5 Lessons You Only Learn Working at a Start-Up- Clinical Operations edition

If you’ve spent any time in clinical research- and if you're here, it's pretty likely you have- you know that working at a large, well-established sponsor (or CRO) can feel structured and predictable. I am not one to yuck anyone's yum- I know there is a time and a place for that structure in every career. However, when you join a start-up medical device company, the rules change fast. No matter what your title actually is, clinical operations in a start-up environment isn’t just about running trials—it’s about building the department while starting the study. Here are five things you truly learn in the trenches at a start-up medical device company.

1. You Are the Process (Until One Exists)

At a start-up, you’ll quickly realize that SOPs, templates, and workflows might still be in draft form—or not exist at all. Unlike big companies where every step is outlined, start-ups require you to create the roadmap. You may be drafting trial documents, SOPs, and risk assessments from scratch. It's also likely you’ll be asked to wear multiple hats- Clinical Trial Manager? Sure. Contract negotiator? Why not. Regulatory liaison? You got it. All of these tasks need to be done, and in a small group, you'll learn by doing.

Lesson: Flexibility and initiative are your most valuable tools. You don't just follow processes—you help build them.

2. Cross-Functional Collaboration Isn’t Optional

At a small company you work elbow-to-elbow with the engineering, regulatory, quality, marketing, and leadership teams. Clinical operations specifically is interwoven into every strategic decision. You'll be exposed to conversations that would never include clinical team members in a larger organization, from early product design reviews to investor updates.

Lesson: Understanding the bigger picture—and being able to communicate the clinical voice —is CRITICAL. Your input impacts the direction of the company, not just the trial.

3. Speed is Everything—But So Is Quality

Start-ups live and die by milestones- you will know pressure intimately. First-in-human enrollment, FDA submission, CE mark readiness—each deadline will directly affect the ability to fundraise. It is likely that every company goal will be based on clinical (especially enrollment and report) milestones. You’ll learn how to calculate timelines and what areas you can push forward, but you’ll also learn how to do it without compromising data integrity or patient safety. That balance becomes second nature because it is NECESSARY.

Lesson: You develop an instinct for prioritizing what really matters and how to make decisions under pressure without compromising subject safety.

4. You Become Incredibly Resourceful

At start-ups, budgets are lean- you’ll need to figure out how to achieve results without the luxury of large teams or full-service CROs. You will build your own trial trackers, negotiate your own site contracts, and troubleshoot data issues solo. You will likely become VERY good with Excel.

Lesson: Resourcefulness isn’t just valued—it’s necessary. You will learn to do more with less and still deliver high-quality outcomes.

5. You’re Closer to the Impact

At a start-up you're not just a cog in the machine—you’re part of the engine. Whether it’s getting the first subject enrolled or closing out a pivotal study, the results are visible and celebrated. There’s a deep sense of ownership and pride that comes from knowing your contribution helped get an innovative device one step closer to patients.

Lesson: The wins feel personal, and the challenges make you better.

Final Thought: Working in clinical operations at a start-up medical device company is not for the faint of heart—but in my experience it’s been incredibly rewarding. If you want to be challenged, make real impact, and never have the same day twice, the start-up world might be exactly where you belong.