contract research company. Generally, you start in a junior position, for example, writing queries to validate certain data collected with the clinical sites. Depending on your interests and ambitions, you can climb the ladder to reach, in some cases, supervisory positions.