We’re delighted to have Mark from our Permanent Team – and data management expert – talk us through what he’s seen during his time in the industry. Having come from the life sciences industry following spells at Covance, Orion, then latterly as a Clinical Data Manager at Roche before joining Merck Sharp & Dohme as a Data Project Lead, Mark has been placing people in data management roles at SEC since 2012.
Give us a brief overview of the types of positions that you work on and the types of individuals you work with.
We generally work with CROs these days but also we have some big pharma companies we partner with. In the main it is with CROs that we work with because pharmaceutical companies tend to use the CROs as full service to support on all aspects of their work. That type of model has been in place for the last ten years or so, from my time in the industry.
The level of the roles that we look at are the Project Data Manager level and below. This is where we place most of the people in this space. The types of work that the people we work with get involved in will be on leading the study, the design of the study, setting up of the data management plans, the edit checks, validation plans, user acceptance testing, then setting up the study to accept the patients ‘first visit’, which is the milestone.
Thereafter, the role of most Project Data Managers we work with is to co-ordinate the other data managers, who could be based anywhere from Poland to India, China, Colombia, Romania, etc. So the model is that they are working across a variety of different countries where the main Project Manager is the lead in ensuring all other Data Managers are delivering on what is required. These data managers tend to do a lot of the processing and cleaning of data.
The Project Data Managers we work with would typically have between three to five studies to manage – these could be either therapeutically aligned or client aligned – with the majority working with similar studies. The Project Data Managers would then work on the studies throughout the entire life cycle, which sometimes lasts anywhere from six months to a year on the early phase studies, or up to eight years for a full service oncology trial, for example.
Usually the average amount of time you will see a Project Data Manager in a role would be around the three year mark.
How has the data management market changed in the last ten years?
I would say the big change in data management was actually about eight years ago – possibly slightly more. I would say one of the big changes came when a series of major Pharma’s decided to use an outsourced model route to India, pushing more of the entry level data manager roles to India and taking those roles away from the UK and Western Europe. What then emerged in the UK was that you would have more senior roles remaining in the UK and Europe, with the most senior roles remaining within the pharmaceutical companies or the largest of the CROs globally.
Today, data management is moving in to more technically challenging areas, such as clinical data interchange standards consortium (CDISC) which is a consortium of data standards where everyone has to reach the required data standards for regulatory submissions. These are the kinds of technical roles we work on.
What does the perfect candidate look like to a lot of the employers you work with?
Anybody with between five and ten years’ experience and will be somebody who has worked within a CRO or pharmaceutical company. Anybody who has led studies by themselves are always valuable to employers, from study start up to database lock and people who have managed teams are always valuable. Individuals with diverse therapeutic area experience are always sought after too. Communication skills are key because dealing with clients can be difficult whether you are on the CRO or sponsor side.
What does the data management market look like in ten years’ time?
You will always have people talking about artificial intelligence and in many industries I can see why that is a hot topic right now, but it is my belief that you will always need to have an element of human interaction within the data management market. Certainly technology will have its impact, as will the advancement of more intelligent tools to help data managers become more efficient. Perhaps the roles of the future in this space will be in the designing of these tools; doing the work that previously was completed by human hand. Or perhaps in the quality control and monitoring of these tools by human hand. As I said, there will always need to be an element of human interaction in the process, it just depends at what stage that interaction occurs. Can computers manage people effectively? I don’t think so and so there will always be a requirement for people in the industry.
Is there one piece of advice you could give to somebody in this market?
Yes. Equip yourself with CDISC and be ready to adapt. The world of work is constantly shifting and our industry will evolve too.