A clinical trial run by twenty people, and then by two
Hiring for a structure that does not exist, the CRO that makes the difference, and what a consultant is actually working on
When we set up our pivotal trial at ElmediX, essentially two people were coordinating the clinical side from our end. Two. A CEO friend/colleague of mine runs a cardiovascular trial at a mid-sized pharma company with comparable patient numbers — similar protocol complexity, similar regulatory burden — and he has a dedicated team of twenty-two. Medical monitor, data manager, regulatory specialist, quality lead, site activation team, pharmacovigilance officer. Each owns one lane.
We had two people, who owned all of them.
That contrast is not exceptional in early-stage MedTech. It is the default. And it creates a hiring problem that I have been trying to describe clearly for three years: the people with the experience you need for a clinical operation are, almost without exception, people who learned to work in the twenty-two-person structure. Bringing them into the two-person structure is not a matter of scaling down. It is a different job.
Experience comes with assumptions
The appeal of hiring someone with ten years in clinical operations at a large MedTech or pharma company is obvious. They know the regulatory language, the ICH-GCP requirements, the site visit protocols, the audit trails. They have done this before. You are not teaching from scratch.
What you are also getting, always, is ten years of assumptions about how a clinical operation is organized. Clear lanes. Defined handoffs. A quality team that catches the things the clinical team missed. A regulatory affairs department one floor up. An IT system that someone else configured. A manager to escalate to higher management.
In a startup, none of that infrastructure exists. The person doing the site visit is also the person writing the SOP, also the person who will present to the ethics committee next week, also the person on the phone with the CRO at eight in the morning when something goes wrong. The work does not respect lanes, because there are no lanes.
Someone who has spent a career inside the lane structure is not poorly trained. They are trained for a different environment. The gap is not skill — it is operating assumption. And it shows up within the first three months, when the procedural comfort they expected is not there and they spend energy trying to rebuild the structure they came from, rather than adapting to the one they are in.
The supply problem on the other side
The obvious solution is to hire people who already know how to work in a small operation. And they exist. There are people who ran clinical trials for a four-person startup, who coordinated regulatory submissions without a dedicated RA team, who learned to hold fifteen things at once because there was no one else to hold them. Those people are competent in ways that do not appear on a CV, because the CV lists the job title, not the actual workload.
The problem is that those people do not circulate. If you joined a MedTech startup five years ago, and it worked, and you grew with it, you are probably still there. The startup is now twelve people instead of four, and you are the person the new hires come to when they need to understand how things actually work. You are not on the market.
The people on the market are, statistically, more likely to be coming from the larger structure. Which takes us back to the gap.
What hierarchy does and does not do
I want to be precise about what I am criticizing, because it is not hierarchy itself.
A twenty-person clinical operations team at a large company is well-structured for a reason. Lane specialization produces quality in each lane. Handoff protocols prevent things from falling between people. Escalation paths exist because complex trials generate decisions that cannot sit with one person. That system is not bureaucracy for its own sake. It works, for the scale and context it was built for.
The problem is that it produces people for whom structure is invisible — present the way air is present. When the structure is removed, the disorientation is real. I have watched it happen: someone genuinely excellent in a previous role spent their first six months trying to recreate the approval flows and documentation hierarchies they had left behind, rather than doing the actual work the job required. The instinct was not wrong. It was trained. But it was trained for a different environment.
An excellent CRO is what makes the two-person team work
I have described what the two-person team does not have. I should also describe what makes that team functional anyway, because in practice it is not stubbornness and overtime that carries the trial. The single most important external relationship is the CRO.
A good CRO brings the lane structure that does not exist inside the startup. Their medical monitor, their data manager, their regulatory specialists. The twenty people are there. They sit on the outside. The two-person sponsor team coordinates them but does not have to be them. That is the multiplier.
An excellent CRO does more than execute. They challenge the protocol when something is unclear, surface site-level problems before they become regulatory ones, and translate between the tempo of a small sponsor and the formal world the trial has to live in. At their best they behave as a temporary extension of the sponsor team, taking ownership where they could have hidden behind a statement of work.
A mediocre CRO executes what is written and nothing more. With a two-person sponsor team, that is not enough. The sponsor ends up doing both the sponsor work and the work of supervising the CRO’s lanes, which defeats the purpose of having a CRO. Selecting the right CRO, and maintaining that relationship so they choose to act as a partner rather than a vendor, is one of the most consequential operational decisions a small MedTech CEO makes. I would put it ahead of most internal hires.
Consultants, and the question of whose work they are doing
Consultants sit in a related but separate category. The same hiring gap applies to them, with one added ambiguity. Consultants are paid by you, formally, but the question of whose work they are actually doing is not always cleanly answered.
Some consultants work as if they were on your payroll. They internalize the problem, take on tasks beyond their statement of work, and treat the trial as theirs for the duration of the engagement. When a question comes up at nine at night, they answer it. They do not bill differently for things outside the scope, because in their head the scope is whatever it takes to move the project forward.
Other consultants, in equally good faith, stay mostly inside their own framework. They bring the methodology they have built over a career, their preferred suppliers, and the playbook that has worked for them before, and they apply it to your problem. The work is often competent. The directionality is slightly different: the consultant is on your payroll, but a meaningful part of the work also serves the consultant’s own practice and longer-term agenda.
Both versions are real, and neither is dishonest. The first is what a small operation actually needs for the parts of the work that require ownership. The second is well-suited to a defined slice of work with a clear deliverable. The trouble is that engagements are often described as the first and, in practice, look more like the second. The mismatch is rarely visible in the first conversation. It tends to show up around week six, when the consultant either steps into a gap that is not formally theirs, or politely declines to.
I have learned to ask, in the first conversation, what a consultant does when something falls outside the contract. The answer is usually informative.
Three rules I actually try to follow now
One: be explicit about the structure that does not exist. Not in a discouraging way, but specifically.
Two: look for people who have worked in more than one size of organization, even briefly. A year at a small company during or after a large-company stint is more predictive than most of the rest of the CV. It means they have felt the difference and chosen to continue.
Three: watch the first six weeks. The people who adapt well spend those weeks learning how things actually work here, even when how things work here is imperfect. The people who struggle spend those weeks explaining how things worked somewhere else.
What does not resolve neatly
There is a version of this problem I have not solved. The people best suited to work in a small MedTech startup are often people with limited MedTech experience — smart, adaptable generalists who learn fast and do not carry the wrong assumptions. But regulatory and clinical work in MedTech has a real knowledge base. A fast learner with no GCP background is not ready to run a trial. The domain knowledge is necessary. The domain knowledge comes with assumptions. The assumptions create friction.
I navigate this case by case, and I get it wrong sometimes. I thought it was worth saying out loud. And... Luckily I have found the perfect CRO and the perfect project management consultant ....
Disclosures. I am CEO and shareholder of ElmediX, a Belgian MedTech company developing whole-body hyperthermia for metastatic pancreatic cancer. The examples in this post are drawn from that experience. No employee or colleague is identified individually.