In 2004, the role of a Data Manager was very different. So too were the skill sets required in the UK. EDC and ePRO were just starting to become the norm and offshoring was a new concept in data management.
When CK Clinical was established the majority of our business was introducing data managers to the pharmaceutical industry. Part of the rational behind this due to the sheer volume of demand for data managers from UK based businesses that were, at the time, unmet.
Over the past 10 years we’ve seen a complete reversal in supply and demand with supply now far outweighing demand, and the role of the Data Manager now evolving into something very different. The obvious change has been in numbers, with the number of Data Manager roles decreasing significantly, with many offshored to reduce costs. There has also been an increasing value of importance put on ‘fit’ which is now seemingly an essential pre-requisite when helping companies resource their teams. As such the role of CK Clinical has changed from finding ‘lots, of people to now finding the ‘right’ people to get the job done.
A look back over the last ten years shows how the job has evolved. Prior to the acquisition by Pfizer, Wyeth were one of the first innovators to lead the charge in offshoring large swathes of their Biometrics work to Accenture’s service offering in India . This produced an immediate change in the role of Data Managers creating the Project Data Manager. This change quickly cascaded out to other businesses.
Whilst Electronic Patient Diaries and ePRO were being used, a decade ago we saw the pace of acceptance of this technology and its incorporation into the mainstream. This in itself also created a new opportunity for the traditional Data Manager to become a Technical Data Manager or Project Manager.
Today, the Project Data Manager holds many skills that differ to the historically nature of cleaning data sets. The skills now required include but are not limited to:
- A greater ability to multitask
- Tact and diplomacy dealing with multiple cultures and backgrounds
- A willingness to work across multiple time zones often outside of the typical working day
- Greater interaction with other departments than ever before
- Balancing budgets and resource
- An ability to build a team, sometimes without even getting to meet them
The Technical Data Manager also requires a different skill set and is often called upon for their very specialist and niche knowledge – skills that a data manager of the past would never have considered within their role.
The changing expectations and requirements of Data Managers affects everyone working in data management. However 10 years ago, very few people would have known just how much the industry would change. So what does the next decade hold in store and how will this impact on Biometrics?
The current trends in the pharmaceutical sector are leading to increased cost, time and quality pressures. As the cost of developing drugs continues to rise companies are looking at methods to reduce overheads. As clinical monitoring is one of the most expensive costs in running a study, this is likely to feel the greatest pressure resulting in the increasing use of technology and changes in the way sites are managed. In all likelihood, this will either create a new type of role, or lead to further demands on Data Managers to be more technically skilled as well as create and manage relationships remotely.
Another demand from the increased emphasis on effectiveness is cleaner data, faster. Given that the time to complete a study is constantly under pressure, the need to get to database lock more rapidly will be enhanced. This again is likely to make full use of technology but it will also require earlier input from Biostatistics to examine outliers and anomalies to help with data cleansing and database lock. If we look at other sectors like the FMCG market and how Big Data is used, we can expect this to impact on how data is assessed and how quickly trends are spotted using algorithms and powerful computing.
Globalisation will also lead to more changes. Today’s project data managers are often very familiar with working with teams in far reaching countries with a multitude of cultures across many time zones. However as work continues to move to lower cost countries around the world, we look set to see a demand for a shift towards the next wave of cultural differences from countries like China. This could also lead to an increased demand in other language skills that many of the current work force do not possess.
Finally, pharmaceutical companies are increasingly becoming the knowledge base that drives the innovation behind future therapies, with CRO’s assuming the position as experts in operational delivery. It is widely accepted that clinical research organisations will grow at a rapid rate as more and more work is outsourced to them in strategic partnerships. This does mean that in terms of employment opportunities, a role within a CRO is more likely to become available in the future than an “in house role” in a pharmaceutical company. This is also likely to impact on the number of contract roles available.
In summary, the last ten years has seen rapid evolution for the Data Manager. The next ten years will see the impact of increased Globalisation, Big Data and the rapid evolution of technology changing the nature of the role even more. One thing is for sure, it’s an exciting time to be in the business of Data Management.