Leadership and management in bioanalysis (7) – Challenges of being a bioanalytical project manager in a CRO

Management in the bioanalysis industry isn’t just about managing the people; equally important is managing the projects. Of course this isn’t just true in bioanalysis, it is true in most industries. This month’s column is a look at some of the unique challenges that project managers (PMs) in bioanalysis face. To get a current perspective on the topic I have collaborated with PMs in my own company to identify the topics that they see as the most interesting and challenging.

I’d like to start by briefly discussing the job description. One of the first things to recognize is that PMs in bioanalytical laboratories have a variety of different titles; PM, bioanalytical principal investigator, study director and principal scientist are a few of the ones I have heard mentioned at different companies. However, the expectations are similar for all. Those expectations are usually pretty high, as set by both the company and clients they work for. There is little room for error allowed on either side of the equation. A mentor of mine once described the the role of a PM to me as being an extension of the client into the laboratory. As a PM, it is my job to ensure that the client’s studies are completed on time, on budget and with the high quality that the sponsor expects, as if the sponsor herself were here to oversee the work every day. At the same time, the laboratory management expects you to serve at least 3–5 clients in the same way every day, balance the priorities and deliver on everything, on time and under budget! It is a difficult job.

While a traditional line manager works with people and other resources under their direct control to get a job done, a bioanalytical PM often has to work by influence. As the interface between the client and the laboratory operations, this can be a tricky assignment. When the client calls wanting to make changes to schedules for analysis, the PM usually needs to contact a laboratory scheduler or operations leader to make that happen. Sometimes it feels a bit like trying to rebook a flight; you know the person behind the computer can do what you want but you need to convince them your situation is important enough for them to make it happen. I’ve found that PMs who work with the team to accomplish their goal are more successful than those who try to force an issue.

Another aspect of the role of a bioanalytical PM is in quality deliverables. In most industries the PM will manage timelines and resources, but in bioanalysis this is not the extent of their responsibilities. While QA groups provide a critical role of quality oversight in regulated bioanalysis, the PM is the true keeper of quality for individual projects. Quality has so many more facets in a regulated industry and the PM is in the center of it. Quality refers to completing the study within the expectations of the client and your company in all of the key deliverables. Regulatory quality is critical above all else but quality of execution in keeping to study timelines and profit are also very important. Quality also means conducting the study as the sponsor wishes. Even with SOPs that follow the guidelines, regulations and industry best practices, PMs must make judgment calls on data that fall outside the scope of the routine analysis. I’ve found that in bioanalysis, as soon as you think you’ve seen it all, you see something new. It is often up to the PM in a study director role to make the decision on compliance with the data they are presented with. Again, that is compliance with regulations, SOPs, and both local management and client’s expectations. It’s a tricky balance. Even the most experienced PM may have to seek counsel from colleagues within the scientific team but, in the end, must fully understand the final decision and the potential impact to the study. Their role will require them to justify the decisions made and action taken ultimately to both internal and external auditors.

The last responsibility of being a bioanalytical PM that I will cover here is their responsibility as the key client contact for project execution. This is not unlike other industries. For most PMs this is one of their favorite parts of the job. I found it to be, and still find it to be, truly one of the pleasures of the job, working with clients across the country and sometimes around the world. However in this paragraph I’m going to touch on the part that isn’t so fun. Bioanalytical PMs also have the responsibility to share the bad news with a sponsor. We do a lot to avoid problems in any project, but it is a reality of life in any profession. There are three things I’ll comment on that can get in the way of executing on the best plans of a PM in a bioanalytical CRO. We should probably only admit to two of them but that wouldn’t be reality. These three elements are science, people and other clients. Bioanalytical laboratories are conducting research. This means that with every study there is an element of the unknown. A method that works for a year sometimes mysteriously doesn’t perform any more. Usually this is traced back to some change but sometimes, the method needs to be adjusted, leading to re-validation and days to a couple of weeks delay. Although in today’s laboratories I like to think delays lasting weeks are quite uncommon. Secondly, even the most automated bioanalytical laboratory processes are still quite labor intensive, so human mistakes happen. A simple but real example is that a fully automated extraction method requires someone to carry a plate to the autosampler and it can get dropped. A perfectly set up LC–MS/MS system can have a fitting slip or a more significant hardware malfunction. It is simply not a completely predictable situation. The third way timelines can slip is by adjusting priorities. Every sponsor wants the CRO they are working with to be busy. That is a sign of a healthy and sustainable business. It is also a bit like picking the busy restaurant to dine at. The busy restaurants are usually the good ones. You might have to wait a bit longer but ultimately the total experience is better. What this means to the client is that at times they are competing with other companies and the PM has to work within their own clients and their colleagues’ clients to meet everyone’s expectations. If one client comes up with a critical project, you may need to work with another sponsor to agree to a delay in what was previously committed, or you might have to convince the operations management to schedule some overtime to get more projects done.

PMs have a difficult job. They have to please everyone and no one gives them much room for failure. In my experience they are often the first to arrive at work are the last to leave and when I get a work email at 10 PM, it’s usually from one of the PMs. It truly has to be a labor of love for those that make a career of it.