Having worked in clinical research since 1989, Martin has experienced life ‘on the shop floor’ as a CRA and a project manager before his interest and expertise in training took on a primary role in his career. As a co-founder of IAOCR alongside Jacqueline Johnson North, Martin is dedicated to improving all areas of clinical research, from entry level right up to Senior Leadership and everything in between.
How did you get into the clinical research and industry and what career path did you take?
I started out as a bench scientist. My first job was in the Pharmaceutical sector working for Pfizer in drug discovery. After a couple of moves I found myself working in medical diagnostics designing new endpoints for diagnostic kits.
I enjoyed the challenge of trying to solve scientific problems but wanted to work with people and so I chose clinical research which seemed to have the best of both worlds. My first CRA role was with Besselaar Associates which over time became Covance and is now part of LabCorp.
At the time I joined Besselaar, they had just been bought by Corning who were introducing a quality management system across their organization. Part of this initiative involved the staff attending a training course on quality management. I happened to mention that my previous company had had a similar system and so I was invited to help deliver the training program. I had been a CRA only for a few months so ended up in a dual role with my site monitoring interspersed with delivering a two day training program once a month. This is when I first developed an interest in learning and development. Eventually, like a lot of CRAs, I became a Project Manager, but moved full time into a learning and development role for Covance as the company grew and when the opportunity arose.
What do you most enjoy about working at IAOCR?
Variety – no two days are the same. Each client wants a different solution unique to them. Designing tailor made options for our clients, watching the results and how successfully they are implemented is very rewarding. That’s the day to day situation but over the long term we’ve built a great team who share the same values and drive what Jacqueline and I had from day 1 when we were working from each other’s houses. Now when we are all in the office there is a real buzz and we have a lot of fun too.
What is the most challenging aspect of your role at the moment?
Keeping track of the wide variety of areas in which I am supporting our growing business. I manage to keep on top of it but it sometimes feels like driving a car which is on the verge of going out of control. Things are definitely easier now than when we first started out with just the two of us. I remember trying to find an internet café (do they still have those?) in the snow when my router at home had gone down.
How do you think the industry has changed from when you first joined it?
The use of technology, advances in medicine, the increase in outsourcing and even more globalization have probably made the biggest differences. When I first started we had paper CRFs. We didn’t have desktop computers. Mobile phones were the size of house bricks and just about as useful for making calls. Email was very sparsely used and not many organizations had it so the fax machine was in its heyday. I must sound like a time traveler from the Stone Age but somehow we managed. Some of the advances in medicine in the last 30 years have been staggering, particularly in oncology and HIV, both in terms of diagnosis and treatment. One of the consequences of these developments is that many trials have become more complex and this has resulted in new challenges for the sector.
What has changed for the better, in terms of how the industry has evolved during your time in the clinical research industry?
Definitely the use of technology and the ability to collect, manage and analyze large volumes of data very quickly. I also think the regulatory guidance on using a risk based approach is very welcome and it’s good to see that this has found its way into ICH GCP too.
What has changed for the worse if anything, in terms of how the industry has evolved over this timeframe?
I think we have lost some of the glue that holds organizations together – by this I mean the human factors – how people work together in teams and as individuals; how they communicate, negotiate, manage and lead. Society as a whole and the clinical research sector in particular has become over reliant on technology. We are sometimes seduced by its remarkable capabilities but perhaps we don’t stop and think enough about how to exploit technology to its best advantage and integrate it into our working lives so we are adding value rather than trying to use it carte blanche to automate processes and procedures just for automation’s sake. For instance, technology enables many more people to work from home than ever before. This has obvious advantages; reducing costs, minimizing travel time and so on. However, the downside is individuals who rarely meet their work team mates don’t establish such strong bonds with them or with the organization they work for. We have become over-dependent on email and sometimes just picking up the phone or going to see someone in the next office is a far better option.
