Jon Wood is currently Chairman of the Association for Clinical Data Management (ACDM) which he balances with his full-time role as Senior Vice President, Operations at Accelsiors, a CRO Headquartered in Budapest.
How long have you worked in the clinical research industry?
I’ve been working in this sector since 1989.
How did you get into clinical research and what career path did you take?
During my degree in physiology, part of the 3rd year involved a placement; working in industry in a busy hospital cardiac unit. The unit was recruiting cardiac patients who were undergoing clinical trials. This gave me the initial ideas for my career direction. Straight after graduating I worked in another academic unit for a cardiology team in London. I am a bit of a self-confessed geek, so I was asked by the consultant supervising the trial to set up a database for the processing of private patients. I was there for about 18 months when I saw a position advertised by Glaxo who were expanding their data management function. I joined them in 1989 in Greenford. In my spare time I’m also a musician, a semi-professional drummer, which helps keep me sane!
What do you most enjoy about working at ACDM?
The ACDM has been part of my career since I started in clinical research. I joined the organization and found it ideal for networking, especially at the start of my career and then got further involved delivering training and webinars. Training is a field I am very passionate about and it has allowed me to get involved in a wide range of other activities. It has also supported my career by helping build a network with like-minded people.
What is the most challenging aspect of your role?
When I first joined the industry, Data Management was very different from today. It was highly paper-based and very labor intensive. The ACDM has helped to develop Data Management as a formal career path. We’ve still got plenty of work to do in defining the constantly evolving roles in Data Management as well as across areas of professional development; especially given the changing face of clinical research.
What is the most rewarding aspect of your role?
At the ACDM I enjoy delivering training, especially webinars where people share ideas and benefit from applying knowledge to their job roles. I find delivering training very rewarding: giving back and sharing best practice is fun. We just had a great conference in Brussels where we were able to put look at some fresh perspectives on the Data Management industry.
The company for which I have worked for the last two and a half years, Accelsiors is interesting because we specialize in complex trials developing biosimilars which often involve large and challenging studies in a wide range of therapeutic areas. The use of biosimilars has a key role in cost control in the treatment of patients. It is a field which is very highly regulated and each trial is complex with a multitude of moving parts which is what I enjoy. I like being involved in the science and being hands-on but also being part of Accelsiors’ executive management team to contribute to the strategic development of the company.
How has the industry changed since you started out on your career?
At the start of my career, I remember being in a very large office where the space was very cramped because it was full of the paperwork necessary for a regulatory submission at the time. In my early career, the industry was dominated by huge amounts of paper containing patient data, reports and submission information. Case Record Forms were all paper-based, data entry was manual and labor intensive. Lots of effort was expended. There was no internet or email and not much use of IT. Since those days, the clinical research sector probably hasn’t improved efficiencies as much as we would have liked. The internet has made a great difference however the sector was slow in the uptake of remote data capture. Many studies now use e-data capture and other tools such as e-diaries. Nevertheless, it’s important we still maintain our focus on data integrity and patient safety. Nowadays, fewer people are needed to review data and this has opened up new opportunities for data managers and as such the respective roles are continuing to evolve. We have also seen the advent of the use of lower cost regions in Data Management such as across Asia, South America and Central and Eastern Europe. However, the use of technology has not significantly reduced development timelines or costs.
What advice would you give to someone starting out on their clinical research career?
It’s a fantastic career path. Unfortunately many new graduates are not familiar with clinical research as a career option and the opportunities it can offer them. We need to engage graduates and academic institutions in making people aware of the variety of career paths. We need to get the message across that it’s a dynamic sector which is constantly changing, which positively impacts the lives of patients. It’s also attractive because people can readily move across different roles, for example from Clinical Monitor to Data Manager, Statistician, Quality Assurance and so on.
Describe yourself in 5 words
Diplomatic (I had to learn this!), methodical, conscientious, creative and ambitious. Every day I learn something new about the industry and more importantly, myself. When things go wrong – when you don’t perform to your potential – you learn, you build; you are always learning in this industry.
What do you think the industry should be doing to attract, train, qualify and retain talent?
As I mentioned earlier, we need to attract talent by being much better at communicating the opportunities and roles in clinical research. We also need proper frameworks around these roles which will enable us to present defined career paths. We need a clearer definition for these roles.
The best qualifications for becoming a Data Manager are that they need a good life science background plus an eye for detail in the data, understanding new standards, addressing practical challenges of building systems and data sets. Being outward looking, as well as a strong communicator, proactive, solution-focused; someone who can see the big picture, spotting trends etc. Some of best Data Managers don’t have degrees – for example, you can start in a data entry role and for people who enjoy science and are attracted to enabling technologies there are lots of opportunities. At the end of the day we are positively impacting the lives of patients.
What is the ACDM doing to help address to attract, train, and retain talent?
At the ACDM we are continuing to further define our offerings for the industry. We are doing this by networking more broadly and encouraging people to take part in our training programs. More people are moving into freelancing roles and we need to be able to support them. There are real opportunities in the academic areas so we want to support academia by training and mentoring and building relationships with academic institutions.
How do you think IAOCR can help to address the issue of attracting, training, and retaining talent?
By building an effective campaign for having competent people in our sector. We need to have clear competency frameworks which we haven’t had in the past. There has often been no, or limited, clear structure around training – building robust competency frameworks helps. Training has been relatively unstructured and competence based training can reverse this trend. IAOCR can drive recognition of competency frameworks by reaching out to regulators to help refine career paths. Checking competence is not about reviewing training records. We need to have mechanisms in place for verifying and ensuring competence. We are going to see some challenges in retaining new talent and having a competence based structured approach will help attract new talent. We need to attract new talent because the volume of clinical trials is increasing. IAOCR can support by working with regulators and politicians.
What do you think will be the top 3 challenges for the industry in the next few years?
- Geopolitical challenges. President Trump is making big changes at the FDA. We have Brexit looming in the Europe. There is a degree of uncertainty and possible changes in the offing but change is the norm in our industry and we need to deal with it.
- The continuing evolution in technology will continue to change the face of clinical research. We are already taking a more risk based approach in data capture and there is now a much more automated way through the use of e-data technology. We need to continue to embrace new technology and use it in an efficient and effective way.
- Continuing cost control and the efficient delivery of studies. We need to be constantly innovative and creative. The uptake of global data standards for data is helping. Transcelerate has a role to play in creating an environment in cost effective and efficient research.
And finally, there has always been something new to learn and that is one of the key things that motivates me in working in this industry