I also think our sector is still too risk averse. This is perhaps understandable as we are dealing with patients’ wellbeing and rights. Nevertheless we need to question how what we do impacts patients. We have a tendency to overcomplicate things. I’m not sure what the European Clinical Trial Directive has added in terms of improving the quality, reducing risks to patients and enabling clinical trials to be run effectively and efficiently. Similarly, the various updates to the Declaration of Helsinki, although well-intentioned, I think have often complicated matters rather than helped researchers conduct studies ethically. As I said earlier, the risk based approach adopted and promoted by both the FDA and EU Commission is very welcome. I think they were very thoughtful and overdue pieces of guidance. As a sector we need to think about what’s important in conducting trials safely, ethically and efficiently and not get bogged down in unnecessary bureaucracy or get sidetracked by issues that are not significant in protecting patients or data integrity.
What advice would you give to someone starting out in their clinical research career?
Reflect on what you would like out of a job and what you don’t like. Don’t get into clinical research just for the sake of it. Do you want to work on the commercial side or would you consider starting your career on the academic side? Think about what your starting point in the sector might be and what your short term career over the next 2-3 years would be. Consider the longer term too – what is it you ultimately would like to do? Then I think you will start to get a better idea of what you want from your career and what your longer term options might be.
What do you think the industry should be doing to attract, train, qualify and retain talent?
This is a complex issue as there are local (national) forces at work in an international environment. In terms of attracting new talent, one of the peculiar aspects of clinical research is that it seems to be a ‘hidden industry’. I don’t think many university graduates or school leavers have heard of it as a possible career choice or even what the various job options are. I think the industry needs to get out to universities a lot more, for example to careers fairs. There should be more liaison between the industry and universities in terms of collaborating on designing courses, including apprenticeships, so that people coming out of universities already have some of the requisite skills and knowledge. The industry needs to start training new talent too so that we continue to add to the current pool of what we already have. In terms of retention, like any industry we need excellent empowering leaders, engaging managers (many people leave their manager not their job), and organizations who live their values and have them embedded in everyday work. These are the human factors which is the essential glue that hold organizations together
How well do you think the industry is taking on board the competence philosophy and mentality rather than the old paradigm of length of service?
A bit of a mixed bag really. At IAOCR we hear really positive stories about how some regulatory authority inspectors are asking questions regarding how organizations are verifying how people can do their jobs. Then we see the other end of the spectrum where CROs are still being asked by some of their clients to provide staff with a minimum of x years of experience to work on their studies. I think the word competence is much more widely used in conversations we are having with our clients now than ever before and as an industry we are beginning to realize that it is the only reliable measure of a person’s capabilities not just how long they have been in a job but whether that be doing it well or badly.
What development did you receive in preparation for the transition into a leadership role?
In my past career I have had some management training which has helped in a limited way. Although management and leadership do have some overlap there are some big differences particularly in strategic thinking, financial and commercial awareness, leading change, and inspiring other people. There are plenty of management programs out there and many companies run their own management training. Finding a good leadership program is more of a challenge. Consequently I have done a lot of learning by trial and error which is not an ideal approach. I have also read widely and tried to take on key concepts. A book I found really helpful was Good to Great by Jim Collins. His concept of what great leadership should look like and what it can achieve was very insightful. One of the key aspects I have learned is to look hard at yourself and your own behaviors, particularly in adversity. It’s comparatively straightforward to be a leader when things are going well, but good leadership includes being resilient, dealing with tough challenges and taking responsibility. Other people are looking to you to inspire them when things are not going well and you have to be a good role model to help them through the bad times as well as the good.
What other development do you feel you would have benefited from to ease that transition?
I think learning from leaders or experts from other business sectors would have been very helpful. The clinical research sector tends to be quite insular. We could learn a lot from those industries that have had to adapt to huge upheavals and rapidly change their business models. That’s why I think the program we have developed with the Kellogg School of Management, Northwestern University, is a great opportunity for people coming into a leadership role to acquire the competence they need. It is also ideal for people already in a leadership position who have received little or no formal training.
What is your key piece of advice for anyone transitioning into a leadership role?
Always be prepared to learn and adapt. Never stand still and think you have achieved your ultimate goal. Get good people around you and make sure they have the right expertise and attitude to manage your organization.